Dermatology News

Another use for the intense pulsed-light device, pulsed-dye laser, and potassium titanyl phosphate laser in clinical practice is for treating patients who have dry eye, even if you are not an ophthalmologist, suggests R. Rox Anderson, MD.

“I’ve been doing this in my practice for a number of years and it’s quite gratifying,” Dr. Anderson, a dermatologist who directs the Wellman Center for Photomedicine at Massachusetts General Hospital, Boston, said during a virtual course on laser and aesthetic skin therapy. “You treat the periorbital skin, mostly under the eye, just as if you were treating telangiectasia rosacea. The meibomian glands under the upper eyelid that cause this disease are sebaceous glands, and most of the people with dry eye have rosacea.”

In a retrospective noncomparative, interventional case series, 78 patients with severe dry eye syndrome were treated with intense pulsed-light therapy and gland expression at a single outpatient clinic over 30 months. Physician-judged improvement in dry eye tear breakup time was found for 87% of patients with an average of seven treatment visits and four maintenance visits, while 93% of patients reported posttreatment satisfaction with the degree of dry eye syndrome symptoms. More information about the approach were published in Investigative Ophthalmology & Visual Science and Current Opinion in Ophthalmology.

“What’s gratifying here is that most patients will get about 2 months of relief after a single treatment,” Dr. Anderson said. “They are very happy – some of the happiest patients in my practice. Many ophthalmologists don’t have the technology, so I think you can do this depending on your local referral system.”

Light-based approaches are also making promising inroads in cancer treatment. A recent study led by Martin Purschke, PhD, at the Wellman Center evaluated the use of a novel radio-phototherapy approach for killing cancer cells. The center of solid tissue tumors that are treated with radiotherapy is hypoxic, Dr. Anderson explained, “and oxygen is typically located around the perimeter of the tumor. After a radiation therapy treatment, you kill only the outer portion of it, and then the remaining cells grow back, and you end up with the same tumor. This is why you have to do radiation therapy over and over again. In contrast, if you add scintillating nanoparticles, which are particles with a very high C number atoms in them that pick up the x-ray photon and then emit many UV photons from one x-ray photon, they are very efficient at converting x-ray energy to UV energy.” The x-ray, he added, “generates UV light, and the UV light kills the tumor. We’re hoping that we can make a dent in radiotherapy this way.”

Dr. Anderson predicted that fiber lasers, which are highly advanced for industrial applications, will play an increasing role in dermatology and in other areas of medicine. “There are not a new kid on the block anymore but fiber lasers are relatively new to medicine,” he said during the meeting, which was sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. “We are seeing incredible capabilities with fiber lasers: essentially any wavelength, any power, any pulse duration you want. The lasers are efficient, small, rugged, and their lifetime exceeds your lifetime. They are likely to displace many of our old lasers in dermatology. I don’t know when, but I know it will happen.”

He reported having received research funding and/or consulting fees from numerous device and pharmaceutical companies.

[email protected]

Another use for the intense pulsed-light device, pulsed-dye laser, and potassium titanyl phosphate laser in clinical practice is for treating patients who have dry eye, even if you are not an ophthalmologist, suggests R. Rox Anderson, MD.

“I’ve been doing this in my practice for a number of years and it’s quite gratifying,” Dr. Anderson, a dermatologist who directs the Wellman Center for Photomedicine at Massachusetts General Hospital, Boston, said during a virtual course on laser and aesthetic skin therapy. “You treat the periorbital skin, mostly under the eye, just as if you were treating telangiectasia rosacea. The meibomian glands under the upper eyelid that cause this disease are sebaceous glands, and most of the people with dry eye have rosacea.”

In a retrospective noncomparative, interventional case series, 78 patients with severe dry eye syndrome were treated with intense pulsed-light therapy and gland expression at a single outpatient clinic over 30 months. Physician-judged improvement in dry eye tear breakup time was found for 87% of patients with an average of seven treatment visits and four maintenance visits, while 93% of patients reported posttreatment satisfaction with the degree of dry eye syndrome symptoms. More information about the approach were published in Investigative Ophthalmology & Visual Science and Current Opinion in Ophthalmology.

“What’s gratifying here is that most patients will get about 2 months of relief after a single treatment,” Dr. Anderson said. “They are very happy – some of the happiest patients in my practice. Many ophthalmologists don’t have the technology, so I think you can do this depending on your local referral system.”

Light-based approaches are also making promising inroads in cancer treatment. A recent study led by Martin Purschke, PhD, at the Wellman Center evaluated the use of a novel radio-phototherapy approach for killing cancer cells. The center of solid tissue tumors that are treated with radiotherapy is hypoxic, Dr. Anderson explained, “and oxygen is typically located around the perimeter of the tumor. After a radiation therapy treatment, you kill only the outer portion of it, and then the remaining cells grow back, and you end up with the same tumor. This is why you have to do radiation therapy over and over again. In contrast, if you add scintillating nanoparticles, which are particles with a very high C number atoms in them that pick up the x-ray photon and then emit many UV photons from one x-ray photon, they are very efficient at converting x-ray energy to UV energy.” The x-ray, he added, “generates UV light, and the UV light kills the tumor. We’re hoping that we can make a dent in radiotherapy this way.”

Dr. Anderson predicted that fiber lasers, which are highly advanced for industrial applications, will play an increasing role in dermatology and in other areas of medicine. “There are not a new kid on the block anymore but fiber lasers are relatively new to medicine,” he said during the meeting, which was sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. “We are seeing incredible capabilities with fiber lasers: essentially any wavelength, any power, any pulse duration you want. The lasers are efficient, small, rugged, and their lifetime exceeds your lifetime. They are likely to displace many of our old lasers in dermatology. I don’t know when, but I know it will happen.”

He reported having received research funding and/or consulting fees from numerous device and pharmaceutical companies.

[email protected]

Another use for the intense pulsed-light device, pulsed-dye laser, and potassium titanyl phosphate laser in clinical practice is for treating patients who have dry eye, even if you are not an ophthalmologist, suggests R. Rox Anderson, MD.

“I’ve been doing this in my practice for a number of years and it’s quite gratifying,” Dr. Anderson, a dermatologist who directs the Wellman Center for Photomedicine at Massachusetts General Hospital, Boston, said during a virtual course on laser and aesthetic skin therapy. “You treat the periorbital skin, mostly under the eye, just as if you were treating telangiectasia rosacea. The meibomian glands under the upper eyelid that cause this disease are sebaceous glands, and most of the people with dry eye have rosacea.”

In a retrospective noncomparative, interventional case series, 78 patients with severe dry eye syndrome were treated with intense pulsed-light therapy and gland expression at a single outpatient clinic over 30 months. Physician-judged improvement in dry eye tear breakup time was found for 87% of patients with an average of seven treatment visits and four maintenance visits, while 93% of patients reported posttreatment satisfaction with the degree of dry eye syndrome symptoms. More information about the approach were published in Investigative Ophthalmology & Visual Science and Current Opinion in Ophthalmology.

“What’s gratifying here is that most patients will get about 2 months of relief after a single treatment,” Dr. Anderson said. “They are very happy – some of the happiest patients in my practice. Many ophthalmologists don’t have the technology, so I think you can do this depending on your local referral system.”

Light-based approaches are also making promising inroads in cancer treatment. A recent study led by Martin Purschke, PhD, at the Wellman Center evaluated the use of a novel radio-phototherapy approach for killing cancer cells. The center of solid tissue tumors that are treated with radiotherapy is hypoxic, Dr. Anderson explained, “and oxygen is typically located around the perimeter of the tumor. After a radiation therapy treatment, you kill only the outer portion of it, and then the remaining cells grow back, and you end up with the same tumor. This is why you have to do radiation therapy over and over again. In contrast, if you add scintillating nanoparticles, which are particles with a very high C number atoms in them that pick up the x-ray photon and then emit many UV photons from one x-ray photon, they are very efficient at converting x-ray energy to UV energy.” The x-ray, he added, “generates UV light, and the UV light kills the tumor. We’re hoping that we can make a dent in radiotherapy this way.”

Dr. Anderson predicted that fiber lasers, which are highly advanced for industrial applications, will play an increasing role in dermatology and in other areas of medicine. “There are not a new kid on the block anymore but fiber lasers are relatively new to medicine,” he said during the meeting, which was sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. “We are seeing incredible capabilities with fiber lasers: essentially any wavelength, any power, any pulse duration you want. The lasers are efficient, small, rugged, and their lifetime exceeds your lifetime. They are likely to displace many of our old lasers in dermatology. I don’t know when, but I know it will happen.”

He reported having received research funding and/or consulting fees from numerous device and pharmaceutical companies.

[email protected]

On Monday, members of an influential federal panel delved into the challenges ahead in deciding who will get the first doses of COVID-19 vaccines, including questions about which healthcare workers need those initial vaccinations the most.

The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) did not take any votes or seek to establish formal positions. Instead, the meeting served as a forum for experts to discuss the thorny issues ahead. The US Food and Drug Administration (FDA) could make a decision next month regarding clearance for the first COVID-19 vaccine.

An FDA advisory committee will meet December 10 to review the request for emergency use authorization (EUA) of a COVID-19 vaccine from Pfizer, in partnership with BioNTech. Moderna Inc said on November 16 that it expects to soon ask the FDA for an EUA of its rival COVID vaccine.

ACIP will face a two-part task after the FDA clears COVID-19 vaccines, said Nancy Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases. ACIP will need to first decide whether to recommend use of the vaccine and then address the “complicated and difficult” question of which groups should get the initial limited quantities.

“There aren’t any perfect decisions,” she told the ACIP members. “I know this is something that most of you didn’t anticipate doing, making these kinds of huge decisions in the midst of a pandemic.”

There has been considerable public discussion of prioritization of COVID-19 vaccines, including a set of recommendations offered by a special committee created by the National Academies of Sciences, Engineering and Medicine. In addition, CDC staff and members of ACIP outlined what they termed the “four ethical principles” meant to guide these decisions in a November 23 report in the agency’s Morbidity and Mortality Weekly Report. These four principles are to maximize benefits and minimize harms; promote justice; mitigate health inequities; and promote transparency.

But as the issuing of the first EUA nears, it falls to ACIP to move beyond endorsing broad goals. The panel will need to make decisions as to which groups will have to wait for COVID-19 vaccines.

ACIP members on Monday delved into these kinds of more detailed questions, using a proposed three-stage model as a discussion point.

In phase 1a of this model, healthcare workers and residents of long-term care facilities would be the first people to be vaccinated. Phase 1b would include those deemed essential workers, including police officers, firefighters, and those in education, transportation, food, and agriculture sectors. Phase 1c would include adults with high-risk medical conditions and those aged 65 years and older.

ACIP member Grace M. Lee, MD, MPH, of Stanford University, Stanford, California, questioned whether healthcare workers who are not seeing patients in person should wait to get the vaccines. There has been a marked rise in the use of telehealth during the pandemic, which has spared some clinicians from in-person COVID-19 patient visits in their practices.

“Close partnership with our public health colleagues will be critically important to make sure that we are not trying to vaccinate 100% of our healthcare workforce, if some proportion of our workforce can work from home,” Lee said.

ACIP member Pablo Sánchez, MD, of the Research Institute at Nationwide Children’s Hospital in Columbus, Ohio, concurred. Some clinicians, he noted, may have better access to personal protective equipment than others, he said.

“Unfortunately, not all healthcare workers are equal in terms of risk,” Sánchez said. “Within institutions, we’re going to have to prioritize which ones will get” the vaccine.

Clinicians may also make judgments about their own risk and need for early access to COVID-19 vaccinations, Sánchez said.

“I’m 66, and I’d rather give it to somebody much older and sicker than me,” he said.
 

Broader access

Fairly large populations will essentially be competing for limited doses of the first vaccines to reach the market.

The overlap is significant in the four priority groups put forward by CDC. The CDC staff estimated that about 21 million people would fall into the healthcare personnel category, which includes hospital staff, pharmacists, and those working in long-term care facilities. There are about 87 million people in the essential workers groups. More than 100 million adults in the United States, such as those with diabetes and cancers, fall into the high-risk medical conditions group. Another 53 million people are aged 65 and older.

Department of Health and Human Services Secretary Alex Azar on November 18 said the federal government expects to have about 40 million doses of these two vaccines by the end of December, which is enough to provide the two-dose regimen for about 20 million. If all goes as expected, Pfizer and Moderna will ramp up production.

Moderna has said that it expects by the end of this year to have approximately 20 million doses of its vaccine ready to ship in the United States and that it is on track to manufacture 500 million to 1 billion doses globally in 2021. Pfizer and BioNTech have said they expect to produce globally up to 50 million doses in 2020 and up to 1.3 billion doses by the end of 2021.

At the Monday meeting, several ACIP panelists stressed the need to ensure that essential workers get early doses of vaccines.

In many cases, these workers serve in jobs with significant public interaction and live in poor communities. They put themselves and their families at risk. Many of them lack the resources to take precautions available to those better able to isolate, said ACIP member Beth Bell, MD, MPH, of the University of Washington, Seattle, Washington.

“These essential workers are out there putting themselves at risk to allow the rest of us to socially distance,” she said. “Recognizing that not all of them may want to be vaccinated at this stage, we need to provide them with the opportunity early on in the process.”

In Bell’s view, the initial rollout of COVID-19 vaccines will send an important message about sharing this resource.

“If we’re serious about valuing equity, we need to have that baked in early on in the vaccination program,” she said.

Bell also said she was in favor of including people living in nursing homes in the initial wave of vaccinations. Concerns were raised about the frailty of this population.

“Given the mortality impact on the healthcare system from the number of nursing home residents that have been dying, I think on balance it makes sense to include them in phase 1a,” Bell said.

Other ACIP panelists said missteps with early vaccination of people in nursing homes could undermine faith in the treatments. Because of the ages and medical conditions of people in nursing homes, many of them may die after receiving the COVID-19 vaccine. Such deaths would not be associated with vaccine, but the medical community would not yet have evidence to disprove a connection.

There could be a backlash, with people falsely linking the death of a grandparent to the vaccine.

Fellow ACIP member Robert L. Atmar, MD, Baylor College of Medicine, Houston, Texas, was among those who had raised concerns about including people living in long-term care facilities in phase 1a. He said there are not yet enough data to judge the balance of benefits and harms of vaccination for this population.

The Pfizer and Moderna vaccines are “reactagenic,” meaning people may not feel well in the days after receiving the shots. The symptoms could lead to additional health evaluations of older people in nursing homes as clinicians try to figure out whether the patient’s reactions to the vaccine are caused by some condition or infection, Atmar said.

“Those of us who see these patients in the hospital recognize that there are often medical interventions that are done in the pursuit of a diagnosis, of a change in clinical status, that in and of themselves can lead to harm,” Atmar said.

Clinicians likely will have to encourage their patients of all ages to receive second doses of COVID-19 vaccines, despite the malaise they may provoke.

“We really need to make patients aware that this is not going to be a walk in the park. I mean, they’re going to know they had a vaccine, they’re probably not going to feel wonderful, but they’ve got to come back for that second dose,” said Sandra Adamson Fryhofer, MD, who represented the American Medical Association.

ACIP is expected to meet again to offer specific recommendations on the Pfizer and Moderna vaccines. ACIP’s recommendations trigger reimbursement processes, Azar said at a Tuesday press conference. ACIP’s work will inform decisions made by the federal government and governors about deploying shipments of COVID-19 vaccines, he said.

“At the end of the day, that is a decision, though, of the US government to make, which is where to recommend the prioritization,” Azar said. “It will be our nation’s governors in implementing the distribution plans to tell us” where to ship the vaccine.

This article first appeared on Medscape.com.

On Monday, members of an influential federal panel delved into the challenges ahead in deciding who will get the first doses of COVID-19 vaccines, including questions about which healthcare workers need those initial vaccinations the most.

The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) did not take any votes or seek to establish formal positions. Instead, the meeting served as a forum for experts to discuss the thorny issues ahead. The US Food and Drug Administration (FDA) could make a decision next month regarding clearance for the first COVID-19 vaccine.

An FDA advisory committee will meet December 10 to review the request for emergency use authorization (EUA) of a COVID-19 vaccine from Pfizer, in partnership with BioNTech. Moderna Inc said on November 16 that it expects to soon ask the FDA for an EUA of its rival COVID vaccine.

ACIP will face a two-part task after the FDA clears COVID-19 vaccines, said Nancy Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases. ACIP will need to first decide whether to recommend use of the vaccine and then address the “complicated and difficult” question of which groups should get the initial limited quantities.

“There aren’t any perfect decisions,” she told the ACIP members. “I know this is something that most of you didn’t anticipate doing, making these kinds of huge decisions in the midst of a pandemic.”

There has been considerable public discussion of prioritization of COVID-19 vaccines, including a set of recommendations offered by a special committee created by the National Academies of Sciences, Engineering and Medicine. In addition, CDC staff and members of ACIP outlined what they termed the “four ethical principles” meant to guide these decisions in a November 23 report in the agency’s Morbidity and Mortality Weekly Report. These four principles are to maximize benefits and minimize harms; promote justice; mitigate health inequities; and promote transparency.

But as the issuing of the first EUA nears, it falls to ACIP to move beyond endorsing broad goals. The panel will need to make decisions as to which groups will have to wait for COVID-19 vaccines.

ACIP members on Monday delved into these kinds of more detailed questions, using a proposed three-stage model as a discussion point.

In phase 1a of this model, healthcare workers and residents of long-term care facilities would be the first people to be vaccinated. Phase 1b would include those deemed essential workers, including police officers, firefighters, and those in education, transportation, food, and agriculture sectors. Phase 1c would include adults with high-risk medical conditions and those aged 65 years and older.

ACIP member Grace M. Lee, MD, MPH, of Stanford University, Stanford, California, questioned whether healthcare workers who are not seeing patients in person should wait to get the vaccines. There has been a marked rise in the use of telehealth during the pandemic, which has spared some clinicians from in-person COVID-19 patient visits in their practices.

“Close partnership with our public health colleagues will be critically important to make sure that we are not trying to vaccinate 100% of our healthcare workforce, if some proportion of our workforce can work from home,” Lee said.

ACIP member Pablo Sánchez, MD, of the Research Institute at Nationwide Children’s Hospital in Columbus, Ohio, concurred. Some clinicians, he noted, may have better access to personal protective equipment than others, he said.

“Unfortunately, not all healthcare workers are equal in terms of risk,” Sánchez said. “Within institutions, we’re going to have to prioritize which ones will get” the vaccine.

Clinicians may also make judgments about their own risk and need for early access to COVID-19 vaccinations, Sánchez said.

“I’m 66, and I’d rather give it to somebody much older and sicker than me,” he said.
 

Broader access

Fairly large populations will essentially be competing for limited doses of the first vaccines to reach the market.

The overlap is significant in the four priority groups put forward by CDC. The CDC staff estimated that about 21 million people would fall into the healthcare personnel category, which includes hospital staff, pharmacists, and those working in long-term care facilities. There are about 87 million people in the essential workers groups. More than 100 million adults in the United States, such as those with diabetes and cancers, fall into the high-risk medical conditions group. Another 53 million people are aged 65 and older.

Department of Health and Human Services Secretary Alex Azar on November 18 said the federal government expects to have about 40 million doses of these two vaccines by the end of December, which is enough to provide the two-dose regimen for about 20 million. If all goes as expected, Pfizer and Moderna will ramp up production.

Moderna has said that it expects by the end of this year to have approximately 20 million doses of its vaccine ready to ship in the United States and that it is on track to manufacture 500 million to 1 billion doses globally in 2021. Pfizer and BioNTech have said they expect to produce globally up to 50 million doses in 2020 and up to 1.3 billion doses by the end of 2021.

At the Monday meeting, several ACIP panelists stressed the need to ensure that essential workers get early doses of vaccines.

In many cases, these workers serve in jobs with significant public interaction and live in poor communities. They put themselves and their families at risk. Many of them lack the resources to take precautions available to those better able to isolate, said ACIP member Beth Bell, MD, MPH, of the University of Washington, Seattle, Washington.

“These essential workers are out there putting themselves at risk to allow the rest of us to socially distance,” she said. “Recognizing that not all of them may want to be vaccinated at this stage, we need to provide them with the opportunity early on in the process.”

In Bell’s view, the initial rollout of COVID-19 vaccines will send an important message about sharing this resource.

“If we’re serious about valuing equity, we need to have that baked in early on in the vaccination program,” she said.

Bell also said she was in favor of including people living in nursing homes in the initial wave of vaccinations. Concerns were raised about the frailty of this population.

“Given the mortality impact on the healthcare system from the number of nursing home residents that have been dying, I think on balance it makes sense to include them in phase 1a,” Bell said.

Other ACIP panelists said missteps with early vaccination of people in nursing homes could undermine faith in the treatments. Because of the ages and medical conditions of people in nursing homes, many of them may die after receiving the COVID-19 vaccine. Such deaths would not be associated with vaccine, but the medical community would not yet have evidence to disprove a connection.

There could be a backlash, with people falsely linking the death of a grandparent to the vaccine.

Fellow ACIP member Robert L. Atmar, MD, Baylor College of Medicine, Houston, Texas, was among those who had raised concerns about including people living in long-term care facilities in phase 1a. He said there are not yet enough data to judge the balance of benefits and harms of vaccination for this population.

The Pfizer and Moderna vaccines are “reactagenic,” meaning people may not feel well in the days after receiving the shots. The symptoms could lead to additional health evaluations of older people in nursing homes as clinicians try to figure out whether the patient’s reactions to the vaccine are caused by some condition or infection, Atmar said.

“Those of us who see these patients in the hospital recognize that there are often medical interventions that are done in the pursuit of a diagnosis, of a change in clinical status, that in and of themselves can lead to harm,” Atmar said.

Clinicians likely will have to encourage their patients of all ages to receive second doses of COVID-19 vaccines, despite the malaise they may provoke.

“We really need to make patients aware that this is not going to be a walk in the park. I mean, they’re going to know they had a vaccine, they’re probably not going to feel wonderful, but they’ve got to come back for that second dose,” said Sandra Adamson Fryhofer, MD, who represented the American Medical Association.

ACIP is expected to meet again to offer specific recommendations on the Pfizer and Moderna vaccines. ACIP’s recommendations trigger reimbursement processes, Azar said at a Tuesday press conference. ACIP’s work will inform decisions made by the federal government and governors about deploying shipments of COVID-19 vaccines, he said.

“At the end of the day, that is a decision, though, of the US government to make, which is where to recommend the prioritization,” Azar said. “It will be our nation’s governors in implementing the distribution plans to tell us” where to ship the vaccine.

This article first appeared on Medscape.com.

On Monday, members of an influential federal panel delved into the challenges ahead in deciding who will get the first doses of COVID-19 vaccines, including questions about which healthcare workers need those initial vaccinations the most.

The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) did not take any votes or seek to establish formal positions. Instead, the meeting served as a forum for experts to discuss the thorny issues ahead. The US Food and Drug Administration (FDA) could make a decision next month regarding clearance for the first COVID-19 vaccine.

An FDA advisory committee will meet December 10 to review the request for emergency use authorization (EUA) of a COVID-19 vaccine from Pfizer, in partnership with BioNTech. Moderna Inc said on November 16 that it expects to soon ask the FDA for an EUA of its rival COVID vaccine.

ACIP will face a two-part task after the FDA clears COVID-19 vaccines, said Nancy Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases. ACIP will need to first decide whether to recommend use of the vaccine and then address the “complicated and difficult” question of which groups should get the initial limited quantities.

“There aren’t any perfect decisions,” she told the ACIP members. “I know this is something that most of you didn’t anticipate doing, making these kinds of huge decisions in the midst of a pandemic.”

There has been considerable public discussion of prioritization of COVID-19 vaccines, including a set of recommendations offered by a special committee created by the National Academies of Sciences, Engineering and Medicine. In addition, CDC staff and members of ACIP outlined what they termed the “four ethical principles” meant to guide these decisions in a November 23 report in the agency’s Morbidity and Mortality Weekly Report. These four principles are to maximize benefits and minimize harms; promote justice; mitigate health inequities; and promote transparency.

But as the issuing of the first EUA nears, it falls to ACIP to move beyond endorsing broad goals. The panel will need to make decisions as to which groups will have to wait for COVID-19 vaccines.

ACIP members on Monday delved into these kinds of more detailed questions, using a proposed three-stage model as a discussion point.

In phase 1a of this model, healthcare workers and residents of long-term care facilities would be the first people to be vaccinated. Phase 1b would include those deemed essential workers, including police officers, firefighters, and those in education, transportation, food, and agriculture sectors. Phase 1c would include adults with high-risk medical conditions and those aged 65 years and older.

ACIP member Grace M. Lee, MD, MPH, of Stanford University, Stanford, California, questioned whether healthcare workers who are not seeing patients in person should wait to get the vaccines. There has been a marked rise in the use of telehealth during the pandemic, which has spared some clinicians from in-person COVID-19 patient visits in their practices.

“Close partnership with our public health colleagues will be critically important to make sure that we are not trying to vaccinate 100% of our healthcare workforce, if some proportion of our workforce can work from home,” Lee said.

ACIP member Pablo Sánchez, MD, of the Research Institute at Nationwide Children’s Hospital in Columbus, Ohio, concurred. Some clinicians, he noted, may have better access to personal protective equipment than others, he said.

“Unfortunately, not all healthcare workers are equal in terms of risk,” Sánchez said. “Within institutions, we’re going to have to prioritize which ones will get” the vaccine.

Clinicians may also make judgments about their own risk and need for early access to COVID-19 vaccinations, Sánchez said.

“I’m 66, and I’d rather give it to somebody much older and sicker than me,” he said.
 

Broader access

Fairly large populations will essentially be competing for limited doses of the first vaccines to reach the market.

The overlap is significant in the four priority groups put forward by CDC. The CDC staff estimated that about 21 million people would fall into the healthcare personnel category, which includes hospital staff, pharmacists, and those working in long-term care facilities. There are about 87 million people in the essential workers groups. More than 100 million adults in the United States, such as those with diabetes and cancers, fall into the high-risk medical conditions group. Another 53 million people are aged 65 and older.

Department of Health and Human Services Secretary Alex Azar on November 18 said the federal government expects to have about 40 million doses of these two vaccines by the end of December, which is enough to provide the two-dose regimen for about 20 million. If all goes as expected, Pfizer and Moderna will ramp up production.

Moderna has said that it expects by the end of this year to have approximately 20 million doses of its vaccine ready to ship in the United States and that it is on track to manufacture 500 million to 1 billion doses globally in 2021. Pfizer and BioNTech have said they expect to produce globally up to 50 million doses in 2020 and up to 1.3 billion doses by the end of 2021.

At the Monday meeting, several ACIP panelists stressed the need to ensure that essential workers get early doses of vaccines.

In many cases, these workers serve in jobs with significant public interaction and live in poor communities. They put themselves and their families at risk. Many of them lack the resources to take precautions available to those better able to isolate, said ACIP member Beth Bell, MD, MPH, of the University of Washington, Seattle, Washington.

“These essential workers are out there putting themselves at risk to allow the rest of us to socially distance,” she said. “Recognizing that not all of them may want to be vaccinated at this stage, we need to provide them with the opportunity early on in the process.”

In Bell’s view, the initial rollout of COVID-19 vaccines will send an important message about sharing this resource.

“If we’re serious about valuing equity, we need to have that baked in early on in the vaccination program,” she said.

Bell also said she was in favor of including people living in nursing homes in the initial wave of vaccinations. Concerns were raised about the frailty of this population.

“Given the mortality impact on the healthcare system from the number of nursing home residents that have been dying, I think on balance it makes sense to include them in phase 1a,” Bell said.

Other ACIP panelists said missteps with early vaccination of people in nursing homes could undermine faith in the treatments. Because of the ages and medical conditions of people in nursing homes, many of them may die after receiving the COVID-19 vaccine. Such deaths would not be associated with vaccine, but the medical community would not yet have evidence to disprove a connection.

There could be a backlash, with people falsely linking the death of a grandparent to the vaccine.

Fellow ACIP member Robert L. Atmar, MD, Baylor College of Medicine, Houston, Texas, was among those who had raised concerns about including people living in long-term care facilities in phase 1a. He said there are not yet enough data to judge the balance of benefits and harms of vaccination for this population.

The Pfizer and Moderna vaccines are “reactagenic,” meaning people may not feel well in the days after receiving the shots. The symptoms could lead to additional health evaluations of older people in nursing homes as clinicians try to figure out whether the patient’s reactions to the vaccine are caused by some condition or infection, Atmar said.

“Those of us who see these patients in the hospital recognize that there are often medical interventions that are done in the pursuit of a diagnosis, of a change in clinical status, that in and of themselves can lead to harm,” Atmar said.

Clinicians likely will have to encourage their patients of all ages to receive second doses of COVID-19 vaccines, despite the malaise they may provoke.

“We really need to make patients aware that this is not going to be a walk in the park. I mean, they’re going to know they had a vaccine, they’re probably not going to feel wonderful, but they’ve got to come back for that second dose,” said Sandra Adamson Fryhofer, MD, who represented the American Medical Association.

ACIP is expected to meet again to offer specific recommendations on the Pfizer and Moderna vaccines. ACIP’s recommendations trigger reimbursement processes, Azar said at a Tuesday press conference. ACIP’s work will inform decisions made by the federal government and governors about deploying shipments of COVID-19 vaccines, he said.

“At the end of the day, that is a decision, though, of the US government to make, which is where to recommend the prioritization,” Azar said. “It will be our nation’s governors in implementing the distribution plans to tell us” where to ship the vaccine.

This article first appeared on Medscape.com.

A limited number of high-quality studies demonstrate the efficacy of microneedling, but it’s a good alternative to lasers, especially for darker skin types, according to Catherine M. DiGiorgio, MD, MS.

During a virtual course on laser and aesthetic skin therapy, Dr. DiGiorgio, a laser and cosmetic dermatologist at the Boston Center for Facial Rejuvenation, provided a state-of-the-art update on microneedling, a procedure in which microneedles are rolled over the skin to create epidermal and dermal microwounds.

“The depths are adjustable and it’s purely mechanical: no energy is being delivered with these treatments,” she said. “The hypothesized mechanism of action is that microneedling creates microwounds which initiate wound healing to stimulate new collagen production. This breaks apart compact collagen in the superficial dermis while stimulating new collagen and elastin,” she explained, adding that it is also hypothesized that this “stimulates growth factors that directly impact collagen and elastin synthesis.”

Conditions that have been reported to be treatable with microneedling in the medical literature include scars – especially acne scars – as well as rhytides, skin laxity, striae, melasma, and enlarged pores. Microneedling can also be used for transdermal drug delivery, although it’s far inferior to microinjection of medications. Contraindications are similar to those with laser surgery, including active infection of the area, history of keloids, inflammatory acne, and immunosuppression; and it should not be performed on the same day as neuromodulator treatment, to avoid diffusion of the neuromodulator. Herpes simplex virus prophylaxis is also indicated prior to microneedling treatment.

Many devices are available for use, including fixed, manual needle rollers and electric-powered pens with single-use sterile cartridges. The devices vary by needle length, quantity, diameter, configuration, and material of which the microneedles are made of. The needle length is not reliable for penetration depth, especially when greater than 1 mm. Treatment guidelines vary based on the area being treated.

“You put tension on the skin and apply the device perpendicularly,” Dr. DiGiorgio said during the meeting, which was sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. “It should be performed in quadrants, and I prefer to treat in cosmetic units. The endpoint is pinpoint bleeding versus deep purpura. Ice water–soaked sterile gauze can be applied after treatment and skin care can be resumed in 5-7 days.”

In an effort to compare the efficacy and safety of the 2940-nm Er:YAG laser and microneedling for the treatment of atrophic acne scars, researchers in Egypt performed a randomized, split-face study in 30 patients. Study participants were evaluated by two blinded physicians at baseline and at 3 months follow-up. Both modalities showed a significant improvement in acne scars, but those treated with the Er:YAG laser showed a statistically significant greater improvement (70% vs. 30%, respectively; P < .001). Histology revealed a significantly higher increase in the mean quantity of collagen fibers in the Er:YAG-treated patients, compared with those who underwent microneedling, but patients in the microneedling group experienced less erythema and edema. Pain scores were significantly higher in the microneedling group compared with the Er:YAG group.

In a more recent study, researchers performed a systematic review of 37 articles in the medical literature related to microneedling. They found that the procedure provides good results when used on its own, and is preferred by patients because of its minimal downtime and side effects. However, they concluded that, while microneedling is a safe and effective option, methodological shortcomings and further research is required to establish it as an evidence-based therapeutic option.

“There are a limited number of high-quality studies demonstrating the efficacy of microneedling,” Dr. DiGiorgio said. “It is a safe procedure, which could complement laser treatments, so you could perform it between expensive and high-downtime lasers. It is an option for patients who seek measurable results with little to no downtime, and it’s also an option for clinicians who do not use laser-resurfacing devices. Basically, further research is needed to establish microneedling as an evidence-based therapeutic option. Laser continues to remain the gold standard for treatment.”

Another treatment option is fractional microneedling with radiofrequency (RF). These are microneedles which deliver energy in the form of RF at the tip of the needle, which denatures collagen and creates thermal coagulative injury zones at temperatures greater than 65° C. The microneedles can be insulated or noninsulated. “Insulated tips are safer for darker skin types because the epidermis is protected from the heat damage,” Dr. DiGiorgio said.

These treatments are used for the improvement of rhytides and scars and for skin tightening. “The treatments are painful and require topical anesthesia,” she said. “Erythema can range from about 24 hours to 4 days depending on the device being used. Usually monthly treatments are recommended.”

A study by investigators in South Korea and China set out to analyze histometric changes of this approach in pigs. They treated the pigs with a fractional microneedle delivery system at various depths, conduction times, and energies, and performed punch biopsies immediately after treatment, 4 days post treatment, and at 2 weeks post treatment. They noted that depth and conduction time affected the height, width, and volume of the columns of coagulation, but that the energy only affected the level of tissue destruction. “They also noted that RF-induced coagulated columns had a mixed cellular infiltrate, neovascularization, granular tissue formation with fibroblasts, and neocollagenesis and elastogenesis in the dermis,” Dr. DiGiorgio said.

In another study, researchers in Thailand performed a study in two women who were going to undergo abdominoplasty. Participants received six treatments prior to abdominoplasty with biopsies at different time intervals following microneedling with radiofrequency. The researchers tested five energy levels and five test areas; no collagen denaturization was observed with microneedling alone.

“This supports the idea that heat is required to stimulate neocollagenesis, and needles alone do not denature collagen,” Dr. DiGiorgio said. “They also found that neocollagenesis and neoelastogenesis occurred at optimal heating levels.”

In a separate study, researchers from Denmark used a number of different imaging modalities to evaluate the impact of microneedle fractional RF-induced micropores. When they used reflectance confocal microscopy, they observed that the micropores showed a concentric shape. “They contained hyper-reflective granules, and the coagulated tissue was seen from the epidermis to the dermal-epidermal junction,” Dr. DiGiorgio said. “This was not seen in the low energy microneedle RF. On optical coherence tomography, they noted that high-energy needle RF showed deeper, more easily identifiable micropores versus low-energy microneedle RF.” On histology the researchers noted that tissue coagulation reached a depth of 1,500 mcm with high-energy microneedle RF, but low-energy microneedle RF only showed visible damage to the epidermis. “This also supports the idea that microneedles alone without energy do not reach the deeper layers of the dermis,” she said.

Dr. DiGiorgio concluded her presentation by discussing promising results from a split-face study of fractional microneedling RF for the treatment of rosacea. For the 12-week randomized study, researchers from South Korea performed two sessions 4 weeks apart, with no treatment to the control side. Erythema decreased 13.6% and results were maintained for about 2 months after treatment. The researchers also measured inflammatory markers and noticed decreased dermal inflammation and mast cell counts and decreased markers related to angiogenesis, inflammation, innate immunity, and neuronal cation channels. “This could be a promising treatment for inflammatory rosacea in the future,” Dr. DiGiorgio said.

She disclosed that she is a consultant for Allergan Aesthetics.

[email protected]

A limited number of high-quality studies demonstrate the efficacy of microneedling, but it’s a good alternative to lasers, especially for darker skin types, according to Catherine M. DiGiorgio, MD, MS.

During a virtual course on laser and aesthetic skin therapy, Dr. DiGiorgio, a laser and cosmetic dermatologist at the Boston Center for Facial Rejuvenation, provided a state-of-the-art update on microneedling, a procedure in which microneedles are rolled over the skin to create epidermal and dermal microwounds.

“The depths are adjustable and it’s purely mechanical: no energy is being delivered with these treatments,” she said. “The hypothesized mechanism of action is that microneedling creates microwounds which initiate wound healing to stimulate new collagen production. This breaks apart compact collagen in the superficial dermis while stimulating new collagen and elastin,” she explained, adding that it is also hypothesized that this “stimulates growth factors that directly impact collagen and elastin synthesis.”

Conditions that have been reported to be treatable with microneedling in the medical literature include scars – especially acne scars – as well as rhytides, skin laxity, striae, melasma, and enlarged pores. Microneedling can also be used for transdermal drug delivery, although it’s far inferior to microinjection of medications. Contraindications are similar to those with laser surgery, including active infection of the area, history of keloids, inflammatory acne, and immunosuppression; and it should not be performed on the same day as neuromodulator treatment, to avoid diffusion of the neuromodulator. Herpes simplex virus prophylaxis is also indicated prior to microneedling treatment.

Many devices are available for use, including fixed, manual needle rollers and electric-powered pens with single-use sterile cartridges. The devices vary by needle length, quantity, diameter, configuration, and material of which the microneedles are made of. The needle length is not reliable for penetration depth, especially when greater than 1 mm. Treatment guidelines vary based on the area being treated.

“You put tension on the skin and apply the device perpendicularly,” Dr. DiGiorgio said during the meeting, which was sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. “It should be performed in quadrants, and I prefer to treat in cosmetic units. The endpoint is pinpoint bleeding versus deep purpura. Ice water–soaked sterile gauze can be applied after treatment and skin care can be resumed in 5-7 days.”

In an effort to compare the efficacy and safety of the 2940-nm Er:YAG laser and microneedling for the treatment of atrophic acne scars, researchers in Egypt performed a randomized, split-face study in 30 patients. Study participants were evaluated by two blinded physicians at baseline and at 3 months follow-up. Both modalities showed a significant improvement in acne scars, but those treated with the Er:YAG laser showed a statistically significant greater improvement (70% vs. 30%, respectively; P < .001). Histology revealed a significantly higher increase in the mean quantity of collagen fibers in the Er:YAG-treated patients, compared with those who underwent microneedling, but patients in the microneedling group experienced less erythema and edema. Pain scores were significantly higher in the microneedling group compared with the Er:YAG group.

In a more recent study, researchers performed a systematic review of 37 articles in the medical literature related to microneedling. They found that the procedure provides good results when used on its own, and is preferred by patients because of its minimal downtime and side effects. However, they concluded that, while microneedling is a safe and effective option, methodological shortcomings and further research is required to establish it as an evidence-based therapeutic option.

“There are a limited number of high-quality studies demonstrating the efficacy of microneedling,” Dr. DiGiorgio said. “It is a safe procedure, which could complement laser treatments, so you could perform it between expensive and high-downtime lasers. It is an option for patients who seek measurable results with little to no downtime, and it’s also an option for clinicians who do not use laser-resurfacing devices. Basically, further research is needed to establish microneedling as an evidence-based therapeutic option. Laser continues to remain the gold standard for treatment.”

Another treatment option is fractional microneedling with radiofrequency (RF). These are microneedles which deliver energy in the form of RF at the tip of the needle, which denatures collagen and creates thermal coagulative injury zones at temperatures greater than 65° C. The microneedles can be insulated or noninsulated. “Insulated tips are safer for darker skin types because the epidermis is protected from the heat damage,” Dr. DiGiorgio said.

These treatments are used for the improvement of rhytides and scars and for skin tightening. “The treatments are painful and require topical anesthesia,” she said. “Erythema can range from about 24 hours to 4 days depending on the device being used. Usually monthly treatments are recommended.”

A study by investigators in South Korea and China set out to analyze histometric changes of this approach in pigs. They treated the pigs with a fractional microneedle delivery system at various depths, conduction times, and energies, and performed punch biopsies immediately after treatment, 4 days post treatment, and at 2 weeks post treatment. They noted that depth and conduction time affected the height, width, and volume of the columns of coagulation, but that the energy only affected the level of tissue destruction. “They also noted that RF-induced coagulated columns had a mixed cellular infiltrate, neovascularization, granular tissue formation with fibroblasts, and neocollagenesis and elastogenesis in the dermis,” Dr. DiGiorgio said.

In another study, researchers in Thailand performed a study in two women who were going to undergo abdominoplasty. Participants received six treatments prior to abdominoplasty with biopsies at different time intervals following microneedling with radiofrequency. The researchers tested five energy levels and five test areas; no collagen denaturization was observed with microneedling alone.

“This supports the idea that heat is required to stimulate neocollagenesis, and needles alone do not denature collagen,” Dr. DiGiorgio said. “They also found that neocollagenesis and neoelastogenesis occurred at optimal heating levels.”

In a separate study, researchers from Denmark used a number of different imaging modalities to evaluate the impact of microneedle fractional RF-induced micropores. When they used reflectance confocal microscopy, they observed that the micropores showed a concentric shape. “They contained hyper-reflective granules, and the coagulated tissue was seen from the epidermis to the dermal-epidermal junction,” Dr. DiGiorgio said. “This was not seen in the low energy microneedle RF. On optical coherence tomography, they noted that high-energy needle RF showed deeper, more easily identifiable micropores versus low-energy microneedle RF.” On histology the researchers noted that tissue coagulation reached a depth of 1,500 mcm with high-energy microneedle RF, but low-energy microneedle RF only showed visible damage to the epidermis. “This also supports the idea that microneedles alone without energy do not reach the deeper layers of the dermis,” she said.

Dr. DiGiorgio concluded her presentation by discussing promising results from a split-face study of fractional microneedling RF for the treatment of rosacea. For the 12-week randomized study, researchers from South Korea performed two sessions 4 weeks apart, with no treatment to the control side. Erythema decreased 13.6% and results were maintained for about 2 months after treatment. The researchers also measured inflammatory markers and noticed decreased dermal inflammation and mast cell counts and decreased markers related to angiogenesis, inflammation, innate immunity, and neuronal cation channels. “This could be a promising treatment for inflammatory rosacea in the future,” Dr. DiGiorgio said.

She disclosed that she is a consultant for Allergan Aesthetics.

[email protected]

A limited number of high-quality studies demonstrate the efficacy of microneedling, but it’s a good alternative to lasers, especially for darker skin types, according to Catherine M. DiGiorgio, MD, MS.

During a virtual course on laser and aesthetic skin therapy, Dr. DiGiorgio, a laser and cosmetic dermatologist at the Boston Center for Facial Rejuvenation, provided a state-of-the-art update on microneedling, a procedure in which microneedles are rolled over the skin to create epidermal and dermal microwounds.

“The depths are adjustable and it’s purely mechanical: no energy is being delivered with these treatments,” she said. “The hypothesized mechanism of action is that microneedling creates microwounds which initiate wound healing to stimulate new collagen production. This breaks apart compact collagen in the superficial dermis while stimulating new collagen and elastin,” she explained, adding that it is also hypothesized that this “stimulates growth factors that directly impact collagen and elastin synthesis.”

Conditions that have been reported to be treatable with microneedling in the medical literature include scars – especially acne scars – as well as rhytides, skin laxity, striae, melasma, and enlarged pores. Microneedling can also be used for transdermal drug delivery, although it’s far inferior to microinjection of medications. Contraindications are similar to those with laser surgery, including active infection of the area, history of keloids, inflammatory acne, and immunosuppression; and it should not be performed on the same day as neuromodulator treatment, to avoid diffusion of the neuromodulator. Herpes simplex virus prophylaxis is also indicated prior to microneedling treatment.

Many devices are available for use, including fixed, manual needle rollers and electric-powered pens with single-use sterile cartridges. The devices vary by needle length, quantity, diameter, configuration, and material of which the microneedles are made of. The needle length is not reliable for penetration depth, especially when greater than 1 mm. Treatment guidelines vary based on the area being treated.

“You put tension on the skin and apply the device perpendicularly,” Dr. DiGiorgio said during the meeting, which was sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. “It should be performed in quadrants, and I prefer to treat in cosmetic units. The endpoint is pinpoint bleeding versus deep purpura. Ice water–soaked sterile gauze can be applied after treatment and skin care can be resumed in 5-7 days.”

In an effort to compare the efficacy and safety of the 2940-nm Er:YAG laser and microneedling for the treatment of atrophic acne scars, researchers in Egypt performed a randomized, split-face study in 30 patients. Study participants were evaluated by two blinded physicians at baseline and at 3 months follow-up. Both modalities showed a significant improvement in acne scars, but those treated with the Er:YAG laser showed a statistically significant greater improvement (70% vs. 30%, respectively; P < .001). Histology revealed a significantly higher increase in the mean quantity of collagen fibers in the Er:YAG-treated patients, compared with those who underwent microneedling, but patients in the microneedling group experienced less erythema and edema. Pain scores were significantly higher in the microneedling group compared with the Er:YAG group.

In a more recent study, researchers performed a systematic review of 37 articles in the medical literature related to microneedling. They found that the procedure provides good results when used on its own, and is preferred by patients because of its minimal downtime and side effects. However, they concluded that, while microneedling is a safe and effective option, methodological shortcomings and further research is required to establish it as an evidence-based therapeutic option.

“There are a limited number of high-quality studies demonstrating the efficacy of microneedling,” Dr. DiGiorgio said. “It is a safe procedure, which could complement laser treatments, so you could perform it between expensive and high-downtime lasers. It is an option for patients who seek measurable results with little to no downtime, and it’s also an option for clinicians who do not use laser-resurfacing devices. Basically, further research is needed to establish microneedling as an evidence-based therapeutic option. Laser continues to remain the gold standard for treatment.”

Another treatment option is fractional microneedling with radiofrequency (RF). These are microneedles which deliver energy in the form of RF at the tip of the needle, which denatures collagen and creates thermal coagulative injury zones at temperatures greater than 65° C. The microneedles can be insulated or noninsulated. “Insulated tips are safer for darker skin types because the epidermis is protected from the heat damage,” Dr. DiGiorgio said.

These treatments are used for the improvement of rhytides and scars and for skin tightening. “The treatments are painful and require topical anesthesia,” she said. “Erythema can range from about 24 hours to 4 days depending on the device being used. Usually monthly treatments are recommended.”

A study by investigators in South Korea and China set out to analyze histometric changes of this approach in pigs. They treated the pigs with a fractional microneedle delivery system at various depths, conduction times, and energies, and performed punch biopsies immediately after treatment, 4 days post treatment, and at 2 weeks post treatment. They noted that depth and conduction time affected the height, width, and volume of the columns of coagulation, but that the energy only affected the level of tissue destruction. “They also noted that RF-induced coagulated columns had a mixed cellular infiltrate, neovascularization, granular tissue formation with fibroblasts, and neocollagenesis and elastogenesis in the dermis,” Dr. DiGiorgio said.

In another study, researchers in Thailand performed a study in two women who were going to undergo abdominoplasty. Participants received six treatments prior to abdominoplasty with biopsies at different time intervals following microneedling with radiofrequency. The researchers tested five energy levels and five test areas; no collagen denaturization was observed with microneedling alone.

“This supports the idea that heat is required to stimulate neocollagenesis, and needles alone do not denature collagen,” Dr. DiGiorgio said. “They also found that neocollagenesis and neoelastogenesis occurred at optimal heating levels.”

In a separate study, researchers from Denmark used a number of different imaging modalities to evaluate the impact of microneedle fractional RF-induced micropores. When they used reflectance confocal microscopy, they observed that the micropores showed a concentric shape. “They contained hyper-reflective granules, and the coagulated tissue was seen from the epidermis to the dermal-epidermal junction,” Dr. DiGiorgio said. “This was not seen in the low energy microneedle RF. On optical coherence tomography, they noted that high-energy needle RF showed deeper, more easily identifiable micropores versus low-energy microneedle RF.” On histology the researchers noted that tissue coagulation reached a depth of 1,500 mcm with high-energy microneedle RF, but low-energy microneedle RF only showed visible damage to the epidermis. “This also supports the idea that microneedles alone without energy do not reach the deeper layers of the dermis,” she said.

Dr. DiGiorgio concluded her presentation by discussing promising results from a split-face study of fractional microneedling RF for the treatment of rosacea. For the 12-week randomized study, researchers from South Korea performed two sessions 4 weeks apart, with no treatment to the control side. Erythema decreased 13.6% and results were maintained for about 2 months after treatment. The researchers also measured inflammatory markers and noticed decreased dermal inflammation and mast cell counts and decreased markers related to angiogenesis, inflammation, innate immunity, and neuronal cation channels. “This could be a promising treatment for inflammatory rosacea in the future,” Dr. DiGiorgio said.

She disclosed that she is a consultant for Allergan Aesthetics.

[email protected]

A neoadjuvant strategy combining two immunostimulatory agents with differing mechanisms of action is efficacious and safe in patients with high-risk, resectable melanoma, according to final results of the phase 2 Neo-C-Nivo trial.

The two agents are the PD-1 inhibitor nivolumab and CMP-001, an investigational Toll-like receptor 9 agonist that activates tumor-associated plasmacytoid dendritic cells.

CMP-001 and nivolumab produced a major pathologic response in 60% of patients, and these patients had a 1-year relapse-free survival rate of 89%. About 23% of patients had grade 3 treatment-related adverse events, and there were no grade 4-5 treatment-related events.

These data were reported at the Society for Immunotherapy of Cancer’s 35th Anniversary Annual Meeting.

“Stage III melanoma is a very, very high risk disease. Despite appropriate management, which involves surgical resection followed by adjuvant immunotherapy, a large number of patients still relapse,” noted study author Diwakar Davar, MD, of the University of Pittsburgh Hillman Cancer Center.

“Neoadjuvant immunotherapy in this setting enhances the systemic T-cell response to tumor antigens,” he explained. “As a result, there is greater detection and killing of micrometastatic disease. And, indeed, neoadjuvant immunotherapy with anti–[programmed death–1] monotherapy or with anti-PD1 and anti-CTLA4 combination therapy produces high response rates, although the combination therapy is associated with significant toxicity.”
 

Patients, treatment, and response

The Neo-C-Nivo trial enrolled 31 patients with resectable stage IIIB/C/D melanoma having clinically apparent lymph node disease.

The patients were treated with three cycles of nivolumab given every 2 weeks. They also received seven weekly injections of CMP-001 subcutaneously and then intratumorally. After surgical resection, the patients received more of the same immunotherapy.

At a median follow-up of 15 months, 60% of patients had a major pathologic response, 50% had a complete response, and 10% had a major response. Some 70% of patients (after additionally including partial responders) had any pathologic response.

“More than half of the patients that we treated had more than one injectable lesion,” Dr. Davar noted. “I want to emphasize that only one lesion was injected, so the results we got illustrate that the rest of the patients who had more than one injectable lesion had regression in their injected and uninjected lesions.”

Biomarker analyses showed that response was associated with evidence of immune activation, both in the tumor and in the blood. With immunotherapy, the density of CD8 tumor-infiltrating lymphocytes increased by a median of 10.3-fold in pathologic responders as compared with only 0.8-fold in nonresponders (P < .05). In addition, responders had evidence of activated CD8-positive T cells peripherally, as well as presence of plasmacytoid dendritic cells within the tumor microenvironment.
 

Survival and safety

Patients had better median relapse-free survival if they attained a major pathologic response (not reached in either group, P = .0106) or any pathologic response (not reached vs. 5 months, P = .0001).

The landmark 1-year relapse-free survival rate was 89% for major pathologic responders and 90% for all pathologic responders.

Overall, 22.6% of patients experienced grade 3 treatment-related adverse events, the majority of which did not require medical intervention and none of which delayed planned surgery. There were no grade 4-5 treatment-related adverse events.

Cytokine release syndrome was uncommon, seen in 16.1% of patients, possibly because the cohort received prophylaxis, Dr. Davar proposed.
 

Another treatment option?

“Intratumoral CMP-001 increases clinical efficacy of PD-1 blockade with minimal additional toxicity in patients with regionally advanced melanoma. Further study of this combination in high-risk resectable melanoma is planned,” Dr. Davar concluded.

“This combination achieved high response rates and certainly should be considered for a larger trial,” agreed session cochair Brian Gastman, MD, of the Cleveland (Ohio) Clinic.

However, long-term outcomes are pending, and it is not clear how efficacy of the studied combination will ultimately stack up against that of other treatment options, Dr. Gastman cautioned in an interview. “For example, it’s hard to tell if this will lead to better results versus, say, T-VEC [talimogene laherparepvec] with an anti-PD-1 agent,” he elaborated.

Nonetheless, “the implication of these findings is that there is another potential injectable option that can be combined with checkpoint inhibitors, and it may be useful for patients with refractory disease,” Dr. Gastman concluded.

The trial was funded by Checkmate Pharmaceuticals. Dr. Davar disclosed relationships with Checkmate Pharmaceuticals, Array Biopharma, Merck, Shionogi, Vedanta, Bristol-Myers Squibb, CellSight Technologies, GlaxoSmithKline/Tesaro, and Medpacto. Dr. Gastman disclosed no relevant conflicts of interest.

SOURCE: Davar D et al. SITC 2020, Abstract 303.

A neoadjuvant strategy combining two immunostimulatory agents with differing mechanisms of action is efficacious and safe in patients with high-risk, resectable melanoma, according to final results of the phase 2 Neo-C-Nivo trial.

The two agents are the PD-1 inhibitor nivolumab and CMP-001, an investigational Toll-like receptor 9 agonist that activates tumor-associated plasmacytoid dendritic cells.

CMP-001 and nivolumab produced a major pathologic response in 60% of patients, and these patients had a 1-year relapse-free survival rate of 89%. About 23% of patients had grade 3 treatment-related adverse events, and there were no grade 4-5 treatment-related events.

These data were reported at the Society for Immunotherapy of Cancer’s 35th Anniversary Annual Meeting.

“Stage III melanoma is a very, very high risk disease. Despite appropriate management, which involves surgical resection followed by adjuvant immunotherapy, a large number of patients still relapse,” noted study author Diwakar Davar, MD, of the University of Pittsburgh Hillman Cancer Center.

“Neoadjuvant immunotherapy in this setting enhances the systemic T-cell response to tumor antigens,” he explained. “As a result, there is greater detection and killing of micrometastatic disease. And, indeed, neoadjuvant immunotherapy with anti–[programmed death–1] monotherapy or with anti-PD1 and anti-CTLA4 combination therapy produces high response rates, although the combination therapy is associated with significant toxicity.”
 

Patients, treatment, and response

The Neo-C-Nivo trial enrolled 31 patients with resectable stage IIIB/C/D melanoma having clinically apparent lymph node disease.

The patients were treated with three cycles of nivolumab given every 2 weeks. They also received seven weekly injections of CMP-001 subcutaneously and then intratumorally. After surgical resection, the patients received more of the same immunotherapy.

At a median follow-up of 15 months, 60% of patients had a major pathologic response, 50% had a complete response, and 10% had a major response. Some 70% of patients (after additionally including partial responders) had any pathologic response.

“More than half of the patients that we treated had more than one injectable lesion,” Dr. Davar noted. “I want to emphasize that only one lesion was injected, so the results we got illustrate that the rest of the patients who had more than one injectable lesion had regression in their injected and uninjected lesions.”

Biomarker analyses showed that response was associated with evidence of immune activation, both in the tumor and in the blood. With immunotherapy, the density of CD8 tumor-infiltrating lymphocytes increased by a median of 10.3-fold in pathologic responders as compared with only 0.8-fold in nonresponders (P < .05). In addition, responders had evidence of activated CD8-positive T cells peripherally, as well as presence of plasmacytoid dendritic cells within the tumor microenvironment.
 

Survival and safety

Patients had better median relapse-free survival if they attained a major pathologic response (not reached in either group, P = .0106) or any pathologic response (not reached vs. 5 months, P = .0001).

The landmark 1-year relapse-free survival rate was 89% for major pathologic responders and 90% for all pathologic responders.

Overall, 22.6% of patients experienced grade 3 treatment-related adverse events, the majority of which did not require medical intervention and none of which delayed planned surgery. There were no grade 4-5 treatment-related adverse events.

Cytokine release syndrome was uncommon, seen in 16.1% of patients, possibly because the cohort received prophylaxis, Dr. Davar proposed.
 

Another treatment option?

“Intratumoral CMP-001 increases clinical efficacy of PD-1 blockade with minimal additional toxicity in patients with regionally advanced melanoma. Further study of this combination in high-risk resectable melanoma is planned,” Dr. Davar concluded.

“This combination achieved high response rates and certainly should be considered for a larger trial,” agreed session cochair Brian Gastman, MD, of the Cleveland (Ohio) Clinic.

However, long-term outcomes are pending, and it is not clear how efficacy of the studied combination will ultimately stack up against that of other treatment options, Dr. Gastman cautioned in an interview. “For example, it’s hard to tell if this will lead to better results versus, say, T-VEC [talimogene laherparepvec] with an anti-PD-1 agent,” he elaborated.

Nonetheless, “the implication of these findings is that there is another potential injectable option that can be combined with checkpoint inhibitors, and it may be useful for patients with refractory disease,” Dr. Gastman concluded.

The trial was funded by Checkmate Pharmaceuticals. Dr. Davar disclosed relationships with Checkmate Pharmaceuticals, Array Biopharma, Merck, Shionogi, Vedanta, Bristol-Myers Squibb, CellSight Technologies, GlaxoSmithKline/Tesaro, and Medpacto. Dr. Gastman disclosed no relevant conflicts of interest.

SOURCE: Davar D et al. SITC 2020, Abstract 303.

A neoadjuvant strategy combining two immunostimulatory agents with differing mechanisms of action is efficacious and safe in patients with high-risk, resectable melanoma, according to final results of the phase 2 Neo-C-Nivo trial.

The two agents are the PD-1 inhibitor nivolumab and CMP-001, an investigational Toll-like receptor 9 agonist that activates tumor-associated plasmacytoid dendritic cells.

CMP-001 and nivolumab produced a major pathologic response in 60% of patients, and these patients had a 1-year relapse-free survival rate of 89%. About 23% of patients had grade 3 treatment-related adverse events, and there were no grade 4-5 treatment-related events.

These data were reported at the Society for Immunotherapy of Cancer’s 35th Anniversary Annual Meeting.

“Stage III melanoma is a very, very high risk disease. Despite appropriate management, which involves surgical resection followed by adjuvant immunotherapy, a large number of patients still relapse,” noted study author Diwakar Davar, MD, of the University of Pittsburgh Hillman Cancer Center.

“Neoadjuvant immunotherapy in this setting enhances the systemic T-cell response to tumor antigens,” he explained. “As a result, there is greater detection and killing of micrometastatic disease. And, indeed, neoadjuvant immunotherapy with anti–[programmed death–1] monotherapy or with anti-PD1 and anti-CTLA4 combination therapy produces high response rates, although the combination therapy is associated with significant toxicity.”
 

Patients, treatment, and response

The Neo-C-Nivo trial enrolled 31 patients with resectable stage IIIB/C/D melanoma having clinically apparent lymph node disease.

The patients were treated with three cycles of nivolumab given every 2 weeks. They also received seven weekly injections of CMP-001 subcutaneously and then intratumorally. After surgical resection, the patients received more of the same immunotherapy.

At a median follow-up of 15 months, 60% of patients had a major pathologic response, 50% had a complete response, and 10% had a major response. Some 70% of patients (after additionally including partial responders) had any pathologic response.

“More than half of the patients that we treated had more than one injectable lesion,” Dr. Davar noted. “I want to emphasize that only one lesion was injected, so the results we got illustrate that the rest of the patients who had more than one injectable lesion had regression in their injected and uninjected lesions.”

Biomarker analyses showed that response was associated with evidence of immune activation, both in the tumor and in the blood. With immunotherapy, the density of CD8 tumor-infiltrating lymphocytes increased by a median of 10.3-fold in pathologic responders as compared with only 0.8-fold in nonresponders (P < .05). In addition, responders had evidence of activated CD8-positive T cells peripherally, as well as presence of plasmacytoid dendritic cells within the tumor microenvironment.
 

Survival and safety

Patients had better median relapse-free survival if they attained a major pathologic response (not reached in either group, P = .0106) or any pathologic response (not reached vs. 5 months, P = .0001).

The landmark 1-year relapse-free survival rate was 89% for major pathologic responders and 90% for all pathologic responders.

Overall, 22.6% of patients experienced grade 3 treatment-related adverse events, the majority of which did not require medical intervention and none of which delayed planned surgery. There were no grade 4-5 treatment-related adverse events.

Cytokine release syndrome was uncommon, seen in 16.1% of patients, possibly because the cohort received prophylaxis, Dr. Davar proposed.
 

Another treatment option?

“Intratumoral CMP-001 increases clinical efficacy of PD-1 blockade with minimal additional toxicity in patients with regionally advanced melanoma. Further study of this combination in high-risk resectable melanoma is planned,” Dr. Davar concluded.

“This combination achieved high response rates and certainly should be considered for a larger trial,” agreed session cochair Brian Gastman, MD, of the Cleveland (Ohio) Clinic.

However, long-term outcomes are pending, and it is not clear how efficacy of the studied combination will ultimately stack up against that of other treatment options, Dr. Gastman cautioned in an interview. “For example, it’s hard to tell if this will lead to better results versus, say, T-VEC [talimogene laherparepvec] with an anti-PD-1 agent,” he elaborated.

Nonetheless, “the implication of these findings is that there is another potential injectable option that can be combined with checkpoint inhibitors, and it may be useful for patients with refractory disease,” Dr. Gastman concluded.

The trial was funded by Checkmate Pharmaceuticals. Dr. Davar disclosed relationships with Checkmate Pharmaceuticals, Array Biopharma, Merck, Shionogi, Vedanta, Bristol-Myers Squibb, CellSight Technologies, GlaxoSmithKline/Tesaro, and Medpacto. Dr. Gastman disclosed no relevant conflicts of interest.

SOURCE: Davar D et al. SITC 2020, Abstract 303.

In a single-center retrospective analysis of 102 patients with psoriasis induced by tumor necrosis factor (TNF) inhibitors, most cases improved or resolved with use of topical medications or with discontinuation of the inciting TNF inhibitor, with or without other interventions. All patients were treated and diagnosed by dermatologists.

While TNF inhibitors have revolutionized management of numerous debilitating chronic inflammatory diseases, they are associated with mild and potentially serious adverse reactions, including de novo psoriasiform eruptions, noted Sean E. Mazloom, MD, and colleagues, at the Cleveland Clinic, Cleveland, Ohio, in the Journal of the American Academy of Dermatology. Despite the fact that it has been more than 15 years since the first reports of TNF inhibitor-induced psoriasis, optimal treatment strategies still remain poorly understood.
 

IBD and RA most common

Dr. Mazloom and colleagues identified 102 patients (median onset, 41 years; 72.5% female) with TNF inhibitor-induced psoriasis seen at a single tertiary care institution (the Cleveland Clinic) over a 10-year period. The authors proposed a treatment algorithm based on their findings.

Inciting TNF inhibitors were prescribed most commonly for inflammatory bowel disease (IBD) (52%) and rheumatoid arthritis (RA) (24.5%). The most common inciting TNF inhibitor was infliximab (52%). TNF inhibitor-induced psoriasis improved or resolved with topical medications alone in 63.5% of patients, and cyclosporine and methotrexate (10 mg weekly) were often effective (cyclosporine in five of five patients; methotrexate in 7 of 13) if topicals failed.

Noting that the success with topicals in this cohort exceeded that of earlier reports, the authors suggested that more accurate diagnoses and optimal strategies attributable to the involvement of dermatologists may be explanatory.

In 67% of refractory cases, discontinuation of the inciting TNF inhibitor with or without other interventions improved or resolved TNF inhibitor-induced psoriasis. With switching of TNF inhibitors, persistence or worsening of TNF inhibitor-induced psoriasis was reported in 16 of 25 patients (64%).

Algorithm aims at balancing control

The treatment algorithm proposed by Dr. Mazloom and colleagues aims at balancing control of the primary disease with minimization of skin symptom discomfort and continuation of the inciting TNF inhibitor if possible. Only with cyclosporine or methotrexate failure amid severe symptoms and less-than-optimal primary disease control should TNF inhibitors be discontinued and biologics and/or small-molecule inhibitors with alternative mechanisms of action be introduced. Transitioning to other TNF inhibitors may be tried before alternative strategies when the underlying disease is well-controlled but TNF inhibitor-induced psoriasis remains severe.

“Most dermatologists who see TNF-induced psoriasis often are likely already using strategies like the one proposed in the algorithm,” commented senior author Anthony Fernandez, MD, PhD, of the Cleveland (Ohio) Clinic, in an interview. “The concern is over those who may not see TNF inhibitor-induced psoriasis very often, and who may, as a knee-jerk response to TNF-induced psoriasis, stop the inciting medication. When strong side effects occur in IBD and RA, it’s critical to know how well the TNF inhibitor is controlling the underlying disease because lack of control can lead to permanent damage.”

Risk to benefit ratio favors retaining TNF inhibitors

The dermatologist’s goal, if the TNF inhibitor is working well, should be to exhaust all reasonable options to control the psoriasiform eruption and keep the patient on the TNF inhibitor rather than turn to potentially less effective alternatives, Dr. Fernandez added. “The risk:benefit ratio still usually favors adding more immune therapies to treat these reactions in order to enable patients to stay” on their TNF inhibitors.

Study authors disclosed no direct funding for the study. Dr Fernandez, the senior author, receives research funding from Pfizer, Mallinckrodt, and Novartis, consults for AbbVie and Celgene, and is a speaker for AbbVie and Mallinckrodt.

SOURCE: Mazloom SE et al. J Am Acad Dermatol. 2020 Dec;83(6):1590-8.

In a single-center retrospective analysis of 102 patients with psoriasis induced by tumor necrosis factor (TNF) inhibitors, most cases improved or resolved with use of topical medications or with discontinuation of the inciting TNF inhibitor, with or without other interventions. All patients were treated and diagnosed by dermatologists.

While TNF inhibitors have revolutionized management of numerous debilitating chronic inflammatory diseases, they are associated with mild and potentially serious adverse reactions, including de novo psoriasiform eruptions, noted Sean E. Mazloom, MD, and colleagues, at the Cleveland Clinic, Cleveland, Ohio, in the Journal of the American Academy of Dermatology. Despite the fact that it has been more than 15 years since the first reports of TNF inhibitor-induced psoriasis, optimal treatment strategies still remain poorly understood.
 

IBD and RA most common

Dr. Mazloom and colleagues identified 102 patients (median onset, 41 years; 72.5% female) with TNF inhibitor-induced psoriasis seen at a single tertiary care institution (the Cleveland Clinic) over a 10-year period. The authors proposed a treatment algorithm based on their findings.

Inciting TNF inhibitors were prescribed most commonly for inflammatory bowel disease (IBD) (52%) and rheumatoid arthritis (RA) (24.5%). The most common inciting TNF inhibitor was infliximab (52%). TNF inhibitor-induced psoriasis improved or resolved with topical medications alone in 63.5% of patients, and cyclosporine and methotrexate (10 mg weekly) were often effective (cyclosporine in five of five patients; methotrexate in 7 of 13) if topicals failed.

Noting that the success with topicals in this cohort exceeded that of earlier reports, the authors suggested that more accurate diagnoses and optimal strategies attributable to the involvement of dermatologists may be explanatory.

In 67% of refractory cases, discontinuation of the inciting TNF inhibitor with or without other interventions improved or resolved TNF inhibitor-induced psoriasis. With switching of TNF inhibitors, persistence or worsening of TNF inhibitor-induced psoriasis was reported in 16 of 25 patients (64%).

Algorithm aims at balancing control

The treatment algorithm proposed by Dr. Mazloom and colleagues aims at balancing control of the primary disease with minimization of skin symptom discomfort and continuation of the inciting TNF inhibitor if possible. Only with cyclosporine or methotrexate failure amid severe symptoms and less-than-optimal primary disease control should TNF inhibitors be discontinued and biologics and/or small-molecule inhibitors with alternative mechanisms of action be introduced. Transitioning to other TNF inhibitors may be tried before alternative strategies when the underlying disease is well-controlled but TNF inhibitor-induced psoriasis remains severe.

“Most dermatologists who see TNF-induced psoriasis often are likely already using strategies like the one proposed in the algorithm,” commented senior author Anthony Fernandez, MD, PhD, of the Cleveland (Ohio) Clinic, in an interview. “The concern is over those who may not see TNF inhibitor-induced psoriasis very often, and who may, as a knee-jerk response to TNF-induced psoriasis, stop the inciting medication. When strong side effects occur in IBD and RA, it’s critical to know how well the TNF inhibitor is controlling the underlying disease because lack of control can lead to permanent damage.”

Risk to benefit ratio favors retaining TNF inhibitors

The dermatologist’s goal, if the TNF inhibitor is working well, should be to exhaust all reasonable options to control the psoriasiform eruption and keep the patient on the TNF inhibitor rather than turn to potentially less effective alternatives, Dr. Fernandez added. “The risk:benefit ratio still usually favors adding more immune therapies to treat these reactions in order to enable patients to stay” on their TNF inhibitors.

Study authors disclosed no direct funding for the study. Dr Fernandez, the senior author, receives research funding from Pfizer, Mallinckrodt, and Novartis, consults for AbbVie and Celgene, and is a speaker for AbbVie and Mallinckrodt.

SOURCE: Mazloom SE et al. J Am Acad Dermatol. 2020 Dec;83(6):1590-8.

In a single-center retrospective analysis of 102 patients with psoriasis induced by tumor necrosis factor (TNF) inhibitors, most cases improved or resolved with use of topical medications or with discontinuation of the inciting TNF inhibitor, with or without other interventions. All patients were treated and diagnosed by dermatologists.

While TNF inhibitors have revolutionized management of numerous debilitating chronic inflammatory diseases, they are associated with mild and potentially serious adverse reactions, including de novo psoriasiform eruptions, noted Sean E. Mazloom, MD, and colleagues, at the Cleveland Clinic, Cleveland, Ohio, in the Journal of the American Academy of Dermatology. Despite the fact that it has been more than 15 years since the first reports of TNF inhibitor-induced psoriasis, optimal treatment strategies still remain poorly understood.
 

IBD and RA most common

Dr. Mazloom and colleagues identified 102 patients (median onset, 41 years; 72.5% female) with TNF inhibitor-induced psoriasis seen at a single tertiary care institution (the Cleveland Clinic) over a 10-year period. The authors proposed a treatment algorithm based on their findings.

Inciting TNF inhibitors were prescribed most commonly for inflammatory bowel disease (IBD) (52%) and rheumatoid arthritis (RA) (24.5%). The most common inciting TNF inhibitor was infliximab (52%). TNF inhibitor-induced psoriasis improved or resolved with topical medications alone in 63.5% of patients, and cyclosporine and methotrexate (10 mg weekly) were often effective (cyclosporine in five of five patients; methotrexate in 7 of 13) if topicals failed.

Noting that the success with topicals in this cohort exceeded that of earlier reports, the authors suggested that more accurate diagnoses and optimal strategies attributable to the involvement of dermatologists may be explanatory.

In 67% of refractory cases, discontinuation of the inciting TNF inhibitor with or without other interventions improved or resolved TNF inhibitor-induced psoriasis. With switching of TNF inhibitors, persistence or worsening of TNF inhibitor-induced psoriasis was reported in 16 of 25 patients (64%).

Algorithm aims at balancing control

The treatment algorithm proposed by Dr. Mazloom and colleagues aims at balancing control of the primary disease with minimization of skin symptom discomfort and continuation of the inciting TNF inhibitor if possible. Only with cyclosporine or methotrexate failure amid severe symptoms and less-than-optimal primary disease control should TNF inhibitors be discontinued and biologics and/or small-molecule inhibitors with alternative mechanisms of action be introduced. Transitioning to other TNF inhibitors may be tried before alternative strategies when the underlying disease is well-controlled but TNF inhibitor-induced psoriasis remains severe.

“Most dermatologists who see TNF-induced psoriasis often are likely already using strategies like the one proposed in the algorithm,” commented senior author Anthony Fernandez, MD, PhD, of the Cleveland (Ohio) Clinic, in an interview. “The concern is over those who may not see TNF inhibitor-induced psoriasis very often, and who may, as a knee-jerk response to TNF-induced psoriasis, stop the inciting medication. When strong side effects occur in IBD and RA, it’s critical to know how well the TNF inhibitor is controlling the underlying disease because lack of control can lead to permanent damage.”

Risk to benefit ratio favors retaining TNF inhibitors

The dermatologist’s goal, if the TNF inhibitor is working well, should be to exhaust all reasonable options to control the psoriasiform eruption and keep the patient on the TNF inhibitor rather than turn to potentially less effective alternatives, Dr. Fernandez added. “The risk:benefit ratio still usually favors adding more immune therapies to treat these reactions in order to enable patients to stay” on their TNF inhibitors.

Study authors disclosed no direct funding for the study. Dr Fernandez, the senior author, receives research funding from Pfizer, Mallinckrodt, and Novartis, consults for AbbVie and Celgene, and is a speaker for AbbVie and Mallinckrodt.

SOURCE: Mazloom SE et al. J Am Acad Dermatol. 2020 Dec;83(6):1590-8.

Treatments in the pipeline may offer more options for rosacea sufferers, according to Linda Stein Gold, MD, director of clinical research, in the department of dermatology, Henry Ford Hospital in Detroit.

sruilk/shutterstock

In addition, topical minocycline has recently been approved by the Food and Drug Administration for the treatment of rosacea in a 1.5% foam formulation. “The reason it has taken so long to have a minocycline product is that it is challenging to deliver it topically,” she said in a presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar, held virtually. Studies of higher concentrations were not significantly better for rosacea, so development of the 1.5% foam was pursued, although a 4% foam is approved for the treatment of acne.

Dr. Stein Gold shared results from a pair of 12-week randomized trials in which significantly more patients treated with topical minocycline foam showed treatment success, compared with those on vehicle, based on Investigator’s Global Assessment (IGA) scores of clear or almost clear and a decrease of at least two grades from baseline: 52.1% versus 43.0% in one study and 49.1% versus 39.0% in the second, statistically significant differences. The product also was well tolerated, with most patients reporting no side effects or mild side effects.

Research on how to maximize effectiveness of available treatments such as ivermectin is ongoing, but several new treatments in the pipeline continue to show promising results, she noted.

An up-and-coming rosacea treatment is an old product used in a new way: Benzoyl peroxide in a microencapsulated form. “Benzoyl peroxide is encased in silica molecules that allow very slow release of the benzoyl peroxide into the skin and that leads to decreased irritation,” Dr. Stein Gold explained. The deposit of active ingredient on the skin appears to stay below the level of irritation.

Dr. Stein Gold and colleagues conducted two randomized, vehicle-controlled trials in which 733 adults with moderate to severe rosacea were treated with either the encapsulated benzoyl peroxide cream formulation or a vehicle applied once daily for 12 weeks.

At 12 weeks, IGA success increased over the course of the studies, and reached 43.5% in one and 50.1% in the other, compared with 16.1% and 25.9%, respectively, for the vehicle groups in those studies (P < .001 for both). Overall, she described this as “a nice improvement for a drug that we had not considered to be part of our treatment armamentarium for our rosacea patients.”

Dr. Stein Gold also shared data from a phase 2 study of low-dose oral minocycline in adults with papulopustular rosacea. A group of 200 patients used the drug or a placebo once daily for 16 weeks. The study examined 20-mg and 40-mg extended-release formulations, and found a significant improvement with the 40-mg dose over the 20-mg dose and over placebo, in terms of those who reached an IGA of 0 or 1, with a 2 grade improvement. While this is a phase 2 study, it may lead to oral minocycline as another treatment option, she said.

“It is an exciting time for the treatment of rosacea, with a variety of options and an active pipeline, so we can aim for clear skin for our patients,” she commented.

Dr. Stein Gold disclosed serving as an investigator and consultant for Galderma, Vyne, Sun, Sol Gel, and Almirall; she is a consultant and speaker for Ortho.

MedscapeLive and this news organization are owned by the same parent company.
 

Treatments in the pipeline may offer more options for rosacea sufferers, according to Linda Stein Gold, MD, director of clinical research, in the department of dermatology, Henry Ford Hospital in Detroit.

sruilk/shutterstock

In addition, topical minocycline has recently been approved by the Food and Drug Administration for the treatment of rosacea in a 1.5% foam formulation. “The reason it has taken so long to have a minocycline product is that it is challenging to deliver it topically,” she said in a presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar, held virtually. Studies of higher concentrations were not significantly better for rosacea, so development of the 1.5% foam was pursued, although a 4% foam is approved for the treatment of acne.

Dr. Stein Gold shared results from a pair of 12-week randomized trials in which significantly more patients treated with topical minocycline foam showed treatment success, compared with those on vehicle, based on Investigator’s Global Assessment (IGA) scores of clear or almost clear and a decrease of at least two grades from baseline: 52.1% versus 43.0% in one study and 49.1% versus 39.0% in the second, statistically significant differences. The product also was well tolerated, with most patients reporting no side effects or mild side effects.

Research on how to maximize effectiveness of available treatments such as ivermectin is ongoing, but several new treatments in the pipeline continue to show promising results, she noted.

An up-and-coming rosacea treatment is an old product used in a new way: Benzoyl peroxide in a microencapsulated form. “Benzoyl peroxide is encased in silica molecules that allow very slow release of the benzoyl peroxide into the skin and that leads to decreased irritation,” Dr. Stein Gold explained. The deposit of active ingredient on the skin appears to stay below the level of irritation.

Dr. Stein Gold and colleagues conducted two randomized, vehicle-controlled trials in which 733 adults with moderate to severe rosacea were treated with either the encapsulated benzoyl peroxide cream formulation or a vehicle applied once daily for 12 weeks.

At 12 weeks, IGA success increased over the course of the studies, and reached 43.5% in one and 50.1% in the other, compared with 16.1% and 25.9%, respectively, for the vehicle groups in those studies (P < .001 for both). Overall, she described this as “a nice improvement for a drug that we had not considered to be part of our treatment armamentarium for our rosacea patients.”

Dr. Stein Gold also shared data from a phase 2 study of low-dose oral minocycline in adults with papulopustular rosacea. A group of 200 patients used the drug or a placebo once daily for 16 weeks. The study examined 20-mg and 40-mg extended-release formulations, and found a significant improvement with the 40-mg dose over the 20-mg dose and over placebo, in terms of those who reached an IGA of 0 or 1, with a 2 grade improvement. While this is a phase 2 study, it may lead to oral minocycline as another treatment option, she said.

“It is an exciting time for the treatment of rosacea, with a variety of options and an active pipeline, so we can aim for clear skin for our patients,” she commented.

Dr. Stein Gold disclosed serving as an investigator and consultant for Galderma, Vyne, Sun, Sol Gel, and Almirall; she is a consultant and speaker for Ortho.

MedscapeLive and this news organization are owned by the same parent company.
 

Treatments in the pipeline may offer more options for rosacea sufferers, according to Linda Stein Gold, MD, director of clinical research, in the department of dermatology, Henry Ford Hospital in Detroit.

sruilk/shutterstock

In addition, topical minocycline has recently been approved by the Food and Drug Administration for the treatment of rosacea in a 1.5% foam formulation. “The reason it has taken so long to have a minocycline product is that it is challenging to deliver it topically,” she said in a presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar, held virtually. Studies of higher concentrations were not significantly better for rosacea, so development of the 1.5% foam was pursued, although a 4% foam is approved for the treatment of acne.

Dr. Stein Gold shared results from a pair of 12-week randomized trials in which significantly more patients treated with topical minocycline foam showed treatment success, compared with those on vehicle, based on Investigator’s Global Assessment (IGA) scores of clear or almost clear and a decrease of at least two grades from baseline: 52.1% versus 43.0% in one study and 49.1% versus 39.0% in the second, statistically significant differences. The product also was well tolerated, with most patients reporting no side effects or mild side effects.

Research on how to maximize effectiveness of available treatments such as ivermectin is ongoing, but several new treatments in the pipeline continue to show promising results, she noted.

An up-and-coming rosacea treatment is an old product used in a new way: Benzoyl peroxide in a microencapsulated form. “Benzoyl peroxide is encased in silica molecules that allow very slow release of the benzoyl peroxide into the skin and that leads to decreased irritation,” Dr. Stein Gold explained. The deposit of active ingredient on the skin appears to stay below the level of irritation.

Dr. Stein Gold and colleagues conducted two randomized, vehicle-controlled trials in which 733 adults with moderate to severe rosacea were treated with either the encapsulated benzoyl peroxide cream formulation or a vehicle applied once daily for 12 weeks.

At 12 weeks, IGA success increased over the course of the studies, and reached 43.5% in one and 50.1% in the other, compared with 16.1% and 25.9%, respectively, for the vehicle groups in those studies (P < .001 for both). Overall, she described this as “a nice improvement for a drug that we had not considered to be part of our treatment armamentarium for our rosacea patients.”

Dr. Stein Gold also shared data from a phase 2 study of low-dose oral minocycline in adults with papulopustular rosacea. A group of 200 patients used the drug or a placebo once daily for 16 weeks. The study examined 20-mg and 40-mg extended-release formulations, and found a significant improvement with the 40-mg dose over the 20-mg dose and over placebo, in terms of those who reached an IGA of 0 or 1, with a 2 grade improvement. While this is a phase 2 study, it may lead to oral minocycline as another treatment option, she said.

“It is an exciting time for the treatment of rosacea, with a variety of options and an active pipeline, so we can aim for clear skin for our patients,” she commented.

Dr. Stein Gold disclosed serving as an investigator and consultant for Galderma, Vyne, Sun, Sol Gel, and Almirall; she is a consultant and speaker for Ortho.

MedscapeLive and this news organization are owned by the same parent company.
 

Conventional wisdom holds that patients with atopic dermatitis (AD) should shun wool clothing in favor of cotton or silk, because wool is said to be irritating and promote itching. But not so when the garments are made of fine-diameter fibers of merino wool, Joseph F. Fowler, Jr., MD, said at MedscapeLive’s annual Las Vegas Dermatology Seminar, held virtually.

“We’ve always though that wool is bad in atopics, right? Indeed, rough wool might be. But fine wool garments can actually improve atopic dermatitis, probably because wool is the most breathable fabric and has the best temperature regulation qualities of any fabric we can wear,” said Dr. Fowler, a dermatologist at the University of Louisville (Ky).

He was first author of a randomized, 12-week, crossover, assessor-blinded clinical trial which showed precisely that. And a second, similarly designed study, this one conducted in Australia, also concluded that fine merino wool assists in the management of AD.

The study by Dr. Fowler and coinvestigators included 50 children and adults with mild or moderate AD who either wore top-and-bottom base layer merino wool ensembles for 6 weeks and then switched to their regular nonwoolen clothing, or vice versa. The mean Eczema Area and Severity Index (EASI) score in those initially randomized to merino wool improved from a mean baseline of 4.5 to 1.7 at week 6, a significantly greater improvement than in the group wearing their regular clothing. Similarly, those who switched to merino wool after 6 weeks experienced a significant decrease in EASI scores from that point on to week 12, while those who switched from merino wool to their regular clothing did not.

Mean Dermatology Life Quality Index (DLQI) scores in patients who wore merino wool first improved from 6.9 at baseline to 3.4 at week 6. Those who wore their regular clothing first went from a mean baseline DLQI of 6.7 to 6.2 at week 6 – a nonsignificant change – but then improved to a week 12 mean DLQI of 3.7 while wearing wool. There was no improvement in DLQI scores while participants were wearing their regular clothing.

Static Investigator’s Global Assessment scores showed significantly greater improvement while patients wore merino wool garments than their regular clothing.

The Australian study included 39 patients with mild to moderate AD aged between 4 weeks and 3 years. This, too, was a 12-week, randomized, crossover, assessor-blinded clinical trial. Participating children wore merino wool for 6 weeks and cotton ensembles chosen by their parents for an equal time. The primary endpoint was change in the SCORing Atopic Dermatitis (SCORAD) index after each 6-week period. The mean 7.6-point greater SCORAD reduction at 6 weeks while wearing merino wool, compared with cotton, was “a pretty impressive reduction,” Dr. Fowler observed.

Reductions in the secondary endpoints of Atopic Dermatitis Severity Index and Infants’ Dermatitis Quality of Life Index while wearing merino wool followed suit. In contrast, switching from wool to cotton resulted in an increase in both scores. Also, use of topical corticosteroids was significantly reduced while patients wore merino wool.

Wool harvested from merino sheep is characterized by fine-diameter fibers. In Dr. Fowler’s study the mean fiber diameter was 17.5 mcm. This makes for a soft fabric with outstanding moisture absorbance capacity, a quality that’s beneficial in patients with AD, since their lesional skin loses the ability to regulate moisture, the dermatologist explained.

Both randomized trials were funded by Australian Wool Innovation and the Australian government.

MedscapeLive and this news organization are owned by the same parent company.
 

[email protected]

Conventional wisdom holds that patients with atopic dermatitis (AD) should shun wool clothing in favor of cotton or silk, because wool is said to be irritating and promote itching. But not so when the garments are made of fine-diameter fibers of merino wool, Joseph F. Fowler, Jr., MD, said at MedscapeLive’s annual Las Vegas Dermatology Seminar, held virtually.

“We’ve always though that wool is bad in atopics, right? Indeed, rough wool might be. But fine wool garments can actually improve atopic dermatitis, probably because wool is the most breathable fabric and has the best temperature regulation qualities of any fabric we can wear,” said Dr. Fowler, a dermatologist at the University of Louisville (Ky).

He was first author of a randomized, 12-week, crossover, assessor-blinded clinical trial which showed precisely that. And a second, similarly designed study, this one conducted in Australia, also concluded that fine merino wool assists in the management of AD.

The study by Dr. Fowler and coinvestigators included 50 children and adults with mild or moderate AD who either wore top-and-bottom base layer merino wool ensembles for 6 weeks and then switched to their regular nonwoolen clothing, or vice versa. The mean Eczema Area and Severity Index (EASI) score in those initially randomized to merino wool improved from a mean baseline of 4.5 to 1.7 at week 6, a significantly greater improvement than in the group wearing their regular clothing. Similarly, those who switched to merino wool after 6 weeks experienced a significant decrease in EASI scores from that point on to week 12, while those who switched from merino wool to their regular clothing did not.

Mean Dermatology Life Quality Index (DLQI) scores in patients who wore merino wool first improved from 6.9 at baseline to 3.4 at week 6. Those who wore their regular clothing first went from a mean baseline DLQI of 6.7 to 6.2 at week 6 – a nonsignificant change – but then improved to a week 12 mean DLQI of 3.7 while wearing wool. There was no improvement in DLQI scores while participants were wearing their regular clothing.

Static Investigator’s Global Assessment scores showed significantly greater improvement while patients wore merino wool garments than their regular clothing.

The Australian study included 39 patients with mild to moderate AD aged between 4 weeks and 3 years. This, too, was a 12-week, randomized, crossover, assessor-blinded clinical trial. Participating children wore merino wool for 6 weeks and cotton ensembles chosen by their parents for an equal time. The primary endpoint was change in the SCORing Atopic Dermatitis (SCORAD) index after each 6-week period. The mean 7.6-point greater SCORAD reduction at 6 weeks while wearing merino wool, compared with cotton, was “a pretty impressive reduction,” Dr. Fowler observed.

Reductions in the secondary endpoints of Atopic Dermatitis Severity Index and Infants’ Dermatitis Quality of Life Index while wearing merino wool followed suit. In contrast, switching from wool to cotton resulted in an increase in both scores. Also, use of topical corticosteroids was significantly reduced while patients wore merino wool.

Wool harvested from merino sheep is characterized by fine-diameter fibers. In Dr. Fowler’s study the mean fiber diameter was 17.5 mcm. This makes for a soft fabric with outstanding moisture absorbance capacity, a quality that’s beneficial in patients with AD, since their lesional skin loses the ability to regulate moisture, the dermatologist explained.

Both randomized trials were funded by Australian Wool Innovation and the Australian government.

MedscapeLive and this news organization are owned by the same parent company.
 

[email protected]

Conventional wisdom holds that patients with atopic dermatitis (AD) should shun wool clothing in favor of cotton or silk, because wool is said to be irritating and promote itching. But not so when the garments are made of fine-diameter fibers of merino wool, Joseph F. Fowler, Jr., MD, said at MedscapeLive’s annual Las Vegas Dermatology Seminar, held virtually.

“We’ve always though that wool is bad in atopics, right? Indeed, rough wool might be. But fine wool garments can actually improve atopic dermatitis, probably because wool is the most breathable fabric and has the best temperature regulation qualities of any fabric we can wear,” said Dr. Fowler, a dermatologist at the University of Louisville (Ky).

He was first author of a randomized, 12-week, crossover, assessor-blinded clinical trial which showed precisely that. And a second, similarly designed study, this one conducted in Australia, also concluded that fine merino wool assists in the management of AD.

The study by Dr. Fowler and coinvestigators included 50 children and adults with mild or moderate AD who either wore top-and-bottom base layer merino wool ensembles for 6 weeks and then switched to their regular nonwoolen clothing, or vice versa. The mean Eczema Area and Severity Index (EASI) score in those initially randomized to merino wool improved from a mean baseline of 4.5 to 1.7 at week 6, a significantly greater improvement than in the group wearing their regular clothing. Similarly, those who switched to merino wool after 6 weeks experienced a significant decrease in EASI scores from that point on to week 12, while those who switched from merino wool to their regular clothing did not.

Mean Dermatology Life Quality Index (DLQI) scores in patients who wore merino wool first improved from 6.9 at baseline to 3.4 at week 6. Those who wore their regular clothing first went from a mean baseline DLQI of 6.7 to 6.2 at week 6 – a nonsignificant change – but then improved to a week 12 mean DLQI of 3.7 while wearing wool. There was no improvement in DLQI scores while participants were wearing their regular clothing.

Static Investigator’s Global Assessment scores showed significantly greater improvement while patients wore merino wool garments than their regular clothing.

The Australian study included 39 patients with mild to moderate AD aged between 4 weeks and 3 years. This, too, was a 12-week, randomized, crossover, assessor-blinded clinical trial. Participating children wore merino wool for 6 weeks and cotton ensembles chosen by their parents for an equal time. The primary endpoint was change in the SCORing Atopic Dermatitis (SCORAD) index after each 6-week period. The mean 7.6-point greater SCORAD reduction at 6 weeks while wearing merino wool, compared with cotton, was “a pretty impressive reduction,” Dr. Fowler observed.

Reductions in the secondary endpoints of Atopic Dermatitis Severity Index and Infants’ Dermatitis Quality of Life Index while wearing merino wool followed suit. In contrast, switching from wool to cotton resulted in an increase in both scores. Also, use of topical corticosteroids was significantly reduced while patients wore merino wool.

Wool harvested from merino sheep is characterized by fine-diameter fibers. In Dr. Fowler’s study the mean fiber diameter was 17.5 mcm. This makes for a soft fabric with outstanding moisture absorbance capacity, a quality that’s beneficial in patients with AD, since their lesional skin loses the ability to regulate moisture, the dermatologist explained.

Both randomized trials were funded by Australian Wool Innovation and the Australian government.

MedscapeLive and this news organization are owned by the same parent company.
 

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Some patients with photosensitivity disorders present with a rash, while others report a history of reactivity, said Vincent DeLeo, MD, of the University of Southern California, Los Angeles.

“When a patient comes in who makes you suspect a photosensitivity, there will be two different presentations,” he said in a virtual presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar.

In some cases, the patient presents with a reaction they believe is sun related, although they don’t have a rash currently, he said. In other cases, “you as a good clinician suspect photosensitivity because the eruption is in a photo distribution,” although the patient may or may not relate it to sun exposure, he added.

Dr. DeLeo noted a few key points to include when taking the history in patients with likely photosensitivity, whether or not they present with a rash.

“I always ask patients when did the episode occur? Is it chronic?” Also ask about timing: Does the reaction occur in the sun, or later? Does it occur quickly and go away within hours, or occur within days or weeks of exposure?

“Always take a good drug history, as photosensitivity can often be related to drugs,” Dr. DeLeo noted. For example, approximately 50% of individuals on amiodarone will have some type of photosensitivity, he said.

Other drug-induced photosensitive conditions include drug-induced subacute cutaneous lupus and pseudoporphyria from NSAIDs, as well as hyperpigmentation from diltiazem, which most often occurs in Black women, he said.

“Photodrug reactions are usually related to UVA radiation, and that is important because you can develop it through the window while driving in your car”: The car windows do not protect against UVA, Dr. DeLeo said. If you have a patient who tells you about a photosensitivity or has a rash and they are on a photosensitizing drug, first rule out connective tissue disease, then discontinue the drug in collaboration with the patient’s internist and wait for the reaction to disappear, and it should, he said.

Some photosensitivity rashes have characteristic patterns, notably connective tissue disease patterns in lupus and dermatomyositis patients, bullous eruptions in cases of porphyria or phototoxic contact dermatitis, and eczematous eruptions, Dr. DeLeo noted.

Patients who present without a rash, but report a history of a reaction that they believe is related to sun exposure, fall into two categories: some had a rash that occurred while in the sun and disappeared quickly, and some had one that occurred hours or days after exposure and lasted a few days to weeks, said Dr. DeLeo.

The differential diagnosis in the patient with immediate photosensitivity is fairly clear: These patients usually have solar urticaria, he said. However, some lupus patients may report this reaction so it is important to rule out connective tissue disease. The diagnosis can be made with phototesting or do a simple test by having the patient sit out in the sunshine, he said.

For the patient who has a delayed reactivity after sun exposure, and doesn’t have the reaction when they come to the office, the differential diagnosis in a simply applied way is that, if the reaction spared the face, it is likely polymorphous light eruption (PMLE); but if the face is involved, the patient likely has photoallergic contact dermatitis, Dr. DeLeo explained. However, always consider the alternatives of connective tissue disease, drug reactions, and contact dermatitis that is not photoallergic, he noted.

PMLE “is the most common photosensitivity reaction that we see in the United States,” and it almost always occurs when people are away from home, usually on vacation, said Dr. DeLeo. The differential diagnosis for patients with recurrent or delayed rash involving the face could be photoallergic contact dermatitis, but rule out airborne contact dermatitis, personal care product contact dermatitis, and chronic actinic dermatitis, he said. A work-up for these patients could include a photo test, photopatch test, or patch test.

Dr. DeLeo disclosed serving as a consultant for Estee Lauder.

MedscapeLive and this news organization are owned by the same parent company.

Some patients with photosensitivity disorders present with a rash, while others report a history of reactivity, said Vincent DeLeo, MD, of the University of Southern California, Los Angeles.

“When a patient comes in who makes you suspect a photosensitivity, there will be two different presentations,” he said in a virtual presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar.

In some cases, the patient presents with a reaction they believe is sun related, although they don’t have a rash currently, he said. In other cases, “you as a good clinician suspect photosensitivity because the eruption is in a photo distribution,” although the patient may or may not relate it to sun exposure, he added.

Dr. DeLeo noted a few key points to include when taking the history in patients with likely photosensitivity, whether or not they present with a rash.

“I always ask patients when did the episode occur? Is it chronic?” Also ask about timing: Does the reaction occur in the sun, or later? Does it occur quickly and go away within hours, or occur within days or weeks of exposure?

“Always take a good drug history, as photosensitivity can often be related to drugs,” Dr. DeLeo noted. For example, approximately 50% of individuals on amiodarone will have some type of photosensitivity, he said.

Other drug-induced photosensitive conditions include drug-induced subacute cutaneous lupus and pseudoporphyria from NSAIDs, as well as hyperpigmentation from diltiazem, which most often occurs in Black women, he said.

“Photodrug reactions are usually related to UVA radiation, and that is important because you can develop it through the window while driving in your car”: The car windows do not protect against UVA, Dr. DeLeo said. If you have a patient who tells you about a photosensitivity or has a rash and they are on a photosensitizing drug, first rule out connective tissue disease, then discontinue the drug in collaboration with the patient’s internist and wait for the reaction to disappear, and it should, he said.

Some photosensitivity rashes have characteristic patterns, notably connective tissue disease patterns in lupus and dermatomyositis patients, bullous eruptions in cases of porphyria or phototoxic contact dermatitis, and eczematous eruptions, Dr. DeLeo noted.

Patients who present without a rash, but report a history of a reaction that they believe is related to sun exposure, fall into two categories: some had a rash that occurred while in the sun and disappeared quickly, and some had one that occurred hours or days after exposure and lasted a few days to weeks, said Dr. DeLeo.

The differential diagnosis in the patient with immediate photosensitivity is fairly clear: These patients usually have solar urticaria, he said. However, some lupus patients may report this reaction so it is important to rule out connective tissue disease. The diagnosis can be made with phototesting or do a simple test by having the patient sit out in the sunshine, he said.

For the patient who has a delayed reactivity after sun exposure, and doesn’t have the reaction when they come to the office, the differential diagnosis in a simply applied way is that, if the reaction spared the face, it is likely polymorphous light eruption (PMLE); but if the face is involved, the patient likely has photoallergic contact dermatitis, Dr. DeLeo explained. However, always consider the alternatives of connective tissue disease, drug reactions, and contact dermatitis that is not photoallergic, he noted.

PMLE “is the most common photosensitivity reaction that we see in the United States,” and it almost always occurs when people are away from home, usually on vacation, said Dr. DeLeo. The differential diagnosis for patients with recurrent or delayed rash involving the face could be photoallergic contact dermatitis, but rule out airborne contact dermatitis, personal care product contact dermatitis, and chronic actinic dermatitis, he said. A work-up for these patients could include a photo test, photopatch test, or patch test.

Dr. DeLeo disclosed serving as a consultant for Estee Lauder.

MedscapeLive and this news organization are owned by the same parent company.

Some patients with photosensitivity disorders present with a rash, while others report a history of reactivity, said Vincent DeLeo, MD, of the University of Southern California, Los Angeles.

“When a patient comes in who makes you suspect a photosensitivity, there will be two different presentations,” he said in a virtual presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar.

In some cases, the patient presents with a reaction they believe is sun related, although they don’t have a rash currently, he said. In other cases, “you as a good clinician suspect photosensitivity because the eruption is in a photo distribution,” although the patient may or may not relate it to sun exposure, he added.

Dr. DeLeo noted a few key points to include when taking the history in patients with likely photosensitivity, whether or not they present with a rash.

“I always ask patients when did the episode occur? Is it chronic?” Also ask about timing: Does the reaction occur in the sun, or later? Does it occur quickly and go away within hours, or occur within days or weeks of exposure?

“Always take a good drug history, as photosensitivity can often be related to drugs,” Dr. DeLeo noted. For example, approximately 50% of individuals on amiodarone will have some type of photosensitivity, he said.

Other drug-induced photosensitive conditions include drug-induced subacute cutaneous lupus and pseudoporphyria from NSAIDs, as well as hyperpigmentation from diltiazem, which most often occurs in Black women, he said.

“Photodrug reactions are usually related to UVA radiation, and that is important because you can develop it through the window while driving in your car”: The car windows do not protect against UVA, Dr. DeLeo said. If you have a patient who tells you about a photosensitivity or has a rash and they are on a photosensitizing drug, first rule out connective tissue disease, then discontinue the drug in collaboration with the patient’s internist and wait for the reaction to disappear, and it should, he said.

Some photosensitivity rashes have characteristic patterns, notably connective tissue disease patterns in lupus and dermatomyositis patients, bullous eruptions in cases of porphyria or phototoxic contact dermatitis, and eczematous eruptions, Dr. DeLeo noted.

Patients who present without a rash, but report a history of a reaction that they believe is related to sun exposure, fall into two categories: some had a rash that occurred while in the sun and disappeared quickly, and some had one that occurred hours or days after exposure and lasted a few days to weeks, said Dr. DeLeo.

The differential diagnosis in the patient with immediate photosensitivity is fairly clear: These patients usually have solar urticaria, he said. However, some lupus patients may report this reaction so it is important to rule out connective tissue disease. The diagnosis can be made with phototesting or do a simple test by having the patient sit out in the sunshine, he said.

For the patient who has a delayed reactivity after sun exposure, and doesn’t have the reaction when they come to the office, the differential diagnosis in a simply applied way is that, if the reaction spared the face, it is likely polymorphous light eruption (PMLE); but if the face is involved, the patient likely has photoallergic contact dermatitis, Dr. DeLeo explained. However, always consider the alternatives of connective tissue disease, drug reactions, and contact dermatitis that is not photoallergic, he noted.

PMLE “is the most common photosensitivity reaction that we see in the United States,” and it almost always occurs when people are away from home, usually on vacation, said Dr. DeLeo. The differential diagnosis for patients with recurrent or delayed rash involving the face could be photoallergic contact dermatitis, but rule out airborne contact dermatitis, personal care product contact dermatitis, and chronic actinic dermatitis, he said. A work-up for these patients could include a photo test, photopatch test, or patch test.

Dr. DeLeo disclosed serving as a consultant for Estee Lauder.

MedscapeLive and this news organization are owned by the same parent company.

Many myths persist about sunscreen use and safety, and further sunscreen regulations may be impacted by legislation in the wake of the ongoing COVID-19 pandemic, according to Steven Q. Wang, MD, director of dermatologic surgery and dermatology, Memorial Sloan-Kettering Cancer Center, Basking Ridge, N.J.

Aja Koska/Getty Images

Although sunscreens are regulated as an OTC drug under the Food and Drug Administration, concerns persist about the safety of sunscreen active ingredients, including avobenzone, oxybenzone, and octocrylene, Dr. Wang said in a virtual presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar.

In 2019, the FDA proposed a rule that requested additional information on sunscreen ingredients. In response, researchers examined six active ingredients used in sunscreen products. The preliminary results were published in JAMA Dermatology in 2019, with a follow-up study published in 2020 . The studies examined the effect of sunscreen application on plasma concentration as a sign of absorption of sunscreen active ingredients.
 

High absorption

Overall, the maximum level of blood concentration went above the 0.5 ng/mL threshold for waiving nonclinical toxicology studies for all six ingredients. However, the studies had several key limitations, Dr. Wang pointed out. “The maximum usage condition applied in these studies was unrealistic,” he said. “Most people when they use a sunscreen don’t reapply and don’t use enough,” he said.

Also, just because an ingredient is absorbed into the bloodstream does not mean it is toxic or harmful to humans, he said. Sunscreens have been used for 5 or 6 decades with almost zero reports of systemic toxicity, he observed.

The conclusions from the studies were that the FDA wanted additional research, but “they do not indicate that individuals should refrain from using sunscreen as a way to protect themselves from skin cancer,” Dr. Wang emphasized.

Congress passed the CARES Act in March 2020 to provide financial relief for individuals affected by the novel coronavirus, COVID-19. “Within that act, there is a provision to reform modernized U.S. regulatory framework on OTC drug reviews,” which will add confusion to the development of a comprehensive monograph about sunscreen because the regulatory process will change, he said.

In the meantime, confusion will likely increase among patients, who may, among other strategies, attempt to make their own sunscreen products at home, as evidenced by videos of individuals making their own products that have had thousands of views, said Dr. Wang. However, these products have no UV protection, he said.

For current sunscreen products, manufacturers are likely to focus on titanium dioxide and zinc oxide products, which fall into the GRASE I category for active ingredients recognized as safe and effective. More research is needed on homosalate, avobenzone, octisalate, and octocrylene, which are currently in the GRASE III category, meaning the data are insufficient to make statements about safety, he said.

Vitamin D concerns

Another sunscreen concern is that use will block healthy vitamin D production, Dr. Wang said. Vitamin D enters the body in two ways, either through food or through the skin, and the latter requires UVB exposure, he explained. “If you started using a sunscreen with SPF 15 that blocks 93% of UVB, you can essentially shut down vitamin D production in the skin,” but that is in the laboratory setting, he said. What happens in reality is different, as people use much less than in a lab setting, and many people put on a small amount of sunscreen and then spend more time in the sun, thereby increasing exposure, Dr. Wang noted.

For example, a study published in 1988 showed that long-term sunscreen users had levels of vitamin D that were less than 50% of those seen in non–sunscreen users. However, another study published in 1995 showed that serum vitamin D levels were not significantly different between users of an SPF 17 sunscreen and a placebo over a 7-month period.
 

Is a higher SPF better?

Many patients believe that the difference between a sunscreen with an SPF of 30 and 60 is negligible. “People generally say that SPF 30 blocks 96.7% of UVB and SPF 60 blocks 98.3%, but that’s the wrong way of looking at it,” said Dr. Wang. Instead, consider “how much of the UV ray is able to pass through the sunscreen and reach your skin and do damage,” he said. If a product with SPF 30 allows a transmission of 3.3% and a product with SPF 60 allows a transmission of 1.7%, “the SPF 60 product has 194% better protection in preventing the UV reaching the skin,” he said.

Over a lifetime, individuals will build up more UV damage with consistent use of SPF 30, compared with SPF 60 products, so this myth is important to dispel, Dr. Wang emphasized. “It is the transmission we should focus on, not the blockage,” he said.

Also, consider that the inactive ingredients matter in sunscreens, such as water resistance and film-forming technology that helps promote full coverage, Dr. Wang said, but don’t discount features such as texture, aesthetics, smell, and color, all of which impact compliance.

“Sunscreen is very personal, and people do not want to use a product just because of the SPF value, they want to use a product based on how it makes them feel,” he said.

At the end of the day, “the best sunscreen is the one a patient will use regularly and actually enjoy using,” Dr. Wang concluded.

Dr. Wang had no relevant financial conflicts to disclose.

MedscapeLive and this news organization are owned by the same parent company.

Many myths persist about sunscreen use and safety, and further sunscreen regulations may be impacted by legislation in the wake of the ongoing COVID-19 pandemic, according to Steven Q. Wang, MD, director of dermatologic surgery and dermatology, Memorial Sloan-Kettering Cancer Center, Basking Ridge, N.J.

Aja Koska/Getty Images

Although sunscreens are regulated as an OTC drug under the Food and Drug Administration, concerns persist about the safety of sunscreen active ingredients, including avobenzone, oxybenzone, and octocrylene, Dr. Wang said in a virtual presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar.

In 2019, the FDA proposed a rule that requested additional information on sunscreen ingredients. In response, researchers examined six active ingredients used in sunscreen products. The preliminary results were published in JAMA Dermatology in 2019, with a follow-up study published in 2020 . The studies examined the effect of sunscreen application on plasma concentration as a sign of absorption of sunscreen active ingredients.
 

High absorption

Overall, the maximum level of blood concentration went above the 0.5 ng/mL threshold for waiving nonclinical toxicology studies for all six ingredients. However, the studies had several key limitations, Dr. Wang pointed out. “The maximum usage condition applied in these studies was unrealistic,” he said. “Most people when they use a sunscreen don’t reapply and don’t use enough,” he said.

Also, just because an ingredient is absorbed into the bloodstream does not mean it is toxic or harmful to humans, he said. Sunscreens have been used for 5 or 6 decades with almost zero reports of systemic toxicity, he observed.

The conclusions from the studies were that the FDA wanted additional research, but “they do not indicate that individuals should refrain from using sunscreen as a way to protect themselves from skin cancer,” Dr. Wang emphasized.

Congress passed the CARES Act in March 2020 to provide financial relief for individuals affected by the novel coronavirus, COVID-19. “Within that act, there is a provision to reform modernized U.S. regulatory framework on OTC drug reviews,” which will add confusion to the development of a comprehensive monograph about sunscreen because the regulatory process will change, he said.

In the meantime, confusion will likely increase among patients, who may, among other strategies, attempt to make their own sunscreen products at home, as evidenced by videos of individuals making their own products that have had thousands of views, said Dr. Wang. However, these products have no UV protection, he said.

For current sunscreen products, manufacturers are likely to focus on titanium dioxide and zinc oxide products, which fall into the GRASE I category for active ingredients recognized as safe and effective. More research is needed on homosalate, avobenzone, octisalate, and octocrylene, which are currently in the GRASE III category, meaning the data are insufficient to make statements about safety, he said.

Vitamin D concerns

Another sunscreen concern is that use will block healthy vitamin D production, Dr. Wang said. Vitamin D enters the body in two ways, either through food or through the skin, and the latter requires UVB exposure, he explained. “If you started using a sunscreen with SPF 15 that blocks 93% of UVB, you can essentially shut down vitamin D production in the skin,” but that is in the laboratory setting, he said. What happens in reality is different, as people use much less than in a lab setting, and many people put on a small amount of sunscreen and then spend more time in the sun, thereby increasing exposure, Dr. Wang noted.

For example, a study published in 1988 showed that long-term sunscreen users had levels of vitamin D that were less than 50% of those seen in non–sunscreen users. However, another study published in 1995 showed that serum vitamin D levels were not significantly different between users of an SPF 17 sunscreen and a placebo over a 7-month period.
 

Is a higher SPF better?

Many patients believe that the difference between a sunscreen with an SPF of 30 and 60 is negligible. “People generally say that SPF 30 blocks 96.7% of UVB and SPF 60 blocks 98.3%, but that’s the wrong way of looking at it,” said Dr. Wang. Instead, consider “how much of the UV ray is able to pass through the sunscreen and reach your skin and do damage,” he said. If a product with SPF 30 allows a transmission of 3.3% and a product with SPF 60 allows a transmission of 1.7%, “the SPF 60 product has 194% better protection in preventing the UV reaching the skin,” he said.

Over a lifetime, individuals will build up more UV damage with consistent use of SPF 30, compared with SPF 60 products, so this myth is important to dispel, Dr. Wang emphasized. “It is the transmission we should focus on, not the blockage,” he said.

Also, consider that the inactive ingredients matter in sunscreens, such as water resistance and film-forming technology that helps promote full coverage, Dr. Wang said, but don’t discount features such as texture, aesthetics, smell, and color, all of which impact compliance.

“Sunscreen is very personal, and people do not want to use a product just because of the SPF value, they want to use a product based on how it makes them feel,” he said.

At the end of the day, “the best sunscreen is the one a patient will use regularly and actually enjoy using,” Dr. Wang concluded.

Dr. Wang had no relevant financial conflicts to disclose.

MedscapeLive and this news organization are owned by the same parent company.

Many myths persist about sunscreen use and safety, and further sunscreen regulations may be impacted by legislation in the wake of the ongoing COVID-19 pandemic, according to Steven Q. Wang, MD, director of dermatologic surgery and dermatology, Memorial Sloan-Kettering Cancer Center, Basking Ridge, N.J.

Aja Koska/Getty Images

Although sunscreens are regulated as an OTC drug under the Food and Drug Administration, concerns persist about the safety of sunscreen active ingredients, including avobenzone, oxybenzone, and octocrylene, Dr. Wang said in a virtual presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar.

In 2019, the FDA proposed a rule that requested additional information on sunscreen ingredients. In response, researchers examined six active ingredients used in sunscreen products. The preliminary results were published in JAMA Dermatology in 2019, with a follow-up study published in 2020 . The studies examined the effect of sunscreen application on plasma concentration as a sign of absorption of sunscreen active ingredients.
 

High absorption

Overall, the maximum level of blood concentration went above the 0.5 ng/mL threshold for waiving nonclinical toxicology studies for all six ingredients. However, the studies had several key limitations, Dr. Wang pointed out. “The maximum usage condition applied in these studies was unrealistic,” he said. “Most people when they use a sunscreen don’t reapply and don’t use enough,” he said.

Also, just because an ingredient is absorbed into the bloodstream does not mean it is toxic or harmful to humans, he said. Sunscreens have been used for 5 or 6 decades with almost zero reports of systemic toxicity, he observed.

The conclusions from the studies were that the FDA wanted additional research, but “they do not indicate that individuals should refrain from using sunscreen as a way to protect themselves from skin cancer,” Dr. Wang emphasized.

Congress passed the CARES Act in March 2020 to provide financial relief for individuals affected by the novel coronavirus, COVID-19. “Within that act, there is a provision to reform modernized U.S. regulatory framework on OTC drug reviews,” which will add confusion to the development of a comprehensive monograph about sunscreen because the regulatory process will change, he said.

In the meantime, confusion will likely increase among patients, who may, among other strategies, attempt to make their own sunscreen products at home, as evidenced by videos of individuals making their own products that have had thousands of views, said Dr. Wang. However, these products have no UV protection, he said.

For current sunscreen products, manufacturers are likely to focus on titanium dioxide and zinc oxide products, which fall into the GRASE I category for active ingredients recognized as safe and effective. More research is needed on homosalate, avobenzone, octisalate, and octocrylene, which are currently in the GRASE III category, meaning the data are insufficient to make statements about safety, he said.

Vitamin D concerns

Another sunscreen concern is that use will block healthy vitamin D production, Dr. Wang said. Vitamin D enters the body in two ways, either through food or through the skin, and the latter requires UVB exposure, he explained. “If you started using a sunscreen with SPF 15 that blocks 93% of UVB, you can essentially shut down vitamin D production in the skin,” but that is in the laboratory setting, he said. What happens in reality is different, as people use much less than in a lab setting, and many people put on a small amount of sunscreen and then spend more time in the sun, thereby increasing exposure, Dr. Wang noted.

For example, a study published in 1988 showed that long-term sunscreen users had levels of vitamin D that were less than 50% of those seen in non–sunscreen users. However, another study published in 1995 showed that serum vitamin D levels were not significantly different between users of an SPF 17 sunscreen and a placebo over a 7-month period.
 

Is a higher SPF better?

Many patients believe that the difference between a sunscreen with an SPF of 30 and 60 is negligible. “People generally say that SPF 30 blocks 96.7% of UVB and SPF 60 blocks 98.3%, but that’s the wrong way of looking at it,” said Dr. Wang. Instead, consider “how much of the UV ray is able to pass through the sunscreen and reach your skin and do damage,” he said. If a product with SPF 30 allows a transmission of 3.3% and a product with SPF 60 allows a transmission of 1.7%, “the SPF 60 product has 194% better protection in preventing the UV reaching the skin,” he said.

Over a lifetime, individuals will build up more UV damage with consistent use of SPF 30, compared with SPF 60 products, so this myth is important to dispel, Dr. Wang emphasized. “It is the transmission we should focus on, not the blockage,” he said.

Also, consider that the inactive ingredients matter in sunscreens, such as water resistance and film-forming technology that helps promote full coverage, Dr. Wang said, but don’t discount features such as texture, aesthetics, smell, and color, all of which impact compliance.

“Sunscreen is very personal, and people do not want to use a product just because of the SPF value, they want to use a product based on how it makes them feel,” he said.

At the end of the day, “the best sunscreen is the one a patient will use regularly and actually enjoy using,” Dr. Wang concluded.

Dr. Wang had no relevant financial conflicts to disclose.

MedscapeLive and this news organization are owned by the same parent company.

The COVID-19 pandemic has decimated the bottom lines of many private practices, prompting physician-owners to seriously contemplate selling.

Physician-owners have had to sell at lower prices, reflecting lower cash flow under COVID-19. But sales prices may rebound following news on Nov. 9 that a COVID-19 vaccine candidate produced by Pfizer and its German partner, BioNTech, may be ready for initial distribution before the end of the year.

“There are a lot of ifs still, but if things go according to expectations, we may see an increase in the value of practices,” said Mark O. Dietrich, a CPA in Framingham, Mass., who deals mostly with valuations of physician practices.

“Practice valuations have been lower because many patients have kept away and cash flow has been reduced,” Mr. Dietrich said. “But once patients feel safe, that barrier would be removed, and cash flow, which sales prices are generally based on, could rise. However, this may take a while. One major hurdle would be getting people to take the vaccine.”
 

Many doctors have been contemplating closing

The nation is currently undergoing a significant spike in COVID-19 hospitalizations, which could prompt another COVID-19–related downturn in practice volume, as occurred earlier in the year. That downturn forced many private practitioners to contemplate selling their practices.

In a survey released this summer by McKinsey & Company, 53% of independent physicians reported that they were worried about their practices surviving. Although many physicians have now reopened their offices, patient volume is reduced, and physicians are earning far less than before.

“In many cases, physicians who had been considering retirement in the next few years have moved their planning up and want to sell as soon as possible,” said John D. Fanburg, an attorney at Brach Eichler, a law firm in Roseland, N.J., who specializes in medical practice sales and mergers.

“For physicians over age 65, it’s not just worries about finances; it’s also worries about the health risks of staying open,” Mr. Fanburg added.

Mid-career physicians are also selling their practices. Many of them become employees of the hospital, large practice, or private-equity firm that bought the practice – receiving a level of compensation set by the sales agreement.
 

Will your practice be hard to sell?

With so many physicians ready to sell, are there enough potential buyers to acquire them all? Probably not, said Mr. Dietrich.

“Many hospitals may not need new practices right now,” he said. “In the depths of the pandemic, they furloughed many of their existing doctors and may not have brought all of them back yet.”

In fact, because of the pandemic, some buyers have delayed sales that were already in progress, said Monica H. Kaden, director of business valuations at Sobel Valuations, based in Livingston, N.J.

“Buyers are not only worried about their own cash flow but also about the possibility of lower revenues of the selling practices due to COVID-19,” she said, citing a very large multispecialty group that has put its purchase of a another large multispecialty group on hold.
 

Practice values have (temporarily) fallen

Many potential buyers are still looking, though. One thing that drives them is the possibility of discounted sales because of COVID-19. “The sense I get is that a lot of hospitals see this as an opportunity to pick up practices on the cheap,” Mr. Dietrich said.

COVID-19 has been reducing practice values somewhat, said Reed Tinsley, a CPA in Houston who performs medical practice valuations and runs a practice brokerage firm. “Practice revenues and net income are lower under COVID-19, so prices are lower.”

Ms. Kadan advised physicians to hold off selling if they can afford to wait. “It’s always best to sell when the practice volume looks the best, because then the practice is worth more. But there are doctors who can’t wait because revenues are really falling and they are running out of money. They may have no choice but to sell.”

Even in the best of times, not all practices can be sold, said Sean Tinsley, a broker and licensed financial adviser at Tinsley Medical Practice Brokers in Austin, Tex., which he runs with his father, Reed Tinsley.

“We turn down about as many deals to sell practices as we accept,” he said. “Brokers have to be very selective because we don’t get paid until the practice gets sold. Generally, we won’t take practices in rural areas or practices that still only have a fraction of their pre–COVID-19 volume.”
 

How long will it take to sell your practice?

Some practices find a buyer within weeks, but in other cases, it can take as long as a year, he said. Once the buyer is located, preparing the paperwork for the sale can take 45-60 days.

Doctors can sell their practices on their own, but a broker can help them find potential buyers and select the right price. Business brokers generally receive a greater percentage of the sales price than residential brokers. They have greater command of business and finance, and the sale is more complex than a residential sale.

The broker may also help with selling the building where the practice is located, which is usually a separate sale, said Bruce E. Wood, an attorney at CCB Law in Syracuse, N.Y., who deals with practice sales. “A hospital buying your practice may not want to buy the building, so it has to be sold separately. You can always sell the space to a different buyer.”
 

What’s the right price for your practice?

For small practices, brokers often set a price by establishing a multiple, such as two times net earnings, Sean Tinsley said. In many cases, practices haven’t retained net earnings, so the broker uses gross annual revenue and sets the price at 50%-55% of that figure.

An alternative that is widely used in the business world and for many large practices is to base the price on earnings before interest, taxes, depreciation, and amortization (EBITDA). To determine a price, the EBITDA is then multiplied by a particular multiple, which depends on the perceived value of the practice.

Higher multiples go to practices that have a qualified management team, have documented financial policies and procedures, or have had significant past growth. Generally, the multiple of EBITDA at smaller practices is 1 or 2; larger practices have a multiple of 5-7 times EBITDA, Sean Tinsley said.

COVID-19 has had the effect of reducing the multiple somewhat. “As market forces shift from a seller’s market to a buyer’s market, multiples will likely remain below pre–COVID-19 levels for the remainder of 2020 and the first half of 2021,” one report stated.

Certified valuators like Reed Tinsley have more complex ways to establish the value of a practice, but as a broker, Sean Tinsley tends to use the multiples approach. He asserted that the prices derived from this method are on the mark. “Almost all the time we sell at the asking price.”
 

Using valuations to set the price

A more complex and expensive way to set a price for a practice is to order a valuation of the practice. The valuator issues a report that runs dozens of pages and costs thousands of dollars.

Mr. Fanburg said that very few physicians selling practices order valuation reports, owing to the cost and complexity. As a result, “they don’t have a clear idea what their practices are worth.”

A comprehensive report is called a conclusion of value. The amount it finds – expressed as a range – is called “fair market value.” The report can be used in the courts for legal disputes as well as for deriving a sales price.

Practices that don’t want to pay for a conclusion of value can ask a valuator to assemble a less extensive report, called an opinion of calculated value. Also known as a calculation engagement or engagement letter, it still costs several thousand dollars.

This report has limited validity and can’t be used in the courts, according to Jarrod Barraza, a certified valuator in the Nashville, Tenn., office of Horne, a health care business valuator. “When I issue an engagement letter, I am not talking as an appraiser but as a valuation consultant, and I don’t call the result fair market value; it’s only estimating,” he said.

For all of the precision of formal reports, however, valuations of a practice can vary widely, according to Reed Tinsley. “Two valuations using the same methodology can differ by $300,000.”

Also, the valuation can be well above a reasonable asking price, said Sean Tinsley. “The market dictates the price. A traditional valuation almost invariably quotes a higher return than the market is willing to pay.”
 

Buyers’ valuations

Physicians who decide not to get a valuation still have to deal with valuations ordered by buyers. Hospitals and large practices often order valuations of the practices they want to buy, and private-equity firms use methods much like a valuation for the practices they are interested in.

Buyers rarely share the valuation report with the seller, so the seller has to accept the buyer’s price without being able to review the thought process behind it, Mr. Fanburg said. “Relying on the buyer to tell you what you’re worth means you may sell your practice well below its true value.”

When the buyer orders a valuation, the valuator interviews managers of the practice and asks for a great deal of information, says G. Don Barbo, managing director at VMG Health, a health care valuation firm based in Dallas.

Mr. Barbo said these documents include financial statements for the practice, usually going back 3-5 years; productivity reports for doctors and other providers; accounts receivables; reports of fixed assets; a roster of employees; employment agreements and management services agreements; reports on payer mix; facility leases and equipment lease agreements; budgets and projections; and tax returns.

Mr. Dietrich said valuators hone in on the practice’s current procedural terminology codes. “If the practice is coding too high, this would artificially increase the profit and purported value of the practice. For example, coding at 99214 rather than 99213 for an established patient means that the practice is being paid 45% more for each visit.” The valuator then reduces the value of the practice on the basis of the extent of the improper up-coding.

Mr. Barbo said some sellers don’t want all the scrutiny of the buyer’s valuation and just sell the practice’s tangible assets – furnishings, fixtures, and equipment – which do not require a great deal of documentation but yield a much lower price.
 

A primer on valuations

As a valuator, “my job is to project into the future,” Mr. Barraza said. “I am trying to see how the practice will fare going forward.”

Mr. Dietrich agreed, with one caveat: “As Yogi Berra said: ‘It’s difficult to make predictions, especially about the future.’ ”

The formal valuation assesses the practice in three ways: measuring income, assets, and what other practices sell for, called the market approach.

With the income approach, the most used measurement for practices, one tries to determine future income, which is what buyers are most interested in, Mr. Dietrich said. The income equals revenue (total collections) minus operating expenses and overhead.

“You are then left with all the money the physician is paid,” he said. “The issue is, how much is attributed to the physician’s own labor and how much to his or her ownership of the practice? This second category helps determine the value of the practice.”

The market approach is often used as a way to double-check the accuracy of the income approach. The appraiser looks for the prices of similar practices that have already been sold and then adjusts the price on the basis of differences with the practice up for sale.

The asset approach may be used when the practice has no positive cash flow. It establishes a price for tangible assets, which are often much lower in value than the values that the other approaches come up with. The asset approach can be a lower-priced alternative for practices that can’t be measured under the income or market approach.

“Equipment appraisers can do an inventory of your equipment,” Mr. Wood said. “Generally, equipment that is more than 3 years old, such as computers, is not that valuable, but an ultrasound machine probably has some resale value.”
 

Will the buyer pay for goodwill?

Many practice owners hope they can get money for the “goodwill” of their practice when they sell. Goodwill basically represents the reputation of the practice, which is difficult to pinpoint, and Mr. Wood said buyers often don’t want to pay for it.

“The goodwill is a wild card,” Mr. Wood said. “It can range from zero to crazy numbers. There is a Goodwill Registry – a list of the goodwill in other practice sales – that you can consult.”

One simple way to calculate the goodwill, he said, is to take the value of the practice based on examining income and remove the value of tangible assets. What is left is considered the goodwill.

Another form of intangible asset that is sometimes lumped together with goodwill is the value of the practice’s trained staff. “Some buyers agree to pay for the staff in place, because they plan to use that staff,” Ms. Kadan said. In one large deal she was involved with, the buyer agreed to pay something for the selling practice’s staff of 180 people.

Another item that buyers also do not typically pay for is the practice’s accounts receivable. They may also not pay for any liabilities the practice holds, such as the facility lease, equipment lease, and maintenance contracts, Mr. Barbo said. “The buyer then often stipulates that all liabilities are left to the practice, or stipulates any specific liabilities that it may assume.”
 

Selling to other doctors

Doctors can sell practices or shares in practices to other doctors. A retiring physician, for example, can sell his or her share to the other partners. A valuator may be brought in to establish the value of the doctor’s equity interest in the practice.

“Generally, practice buyouts aren’t lucrative for selling physician,” Mr. Wood said. “There are exceptions, of course, such as specialty practices in some cases.”

A practice can also be sold to a new doctor or to a previously employed physician who wants to be an owner. These physicians usually need to get a bank loan to buy the practice.

The bank assesses the finances of the selling practice to determine whether the buying physician will earn enough money to pay back the loan. “Banks don’t want lend more than the gross annual revenue of the practice, and some banks will only lend at 65% of gross annual revenue,” Sean Tinsley said.

COVID-19 has seriously affected banks’ lending decisions. Banks stopped lending to practice buyers at the beginning of the pandemic, and when they started lending again, they were more cautious, Sean Tinsley said. “Generally, banks want to see the practice at 85%-90% of pre–COVID-19 numbers before they make a loan.”

He added that, if a buyer can’t get a bank loan, the selling doctor may decide to finance the sale. The buyer agrees to a payment schedule to pay off the full price over several years.
 

Selling to or merging with other practices

The usual buyer is another practice, Reed Tinsley said. “You can sell to a group, but prices are low because, with COVID-19, buyers don’t want to incur a lot of money up front. Or you can merge with the practice, which means the selling doctor usually doesn’t get any money, but he does get a share in the larger practice. In that case, the partnership is the object of value, and it can be cashed out when the physician leaves the practice.”

Mergers can get very complicated. Mr. Fanburg said he has been working with seven groups that are merging into one. “The merger was scheduled to go live last January, but it was slowed down over negotiations about new managed care contracts and putting together a management structure, plus the groups were a little wary of each other. Now the deal is scheduled to go live next January.”

One advantage to selling to a larger entity, such as a big group practice or a hospital, is that the selling physician benefits from the higher reimbursement rates that large providers usually command. “If the buyer has more favorable reimbursement rates with insurers, it could pay the selling doctor much more than he is making now,” Mr. Barraza said.
 

Hospitals as buyers

Because of COVID-19, currently many hospitals don’t have money to buy more practices. However, this is most likely a temporary situation.

Hospitals typically offer less money than other buyers, according to Sean Tinsley. “We have never sold to a hospital, because hospitals generally don’t pay for goodwill. They pay for the practice assets and offer a dollar amount for each chart.”

Hospitals have to be careful not to pay physicians more than the usual amount for their practices, because the extra amount could be seen as a kickback for referrals, which would violate the federal Stark law and Anti-Kickback Statute. Not-for-profit hospitals also have to comply with regulations at the Internal Revenue Service.

Hospitals usually require that the selling physician continue to work in the practice after it is sold. The selling physician’s presence helps ensure that the practice’s output will not decline after sale. Although the sales price may be low, the hospital may make up for it by paying a higher compensation, Sean Tinsley said.
 

Selling to private-equity firms

Private-equity purchases are financed by investors who essentially want to “flip” practices – that is, they want to make them more profitable and then sell them to someone else. The private-equity firm starts by buying a “platform” practice, which forms the core of the venture. It then buys smaller practices that will be managed by the platform practice.

The number of private-equity deals increased continually through 2019, then plummeted in March because of COVID-19, but by the summer, activity began to rise again.

Physicians are very intrigued about selling to private-equity firms because they are known to pay the most for practices. But private-equity buyers focus on a fairly narrow group of specialties.

Generally, Sean Tinsley said, private-equity firms only look for pain, dermatology, and ophthalmology practices, but they have been starting to branch out to specialties such as gastroenterology. In 2018, there were only two private-equity deals for gastroenterology practices, but in 2019, there were 16, according to one assessment.

Private-equity firms buy very few of the practices they initially review, according to Mr. Fanburg. “Private equity negotiates with dozens or even hundreds of physician practices at a time, with only 1%-5% of those practices actually being acquired.”

The private-equity firm’s upfront payment to selling physicians is quite high, but then the physicians become employees of the new group and earn much less in compensation than they earned on this own.

“In order for the venture to get any value out of the acquisition, the doctors have to make less going forward than they did historically,” Mr. Dietrich said. That freed-up money boosts the value of the venture.

When the platform practice is sold – usually after 5 years or so – “chances are the management team will be replaced,” Mr. Fanburg said. “There could be new policies and objectives, which could mean a bumpy ride for physicians.”
 

Do you really want to sell?

“When a group of physicians comes to me asking for help selling their practice, my first question is, Why are you doing this?” Mr. Fanburg said. “You need a better reason for selling than just the money.

“Once you make the leap, there is a certain amount of autonomy you lose,” he continued. “The sale gives you an economic boost, but it may not be enough for the long haul. If you stay on with the buyer, your compensation is often lower. That makes sense if you’re retiring, but not if you’re a younger physician with many years of practice in the years ahead.

“When physicians say they see no other way out except to sell,” Mr. Fanburg said, “I tell them that their buyer will see a path to future growth for your practice. If you think reimbursements are getting worse, why are the buyers pressing ahead?”

A version of this article originally appeared on Medscape.com.

The COVID-19 pandemic has decimated the bottom lines of many private practices, prompting physician-owners to seriously contemplate selling.

Physician-owners have had to sell at lower prices, reflecting lower cash flow under COVID-19. But sales prices may rebound following news on Nov. 9 that a COVID-19 vaccine candidate produced by Pfizer and its German partner, BioNTech, may be ready for initial distribution before the end of the year.

“There are a lot of ifs still, but if things go according to expectations, we may see an increase in the value of practices,” said Mark O. Dietrich, a CPA in Framingham, Mass., who deals mostly with valuations of physician practices.

“Practice valuations have been lower because many patients have kept away and cash flow has been reduced,” Mr. Dietrich said. “But once patients feel safe, that barrier would be removed, and cash flow, which sales prices are generally based on, could rise. However, this may take a while. One major hurdle would be getting people to take the vaccine.”
 

Many doctors have been contemplating closing

The nation is currently undergoing a significant spike in COVID-19 hospitalizations, which could prompt another COVID-19–related downturn in practice volume, as occurred earlier in the year. That downturn forced many private practitioners to contemplate selling their practices.

In a survey released this summer by McKinsey & Company, 53% of independent physicians reported that they were worried about their practices surviving. Although many physicians have now reopened their offices, patient volume is reduced, and physicians are earning far less than before.

“In many cases, physicians who had been considering retirement in the next few years have moved their planning up and want to sell as soon as possible,” said John D. Fanburg, an attorney at Brach Eichler, a law firm in Roseland, N.J., who specializes in medical practice sales and mergers.

“For physicians over age 65, it’s not just worries about finances; it’s also worries about the health risks of staying open,” Mr. Fanburg added.

Mid-career physicians are also selling their practices. Many of them become employees of the hospital, large practice, or private-equity firm that bought the practice – receiving a level of compensation set by the sales agreement.
 

Will your practice be hard to sell?

With so many physicians ready to sell, are there enough potential buyers to acquire them all? Probably not, said Mr. Dietrich.

“Many hospitals may not need new practices right now,” he said. “In the depths of the pandemic, they furloughed many of their existing doctors and may not have brought all of them back yet.”

In fact, because of the pandemic, some buyers have delayed sales that were already in progress, said Monica H. Kaden, director of business valuations at Sobel Valuations, based in Livingston, N.J.

“Buyers are not only worried about their own cash flow but also about the possibility of lower revenues of the selling practices due to COVID-19,” she said, citing a very large multispecialty group that has put its purchase of a another large multispecialty group on hold.
 

Practice values have (temporarily) fallen

Many potential buyers are still looking, though. One thing that drives them is the possibility of discounted sales because of COVID-19. “The sense I get is that a lot of hospitals see this as an opportunity to pick up practices on the cheap,” Mr. Dietrich said.

COVID-19 has been reducing practice values somewhat, said Reed Tinsley, a CPA in Houston who performs medical practice valuations and runs a practice brokerage firm. “Practice revenues and net income are lower under COVID-19, so prices are lower.”

Ms. Kadan advised physicians to hold off selling if they can afford to wait. “It’s always best to sell when the practice volume looks the best, because then the practice is worth more. But there are doctors who can’t wait because revenues are really falling and they are running out of money. They may have no choice but to sell.”

Even in the best of times, not all practices can be sold, said Sean Tinsley, a broker and licensed financial adviser at Tinsley Medical Practice Brokers in Austin, Tex., which he runs with his father, Reed Tinsley.

“We turn down about as many deals to sell practices as we accept,” he said. “Brokers have to be very selective because we don’t get paid until the practice gets sold. Generally, we won’t take practices in rural areas or practices that still only have a fraction of their pre–COVID-19 volume.”
 

How long will it take to sell your practice?

Some practices find a buyer within weeks, but in other cases, it can take as long as a year, he said. Once the buyer is located, preparing the paperwork for the sale can take 45-60 days.

Doctors can sell their practices on their own, but a broker can help them find potential buyers and select the right price. Business brokers generally receive a greater percentage of the sales price than residential brokers. They have greater command of business and finance, and the sale is more complex than a residential sale.

The broker may also help with selling the building where the practice is located, which is usually a separate sale, said Bruce E. Wood, an attorney at CCB Law in Syracuse, N.Y., who deals with practice sales. “A hospital buying your practice may not want to buy the building, so it has to be sold separately. You can always sell the space to a different buyer.”
 

What’s the right price for your practice?

For small practices, brokers often set a price by establishing a multiple, such as two times net earnings, Sean Tinsley said. In many cases, practices haven’t retained net earnings, so the broker uses gross annual revenue and sets the price at 50%-55% of that figure.

An alternative that is widely used in the business world and for many large practices is to base the price on earnings before interest, taxes, depreciation, and amortization (EBITDA). To determine a price, the EBITDA is then multiplied by a particular multiple, which depends on the perceived value of the practice.

Higher multiples go to practices that have a qualified management team, have documented financial policies and procedures, or have had significant past growth. Generally, the multiple of EBITDA at smaller practices is 1 or 2; larger practices have a multiple of 5-7 times EBITDA, Sean Tinsley said.

COVID-19 has had the effect of reducing the multiple somewhat. “As market forces shift from a seller’s market to a buyer’s market, multiples will likely remain below pre–COVID-19 levels for the remainder of 2020 and the first half of 2021,” one report stated.

Certified valuators like Reed Tinsley have more complex ways to establish the value of a practice, but as a broker, Sean Tinsley tends to use the multiples approach. He asserted that the prices derived from this method are on the mark. “Almost all the time we sell at the asking price.”
 

Using valuations to set the price

A more complex and expensive way to set a price for a practice is to order a valuation of the practice. The valuator issues a report that runs dozens of pages and costs thousands of dollars.

Mr. Fanburg said that very few physicians selling practices order valuation reports, owing to the cost and complexity. As a result, “they don’t have a clear idea what their practices are worth.”

A comprehensive report is called a conclusion of value. The amount it finds – expressed as a range – is called “fair market value.” The report can be used in the courts for legal disputes as well as for deriving a sales price.

Practices that don’t want to pay for a conclusion of value can ask a valuator to assemble a less extensive report, called an opinion of calculated value. Also known as a calculation engagement or engagement letter, it still costs several thousand dollars.

This report has limited validity and can’t be used in the courts, according to Jarrod Barraza, a certified valuator in the Nashville, Tenn., office of Horne, a health care business valuator. “When I issue an engagement letter, I am not talking as an appraiser but as a valuation consultant, and I don’t call the result fair market value; it’s only estimating,” he said.

For all of the precision of formal reports, however, valuations of a practice can vary widely, according to Reed Tinsley. “Two valuations using the same methodology can differ by $300,000.”

Also, the valuation can be well above a reasonable asking price, said Sean Tinsley. “The market dictates the price. A traditional valuation almost invariably quotes a higher return than the market is willing to pay.”
 

Buyers’ valuations

Physicians who decide not to get a valuation still have to deal with valuations ordered by buyers. Hospitals and large practices often order valuations of the practices they want to buy, and private-equity firms use methods much like a valuation for the practices they are interested in.

Buyers rarely share the valuation report with the seller, so the seller has to accept the buyer’s price without being able to review the thought process behind it, Mr. Fanburg said. “Relying on the buyer to tell you what you’re worth means you may sell your practice well below its true value.”

When the buyer orders a valuation, the valuator interviews managers of the practice and asks for a great deal of information, says G. Don Barbo, managing director at VMG Health, a health care valuation firm based in Dallas.

Mr. Barbo said these documents include financial statements for the practice, usually going back 3-5 years; productivity reports for doctors and other providers; accounts receivables; reports of fixed assets; a roster of employees; employment agreements and management services agreements; reports on payer mix; facility leases and equipment lease agreements; budgets and projections; and tax returns.

Mr. Dietrich said valuators hone in on the practice’s current procedural terminology codes. “If the practice is coding too high, this would artificially increase the profit and purported value of the practice. For example, coding at 99214 rather than 99213 for an established patient means that the practice is being paid 45% more for each visit.” The valuator then reduces the value of the practice on the basis of the extent of the improper up-coding.

Mr. Barbo said some sellers don’t want all the scrutiny of the buyer’s valuation and just sell the practice’s tangible assets – furnishings, fixtures, and equipment – which do not require a great deal of documentation but yield a much lower price.
 

A primer on valuations

As a valuator, “my job is to project into the future,” Mr. Barraza said. “I am trying to see how the practice will fare going forward.”

Mr. Dietrich agreed, with one caveat: “As Yogi Berra said: ‘It’s difficult to make predictions, especially about the future.’ ”

The formal valuation assesses the practice in three ways: measuring income, assets, and what other practices sell for, called the market approach.

With the income approach, the most used measurement for practices, one tries to determine future income, which is what buyers are most interested in, Mr. Dietrich said. The income equals revenue (total collections) minus operating expenses and overhead.

“You are then left with all the money the physician is paid,” he said. “The issue is, how much is attributed to the physician’s own labor and how much to his or her ownership of the practice? This second category helps determine the value of the practice.”

The market approach is often used as a way to double-check the accuracy of the income approach. The appraiser looks for the prices of similar practices that have already been sold and then adjusts the price on the basis of differences with the practice up for sale.

The asset approach may be used when the practice has no positive cash flow. It establishes a price for tangible assets, which are often much lower in value than the values that the other approaches come up with. The asset approach can be a lower-priced alternative for practices that can’t be measured under the income or market approach.

“Equipment appraisers can do an inventory of your equipment,” Mr. Wood said. “Generally, equipment that is more than 3 years old, such as computers, is not that valuable, but an ultrasound machine probably has some resale value.”
 

Will the buyer pay for goodwill?

Many practice owners hope they can get money for the “goodwill” of their practice when they sell. Goodwill basically represents the reputation of the practice, which is difficult to pinpoint, and Mr. Wood said buyers often don’t want to pay for it.

“The goodwill is a wild card,” Mr. Wood said. “It can range from zero to crazy numbers. There is a Goodwill Registry – a list of the goodwill in other practice sales – that you can consult.”

One simple way to calculate the goodwill, he said, is to take the value of the practice based on examining income and remove the value of tangible assets. What is left is considered the goodwill.

Another form of intangible asset that is sometimes lumped together with goodwill is the value of the practice’s trained staff. “Some buyers agree to pay for the staff in place, because they plan to use that staff,” Ms. Kadan said. In one large deal she was involved with, the buyer agreed to pay something for the selling practice’s staff of 180 people.

Another item that buyers also do not typically pay for is the practice’s accounts receivable. They may also not pay for any liabilities the practice holds, such as the facility lease, equipment lease, and maintenance contracts, Mr. Barbo said. “The buyer then often stipulates that all liabilities are left to the practice, or stipulates any specific liabilities that it may assume.”
 

Selling to other doctors

Doctors can sell practices or shares in practices to other doctors. A retiring physician, for example, can sell his or her share to the other partners. A valuator may be brought in to establish the value of the doctor’s equity interest in the practice.

“Generally, practice buyouts aren’t lucrative for selling physician,” Mr. Wood said. “There are exceptions, of course, such as specialty practices in some cases.”

A practice can also be sold to a new doctor or to a previously employed physician who wants to be an owner. These physicians usually need to get a bank loan to buy the practice.

The bank assesses the finances of the selling practice to determine whether the buying physician will earn enough money to pay back the loan. “Banks don’t want lend more than the gross annual revenue of the practice, and some banks will only lend at 65% of gross annual revenue,” Sean Tinsley said.

COVID-19 has seriously affected banks’ lending decisions. Banks stopped lending to practice buyers at the beginning of the pandemic, and when they started lending again, they were more cautious, Sean Tinsley said. “Generally, banks want to see the practice at 85%-90% of pre–COVID-19 numbers before they make a loan.”

He added that, if a buyer can’t get a bank loan, the selling doctor may decide to finance the sale. The buyer agrees to a payment schedule to pay off the full price over several years.
 

Selling to or merging with other practices

The usual buyer is another practice, Reed Tinsley said. “You can sell to a group, but prices are low because, with COVID-19, buyers don’t want to incur a lot of money up front. Or you can merge with the practice, which means the selling doctor usually doesn’t get any money, but he does get a share in the larger practice. In that case, the partnership is the object of value, and it can be cashed out when the physician leaves the practice.”

Mergers can get very complicated. Mr. Fanburg said he has been working with seven groups that are merging into one. “The merger was scheduled to go live last January, but it was slowed down over negotiations about new managed care contracts and putting together a management structure, plus the groups were a little wary of each other. Now the deal is scheduled to go live next January.”

One advantage to selling to a larger entity, such as a big group practice or a hospital, is that the selling physician benefits from the higher reimbursement rates that large providers usually command. “If the buyer has more favorable reimbursement rates with insurers, it could pay the selling doctor much more than he is making now,” Mr. Barraza said.
 

Hospitals as buyers

Because of COVID-19, currently many hospitals don’t have money to buy more practices. However, this is most likely a temporary situation.

Hospitals typically offer less money than other buyers, according to Sean Tinsley. “We have never sold to a hospital, because hospitals generally don’t pay for goodwill. They pay for the practice assets and offer a dollar amount for each chart.”

Hospitals have to be careful not to pay physicians more than the usual amount for their practices, because the extra amount could be seen as a kickback for referrals, which would violate the federal Stark law and Anti-Kickback Statute. Not-for-profit hospitals also have to comply with regulations at the Internal Revenue Service.

Hospitals usually require that the selling physician continue to work in the practice after it is sold. The selling physician’s presence helps ensure that the practice’s output will not decline after sale. Although the sales price may be low, the hospital may make up for it by paying a higher compensation, Sean Tinsley said.
 

Selling to private-equity firms

Private-equity purchases are financed by investors who essentially want to “flip” practices – that is, they want to make them more profitable and then sell them to someone else. The private-equity firm starts by buying a “platform” practice, which forms the core of the venture. It then buys smaller practices that will be managed by the platform practice.

The number of private-equity deals increased continually through 2019, then plummeted in March because of COVID-19, but by the summer, activity began to rise again.

Physicians are very intrigued about selling to private-equity firms because they are known to pay the most for practices. But private-equity buyers focus on a fairly narrow group of specialties.

Generally, Sean Tinsley said, private-equity firms only look for pain, dermatology, and ophthalmology practices, but they have been starting to branch out to specialties such as gastroenterology. In 2018, there were only two private-equity deals for gastroenterology practices, but in 2019, there were 16, according to one assessment.

Private-equity firms buy very few of the practices they initially review, according to Mr. Fanburg. “Private equity negotiates with dozens or even hundreds of physician practices at a time, with only 1%-5% of those practices actually being acquired.”

The private-equity firm’s upfront payment to selling physicians is quite high, but then the physicians become employees of the new group and earn much less in compensation than they earned on this own.

“In order for the venture to get any value out of the acquisition, the doctors have to make less going forward than they did historically,” Mr. Dietrich said. That freed-up money boosts the value of the venture.

When the platform practice is sold – usually after 5 years or so – “chances are the management team will be replaced,” Mr. Fanburg said. “There could be new policies and objectives, which could mean a bumpy ride for physicians.”
 

Do you really want to sell?

“When a group of physicians comes to me asking for help selling their practice, my first question is, Why are you doing this?” Mr. Fanburg said. “You need a better reason for selling than just the money.

“Once you make the leap, there is a certain amount of autonomy you lose,” he continued. “The sale gives you an economic boost, but it may not be enough for the long haul. If you stay on with the buyer, your compensation is often lower. That makes sense if you’re retiring, but not if you’re a younger physician with many years of practice in the years ahead.

“When physicians say they see no other way out except to sell,” Mr. Fanburg said, “I tell them that their buyer will see a path to future growth for your practice. If you think reimbursements are getting worse, why are the buyers pressing ahead?”

A version of this article originally appeared on Medscape.com.

The COVID-19 pandemic has decimated the bottom lines of many private practices, prompting physician-owners to seriously contemplate selling.

Physician-owners have had to sell at lower prices, reflecting lower cash flow under COVID-19. But sales prices may rebound following news on Nov. 9 that a COVID-19 vaccine candidate produced by Pfizer and its German partner, BioNTech, may be ready for initial distribution before the end of the year.

“There are a lot of ifs still, but if things go according to expectations, we may see an increase in the value of practices,” said Mark O. Dietrich, a CPA in Framingham, Mass., who deals mostly with valuations of physician practices.

“Practice valuations have been lower because many patients have kept away and cash flow has been reduced,” Mr. Dietrich said. “But once patients feel safe, that barrier would be removed, and cash flow, which sales prices are generally based on, could rise. However, this may take a while. One major hurdle would be getting people to take the vaccine.”
 

Many doctors have been contemplating closing

The nation is currently undergoing a significant spike in COVID-19 hospitalizations, which could prompt another COVID-19–related downturn in practice volume, as occurred earlier in the year. That downturn forced many private practitioners to contemplate selling their practices.

In a survey released this summer by McKinsey & Company, 53% of independent physicians reported that they were worried about their practices surviving. Although many physicians have now reopened their offices, patient volume is reduced, and physicians are earning far less than before.

“In many cases, physicians who had been considering retirement in the next few years have moved their planning up and want to sell as soon as possible,” said John D. Fanburg, an attorney at Brach Eichler, a law firm in Roseland, N.J., who specializes in medical practice sales and mergers.

“For physicians over age 65, it’s not just worries about finances; it’s also worries about the health risks of staying open,” Mr. Fanburg added.

Mid-career physicians are also selling their practices. Many of them become employees of the hospital, large practice, or private-equity firm that bought the practice – receiving a level of compensation set by the sales agreement.
 

Will your practice be hard to sell?

With so many physicians ready to sell, are there enough potential buyers to acquire them all? Probably not, said Mr. Dietrich.

“Many hospitals may not need new practices right now,” he said. “In the depths of the pandemic, they furloughed many of their existing doctors and may not have brought all of them back yet.”

In fact, because of the pandemic, some buyers have delayed sales that were already in progress, said Monica H. Kaden, director of business valuations at Sobel Valuations, based in Livingston, N.J.

“Buyers are not only worried about their own cash flow but also about the possibility of lower revenues of the selling practices due to COVID-19,” she said, citing a very large multispecialty group that has put its purchase of a another large multispecialty group on hold.
 

Practice values have (temporarily) fallen

Many potential buyers are still looking, though. One thing that drives them is the possibility of discounted sales because of COVID-19. “The sense I get is that a lot of hospitals see this as an opportunity to pick up practices on the cheap,” Mr. Dietrich said.

COVID-19 has been reducing practice values somewhat, said Reed Tinsley, a CPA in Houston who performs medical practice valuations and runs a practice brokerage firm. “Practice revenues and net income are lower under COVID-19, so prices are lower.”

Ms. Kadan advised physicians to hold off selling if they can afford to wait. “It’s always best to sell when the practice volume looks the best, because then the practice is worth more. But there are doctors who can’t wait because revenues are really falling and they are running out of money. They may have no choice but to sell.”

Even in the best of times, not all practices can be sold, said Sean Tinsley, a broker and licensed financial adviser at Tinsley Medical Practice Brokers in Austin, Tex., which he runs with his father, Reed Tinsley.

“We turn down about as many deals to sell practices as we accept,” he said. “Brokers have to be very selective because we don’t get paid until the practice gets sold. Generally, we won’t take practices in rural areas or practices that still only have a fraction of their pre–COVID-19 volume.”
 

How long will it take to sell your practice?

Some practices find a buyer within weeks, but in other cases, it can take as long as a year, he said. Once the buyer is located, preparing the paperwork for the sale can take 45-60 days.

Doctors can sell their practices on their own, but a broker can help them find potential buyers and select the right price. Business brokers generally receive a greater percentage of the sales price than residential brokers. They have greater command of business and finance, and the sale is more complex than a residential sale.

The broker may also help with selling the building where the practice is located, which is usually a separate sale, said Bruce E. Wood, an attorney at CCB Law in Syracuse, N.Y., who deals with practice sales. “A hospital buying your practice may not want to buy the building, so it has to be sold separately. You can always sell the space to a different buyer.”
 

What’s the right price for your practice?

For small practices, brokers often set a price by establishing a multiple, such as two times net earnings, Sean Tinsley said. In many cases, practices haven’t retained net earnings, so the broker uses gross annual revenue and sets the price at 50%-55% of that figure.

An alternative that is widely used in the business world and for many large practices is to base the price on earnings before interest, taxes, depreciation, and amortization (EBITDA). To determine a price, the EBITDA is then multiplied by a particular multiple, which depends on the perceived value of the practice.

Higher multiples go to practices that have a qualified management team, have documented financial policies and procedures, or have had significant past growth. Generally, the multiple of EBITDA at smaller practices is 1 or 2; larger practices have a multiple of 5-7 times EBITDA, Sean Tinsley said.

COVID-19 has had the effect of reducing the multiple somewhat. “As market forces shift from a seller’s market to a buyer’s market, multiples will likely remain below pre–COVID-19 levels for the remainder of 2020 and the first half of 2021,” one report stated.

Certified valuators like Reed Tinsley have more complex ways to establish the value of a practice, but as a broker, Sean Tinsley tends to use the multiples approach. He asserted that the prices derived from this method are on the mark. “Almost all the time we sell at the asking price.”
 

Using valuations to set the price

A more complex and expensive way to set a price for a practice is to order a valuation of the practice. The valuator issues a report that runs dozens of pages and costs thousands of dollars.

Mr. Fanburg said that very few physicians selling practices order valuation reports, owing to the cost and complexity. As a result, “they don’t have a clear idea what their practices are worth.”

A comprehensive report is called a conclusion of value. The amount it finds – expressed as a range – is called “fair market value.” The report can be used in the courts for legal disputes as well as for deriving a sales price.

Practices that don’t want to pay for a conclusion of value can ask a valuator to assemble a less extensive report, called an opinion of calculated value. Also known as a calculation engagement or engagement letter, it still costs several thousand dollars.

This report has limited validity and can’t be used in the courts, according to Jarrod Barraza, a certified valuator in the Nashville, Tenn., office of Horne, a health care business valuator. “When I issue an engagement letter, I am not talking as an appraiser but as a valuation consultant, and I don’t call the result fair market value; it’s only estimating,” he said.

For all of the precision of formal reports, however, valuations of a practice can vary widely, according to Reed Tinsley. “Two valuations using the same methodology can differ by $300,000.”

Also, the valuation can be well above a reasonable asking price, said Sean Tinsley. “The market dictates the price. A traditional valuation almost invariably quotes a higher return than the market is willing to pay.”
 

Buyers’ valuations

Physicians who decide not to get a valuation still have to deal with valuations ordered by buyers. Hospitals and large practices often order valuations of the practices they want to buy, and private-equity firms use methods much like a valuation for the practices they are interested in.

Buyers rarely share the valuation report with the seller, so the seller has to accept the buyer’s price without being able to review the thought process behind it, Mr. Fanburg said. “Relying on the buyer to tell you what you’re worth means you may sell your practice well below its true value.”

When the buyer orders a valuation, the valuator interviews managers of the practice and asks for a great deal of information, says G. Don Barbo, managing director at VMG Health, a health care valuation firm based in Dallas.

Mr. Barbo said these documents include financial statements for the practice, usually going back 3-5 years; productivity reports for doctors and other providers; accounts receivables; reports of fixed assets; a roster of employees; employment agreements and management services agreements; reports on payer mix; facility leases and equipment lease agreements; budgets and projections; and tax returns.

Mr. Dietrich said valuators hone in on the practice’s current procedural terminology codes. “If the practice is coding too high, this would artificially increase the profit and purported value of the practice. For example, coding at 99214 rather than 99213 for an established patient means that the practice is being paid 45% more for each visit.” The valuator then reduces the value of the practice on the basis of the extent of the improper up-coding.

Mr. Barbo said some sellers don’t want all the scrutiny of the buyer’s valuation and just sell the practice’s tangible assets – furnishings, fixtures, and equipment – which do not require a great deal of documentation but yield a much lower price.
 

A primer on valuations

As a valuator, “my job is to project into the future,” Mr. Barraza said. “I am trying to see how the practice will fare going forward.”

Mr. Dietrich agreed, with one caveat: “As Yogi Berra said: ‘It’s difficult to make predictions, especially about the future.’ ”

The formal valuation assesses the practice in three ways: measuring income, assets, and what other practices sell for, called the market approach.

With the income approach, the most used measurement for practices, one tries to determine future income, which is what buyers are most interested in, Mr. Dietrich said. The income equals revenue (total collections) minus operating expenses and overhead.

“You are then left with all the money the physician is paid,” he said. “The issue is, how much is attributed to the physician’s own labor and how much to his or her ownership of the practice? This second category helps determine the value of the practice.”

The market approach is often used as a way to double-check the accuracy of the income approach. The appraiser looks for the prices of similar practices that have already been sold and then adjusts the price on the basis of differences with the practice up for sale.

The asset approach may be used when the practice has no positive cash flow. It establishes a price for tangible assets, which are often much lower in value than the values that the other approaches come up with. The asset approach can be a lower-priced alternative for practices that can’t be measured under the income or market approach.

“Equipment appraisers can do an inventory of your equipment,” Mr. Wood said. “Generally, equipment that is more than 3 years old, such as computers, is not that valuable, but an ultrasound machine probably has some resale value.”
 

Will the buyer pay for goodwill?

Many practice owners hope they can get money for the “goodwill” of their practice when they sell. Goodwill basically represents the reputation of the practice, which is difficult to pinpoint, and Mr. Wood said buyers often don’t want to pay for it.

“The goodwill is a wild card,” Mr. Wood said. “It can range from zero to crazy numbers. There is a Goodwill Registry – a list of the goodwill in other practice sales – that you can consult.”

One simple way to calculate the goodwill, he said, is to take the value of the practice based on examining income and remove the value of tangible assets. What is left is considered the goodwill.

Another form of intangible asset that is sometimes lumped together with goodwill is the value of the practice’s trained staff. “Some buyers agree to pay for the staff in place, because they plan to use that staff,” Ms. Kadan said. In one large deal she was involved with, the buyer agreed to pay something for the selling practice’s staff of 180 people.

Another item that buyers also do not typically pay for is the practice’s accounts receivable. They may also not pay for any liabilities the practice holds, such as the facility lease, equipment lease, and maintenance contracts, Mr. Barbo said. “The buyer then often stipulates that all liabilities are left to the practice, or stipulates any specific liabilities that it may assume.”
 

Selling to other doctors

Doctors can sell practices or shares in practices to other doctors. A retiring physician, for example, can sell his or her share to the other partners. A valuator may be brought in to establish the value of the doctor’s equity interest in the practice.

“Generally, practice buyouts aren’t lucrative for selling physician,” Mr. Wood said. “There are exceptions, of course, such as specialty practices in some cases.”

A practice can also be sold to a new doctor or to a previously employed physician who wants to be an owner. These physicians usually need to get a bank loan to buy the practice.

The bank assesses the finances of the selling practice to determine whether the buying physician will earn enough money to pay back the loan. “Banks don’t want lend more than the gross annual revenue of the practice, and some banks will only lend at 65% of gross annual revenue,” Sean Tinsley said.

COVID-19 has seriously affected banks’ lending decisions. Banks stopped lending to practice buyers at the beginning of the pandemic, and when they started lending again, they were more cautious, Sean Tinsley said. “Generally, banks want to see the practice at 85%-90% of pre–COVID-19 numbers before they make a loan.”

He added that, if a buyer can’t get a bank loan, the selling doctor may decide to finance the sale. The buyer agrees to a payment schedule to pay off the full price over several years.
 

Selling to or merging with other practices

The usual buyer is another practice, Reed Tinsley said. “You can sell to a group, but prices are low because, with COVID-19, buyers don’t want to incur a lot of money up front. Or you can merge with the practice, which means the selling doctor usually doesn’t get any money, but he does get a share in the larger practice. In that case, the partnership is the object of value, and it can be cashed out when the physician leaves the practice.”

Mergers can get very complicated. Mr. Fanburg said he has been working with seven groups that are merging into one. “The merger was scheduled to go live last January, but it was slowed down over negotiations about new managed care contracts and putting together a management structure, plus the groups were a little wary of each other. Now the deal is scheduled to go live next January.”

One advantage to selling to a larger entity, such as a big group practice or a hospital, is that the selling physician benefits from the higher reimbursement rates that large providers usually command. “If the buyer has more favorable reimbursement rates with insurers, it could pay the selling doctor much more than he is making now,” Mr. Barraza said.
 

Hospitals as buyers

Because of COVID-19, currently many hospitals don’t have money to buy more practices. However, this is most likely a temporary situation.

Hospitals typically offer less money than other buyers, according to Sean Tinsley. “We have never sold to a hospital, because hospitals generally don’t pay for goodwill. They pay for the practice assets and offer a dollar amount for each chart.”

Hospitals have to be careful not to pay physicians more than the usual amount for their practices, because the extra amount could be seen as a kickback for referrals, which would violate the federal Stark law and Anti-Kickback Statute. Not-for-profit hospitals also have to comply with regulations at the Internal Revenue Service.

Hospitals usually require that the selling physician continue to work in the practice after it is sold. The selling physician’s presence helps ensure that the practice’s output will not decline after sale. Although the sales price may be low, the hospital may make up for it by paying a higher compensation, Sean Tinsley said.
 

Selling to private-equity firms

Private-equity purchases are financed by investors who essentially want to “flip” practices – that is, they want to make them more profitable and then sell them to someone else. The private-equity firm starts by buying a “platform” practice, which forms the core of the venture. It then buys smaller practices that will be managed by the platform practice.

The number of private-equity deals increased continually through 2019, then plummeted in March because of COVID-19, but by the summer, activity began to rise again.

Physicians are very intrigued about selling to private-equity firms because they are known to pay the most for practices. But private-equity buyers focus on a fairly narrow group of specialties.

Generally, Sean Tinsley said, private-equity firms only look for pain, dermatology, and ophthalmology practices, but they have been starting to branch out to specialties such as gastroenterology. In 2018, there were only two private-equity deals for gastroenterology practices, but in 2019, there were 16, according to one assessment.

Private-equity firms buy very few of the practices they initially review, according to Mr. Fanburg. “Private equity negotiates with dozens or even hundreds of physician practices at a time, with only 1%-5% of those practices actually being acquired.”

The private-equity firm’s upfront payment to selling physicians is quite high, but then the physicians become employees of the new group and earn much less in compensation than they earned on this own.

“In order for the venture to get any value out of the acquisition, the doctors have to make less going forward than they did historically,” Mr. Dietrich said. That freed-up money boosts the value of the venture.

When the platform practice is sold – usually after 5 years or so – “chances are the management team will be replaced,” Mr. Fanburg said. “There could be new policies and objectives, which could mean a bumpy ride for physicians.”
 

Do you really want to sell?

“When a group of physicians comes to me asking for help selling their practice, my first question is, Why are you doing this?” Mr. Fanburg said. “You need a better reason for selling than just the money.

“Once you make the leap, there is a certain amount of autonomy you lose,” he continued. “The sale gives you an economic boost, but it may not be enough for the long haul. If you stay on with the buyer, your compensation is often lower. That makes sense if you’re retiring, but not if you’re a younger physician with many years of practice in the years ahead.

“When physicians say they see no other way out except to sell,” Mr. Fanburg said, “I tell them that their buyer will see a path to future growth for your practice. If you think reimbursements are getting worse, why are the buyers pressing ahead?”

A version of this article originally appeared on Medscape.com.