A new study has found that distributing HIV self-tests to at-risk groups such as men who have sex with men can increase testing frequency and uncover more previously undiagnosed infections.

“Based on these findings, HIV prevention programs might consider adding an HIV self-testing mail distribution component to their portfolio of HIV prevention services for high-risk populations,” wrote Robin J. MacGowan, MPH, of the Centers for Disease Control and Prevention and coauthors. The study was published in JAMA Internal Medicine.

To assess the potential benefits of expanded HIV self-testing, the CDC sponsored a 12-month randomized clinical trial called the Evaluation of Rapid HIV Self-testing Among MSM Project (eSTAMP). Participants were recruited via social media, music and dating websites; criteria included being aged at least 18 years, never having tested positive for HIV, and having engaged in anal sex with at least one man in the past year. The 2,665 participants were assigned to either the self-testing (ST) group (n = 1,325) or the control group (n = 1,340); the ST group received four self-tests in the mail with the option for more each quarter. All participants were asked to complete follow-up surveys every 3 months.

Of all participants, 1,991 (74.7%) initiated at least one follow-up survey. Participants in the ST group reported testing more frequently than those in the control group (an average of 5.3 tests vs. 1.5 tests; P less than .001). In addition, a much higher percentage of ST participants tested at least three times in 12 months (777 of 1014 [76.6%]), compared with controls (215 of 977 [22.0%]). A total of 36 participants tested newly positive for HIV during the study; over the first 3 months, 12 of the 14 infections were identified in the ST group (P less than .007). Over 12 months, 25 of the infections came from the ST group, compared with 11 in the control group (P = .02).

When HIV tests are free and convenient, members of high-risk populations will use them, wrote Julia M. Janssen, MD, of the University of California, San Francisco, and Mitchell H. Katz, MD, of New York City Health and Hospitals in an accompanying editorial (JAMA Intern Med. 2019 Nov 18. doi: 10.1001/jamainternmed.2019.5442). But tests are not enough; the authors noted the role of primary care physicians in prescribing pre-exposure prophylaxis (PrEP) for at-risk patients as key in decreasing rates of new HIV diagnoses.

“The self-testing kits targeting individuals at high risk of acquiring HIV complement the use of PrEP,” they added, “and are another way to accelerate the end of the epidemic.”

The study was funded by the CDC. One author reported receiving grants and fees from the CDC and the National Institutes of Health, along with personal fees from Elsevier and the Ontario HIV Treatment Network. Dr. Katz reported receiving royalties for a chapter on HIV in Lange’s Current Medicine and Diagnostic Testing.

SOURCE: MacGowan RJ et al. JAMA Intern Med. 2019 Nov 18. doi: 10.1001/jamainternmed.2019.5222.

A new study has found that distributing HIV self-tests to at-risk groups such as men who have sex with men can increase testing frequency and uncover more previously undiagnosed infections.

“Based on these findings, HIV prevention programs might consider adding an HIV self-testing mail distribution component to their portfolio of HIV prevention services for high-risk populations,” wrote Robin J. MacGowan, MPH, of the Centers for Disease Control and Prevention and coauthors. The study was published in JAMA Internal Medicine.

To assess the potential benefits of expanded HIV self-testing, the CDC sponsored a 12-month randomized clinical trial called the Evaluation of Rapid HIV Self-testing Among MSM Project (eSTAMP). Participants were recruited via social media, music and dating websites; criteria included being aged at least 18 years, never having tested positive for HIV, and having engaged in anal sex with at least one man in the past year. The 2,665 participants were assigned to either the self-testing (ST) group (n = 1,325) or the control group (n = 1,340); the ST group received four self-tests in the mail with the option for more each quarter. All participants were asked to complete follow-up surveys every 3 months.

Of all participants, 1,991 (74.7%) initiated at least one follow-up survey. Participants in the ST group reported testing more frequently than those in the control group (an average of 5.3 tests vs. 1.5 tests; P less than .001). In addition, a much higher percentage of ST participants tested at least three times in 12 months (777 of 1014 [76.6%]), compared with controls (215 of 977 [22.0%]). A total of 36 participants tested newly positive for HIV during the study; over the first 3 months, 12 of the 14 infections were identified in the ST group (P less than .007). Over 12 months, 25 of the infections came from the ST group, compared with 11 in the control group (P = .02).

When HIV tests are free and convenient, members of high-risk populations will use them, wrote Julia M. Janssen, MD, of the University of California, San Francisco, and Mitchell H. Katz, MD, of New York City Health and Hospitals in an accompanying editorial (JAMA Intern Med. 2019 Nov 18. doi: 10.1001/jamainternmed.2019.5442). But tests are not enough; the authors noted the role of primary care physicians in prescribing pre-exposure prophylaxis (PrEP) for at-risk patients as key in decreasing rates of new HIV diagnoses.

“The self-testing kits targeting individuals at high risk of acquiring HIV complement the use of PrEP,” they added, “and are another way to accelerate the end of the epidemic.”

The study was funded by the CDC. One author reported receiving grants and fees from the CDC and the National Institutes of Health, along with personal fees from Elsevier and the Ontario HIV Treatment Network. Dr. Katz reported receiving royalties for a chapter on HIV in Lange’s Current Medicine and Diagnostic Testing.

SOURCE: MacGowan RJ et al. JAMA Intern Med. 2019 Nov 18. doi: 10.1001/jamainternmed.2019.5222.

A new study has found that distributing HIV self-tests to at-risk groups such as men who have sex with men can increase testing frequency and uncover more previously undiagnosed infections.

“Based on these findings, HIV prevention programs might consider adding an HIV self-testing mail distribution component to their portfolio of HIV prevention services for high-risk populations,” wrote Robin J. MacGowan, MPH, of the Centers for Disease Control and Prevention and coauthors. The study was published in JAMA Internal Medicine.

To assess the potential benefits of expanded HIV self-testing, the CDC sponsored a 12-month randomized clinical trial called the Evaluation of Rapid HIV Self-testing Among MSM Project (eSTAMP). Participants were recruited via social media, music and dating websites; criteria included being aged at least 18 years, never having tested positive for HIV, and having engaged in anal sex with at least one man in the past year. The 2,665 participants were assigned to either the self-testing (ST) group (n = 1,325) or the control group (n = 1,340); the ST group received four self-tests in the mail with the option for more each quarter. All participants were asked to complete follow-up surveys every 3 months.

Of all participants, 1,991 (74.7%) initiated at least one follow-up survey. Participants in the ST group reported testing more frequently than those in the control group (an average of 5.3 tests vs. 1.5 tests; P less than .001). In addition, a much higher percentage of ST participants tested at least three times in 12 months (777 of 1014 [76.6%]), compared with controls (215 of 977 [22.0%]). A total of 36 participants tested newly positive for HIV during the study; over the first 3 months, 12 of the 14 infections were identified in the ST group (P less than .007). Over 12 months, 25 of the infections came from the ST group, compared with 11 in the control group (P = .02).

When HIV tests are free and convenient, members of high-risk populations will use them, wrote Julia M. Janssen, MD, of the University of California, San Francisco, and Mitchell H. Katz, MD, of New York City Health and Hospitals in an accompanying editorial (JAMA Intern Med. 2019 Nov 18. doi: 10.1001/jamainternmed.2019.5442). But tests are not enough; the authors noted the role of primary care physicians in prescribing pre-exposure prophylaxis (PrEP) for at-risk patients as key in decreasing rates of new HIV diagnoses.

“The self-testing kits targeting individuals at high risk of acquiring HIV complement the use of PrEP,” they added, “and are another way to accelerate the end of the epidemic.”

The study was funded by the CDC. One author reported receiving grants and fees from the CDC and the National Institutes of Health, along with personal fees from Elsevier and the Ontario HIV Treatment Network. Dr. Katz reported receiving royalties for a chapter on HIV in Lange’s Current Medicine and Diagnostic Testing.

SOURCE: MacGowan RJ et al. JAMA Intern Med. 2019 Nov 18. doi: 10.1001/jamainternmed.2019.5222.

SAN FRANCISCO – Opioid prescription is surprisingly high after laparoscopic colorectal surgery, and is higher at larger hospitals and in some regions of the United States, according to a new study.

“In theory, for management of pain, any opioids required should be lower after laparoscopic surgery, but opioids are still ubiquitous and prescribing patterns have largely been unchanged with laparoscopy,” Deborah S. Keller, MD, assistant professor of surgery at Columbia University, New York, said at the annual clinical congress of the American College of Surgeons.

Several studies show wide variation in opioid use and prescribing after laparoscopic colorectal surgery, Dr. Keller said. She also pointed out that available data are limited on inpatient opioid use and the causes of high opioid use.

The team analyzed records of 18,395 subjects from the Premier Inpatient Database, between Jan. 1, 2014, and Sept. 30, 2015. The mean age was 61 years, and 54% were female. The distribution of hospital-stay milligram morphine equivalents (MME) was 48 at the 25th percentile, 108 at the 50th, and 246 at the 75th percentile. Overall, 18% of patients were in the high use category.

Some factors were associated with high opioid use, including emergency surgery (odds ratio, 1.28; P = .0002), being aged 18-34 (OR, 5.8; P less than .0001), major severity of illness (OR, 4.2; P less than .0001), chronic obstructive pulmonary disease comorbidity (OR, 1.13; P =.0350), having Medicaid insurance (OR, 1.35; P less than .0001), and being treated in a rural hospital (OR, 1.44; P less than.0001).

Factors associated with lower opioid use included female sex (OR, 0.90; P = .0064), being treated in a facility with fewer than 500 beds (OR, 0.706-0.822, all statistically significant), being treated in the Midwest (OR, 0.62; P less than .0001) or the South (OR, 0.66; P less than .0001), and treatment by a surgeon with a lower surgical volume (fewer than 65 cases vs. 300; OR, 0.58; P = .0286).

The study was limited by its reliance on administrative data, and one questioner at the session wondered about the validity of the 75% cutoff for high use, suggesting that it would be better to pick a value that was associated with a known increased risk of opioid dependence.

The findings could help inform future guidelines, Dr. Keller said. “On a local level, it can help optimize enhanced recovery protocols, (assist) providers to proactively recognize patients and scenarios at risk for high use, and create targeted education for younger patients, hospitals in specific geographic regions, and larger bedside hospitals so that they can follow best practices,” she added.

The finding that institutions with fewer beds were associated with lower chances of high opioid use was a surprise. “We’re looking into that,” she said.

Dr. Keller had no relevant financial disclosures.

SOURCE: Keller DS et al. Clinical Congress 2019, Abstract.

SAN FRANCISCO – Opioid prescription is surprisingly high after laparoscopic colorectal surgery, and is higher at larger hospitals and in some regions of the United States, according to a new study.

“In theory, for management of pain, any opioids required should be lower after laparoscopic surgery, but opioids are still ubiquitous and prescribing patterns have largely been unchanged with laparoscopy,” Deborah S. Keller, MD, assistant professor of surgery at Columbia University, New York, said at the annual clinical congress of the American College of Surgeons.

Several studies show wide variation in opioid use and prescribing after laparoscopic colorectal surgery, Dr. Keller said. She also pointed out that available data are limited on inpatient opioid use and the causes of high opioid use.

The team analyzed records of 18,395 subjects from the Premier Inpatient Database, between Jan. 1, 2014, and Sept. 30, 2015. The mean age was 61 years, and 54% were female. The distribution of hospital-stay milligram morphine equivalents (MME) was 48 at the 25th percentile, 108 at the 50th, and 246 at the 75th percentile. Overall, 18% of patients were in the high use category.

Some factors were associated with high opioid use, including emergency surgery (odds ratio, 1.28; P = .0002), being aged 18-34 (OR, 5.8; P less than .0001), major severity of illness (OR, 4.2; P less than .0001), chronic obstructive pulmonary disease comorbidity (OR, 1.13; P =.0350), having Medicaid insurance (OR, 1.35; P less than .0001), and being treated in a rural hospital (OR, 1.44; P less than.0001).

Factors associated with lower opioid use included female sex (OR, 0.90; P = .0064), being treated in a facility with fewer than 500 beds (OR, 0.706-0.822, all statistically significant), being treated in the Midwest (OR, 0.62; P less than .0001) or the South (OR, 0.66; P less than .0001), and treatment by a surgeon with a lower surgical volume (fewer than 65 cases vs. 300; OR, 0.58; P = .0286).

The study was limited by its reliance on administrative data, and one questioner at the session wondered about the validity of the 75% cutoff for high use, suggesting that it would be better to pick a value that was associated with a known increased risk of opioid dependence.

The findings could help inform future guidelines, Dr. Keller said. “On a local level, it can help optimize enhanced recovery protocols, (assist) providers to proactively recognize patients and scenarios at risk for high use, and create targeted education for younger patients, hospitals in specific geographic regions, and larger bedside hospitals so that they can follow best practices,” she added.

The finding that institutions with fewer beds were associated with lower chances of high opioid use was a surprise. “We’re looking into that,” she said.

Dr. Keller had no relevant financial disclosures.

SOURCE: Keller DS et al. Clinical Congress 2019, Abstract.

SAN FRANCISCO – Opioid prescription is surprisingly high after laparoscopic colorectal surgery, and is higher at larger hospitals and in some regions of the United States, according to a new study.

“In theory, for management of pain, any opioids required should be lower after laparoscopic surgery, but opioids are still ubiquitous and prescribing patterns have largely been unchanged with laparoscopy,” Deborah S. Keller, MD, assistant professor of surgery at Columbia University, New York, said at the annual clinical congress of the American College of Surgeons.

Several studies show wide variation in opioid use and prescribing after laparoscopic colorectal surgery, Dr. Keller said. She also pointed out that available data are limited on inpatient opioid use and the causes of high opioid use.

The team analyzed records of 18,395 subjects from the Premier Inpatient Database, between Jan. 1, 2014, and Sept. 30, 2015. The mean age was 61 years, and 54% were female. The distribution of hospital-stay milligram morphine equivalents (MME) was 48 at the 25th percentile, 108 at the 50th, and 246 at the 75th percentile. Overall, 18% of patients were in the high use category.

Some factors were associated with high opioid use, including emergency surgery (odds ratio, 1.28; P = .0002), being aged 18-34 (OR, 5.8; P less than .0001), major severity of illness (OR, 4.2; P less than .0001), chronic obstructive pulmonary disease comorbidity (OR, 1.13; P =.0350), having Medicaid insurance (OR, 1.35; P less than .0001), and being treated in a rural hospital (OR, 1.44; P less than.0001).

Factors associated with lower opioid use included female sex (OR, 0.90; P = .0064), being treated in a facility with fewer than 500 beds (OR, 0.706-0.822, all statistically significant), being treated in the Midwest (OR, 0.62; P less than .0001) or the South (OR, 0.66; P less than .0001), and treatment by a surgeon with a lower surgical volume (fewer than 65 cases vs. 300; OR, 0.58; P = .0286).

The study was limited by its reliance on administrative data, and one questioner at the session wondered about the validity of the 75% cutoff for high use, suggesting that it would be better to pick a value that was associated with a known increased risk of opioid dependence.

The findings could help inform future guidelines, Dr. Keller said. “On a local level, it can help optimize enhanced recovery protocols, (assist) providers to proactively recognize patients and scenarios at risk for high use, and create targeted education for younger patients, hospitals in specific geographic regions, and larger bedside hospitals so that they can follow best practices,” she added.

The finding that institutions with fewer beds were associated with lower chances of high opioid use was a surprise. “We’re looking into that,” she said.

Dr. Keller had no relevant financial disclosures.

SOURCE: Keller DS et al. Clinical Congress 2019, Abstract.

LAS VEGAS – The patient, a 61-year-old man, came to see a dermatologist here about subcutaneous masses on his left arm, abdomen, and on both thighs.

It didn’t take long for Curt Samlaska, MD, of the University of Nevada, Reno, to link the masses to the patient’s daily regimen of seven insulin injections.

But diagnosing the condition required more than asking a few questions. At first, the man appeared to suffer from lipohypertrophy – a lump caused by an accumulation of fat at the site of insulin injections. But, Dr. Samlaska told colleagues, the patient had a different condition that’s barely been discussed in the dermatologic literature – insulin-derived amyloidosis, also known as “insulin ball.”

“It’s probably much more prevalent than we currently appreciate,” said Dr. Samlaska, who spoke in a presentation at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar. “Many cases are not [fully] evaluated and thought to be lipohypertrophy.”

Dr. Samlaska’s patient had suffered from diabetes since age 23 and tightly controls his blood sugar through seven daily injections. He injects short-acting insulin into his arms and abdomen, and long-acting insulin into his thighs.

The masses began appearing about 10 years ago, he told Dr. Samlaska, and he’s suffered more pain while injecting them over time. But the masses are easier to grasp during injections, and the patient’s body did not offer many other sites for injections.

According to Dr. Samlaska, there are about 75 case reports of insulin ball in the medical literature, almost all in endocrinology journals. Ninety percent have a single lump, most commonly in the abdomen, and most have poor glycemic control, he said. (His patient is an outlier.)

Research suggests that insulin balls absorb about 34% of the insulin that’s injected, meaning that patients must inject more than usual to get the same effect. Be careful to advise patients about this, Dr. Samlaska said, because they might try alternative injection sites and get a sudden unexpected flood of insulin – potentially causing hypoglycemia.

He added that another drug – the HIV fusion inhibitor enfuvirtide – also has been linked to amyloidosis.

Pathology can offer insight into whether a mass is an insulin ball or a case of lipohypertrophy, he said. “They’re difficult to distinguish on clinical grounds,” he said, although lipohypertrophy masses are firmer, and they shrink when patients stop injecting insulin. Insulin balls do not.

The treatment for insulin balls is surgical excision, he said. “It’s very easy to do. With the extrusion technique, it comes out like a cheese, like a cyst.”

He said his patient was scheduled to soon undergo excision treatment.

Dr. Samlaska reported no relevant disclosures. SDEF and this news organization are owned by the same parent company.

LAS VEGAS – The patient, a 61-year-old man, came to see a dermatologist here about subcutaneous masses on his left arm, abdomen, and on both thighs.

It didn’t take long for Curt Samlaska, MD, of the University of Nevada, Reno, to link the masses to the patient’s daily regimen of seven insulin injections.

But diagnosing the condition required more than asking a few questions. At first, the man appeared to suffer from lipohypertrophy – a lump caused by an accumulation of fat at the site of insulin injections. But, Dr. Samlaska told colleagues, the patient had a different condition that’s barely been discussed in the dermatologic literature – insulin-derived amyloidosis, also known as “insulin ball.”

“It’s probably much more prevalent than we currently appreciate,” said Dr. Samlaska, who spoke in a presentation at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar. “Many cases are not [fully] evaluated and thought to be lipohypertrophy.”

Dr. Samlaska’s patient had suffered from diabetes since age 23 and tightly controls his blood sugar through seven daily injections. He injects short-acting insulin into his arms and abdomen, and long-acting insulin into his thighs.

The masses began appearing about 10 years ago, he told Dr. Samlaska, and he’s suffered more pain while injecting them over time. But the masses are easier to grasp during injections, and the patient’s body did not offer many other sites for injections.

According to Dr. Samlaska, there are about 75 case reports of insulin ball in the medical literature, almost all in endocrinology journals. Ninety percent have a single lump, most commonly in the abdomen, and most have poor glycemic control, he said. (His patient is an outlier.)

Research suggests that insulin balls absorb about 34% of the insulin that’s injected, meaning that patients must inject more than usual to get the same effect. Be careful to advise patients about this, Dr. Samlaska said, because they might try alternative injection sites and get a sudden unexpected flood of insulin – potentially causing hypoglycemia.

He added that another drug – the HIV fusion inhibitor enfuvirtide – also has been linked to amyloidosis.

Pathology can offer insight into whether a mass is an insulin ball or a case of lipohypertrophy, he said. “They’re difficult to distinguish on clinical grounds,” he said, although lipohypertrophy masses are firmer, and they shrink when patients stop injecting insulin. Insulin balls do not.

The treatment for insulin balls is surgical excision, he said. “It’s very easy to do. With the extrusion technique, it comes out like a cheese, like a cyst.”

He said his patient was scheduled to soon undergo excision treatment.

Dr. Samlaska reported no relevant disclosures. SDEF and this news organization are owned by the same parent company.

LAS VEGAS – The patient, a 61-year-old man, came to see a dermatologist here about subcutaneous masses on his left arm, abdomen, and on both thighs.

It didn’t take long for Curt Samlaska, MD, of the University of Nevada, Reno, to link the masses to the patient’s daily regimen of seven insulin injections.

But diagnosing the condition required more than asking a few questions. At first, the man appeared to suffer from lipohypertrophy – a lump caused by an accumulation of fat at the site of insulin injections. But, Dr. Samlaska told colleagues, the patient had a different condition that’s barely been discussed in the dermatologic literature – insulin-derived amyloidosis, also known as “insulin ball.”

“It’s probably much more prevalent than we currently appreciate,” said Dr. Samlaska, who spoke in a presentation at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar. “Many cases are not [fully] evaluated and thought to be lipohypertrophy.”

Dr. Samlaska’s patient had suffered from diabetes since age 23 and tightly controls his blood sugar through seven daily injections. He injects short-acting insulin into his arms and abdomen, and long-acting insulin into his thighs.

The masses began appearing about 10 years ago, he told Dr. Samlaska, and he’s suffered more pain while injecting them over time. But the masses are easier to grasp during injections, and the patient’s body did not offer many other sites for injections.

According to Dr. Samlaska, there are about 75 case reports of insulin ball in the medical literature, almost all in endocrinology journals. Ninety percent have a single lump, most commonly in the abdomen, and most have poor glycemic control, he said. (His patient is an outlier.)

Research suggests that insulin balls absorb about 34% of the insulin that’s injected, meaning that patients must inject more than usual to get the same effect. Be careful to advise patients about this, Dr. Samlaska said, because they might try alternative injection sites and get a sudden unexpected flood of insulin – potentially causing hypoglycemia.

He added that another drug – the HIV fusion inhibitor enfuvirtide – also has been linked to amyloidosis.

Pathology can offer insight into whether a mass is an insulin ball or a case of lipohypertrophy, he said. “They’re difficult to distinguish on clinical grounds,” he said, although lipohypertrophy masses are firmer, and they shrink when patients stop injecting insulin. Insulin balls do not.

The treatment for insulin balls is surgical excision, he said. “It’s very easy to do. With the extrusion technique, it comes out like a cheese, like a cyst.”

He said his patient was scheduled to soon undergo excision treatment.

Dr. Samlaska reported no relevant disclosures. SDEF and this news organization are owned by the same parent company.

Adolescence is a critical period of development that brings with it unique health challenges, which has prompted the American Academy of Pediatrics to publish a policy statement addressing those issues.

“The importance of addressing the physical and mental health of adolescents has become more evident, with investigators in recent studies pointing to the fact that unmet health needs during adolescence and in the transition to adulthood predict not only poor health outcomes as adults but also lower quality of life in adulthood,” wrote lead authors Elizabeth M. Alderman, MD, and Cora Collette Breuner, MD, MPH, of the AAP’s Committee on Adolescence.

Lisa Quarfoth/Thinkstock

The first key health risk the authors highlighted was risky and risk-taking behaviors, pointing out that nearly three-quarters of adolescent deaths result from vehicle crashes, injuries from firearms, alcohol and illicit substances, homicide, or suicide. They also cited increased concern about the use of e-cigarettes among adolescents.

Recommendations exist on screening for and counseling on high-risk behaviors, but evidence showing that relatively few adolescents actually receive any kind of preventive counseling or discuss these health risks with pediatricians or primary care physicians suggests that improvement is needed.

“New screening codes for depression, substance use, and alcohol and tobacco use as well as brief intervention services may provide opportunities to receive payment for the services pediatricians are providing to adolescents,” wrote Dr. Alderman of the division of adolescent medicine in the department of pediatrics at Albert Einstein College of Medicine and the Children’s Hospital at Montefiore, New York, and Dr. Breuner of the division of adolescent medicine at the University of Washington and Seattle Children’s Hospital.

Thanks to technological advances in pediatric medical care, more adolescents are being identified with chronic medical conditions and developmental challenges. One survey suggested that as many as 31% of adolescents have one moderate to severe chronic health condition, such as asthma, cardiac disease, HIV, and developmental disabilities. Many, however, have unmet health needs that could affect their physical growth and development during adolescence.

The paper also raised the importance of providing culturally competent health care approaches and support for minority youth, with evidence suggesting this group of adolescents is at risk of depression because of the isolation and discrimination they experience.

Similarly, the statement acknowledged the growing diversity of adolescent populations – for example, adolescents who identify as lesbian, gay, bisexual, or transgender – and the importance of delivering appropriate care to those populations.

“Sexual orientation and behaviors should be assessed by the pediatrician without making assumptions,” the authors wrote. “Adolescents should be allowed to apply and explain the labels they choose to use for sexuality and gender using open-ended questions.”

The authors drew attention to the greater mental health risks of adolescents, pointing out that about one in five adolescents have a diagnosable mental health disorder and one-quarter of adults with mood disorders had their first major depressive episode during adolescence. They also cited the Centers for Disease Control and Prevention’s 2017 Youth Risk Behavior Survey of high school students, which showed that adolescents with a parent serving in the military are at increased risk of suicidal ideation.

In addition, Dr. Alderman and Dr. Breuner said, mental health problems experienced by adolescents often are comorbid with eating disorders. Formerly obese adolescents, male teenagers, and young people from lower socioeconomic groups are increasingly developing anorexia nervosa, bulimia nervosa, and other disordered eating.

The paper called for more financial, educational, and training support for pediatricians and other health care professionals to enable them to better meet the health and developmental needs of adolescents.

Dr. Alderman and Dr. Breuner declared having no conflicts of interest.

SOURCE: Alderman EM and Breuner CC. Pediatrics. 2019 Nov 18. doi: 10.1542/peds.2019-3150 .

Adolescence is a critical period of development that brings with it unique health challenges, which has prompted the American Academy of Pediatrics to publish a policy statement addressing those issues.

“The importance of addressing the physical and mental health of adolescents has become more evident, with investigators in recent studies pointing to the fact that unmet health needs during adolescence and in the transition to adulthood predict not only poor health outcomes as adults but also lower quality of life in adulthood,” wrote lead authors Elizabeth M. Alderman, MD, and Cora Collette Breuner, MD, MPH, of the AAP’s Committee on Adolescence.

Lisa Quarfoth/Thinkstock

The first key health risk the authors highlighted was risky and risk-taking behaviors, pointing out that nearly three-quarters of adolescent deaths result from vehicle crashes, injuries from firearms, alcohol and illicit substances, homicide, or suicide. They also cited increased concern about the use of e-cigarettes among adolescents.

Recommendations exist on screening for and counseling on high-risk behaviors, but evidence showing that relatively few adolescents actually receive any kind of preventive counseling or discuss these health risks with pediatricians or primary care physicians suggests that improvement is needed.

“New screening codes for depression, substance use, and alcohol and tobacco use as well as brief intervention services may provide opportunities to receive payment for the services pediatricians are providing to adolescents,” wrote Dr. Alderman of the division of adolescent medicine in the department of pediatrics at Albert Einstein College of Medicine and the Children’s Hospital at Montefiore, New York, and Dr. Breuner of the division of adolescent medicine at the University of Washington and Seattle Children’s Hospital.

Thanks to technological advances in pediatric medical care, more adolescents are being identified with chronic medical conditions and developmental challenges. One survey suggested that as many as 31% of adolescents have one moderate to severe chronic health condition, such as asthma, cardiac disease, HIV, and developmental disabilities. Many, however, have unmet health needs that could affect their physical growth and development during adolescence.

The paper also raised the importance of providing culturally competent health care approaches and support for minority youth, with evidence suggesting this group of adolescents is at risk of depression because of the isolation and discrimination they experience.

Similarly, the statement acknowledged the growing diversity of adolescent populations – for example, adolescents who identify as lesbian, gay, bisexual, or transgender – and the importance of delivering appropriate care to those populations.

“Sexual orientation and behaviors should be assessed by the pediatrician without making assumptions,” the authors wrote. “Adolescents should be allowed to apply and explain the labels they choose to use for sexuality and gender using open-ended questions.”

The authors drew attention to the greater mental health risks of adolescents, pointing out that about one in five adolescents have a diagnosable mental health disorder and one-quarter of adults with mood disorders had their first major depressive episode during adolescence. They also cited the Centers for Disease Control and Prevention’s 2017 Youth Risk Behavior Survey of high school students, which showed that adolescents with a parent serving in the military are at increased risk of suicidal ideation.

In addition, Dr. Alderman and Dr. Breuner said, mental health problems experienced by adolescents often are comorbid with eating disorders. Formerly obese adolescents, male teenagers, and young people from lower socioeconomic groups are increasingly developing anorexia nervosa, bulimia nervosa, and other disordered eating.

The paper called for more financial, educational, and training support for pediatricians and other health care professionals to enable them to better meet the health and developmental needs of adolescents.

Dr. Alderman and Dr. Breuner declared having no conflicts of interest.

SOURCE: Alderman EM and Breuner CC. Pediatrics. 2019 Nov 18. doi: 10.1542/peds.2019-3150 .

Adolescence is a critical period of development that brings with it unique health challenges, which has prompted the American Academy of Pediatrics to publish a policy statement addressing those issues.

“The importance of addressing the physical and mental health of adolescents has become more evident, with investigators in recent studies pointing to the fact that unmet health needs during adolescence and in the transition to adulthood predict not only poor health outcomes as adults but also lower quality of life in adulthood,” wrote lead authors Elizabeth M. Alderman, MD, and Cora Collette Breuner, MD, MPH, of the AAP’s Committee on Adolescence.

Lisa Quarfoth/Thinkstock

The first key health risk the authors highlighted was risky and risk-taking behaviors, pointing out that nearly three-quarters of adolescent deaths result from vehicle crashes, injuries from firearms, alcohol and illicit substances, homicide, or suicide. They also cited increased concern about the use of e-cigarettes among adolescents.

Recommendations exist on screening for and counseling on high-risk behaviors, but evidence showing that relatively few adolescents actually receive any kind of preventive counseling or discuss these health risks with pediatricians or primary care physicians suggests that improvement is needed.

“New screening codes for depression, substance use, and alcohol and tobacco use as well as brief intervention services may provide opportunities to receive payment for the services pediatricians are providing to adolescents,” wrote Dr. Alderman of the division of adolescent medicine in the department of pediatrics at Albert Einstein College of Medicine and the Children’s Hospital at Montefiore, New York, and Dr. Breuner of the division of adolescent medicine at the University of Washington and Seattle Children’s Hospital.

Thanks to technological advances in pediatric medical care, more adolescents are being identified with chronic medical conditions and developmental challenges. One survey suggested that as many as 31% of adolescents have one moderate to severe chronic health condition, such as asthma, cardiac disease, HIV, and developmental disabilities. Many, however, have unmet health needs that could affect their physical growth and development during adolescence.

The paper also raised the importance of providing culturally competent health care approaches and support for minority youth, with evidence suggesting this group of adolescents is at risk of depression because of the isolation and discrimination they experience.

Similarly, the statement acknowledged the growing diversity of adolescent populations – for example, adolescents who identify as lesbian, gay, bisexual, or transgender – and the importance of delivering appropriate care to those populations.

“Sexual orientation and behaviors should be assessed by the pediatrician without making assumptions,” the authors wrote. “Adolescents should be allowed to apply and explain the labels they choose to use for sexuality and gender using open-ended questions.”

The authors drew attention to the greater mental health risks of adolescents, pointing out that about one in five adolescents have a diagnosable mental health disorder and one-quarter of adults with mood disorders had their first major depressive episode during adolescence. They also cited the Centers for Disease Control and Prevention’s 2017 Youth Risk Behavior Survey of high school students, which showed that adolescents with a parent serving in the military are at increased risk of suicidal ideation.

In addition, Dr. Alderman and Dr. Breuner said, mental health problems experienced by adolescents often are comorbid with eating disorders. Formerly obese adolescents, male teenagers, and young people from lower socioeconomic groups are increasingly developing anorexia nervosa, bulimia nervosa, and other disordered eating.

The paper called for more financial, educational, and training support for pediatricians and other health care professionals to enable them to better meet the health and developmental needs of adolescents.

Dr. Alderman and Dr. Breuner declared having no conflicts of interest.

SOURCE: Alderman EM and Breuner CC. Pediatrics. 2019 Nov 18. doi: 10.1542/peds.2019-3150 .

Educating pediatricians to inform their teenage patients about emergency contraception is an important step toward reducing adolescent pregnancy in the United States, according to a policy statement issued by the American Academy of Pediatrics.

“Improved use of contraception, not declines in sexual activity, has been the most significant contributor to the decline in pregnancy risk among U.S. teenagers over the past decade,” wrote Krishna K. Upadhya, MD, MPH, and colleagues on the AAP’s Committee on Adolescence.

Data suggest that adolescents are more likely to use emergency contraception when it has been prescribed or given before they need it; however, many pediatricians do not routinely counsel adolescents about emergency contraception, they noted.

In the statement published Nov. 18 in Pediatrics, the committee listed indications for emergency contraception as unprotected or underprotected intercourse for reasons including sexual assault, lack of contraception use, or ineffective contraception use. The committee recommended that pediatricians provide emergency contraception in the form of oral pills (levonorgestrel or ulipristal acetate) or copper IUDs to adolescents in immediate need of emergency contraception, and ideally, to make those products available in advance so teens have them on hand.

The committee recommended the use of combined contraceptive pills known as the Yuzpe method, if dedicated emergency contraceptive pills or IUDs are not available, and emphasized the possible impact of overweight and obesity on the effectiveness of emergency contraceptive pills.

The recommendations also include advising adolescents about proper use of emergency contraception, and the need for follow-up visits to address ongoing contraception and testing for sexually transmitted diseases. The committee noted that adolescents using emergency contraceptive pills must be counseled to abstain or use additional contraception (such as condoms) because of the delay in ovulation associated with these products.

The committee recommended that all adolescents receive counseling on emergency contraception as part of a general discussion on sexual health, regardless of current sexual activity or lack of it. “In addition, it is important that information about EC be included in all contraceptive and STI counseling for adolescents wherever these visits occur, including emergency departments, clinics, and hospitals,” and that pediatricians provide this information to teens with physical and cognitive disabilities and their parents as well, they wrote.

The committee concluded the recommendations by asking clinicians to advocate for free or inexpensive nonprescription access to emergency contraceptive pills for adolescents regardless of age and insurance status.

M. Susan Jay, MD, program director of adolescent health and medicine at the Children’s Hospital of Wisconsin, Milwaukee, commented in an interview, “Forty years ago, as I completed my training, I don’t believe it would have been possible to contemplate the growth of adolescent health care, including reproductive health care that current pediatric practitioners are asked to provide to the adolescents under their care.”

“Today we are asked to be a resource from topics related to vaping and trafficking as well as psychosocial concerns from anxiety to eating disorders. This policy statement from the AAP addresses how best to approach and counsel both young women and young men as they traverse the issues of sexual engagement and responsibility. I have been privileged to work with pediatric residents who are far more sophisticated and knowledgeable than I have ever been, but they call and ask the very questions so adroitly presented in this policy statement. Most of my pediatric colleagues have had a limited adolescent medicine experience, and yet they are asked to care for youth in sensitive situations and want the tools necessary to provide the very best and safest care to their patients. Most of us will not be skilled in the placement of copper IUDs as outlined as an option for emergency contraception, but knowledge of the medications reviewed is of importance and relevant to everyday practice.

"This policy statement is a resource and educational update rolled into one, and Dr. Upadhya and her colleagues on the AAP’s Committee on Adolescence should be commended for assisting providers to offer the best and safest care,” said Dr. Jay, who was not involved in writing the AAP policy statement, and is a member of the Pediatric News Editorial Advisory Board who was asked to comment on the new policy statement.

 The American College of Pediatricians (ACPeds), a conservative-leaning pediatric organization opposes the AAP’s recent opinion and the provision of emergency contraception to youth, Michelle Cretella, MD, executive director for the group, said in an interview. In its own position statement, ACPeds wrote that preprescribing EC to adolescent patients, or making them available without prescription, “carries significant medical risk and is counterproductive to the parent-adolescent and patient-physician relationships.”  

“Increased access to [EC] does not result in lower pregnancy rates among adolescents and young adults,” said Dr. Cretella, a board-certified pediatrician who is not currently in practice. The ACPeds position statement cites a 2012 study that examined a Washington state program that allowed patients to access EC through pharmacies without a prescription. The analysis found the increased access to EC resulted in a statistically significant rise in gonorrhea for women and overall for both genders. The increased access to EC did not impact birth rates or abortion rates, according to the study (Economic Inquiry. 2013 Jul;51[3]:1682-95).

The ACPeds statement also notes a report by the Heritage Foundation that found sexually active teenagers were less likely to be happy and more likely to be depressed than were youth who were not having sex. The 2003 report, which examined responses from 6,500 adolescents through the 1996 National Longitudinal Survey of Adolescent Health, also found that sexually active teenagers were significantly more likely to attempt suicide, compared with teens who were not sexually active. 


Dr. Upadhya disclosed having no financial conflicts.

SOURCE: Upadhya KK et al. Pediatrics. 2019 Nov 18. doi: 10.1542/peds.2019-3149.

This article was updated on 11/19/19 and 12/16/19.

Educating pediatricians to inform their teenage patients about emergency contraception is an important step toward reducing adolescent pregnancy in the United States, according to a policy statement issued by the American Academy of Pediatrics.

“Improved use of contraception, not declines in sexual activity, has been the most significant contributor to the decline in pregnancy risk among U.S. teenagers over the past decade,” wrote Krishna K. Upadhya, MD, MPH, and colleagues on the AAP’s Committee on Adolescence.

Data suggest that adolescents are more likely to use emergency contraception when it has been prescribed or given before they need it; however, many pediatricians do not routinely counsel adolescents about emergency contraception, they noted.

In the statement published Nov. 18 in Pediatrics, the committee listed indications for emergency contraception as unprotected or underprotected intercourse for reasons including sexual assault, lack of contraception use, or ineffective contraception use. The committee recommended that pediatricians provide emergency contraception in the form of oral pills (levonorgestrel or ulipristal acetate) or copper IUDs to adolescents in immediate need of emergency contraception, and ideally, to make those products available in advance so teens have them on hand.

The committee recommended the use of combined contraceptive pills known as the Yuzpe method, if dedicated emergency contraceptive pills or IUDs are not available, and emphasized the possible impact of overweight and obesity on the effectiveness of emergency contraceptive pills.

The recommendations also include advising adolescents about proper use of emergency contraception, and the need for follow-up visits to address ongoing contraception and testing for sexually transmitted diseases. The committee noted that adolescents using emergency contraceptive pills must be counseled to abstain or use additional contraception (such as condoms) because of the delay in ovulation associated with these products.

The committee recommended that all adolescents receive counseling on emergency contraception as part of a general discussion on sexual health, regardless of current sexual activity or lack of it. “In addition, it is important that information about EC be included in all contraceptive and STI counseling for adolescents wherever these visits occur, including emergency departments, clinics, and hospitals,” and that pediatricians provide this information to teens with physical and cognitive disabilities and their parents as well, they wrote.

The committee concluded the recommendations by asking clinicians to advocate for free or inexpensive nonprescription access to emergency contraceptive pills for adolescents regardless of age and insurance status.

M. Susan Jay, MD, program director of adolescent health and medicine at the Children’s Hospital of Wisconsin, Milwaukee, commented in an interview, “Forty years ago, as I completed my training, I don’t believe it would have been possible to contemplate the growth of adolescent health care, including reproductive health care that current pediatric practitioners are asked to provide to the adolescents under their care.”

“Today we are asked to be a resource from topics related to vaping and trafficking as well as psychosocial concerns from anxiety to eating disorders. This policy statement from the AAP addresses how best to approach and counsel both young women and young men as they traverse the issues of sexual engagement and responsibility. I have been privileged to work with pediatric residents who are far more sophisticated and knowledgeable than I have ever been, but they call and ask the very questions so adroitly presented in this policy statement. Most of my pediatric colleagues have had a limited adolescent medicine experience, and yet they are asked to care for youth in sensitive situations and want the tools necessary to provide the very best and safest care to their patients. Most of us will not be skilled in the placement of copper IUDs as outlined as an option for emergency contraception, but knowledge of the medications reviewed is of importance and relevant to everyday practice.

"This policy statement is a resource and educational update rolled into one, and Dr. Upadhya and her colleagues on the AAP’s Committee on Adolescence should be commended for assisting providers to offer the best and safest care,” said Dr. Jay, who was not involved in writing the AAP policy statement, and is a member of the Pediatric News Editorial Advisory Board who was asked to comment on the new policy statement.

 The American College of Pediatricians (ACPeds), a conservative-leaning pediatric organization opposes the AAP’s recent opinion and the provision of emergency contraception to youth, Michelle Cretella, MD, executive director for the group, said in an interview. In its own position statement, ACPeds wrote that preprescribing EC to adolescent patients, or making them available without prescription, “carries significant medical risk and is counterproductive to the parent-adolescent and patient-physician relationships.”  

“Increased access to [EC] does not result in lower pregnancy rates among adolescents and young adults,” said Dr. Cretella, a board-certified pediatrician who is not currently in practice. The ACPeds position statement cites a 2012 study that examined a Washington state program that allowed patients to access EC through pharmacies without a prescription. The analysis found the increased access to EC resulted in a statistically significant rise in gonorrhea for women and overall for both genders. The increased access to EC did not impact birth rates or abortion rates, according to the study (Economic Inquiry. 2013 Jul;51[3]:1682-95).

The ACPeds statement also notes a report by the Heritage Foundation that found sexually active teenagers were less likely to be happy and more likely to be depressed than were youth who were not having sex. The 2003 report, which examined responses from 6,500 adolescents through the 1996 National Longitudinal Survey of Adolescent Health, also found that sexually active teenagers were significantly more likely to attempt suicide, compared with teens who were not sexually active. 


Dr. Upadhya disclosed having no financial conflicts.

SOURCE: Upadhya KK et al. Pediatrics. 2019 Nov 18. doi: 10.1542/peds.2019-3149.

This article was updated on 11/19/19 and 12/16/19.

Educating pediatricians to inform their teenage patients about emergency contraception is an important step toward reducing adolescent pregnancy in the United States, according to a policy statement issued by the American Academy of Pediatrics.

“Improved use of contraception, not declines in sexual activity, has been the most significant contributor to the decline in pregnancy risk among U.S. teenagers over the past decade,” wrote Krishna K. Upadhya, MD, MPH, and colleagues on the AAP’s Committee on Adolescence.

Data suggest that adolescents are more likely to use emergency contraception when it has been prescribed or given before they need it; however, many pediatricians do not routinely counsel adolescents about emergency contraception, they noted.

In the statement published Nov. 18 in Pediatrics, the committee listed indications for emergency contraception as unprotected or underprotected intercourse for reasons including sexual assault, lack of contraception use, or ineffective contraception use. The committee recommended that pediatricians provide emergency contraception in the form of oral pills (levonorgestrel or ulipristal acetate) or copper IUDs to adolescents in immediate need of emergency contraception, and ideally, to make those products available in advance so teens have them on hand.

The committee recommended the use of combined contraceptive pills known as the Yuzpe method, if dedicated emergency contraceptive pills or IUDs are not available, and emphasized the possible impact of overweight and obesity on the effectiveness of emergency contraceptive pills.

The recommendations also include advising adolescents about proper use of emergency contraception, and the need for follow-up visits to address ongoing contraception and testing for sexually transmitted diseases. The committee noted that adolescents using emergency contraceptive pills must be counseled to abstain or use additional contraception (such as condoms) because of the delay in ovulation associated with these products.

The committee recommended that all adolescents receive counseling on emergency contraception as part of a general discussion on sexual health, regardless of current sexual activity or lack of it. “In addition, it is important that information about EC be included in all contraceptive and STI counseling for adolescents wherever these visits occur, including emergency departments, clinics, and hospitals,” and that pediatricians provide this information to teens with physical and cognitive disabilities and their parents as well, they wrote.

The committee concluded the recommendations by asking clinicians to advocate for free or inexpensive nonprescription access to emergency contraceptive pills for adolescents regardless of age and insurance status.

M. Susan Jay, MD, program director of adolescent health and medicine at the Children’s Hospital of Wisconsin, Milwaukee, commented in an interview, “Forty years ago, as I completed my training, I don’t believe it would have been possible to contemplate the growth of adolescent health care, including reproductive health care that current pediatric practitioners are asked to provide to the adolescents under their care.”

“Today we are asked to be a resource from topics related to vaping and trafficking as well as psychosocial concerns from anxiety to eating disorders. This policy statement from the AAP addresses how best to approach and counsel both young women and young men as they traverse the issues of sexual engagement and responsibility. I have been privileged to work with pediatric residents who are far more sophisticated and knowledgeable than I have ever been, but they call and ask the very questions so adroitly presented in this policy statement. Most of my pediatric colleagues have had a limited adolescent medicine experience, and yet they are asked to care for youth in sensitive situations and want the tools necessary to provide the very best and safest care to their patients. Most of us will not be skilled in the placement of copper IUDs as outlined as an option for emergency contraception, but knowledge of the medications reviewed is of importance and relevant to everyday practice.

"This policy statement is a resource and educational update rolled into one, and Dr. Upadhya and her colleagues on the AAP’s Committee on Adolescence should be commended for assisting providers to offer the best and safest care,” said Dr. Jay, who was not involved in writing the AAP policy statement, and is a member of the Pediatric News Editorial Advisory Board who was asked to comment on the new policy statement.

 The American College of Pediatricians (ACPeds), a conservative-leaning pediatric organization opposes the AAP’s recent opinion and the provision of emergency contraception to youth, Michelle Cretella, MD, executive director for the group, said in an interview. In its own position statement, ACPeds wrote that preprescribing EC to adolescent patients, or making them available without prescription, “carries significant medical risk and is counterproductive to the parent-adolescent and patient-physician relationships.”  

“Increased access to [EC] does not result in lower pregnancy rates among adolescents and young adults,” said Dr. Cretella, a board-certified pediatrician who is not currently in practice. The ACPeds position statement cites a 2012 study that examined a Washington state program that allowed patients to access EC through pharmacies without a prescription. The analysis found the increased access to EC resulted in a statistically significant rise in gonorrhea for women and overall for both genders. The increased access to EC did not impact birth rates or abortion rates, according to the study (Economic Inquiry. 2013 Jul;51[3]:1682-95).

The ACPeds statement also notes a report by the Heritage Foundation that found sexually active teenagers were less likely to be happy and more likely to be depressed than were youth who were not having sex. The 2003 report, which examined responses from 6,500 adolescents through the 1996 National Longitudinal Survey of Adolescent Health, also found that sexually active teenagers were significantly more likely to attempt suicide, compared with teens who were not sexually active. 


Dr. Upadhya disclosed having no financial conflicts.

SOURCE: Upadhya KK et al. Pediatrics. 2019 Nov 18. doi: 10.1542/peds.2019-3149.

This article was updated on 11/19/19 and 12/16/19.

NEW ORLEANS – One way to make sure your practice providing immunizations is in the black is to calculate your “carrying costs” and apply them to the cost of your vaccines.

Another is to make sure that you join an effectively managed and effective group purchasing organization.

Doug Brunk/MDedge News

Those are two tips that Chip Hart shared with attendees at the annual meeting of the American Academy of Pediatrics.

“Your practices will fail if immunizations are not paid,” said Mr. Hart, director of the Winooski, Vt.–based the Pediatric Solutions Consulting Group at the Physicians Computer Company. “Providing immunizations is the single most valuable thing that you do, by far. Yet you get ripped off by the payers all the time.”

Two documents from the AAP – “The business case for pricing vaccines” and “The business case for pricing immunization administration” – provide clear-cut guidance on the impact of vaccine delivery to your bottom line. Based on data from his company’s client base, Mr. Hart said that vaccines have grown from 13% of an average pediatric practice’s revenue in 2003 to 22% in 2018. “The AAP’s own research shows that you need to generate 17%-28% above what you paid for the vaccine in order just to break even,” he said. That’s to cover the administrative overhead required to purchase and store the product in an office-based refrigerator, and the staff time to administer it. Such “carrying costs” often are not factored into the analysis of many managing pediatricians.

“The unfortunate reality is, you are not paid for carrying costs related to the administration of vaccines, including your refrigerator, your sharps and waste management, claim denials, and especially every time you waste a vaccine,” Mr. Hart said. “None of those things are part of any fee schedule.”

How to determine your vaccine product overhead

There are two ways to go about determining your vaccine product overhead. The first is to perform an in-depth analysis of your costs, including time studies and cost accounting. For example, he said that if your hazardous waste costs are $3,500 per year and half of the material is composed of vaccine waste, that leaves $1,750. “If you divide that by the number of vaccines you did last year, it might come out to 13 cents per vaccine,” Mr. Hart said, “but these things add up.” On the administration side, he offered the example of a nurse who makes $45,000 per year and who devotes 10% of her time to vaccines in a practice that administers 13,000 vaccinations per year. In this case, $45,000 per year divided by 13,000 vaccines equals 35 cents than can be added to the cost of every vaccine.

“You can go into each one of these elements and figure out how much you need to clear in order to do all right,” he said.

Alternatively, you can use the research from the AAP to presume that you need to have a margin of 17%-28% on your product. “Use a figure like 20% or 25% – it’s likely as accurate as any analysis a busy private practice is capable of doing, and you can immediately determine if you are in the profitability ballpark,” Mr. Hart said. On the administration side of the equation, in 2009, researchers estimated that the total documented variable cost per injection, excluding vaccine cost, was $11.51 (Pediatrics. 2009 Dec;124 [Suppl 5]:S492-8). That figure is more like $14 or $15 per vaccine in today’s dollars, Mr. Hart estimated. “You can perform a time-motion study and determine all of your immunization administration costs or you can just simply pick an evidence-based figure like $14 and see how well you are doing,” he said.

On his company’s web site, he offers a free administrative analysis tool that clinicians can use to determine how they fare. The AAP also provides information about vaccine financing here.

How to make sure you are operating in the red

Mr. Hart advises practices operating in the red to review their vaccine delivery work flow “to look for leaks,” to use proper administrative codes, and to negotiate the price of vaccine product with payers. “The only payers that don’t negotiate are state Medicaid and Tricare,” he said. “Everyone else negotiates. You want to determine the methodology they use to calculate what they pay you for the vaccine product. Different payers have different rule sets.”

Another strategy to join a group purchasing organization (GPO), which can leverage volume purchasing to negotiate discounts on vaccines. “They’re like [the] Costco or Sam’s Club of vaccine purchasing, and in most cases they can save you about $10,000 per year,” Mr. Hart said. A list of GPOs from the AAP can be found here.

Implementing effective inventory management is also key. “Practices that have the discipline to maintain their inventories are inevitably the ones who are more profitable,” Mr. Hart said. “I’ve worked with too many practices where flu shots go missing. Staff take them home or bring in their friends after hours. You need inventory control, and you should be able to generate an inventory report out of your practice management system. You also should be able to generate a report out of your EHR.”

Mr. Hart reported having no relevant financial disclosures.

[email protected]

NEW ORLEANS – One way to make sure your practice providing immunizations is in the black is to calculate your “carrying costs” and apply them to the cost of your vaccines.

Another is to make sure that you join an effectively managed and effective group purchasing organization.

Doug Brunk/MDedge News

Those are two tips that Chip Hart shared with attendees at the annual meeting of the American Academy of Pediatrics.

“Your practices will fail if immunizations are not paid,” said Mr. Hart, director of the Winooski, Vt.–based the Pediatric Solutions Consulting Group at the Physicians Computer Company. “Providing immunizations is the single most valuable thing that you do, by far. Yet you get ripped off by the payers all the time.”

Two documents from the AAP – “The business case for pricing vaccines” and “The business case for pricing immunization administration” – provide clear-cut guidance on the impact of vaccine delivery to your bottom line. Based on data from his company’s client base, Mr. Hart said that vaccines have grown from 13% of an average pediatric practice’s revenue in 2003 to 22% in 2018. “The AAP’s own research shows that you need to generate 17%-28% above what you paid for the vaccine in order just to break even,” he said. That’s to cover the administrative overhead required to purchase and store the product in an office-based refrigerator, and the staff time to administer it. Such “carrying costs” often are not factored into the analysis of many managing pediatricians.

“The unfortunate reality is, you are not paid for carrying costs related to the administration of vaccines, including your refrigerator, your sharps and waste management, claim denials, and especially every time you waste a vaccine,” Mr. Hart said. “None of those things are part of any fee schedule.”

How to determine your vaccine product overhead

There are two ways to go about determining your vaccine product overhead. The first is to perform an in-depth analysis of your costs, including time studies and cost accounting. For example, he said that if your hazardous waste costs are $3,500 per year and half of the material is composed of vaccine waste, that leaves $1,750. “If you divide that by the number of vaccines you did last year, it might come out to 13 cents per vaccine,” Mr. Hart said, “but these things add up.” On the administration side, he offered the example of a nurse who makes $45,000 per year and who devotes 10% of her time to vaccines in a practice that administers 13,000 vaccinations per year. In this case, $45,000 per year divided by 13,000 vaccines equals 35 cents than can be added to the cost of every vaccine.

“You can go into each one of these elements and figure out how much you need to clear in order to do all right,” he said.

Alternatively, you can use the research from the AAP to presume that you need to have a margin of 17%-28% on your product. “Use a figure like 20% or 25% – it’s likely as accurate as any analysis a busy private practice is capable of doing, and you can immediately determine if you are in the profitability ballpark,” Mr. Hart said. On the administration side of the equation, in 2009, researchers estimated that the total documented variable cost per injection, excluding vaccine cost, was $11.51 (Pediatrics. 2009 Dec;124 [Suppl 5]:S492-8). That figure is more like $14 or $15 per vaccine in today’s dollars, Mr. Hart estimated. “You can perform a time-motion study and determine all of your immunization administration costs or you can just simply pick an evidence-based figure like $14 and see how well you are doing,” he said.

On his company’s web site, he offers a free administrative analysis tool that clinicians can use to determine how they fare. The AAP also provides information about vaccine financing here.

How to make sure you are operating in the red

Mr. Hart advises practices operating in the red to review their vaccine delivery work flow “to look for leaks,” to use proper administrative codes, and to negotiate the price of vaccine product with payers. “The only payers that don’t negotiate are state Medicaid and Tricare,” he said. “Everyone else negotiates. You want to determine the methodology they use to calculate what they pay you for the vaccine product. Different payers have different rule sets.”

Another strategy to join a group purchasing organization (GPO), which can leverage volume purchasing to negotiate discounts on vaccines. “They’re like [the] Costco or Sam’s Club of vaccine purchasing, and in most cases they can save you about $10,000 per year,” Mr. Hart said. A list of GPOs from the AAP can be found here.

Implementing effective inventory management is also key. “Practices that have the discipline to maintain their inventories are inevitably the ones who are more profitable,” Mr. Hart said. “I’ve worked with too many practices where flu shots go missing. Staff take them home or bring in their friends after hours. You need inventory control, and you should be able to generate an inventory report out of your practice management system. You also should be able to generate a report out of your EHR.”

Mr. Hart reported having no relevant financial disclosures.

[email protected]

NEW ORLEANS – One way to make sure your practice providing immunizations is in the black is to calculate your “carrying costs” and apply them to the cost of your vaccines.

Another is to make sure that you join an effectively managed and effective group purchasing organization.

Doug Brunk/MDedge News

Those are two tips that Chip Hart shared with attendees at the annual meeting of the American Academy of Pediatrics.

“Your practices will fail if immunizations are not paid,” said Mr. Hart, director of the Winooski, Vt.–based the Pediatric Solutions Consulting Group at the Physicians Computer Company. “Providing immunizations is the single most valuable thing that you do, by far. Yet you get ripped off by the payers all the time.”

Two documents from the AAP – “The business case for pricing vaccines” and “The business case for pricing immunization administration” – provide clear-cut guidance on the impact of vaccine delivery to your bottom line. Based on data from his company’s client base, Mr. Hart said that vaccines have grown from 13% of an average pediatric practice’s revenue in 2003 to 22% in 2018. “The AAP’s own research shows that you need to generate 17%-28% above what you paid for the vaccine in order just to break even,” he said. That’s to cover the administrative overhead required to purchase and store the product in an office-based refrigerator, and the staff time to administer it. Such “carrying costs” often are not factored into the analysis of many managing pediatricians.

“The unfortunate reality is, you are not paid for carrying costs related to the administration of vaccines, including your refrigerator, your sharps and waste management, claim denials, and especially every time you waste a vaccine,” Mr. Hart said. “None of those things are part of any fee schedule.”

How to determine your vaccine product overhead

There are two ways to go about determining your vaccine product overhead. The first is to perform an in-depth analysis of your costs, including time studies and cost accounting. For example, he said that if your hazardous waste costs are $3,500 per year and half of the material is composed of vaccine waste, that leaves $1,750. “If you divide that by the number of vaccines you did last year, it might come out to 13 cents per vaccine,” Mr. Hart said, “but these things add up.” On the administration side, he offered the example of a nurse who makes $45,000 per year and who devotes 10% of her time to vaccines in a practice that administers 13,000 vaccinations per year. In this case, $45,000 per year divided by 13,000 vaccines equals 35 cents than can be added to the cost of every vaccine.

“You can go into each one of these elements and figure out how much you need to clear in order to do all right,” he said.

Alternatively, you can use the research from the AAP to presume that you need to have a margin of 17%-28% on your product. “Use a figure like 20% or 25% – it’s likely as accurate as any analysis a busy private practice is capable of doing, and you can immediately determine if you are in the profitability ballpark,” Mr. Hart said. On the administration side of the equation, in 2009, researchers estimated that the total documented variable cost per injection, excluding vaccine cost, was $11.51 (Pediatrics. 2009 Dec;124 [Suppl 5]:S492-8). That figure is more like $14 or $15 per vaccine in today’s dollars, Mr. Hart estimated. “You can perform a time-motion study and determine all of your immunization administration costs or you can just simply pick an evidence-based figure like $14 and see how well you are doing,” he said.

On his company’s web site, he offers a free administrative analysis tool that clinicians can use to determine how they fare. The AAP also provides information about vaccine financing here.

How to make sure you are operating in the red

Mr. Hart advises practices operating in the red to review their vaccine delivery work flow “to look for leaks,” to use proper administrative codes, and to negotiate the price of vaccine product with payers. “The only payers that don’t negotiate are state Medicaid and Tricare,” he said. “Everyone else negotiates. You want to determine the methodology they use to calculate what they pay you for the vaccine product. Different payers have different rule sets.”

Another strategy to join a group purchasing organization (GPO), which can leverage volume purchasing to negotiate discounts on vaccines. “They’re like [the] Costco or Sam’s Club of vaccine purchasing, and in most cases they can save you about $10,000 per year,” Mr. Hart said. A list of GPOs from the AAP can be found here.

Implementing effective inventory management is also key. “Practices that have the discipline to maintain their inventories are inevitably the ones who are more profitable,” Mr. Hart said. “I’ve worked with too many practices where flu shots go missing. Staff take them home or bring in their friends after hours. You need inventory control, and you should be able to generate an inventory report out of your practice management system. You also should be able to generate a report out of your EHR.”

Mr. Hart reported having no relevant financial disclosures.

[email protected]

Early ustekinumab levels are significantly associated with a 75% reduction in Psoriasis Area and Severity Index scores from baseline, according to data from 491 adults with psoriasis.

“Evidence suggests that ustekinumab dosing is suboptimal in some patients,” because of factors including weight-based dosing and dosing intervals; therefore “individualized dose optimization and therapeutic drug monitoring (TDM) of ustekinumab may have clinical utility,” Teresa Tsakok, MRCP, of King’s College London, and colleagues wrote in JAMA Dermatology.

The researchers identified 491 adults with psoriasis who were part of the BSTOP (Biomarkers of Systemic Treatment Outcomes in Psoriasis) cohort study in the United Kingdom. Blood samples were collected during clinical reviews to assess ustekinumab levels, and primary treatment response was 75% reduction in Psoriasis Area and Severity Index (PASI 75) scores.

Ustekinumab levels measured from 1-12 weeks after the start of treatment were significantly associated with PASI 75 after 6 months (odds ratio, 1.38) after controlling for factors including baseline PASI scores, age, and ustekinumab dose. The association, however, did not hold for other PASI outcomes, including PASI 90 and PASI scores of 1.5 or less.

The participants had at least one serum sample collected at 0-56 weeks from the start of treatment and at least one PSAI score measured within the first year of treatment. The average baseline PASI score was 13.3, the average body mass index was 32 kg/m², and 65% of the patients were male.

Overall, 348 patients (71%) achieved PASI 75 within a year of starting ustekinumab. Antidrug antibodies were detected in 17 patients (3.5% of the study population), compared with a rate of 37.5% in patients from the same study cohort who were taking adalimumab, the researchers noted.

The study findings were limited by several factors, including a dropoff in patient numbers over the study period and the difficulty in accounting for the association between drug level and treatment response in a logistic regression model, the researchers said.

The results, however, suggest “that adequate drug exposure early in the treatment cycle may be particularly important in determining clinical outcome with ustekinumab,” and that “future work should focus on pharmacokinetic-pharmacodynamic modeling of the whole time course of response to ustekinumab” as a key step toward personalized treatment regimens, they concluded.

The study was supported by several entities, including the Medical Research Council (MRC), the National Institute for Health Research Biomedical Research Center and the Psoriasis Association. Dr. Tsakok had no financial conflicts to disclose and was supported by an MRC Clinical Research Training Fellowship.

SOURCE: Tsakok T et al. JAMA Dermatol. 2019 Sep 18. doi: 10.1001/jamadermatol.2019.1783.

Early ustekinumab levels are significantly associated with a 75% reduction in Psoriasis Area and Severity Index scores from baseline, according to data from 491 adults with psoriasis.

“Evidence suggests that ustekinumab dosing is suboptimal in some patients,” because of factors including weight-based dosing and dosing intervals; therefore “individualized dose optimization and therapeutic drug monitoring (TDM) of ustekinumab may have clinical utility,” Teresa Tsakok, MRCP, of King’s College London, and colleagues wrote in JAMA Dermatology.

The researchers identified 491 adults with psoriasis who were part of the BSTOP (Biomarkers of Systemic Treatment Outcomes in Psoriasis) cohort study in the United Kingdom. Blood samples were collected during clinical reviews to assess ustekinumab levels, and primary treatment response was 75% reduction in Psoriasis Area and Severity Index (PASI 75) scores.

Ustekinumab levels measured from 1-12 weeks after the start of treatment were significantly associated with PASI 75 after 6 months (odds ratio, 1.38) after controlling for factors including baseline PASI scores, age, and ustekinumab dose. The association, however, did not hold for other PASI outcomes, including PASI 90 and PASI scores of 1.5 or less.

The participants had at least one serum sample collected at 0-56 weeks from the start of treatment and at least one PSAI score measured within the first year of treatment. The average baseline PASI score was 13.3, the average body mass index was 32 kg/m², and 65% of the patients were male.

Overall, 348 patients (71%) achieved PASI 75 within a year of starting ustekinumab. Antidrug antibodies were detected in 17 patients (3.5% of the study population), compared with a rate of 37.5% in patients from the same study cohort who were taking adalimumab, the researchers noted.

The study findings were limited by several factors, including a dropoff in patient numbers over the study period and the difficulty in accounting for the association between drug level and treatment response in a logistic regression model, the researchers said.

The results, however, suggest “that adequate drug exposure early in the treatment cycle may be particularly important in determining clinical outcome with ustekinumab,” and that “future work should focus on pharmacokinetic-pharmacodynamic modeling of the whole time course of response to ustekinumab” as a key step toward personalized treatment regimens, they concluded.

The study was supported by several entities, including the Medical Research Council (MRC), the National Institute for Health Research Biomedical Research Center and the Psoriasis Association. Dr. Tsakok had no financial conflicts to disclose and was supported by an MRC Clinical Research Training Fellowship.

SOURCE: Tsakok T et al. JAMA Dermatol. 2019 Sep 18. doi: 10.1001/jamadermatol.2019.1783.

Early ustekinumab levels are significantly associated with a 75% reduction in Psoriasis Area and Severity Index scores from baseline, according to data from 491 adults with psoriasis.

“Evidence suggests that ustekinumab dosing is suboptimal in some patients,” because of factors including weight-based dosing and dosing intervals; therefore “individualized dose optimization and therapeutic drug monitoring (TDM) of ustekinumab may have clinical utility,” Teresa Tsakok, MRCP, of King’s College London, and colleagues wrote in JAMA Dermatology.

The researchers identified 491 adults with psoriasis who were part of the BSTOP (Biomarkers of Systemic Treatment Outcomes in Psoriasis) cohort study in the United Kingdom. Blood samples were collected during clinical reviews to assess ustekinumab levels, and primary treatment response was 75% reduction in Psoriasis Area and Severity Index (PASI 75) scores.

Ustekinumab levels measured from 1-12 weeks after the start of treatment were significantly associated with PASI 75 after 6 months (odds ratio, 1.38) after controlling for factors including baseline PASI scores, age, and ustekinumab dose. The association, however, did not hold for other PASI outcomes, including PASI 90 and PASI scores of 1.5 or less.

The participants had at least one serum sample collected at 0-56 weeks from the start of treatment and at least one PSAI score measured within the first year of treatment. The average baseline PASI score was 13.3, the average body mass index was 32 kg/m², and 65% of the patients were male.

Overall, 348 patients (71%) achieved PASI 75 within a year of starting ustekinumab. Antidrug antibodies were detected in 17 patients (3.5% of the study population), compared with a rate of 37.5% in patients from the same study cohort who were taking adalimumab, the researchers noted.

The study findings were limited by several factors, including a dropoff in patient numbers over the study period and the difficulty in accounting for the association between drug level and treatment response in a logistic regression model, the researchers said.

The results, however, suggest “that adequate drug exposure early in the treatment cycle may be particularly important in determining clinical outcome with ustekinumab,” and that “future work should focus on pharmacokinetic-pharmacodynamic modeling of the whole time course of response to ustekinumab” as a key step toward personalized treatment regimens, they concluded.

The study was supported by several entities, including the Medical Research Council (MRC), the National Institute for Health Research Biomedical Research Center and the Psoriasis Association. Dr. Tsakok had no financial conflicts to disclose and was supported by an MRC Clinical Research Training Fellowship.

SOURCE: Tsakok T et al. JAMA Dermatol. 2019 Sep 18. doi: 10.1001/jamadermatol.2019.1783.

Almost all of the patient assistance programs funded by independent charities for subsidizing prescription medications exclude patients without insurance, a cross-sectional analysis has shown.

Of 274 patient assistance programs analyzed from six independent charities, 267 (97%) listed insurance coverage as an eligibility requirement for their program, according to So-Yeon Kang, MPH, MBA, a PhD student at Johns Hopkins University, Baltimore, and colleagues.

Out-of-pocket prescription costs for Medicare Part D plans can cost “thousands of dollars” because of higher coinsurance rates and no catastrophic cap on the program, the researchers noted in JAMA.

“For this reason, independent charity foundations offering patient assistance programs to these patients are entitled to receive tax-deductible donations from pharmaceutical companies,” they wrote. “However, the findings from this study suggest that several features of the programs may limit their usefulness to financially needy patients and bolster the use of expensive drugs.”

The researchers examined the 274 patient assistance programs funded by the CancerCare Co-Payment Assistance Foundation, Good Days, the HealthWell Foundation, the Patient Access Network Foundation, Patient Advocate Foundation Co-Pay Relief, and Patient Services Incorporated. Copayment assistance alone was provided by 168 programs, 90 programs offered assistance with copayments and health insurance premiums, and 9 programs provided assistance to subsidize health insurance premiums only.

Cancer or cancer-related treatments were covered by 41% of programs, and 34% provided assistance for genetic or rare diseases.

In 2017, the six charities spent an average of 86% of their revenue on patient expenditures: They had a total revenue of between $24 million and $532 million, while the expenditures for patient assistance ranged from $24 million and $353 million. With regard to eligibility, the income limit that was most common was 500% of the federal poverty level.

The researchers also studied which of 18 drugs were covered by assistance programs. They found that brand-name prescriptions were covered by a mean of 3.1 assistance programs, compared with a mean of 1.2 programs that covered a generic version of each drug. Of the 18 drugs studied, 12 drugs (67%) were in protected classes and therefore covered by Medicare Part D. Prescription drugs that were covered were more likely to be expensive, compared with drugs that were not covered (median annual cost of $1,157, versus $367).

The researchers noted several limitations of the study, such the inability to correlate the programs with drug spending, assuming that generic substitution was always possible. In addition, the analysis of drug use was limited to two charity foundations.

In a related editorial, Katherine L. Kraschel and Gregory D. Curfman, MD, wrote that some patient assistance programs might be violating federal law.

“Coupled with recent enforcement activity by the Department of Justice, the data reported by Kang et al. suggest that some programs may warrant continued regulatory scrutiny and enforcement,” wrote Ms. Kraschel, executive director of the Solomon Center for Health Law & Policy at Yale University Law School, New Haven, Conn., and Dr. Curfman, deputy editor of JAMA in Chicago (JAMA. 2019;322[5]:405-6).

In addition, the Office of Inspector General created a special advisory bulletin in 2014 that clarifies how pharmaceutical companies should comply with the Anti-Kickback Statute within a patient assistance program. This guidance states that pharmaceutical companies should make assistance available to all products, rather than simply high-cost or specialty drugs, which pharmaceutical companies have not consistently followed, Ms. Kraschel and Dr. Curfman explained.

To help patients and the health care system, the authors recommended the Office of the Inspector General implement stronger restrictions for pharmaceutical companies contributing to patient assistance programs and develop reporting requirements for transparency purposes.

“The extent to which patient assistance programs violate tax exemption standards that prohibit private benefit that does not further its charitable purpose and is intentionally aimed to benefit the pharmaceutical companies warrants further scrutiny,” Ms. Kraschel and Dr. Curfman wrote. “It is particularly egregious that the payments made from pharmaceutical companies to patient assistance programs may be illegal yet simultaneously tax deductible.”

The study was funded by Arnold Ventures. The authors of the study and the editorial reported no relevant conflicts of interest.

SOURCE: Kang S-Y et al. JAMA. 2019;322(5):422-9.

Almost all of the patient assistance programs funded by independent charities for subsidizing prescription medications exclude patients without insurance, a cross-sectional analysis has shown.

Of 274 patient assistance programs analyzed from six independent charities, 267 (97%) listed insurance coverage as an eligibility requirement for their program, according to So-Yeon Kang, MPH, MBA, a PhD student at Johns Hopkins University, Baltimore, and colleagues.

Out-of-pocket prescription costs for Medicare Part D plans can cost “thousands of dollars” because of higher coinsurance rates and no catastrophic cap on the program, the researchers noted in JAMA.

“For this reason, independent charity foundations offering patient assistance programs to these patients are entitled to receive tax-deductible donations from pharmaceutical companies,” they wrote. “However, the findings from this study suggest that several features of the programs may limit their usefulness to financially needy patients and bolster the use of expensive drugs.”

The researchers examined the 274 patient assistance programs funded by the CancerCare Co-Payment Assistance Foundation, Good Days, the HealthWell Foundation, the Patient Access Network Foundation, Patient Advocate Foundation Co-Pay Relief, and Patient Services Incorporated. Copayment assistance alone was provided by 168 programs, 90 programs offered assistance with copayments and health insurance premiums, and 9 programs provided assistance to subsidize health insurance premiums only.

Cancer or cancer-related treatments were covered by 41% of programs, and 34% provided assistance for genetic or rare diseases.

In 2017, the six charities spent an average of 86% of their revenue on patient expenditures: They had a total revenue of between $24 million and $532 million, while the expenditures for patient assistance ranged from $24 million and $353 million. With regard to eligibility, the income limit that was most common was 500% of the federal poverty level.

The researchers also studied which of 18 drugs were covered by assistance programs. They found that brand-name prescriptions were covered by a mean of 3.1 assistance programs, compared with a mean of 1.2 programs that covered a generic version of each drug. Of the 18 drugs studied, 12 drugs (67%) were in protected classes and therefore covered by Medicare Part D. Prescription drugs that were covered were more likely to be expensive, compared with drugs that were not covered (median annual cost of $1,157, versus $367).

The researchers noted several limitations of the study, such the inability to correlate the programs with drug spending, assuming that generic substitution was always possible. In addition, the analysis of drug use was limited to two charity foundations.

In a related editorial, Katherine L. Kraschel and Gregory D. Curfman, MD, wrote that some patient assistance programs might be violating federal law.

“Coupled with recent enforcement activity by the Department of Justice, the data reported by Kang et al. suggest that some programs may warrant continued regulatory scrutiny and enforcement,” wrote Ms. Kraschel, executive director of the Solomon Center for Health Law & Policy at Yale University Law School, New Haven, Conn., and Dr. Curfman, deputy editor of JAMA in Chicago (JAMA. 2019;322[5]:405-6).

In addition, the Office of Inspector General created a special advisory bulletin in 2014 that clarifies how pharmaceutical companies should comply with the Anti-Kickback Statute within a patient assistance program. This guidance states that pharmaceutical companies should make assistance available to all products, rather than simply high-cost or specialty drugs, which pharmaceutical companies have not consistently followed, Ms. Kraschel and Dr. Curfman explained.

To help patients and the health care system, the authors recommended the Office of the Inspector General implement stronger restrictions for pharmaceutical companies contributing to patient assistance programs and develop reporting requirements for transparency purposes.

“The extent to which patient assistance programs violate tax exemption standards that prohibit private benefit that does not further its charitable purpose and is intentionally aimed to benefit the pharmaceutical companies warrants further scrutiny,” Ms. Kraschel and Dr. Curfman wrote. “It is particularly egregious that the payments made from pharmaceutical companies to patient assistance programs may be illegal yet simultaneously tax deductible.”

The study was funded by Arnold Ventures. The authors of the study and the editorial reported no relevant conflicts of interest.

SOURCE: Kang S-Y et al. JAMA. 2019;322(5):422-9.

Almost all of the patient assistance programs funded by independent charities for subsidizing prescription medications exclude patients without insurance, a cross-sectional analysis has shown.

Of 274 patient assistance programs analyzed from six independent charities, 267 (97%) listed insurance coverage as an eligibility requirement for their program, according to So-Yeon Kang, MPH, MBA, a PhD student at Johns Hopkins University, Baltimore, and colleagues.

Out-of-pocket prescription costs for Medicare Part D plans can cost “thousands of dollars” because of higher coinsurance rates and no catastrophic cap on the program, the researchers noted in JAMA.

“For this reason, independent charity foundations offering patient assistance programs to these patients are entitled to receive tax-deductible donations from pharmaceutical companies,” they wrote. “However, the findings from this study suggest that several features of the programs may limit their usefulness to financially needy patients and bolster the use of expensive drugs.”

The researchers examined the 274 patient assistance programs funded by the CancerCare Co-Payment Assistance Foundation, Good Days, the HealthWell Foundation, the Patient Access Network Foundation, Patient Advocate Foundation Co-Pay Relief, and Patient Services Incorporated. Copayment assistance alone was provided by 168 programs, 90 programs offered assistance with copayments and health insurance premiums, and 9 programs provided assistance to subsidize health insurance premiums only.

Cancer or cancer-related treatments were covered by 41% of programs, and 34% provided assistance for genetic or rare diseases.

In 2017, the six charities spent an average of 86% of their revenue on patient expenditures: They had a total revenue of between $24 million and $532 million, while the expenditures for patient assistance ranged from $24 million and $353 million. With regard to eligibility, the income limit that was most common was 500% of the federal poverty level.

The researchers also studied which of 18 drugs were covered by assistance programs. They found that brand-name prescriptions were covered by a mean of 3.1 assistance programs, compared with a mean of 1.2 programs that covered a generic version of each drug. Of the 18 drugs studied, 12 drugs (67%) were in protected classes and therefore covered by Medicare Part D. Prescription drugs that were covered were more likely to be expensive, compared with drugs that were not covered (median annual cost of $1,157, versus $367).

The researchers noted several limitations of the study, such the inability to correlate the programs with drug spending, assuming that generic substitution was always possible. In addition, the analysis of drug use was limited to two charity foundations.

In a related editorial, Katherine L. Kraschel and Gregory D. Curfman, MD, wrote that some patient assistance programs might be violating federal law.

“Coupled with recent enforcement activity by the Department of Justice, the data reported by Kang et al. suggest that some programs may warrant continued regulatory scrutiny and enforcement,” wrote Ms. Kraschel, executive director of the Solomon Center for Health Law & Policy at Yale University Law School, New Haven, Conn., and Dr. Curfman, deputy editor of JAMA in Chicago (JAMA. 2019;322[5]:405-6).

In addition, the Office of Inspector General created a special advisory bulletin in 2014 that clarifies how pharmaceutical companies should comply with the Anti-Kickback Statute within a patient assistance program. This guidance states that pharmaceutical companies should make assistance available to all products, rather than simply high-cost or specialty drugs, which pharmaceutical companies have not consistently followed, Ms. Kraschel and Dr. Curfman explained.

To help patients and the health care system, the authors recommended the Office of the Inspector General implement stronger restrictions for pharmaceutical companies contributing to patient assistance programs and develop reporting requirements for transparency purposes.

“The extent to which patient assistance programs violate tax exemption standards that prohibit private benefit that does not further its charitable purpose and is intentionally aimed to benefit the pharmaceutical companies warrants further scrutiny,” Ms. Kraschel and Dr. Curfman wrote. “It is particularly egregious that the payments made from pharmaceutical companies to patient assistance programs may be illegal yet simultaneously tax deductible.”

The study was funded by Arnold Ventures. The authors of the study and the editorial reported no relevant conflicts of interest.

SOURCE: Kang S-Y et al. JAMA. 2019;322(5):422-9.

PHILADELPHIA – The eagerly awaited results of the ISCHEMIA trial – the largest-ever randomized trial of an initial invasive versus conservative management strategy for patients with stable ischemic heart disease – were emphatically declared practice-changing by interventional cardiologists and noninterventionalists alike at the American Heart Association scientific sessions.

Bruce Jancin/MDedge News

At a median 3.3 years of follow-up of 5,179 participants with baseline moderate or severe ischemia at 320 sites in 37 countries in ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches), an initial invasive strategy accompanied by optimal medical therapy (OMT) didn’t reduce the risk of the primary composite endpoint of cardiovascular death, MI, hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest, compared with a conservative strategy of OMT alone. The rates at 4 years were 15.5% with the conservative strategy and 13.3% with the invasive strategy, reported study chair Judith S. Hochman, MD, professor of medicine and senior associate dean for clinical sciences at New York University.

Nor was there a significant between-group difference in the major secondary endpoint of cardiovascular death or MI: 13.9% with the conservative strategy, 11.7% with invasive management.

“The probability of at least a 10% benefit of the invasive strategy on all-cause mortality was less than 10%, based on a prespecified Bayesian analysis,” she added.

Prior to enrollment and randomization, CT angiography was routinely performed to rule out left main coronary artery disease.

Fifty-four percent of participants in the National Heart, Lung, and Blood Institute–funded trial had severe ischemia on a baseline noninvasive stress test. To the investigators’ surprise, patients with more severe ischemia or more extensive multivessel involvement didn’t do better with the invasive approach.

Almost a quarter (23%) of patients in the conservative management group crossed over to revascularization within 4 years.
 

Quality-of-life results

An invasive strategy did result in significantly greater improvement in angina control and quality of life, as measured using the Seattle Angina Questionnaire, than OMT alone in patients who had angina at least once a month at baseline.

“We have 100% confidence that there is a treatment benefit associated with an invasive approach early as well as late after randomization,” said John A. Spertus, MD, coprincipal investigator for the ISCHEMIA quality of life analysis.

Indeed, he calculated that, for patients with weekly angina, the number needed to treat with revascularization instead of OMT alone for one to be angina-free at 3 months was three.

However, in the 35% of ISCHEMIA participants who reported no angina within the past month at baseline, the invasive strategy offered no quality of life advantage, he added.

“I really think we need to hit ‘pause’ on asymptomatic revascularization. I just don’t see any benefit in patients without symptoms, left main disease excluded,” commented Dr. Spertus, director of health outcomes research at St. Luke’s Mid-America Heart Institute and professor of medicine at the University of Missouri, Kansas City.

The reaction

ISCHEMIA addressed a key clinical issue that’s long been surrounded by equipoise because of a paucity of high-quality data. As such, it was deemed worthy of its own AHA Late-Breaking Science session. The assembled discussants agreed the results will change their clinical practice.

Bruce Jancin/MDedge News

Bruce Jancin/MDedge News

[email protected]

SOURCE: Hochman JS. AHA late breaker.

PHILADELPHIA – The eagerly awaited results of the ISCHEMIA trial – the largest-ever randomized trial of an initial invasive versus conservative management strategy for patients with stable ischemic heart disease – were emphatically declared practice-changing by interventional cardiologists and noninterventionalists alike at the American Heart Association scientific sessions.

Bruce Jancin/MDedge News

At a median 3.3 years of follow-up of 5,179 participants with baseline moderate or severe ischemia at 320 sites in 37 countries in ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches), an initial invasive strategy accompanied by optimal medical therapy (OMT) didn’t reduce the risk of the primary composite endpoint of cardiovascular death, MI, hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest, compared with a conservative strategy of OMT alone. The rates at 4 years were 15.5% with the conservative strategy and 13.3% with the invasive strategy, reported study chair Judith S. Hochman, MD, professor of medicine and senior associate dean for clinical sciences at New York University.

Nor was there a significant between-group difference in the major secondary endpoint of cardiovascular death or MI: 13.9% with the conservative strategy, 11.7% with invasive management.

“The probability of at least a 10% benefit of the invasive strategy on all-cause mortality was less than 10%, based on a prespecified Bayesian analysis,” she added.

Prior to enrollment and randomization, CT angiography was routinely performed to rule out left main coronary artery disease.

Fifty-four percent of participants in the National Heart, Lung, and Blood Institute–funded trial had severe ischemia on a baseline noninvasive stress test. To the investigators’ surprise, patients with more severe ischemia or more extensive multivessel involvement didn’t do better with the invasive approach.

Almost a quarter (23%) of patients in the conservative management group crossed over to revascularization within 4 years.
 

Quality-of-life results

An invasive strategy did result in significantly greater improvement in angina control and quality of life, as measured using the Seattle Angina Questionnaire, than OMT alone in patients who had angina at least once a month at baseline.

“We have 100% confidence that there is a treatment benefit associated with an invasive approach early as well as late after randomization,” said John A. Spertus, MD, coprincipal investigator for the ISCHEMIA quality of life analysis.

Indeed, he calculated that, for patients with weekly angina, the number needed to treat with revascularization instead of OMT alone for one to be angina-free at 3 months was three.

However, in the 35% of ISCHEMIA participants who reported no angina within the past month at baseline, the invasive strategy offered no quality of life advantage, he added.

“I really think we need to hit ‘pause’ on asymptomatic revascularization. I just don’t see any benefit in patients without symptoms, left main disease excluded,” commented Dr. Spertus, director of health outcomes research at St. Luke’s Mid-America Heart Institute and professor of medicine at the University of Missouri, Kansas City.

The reaction

ISCHEMIA addressed a key clinical issue that’s long been surrounded by equipoise because of a paucity of high-quality data. As such, it was deemed worthy of its own AHA Late-Breaking Science session. The assembled discussants agreed the results will change their clinical practice.

Bruce Jancin/MDedge News

Bruce Jancin/MDedge News

[email protected]

SOURCE: Hochman JS. AHA late breaker.

PHILADELPHIA – The eagerly awaited results of the ISCHEMIA trial – the largest-ever randomized trial of an initial invasive versus conservative management strategy for patients with stable ischemic heart disease – were emphatically declared practice-changing by interventional cardiologists and noninterventionalists alike at the American Heart Association scientific sessions.

Bruce Jancin/MDedge News

At a median 3.3 years of follow-up of 5,179 participants with baseline moderate or severe ischemia at 320 sites in 37 countries in ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches), an initial invasive strategy accompanied by optimal medical therapy (OMT) didn’t reduce the risk of the primary composite endpoint of cardiovascular death, MI, hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest, compared with a conservative strategy of OMT alone. The rates at 4 years were 15.5% with the conservative strategy and 13.3% with the invasive strategy, reported study chair Judith S. Hochman, MD, professor of medicine and senior associate dean for clinical sciences at New York University.

Nor was there a significant between-group difference in the major secondary endpoint of cardiovascular death or MI: 13.9% with the conservative strategy, 11.7% with invasive management.

“The probability of at least a 10% benefit of the invasive strategy on all-cause mortality was less than 10%, based on a prespecified Bayesian analysis,” she added.

Prior to enrollment and randomization, CT angiography was routinely performed to rule out left main coronary artery disease.

Fifty-four percent of participants in the National Heart, Lung, and Blood Institute–funded trial had severe ischemia on a baseline noninvasive stress test. To the investigators’ surprise, patients with more severe ischemia or more extensive multivessel involvement didn’t do better with the invasive approach.

Almost a quarter (23%) of patients in the conservative management group crossed over to revascularization within 4 years.
 

Quality-of-life results

An invasive strategy did result in significantly greater improvement in angina control and quality of life, as measured using the Seattle Angina Questionnaire, than OMT alone in patients who had angina at least once a month at baseline.

“We have 100% confidence that there is a treatment benefit associated with an invasive approach early as well as late after randomization,” said John A. Spertus, MD, coprincipal investigator for the ISCHEMIA quality of life analysis.

Indeed, he calculated that, for patients with weekly angina, the number needed to treat with revascularization instead of OMT alone for one to be angina-free at 3 months was three.

However, in the 35% of ISCHEMIA participants who reported no angina within the past month at baseline, the invasive strategy offered no quality of life advantage, he added.

“I really think we need to hit ‘pause’ on asymptomatic revascularization. I just don’t see any benefit in patients without symptoms, left main disease excluded,” commented Dr. Spertus, director of health outcomes research at St. Luke’s Mid-America Heart Institute and professor of medicine at the University of Missouri, Kansas City.

The reaction

ISCHEMIA addressed a key clinical issue that’s long been surrounded by equipoise because of a paucity of high-quality data. As such, it was deemed worthy of its own AHA Late-Breaking Science session. The assembled discussants agreed the results will change their clinical practice.

Bruce Jancin/MDedge News

Bruce Jancin/MDedge News

[email protected]

SOURCE: Hochman JS. AHA late breaker.

PHILADELPHIA – The primary outcome results from the practice-changing DAPA-HF trial gave clinicians strong evidence that the diabetes drug dapagliflozin was equally effective at reducing cardiovascular death and acute exacerbations in patients with heart failure with reduced ejection fraction, whether or not they also had type 2 diabetes. More detailed findings from the 2,605 enrolled patients in DAPA-HF who lacked diabetes (55% of the total study population) have now sealed the deal.

Mitchel L. Zoler/MDedge News

“The relative and absolute reductions in cardiovascular death and hospitalizations or urgent visits for heart failure were substantial, clinically important, and consistent in patients with or without type 2 diabetes,” John McMurray, MD, declared at the American Heart Association scientific sessions as he summarized new trial results that confirmed the initial finding he reported previously.

While the initial report of the DAPA-HF (Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure) by the study’s lead investigator, Dr. McMurray, was limited to the finding that the relative risk reduction for the study’s primary endpoint was a highly statistically significant 25% in heart failure patients with diabetes and an equally strongly significant 27% relative cut among patients without diabetes (N Engl J Med. 2019 Sep 19;doi: 10.1056/NEJMoa1911303), the new data showed that same consistency across the range of outcomes studied in the trial as well as across the range of glycosylated hemoglobin levels that patients had at study entry.

In an analysis that divided the entire study population of 4,744 patients with heart failure with reduced ejection fraction (HFrEF) into tertiles based on their entry blood level of hemoglobin A^1c, patients with a normal level at or below 5.6% had a 26% relative reduction in the study’s primary endpoint, essentially the same response as the 29% relative cut in adverse events in the tertile of patients with a glycosylated hemoglobin level of 5.7%-5.9% and the relative 28% relative reduction in events in patients diagnosed with type 2 diabetes and having a hemoglobin A_1c of 6.0% or greater, reported Dr. McMurray, professor of cardiology at the University of Glasgow. The results also showed a very benign safety profile in the patients without diabetes, similar to patients with diabetes and to placebo, and with no episodes of major hypoglycemia or diabetic ketoacidosis.

“It’s quite impressive that the result was consistent regardless of the level of hemoglobin A_1c,” commented Larry A. Allen, MD, professor of medicine at the University of Colorado in Aurora and designated discussant for the report. Even though the patients without diabetes constituted just over half of the full DAPA-HF enrollment, the comparison of the effect of dapagliflozin in patients with or without diabetes was prespecified in a trial that enrolled a relatively large number of patients into each of the two subgroups by diabetes status. “I think there a good chance dapagliflozin will get an indication” for treating HFrEF patients without diabetes, Dr. Allen suggested in a video interview.

If the DAPA-HF results persuade the U.S. Food and Drug Administration to grant a supplemental indication to dapagliflozin for use in cutting cardiovascular deaths and acute heart failure exacerbations in patients without diabetes, it would pave the way for health insurers to pay for the drug. Right now, even though Dr. Allen and other heart failure physicians have been impressed by the DAPA-HF findings and are eager to add the drug to the list of agents that HFrEF patients routinely receive, he’s been stymied so far by patients’ out-of pocket cost for using dapagliflozin off-label, roughly $500 a month.

“The DAPA-HF results suggest there is strong reason to consider dapagliflozin for patients without diabetes, and for payers to pay for it. I’m not prescribing dapagliflozin to HFrEF patients without diabetes right now; not because of the data, but because of noncoverage. Payers have not yet caught up with the data,” he said, and they likely will continue to not pay for the drug when used by patients without diabetes until a new labeled indication appears for those patients.

The immediate availability of dapagliflozin (Farxiga) and the two other approved members of the sodium-glucose co-transporter 2 inhibitor class of drugs, empagliflozin (Jardiance) and canagliflozin (Invokana), to treat patients with HFrEF, and the prospect of soon having dapagliflozin and possibly the other drugs in this class to treat patients with HFrEF but without diabetes also raises issues of drug sequencing in these patients and the overall number of drugs that HFrEF patients must now take to be on optimized medical therapy, Dr. Allen noted.

The already-existing lineup of medications for HFrEF patients includes starting on an ACE inhibitor or angiotensin receptor blocker and adding a beta-blocker, a mineralocorticoid receptor antagonist, then swapping out the initial renin-angiotensin system inhibitor for sacubitril/valsartan, and then, on top of all this, adding dapagliflozin or another drug in the same class. It raises questions of what is objectively the best way to introduce all these drugs into patients, and how to do it without subjecting patients to “financial toxicity,” Dr. Allen said during his discussion of the trial’s results.

DAPA-HF was sponsored by AstraZeneca, which markets dapagliflozin (Farxiga). The University of Glasgow received payment from AstraZeneca to compensate for the time Dr. McMurray spent running the study. Dr. Allen has been a consultant to ACI Clinical, Boston Scientific, and Janssen.

[email protected]

SOURCE: McMurray JJV. AHA 19, Late-Breaking Science 1.

PHILADELPHIA – The primary outcome results from the practice-changing DAPA-HF trial gave clinicians strong evidence that the diabetes drug dapagliflozin was equally effective at reducing cardiovascular death and acute exacerbations in patients with heart failure with reduced ejection fraction, whether or not they also had type 2 diabetes. More detailed findings from the 2,605 enrolled patients in DAPA-HF who lacked diabetes (55% of the total study population) have now sealed the deal.

Mitchel L. Zoler/MDedge News

“The relative and absolute reductions in cardiovascular death and hospitalizations or urgent visits for heart failure were substantial, clinically important, and consistent in patients with or without type 2 diabetes,” John McMurray, MD, declared at the American Heart Association scientific sessions as he summarized new trial results that confirmed the initial finding he reported previously.

While the initial report of the DAPA-HF (Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure) by the study’s lead investigator, Dr. McMurray, was limited to the finding that the relative risk reduction for the study’s primary endpoint was a highly statistically significant 25% in heart failure patients with diabetes and an equally strongly significant 27% relative cut among patients without diabetes (N Engl J Med. 2019 Sep 19;doi: 10.1056/NEJMoa1911303), the new data showed that same consistency across the range of outcomes studied in the trial as well as across the range of glycosylated hemoglobin levels that patients had at study entry.

In an analysis that divided the entire study population of 4,744 patients with heart failure with reduced ejection fraction (HFrEF) into tertiles based on their entry blood level of hemoglobin A^1c, patients with a normal level at or below 5.6% had a 26% relative reduction in the study’s primary endpoint, essentially the same response as the 29% relative cut in adverse events in the tertile of patients with a glycosylated hemoglobin level of 5.7%-5.9% and the relative 28% relative reduction in events in patients diagnosed with type 2 diabetes and having a hemoglobin A_1c of 6.0% or greater, reported Dr. McMurray, professor of cardiology at the University of Glasgow. The results also showed a very benign safety profile in the patients without diabetes, similar to patients with diabetes and to placebo, and with no episodes of major hypoglycemia or diabetic ketoacidosis.

“It’s quite impressive that the result was consistent regardless of the level of hemoglobin A_1c,” commented Larry A. Allen, MD, professor of medicine at the University of Colorado in Aurora and designated discussant for the report. Even though the patients without diabetes constituted just over half of the full DAPA-HF enrollment, the comparison of the effect of dapagliflozin in patients with or without diabetes was prespecified in a trial that enrolled a relatively large number of patients into each of the two subgroups by diabetes status. “I think there a good chance dapagliflozin will get an indication” for treating HFrEF patients without diabetes, Dr. Allen suggested in a video interview.

If the DAPA-HF results persuade the U.S. Food and Drug Administration to grant a supplemental indication to dapagliflozin for use in cutting cardiovascular deaths and acute heart failure exacerbations in patients without diabetes, it would pave the way for health insurers to pay for the drug. Right now, even though Dr. Allen and other heart failure physicians have been impressed by the DAPA-HF findings and are eager to add the drug to the list of agents that HFrEF patients routinely receive, he’s been stymied so far by patients’ out-of pocket cost for using dapagliflozin off-label, roughly $500 a month.

“The DAPA-HF results suggest there is strong reason to consider dapagliflozin for patients without diabetes, and for payers to pay for it. I’m not prescribing dapagliflozin to HFrEF patients without diabetes right now; not because of the data, but because of noncoverage. Payers have not yet caught up with the data,” he said, and they likely will continue to not pay for the drug when used by patients without diabetes until a new labeled indication appears for those patients.

The immediate availability of dapagliflozin (Farxiga) and the two other approved members of the sodium-glucose co-transporter 2 inhibitor class of drugs, empagliflozin (Jardiance) and canagliflozin (Invokana), to treat patients with HFrEF, and the prospect of soon having dapagliflozin and possibly the other drugs in this class to treat patients with HFrEF but without diabetes also raises issues of drug sequencing in these patients and the overall number of drugs that HFrEF patients must now take to be on optimized medical therapy, Dr. Allen noted.

The already-existing lineup of medications for HFrEF patients includes starting on an ACE inhibitor or angiotensin receptor blocker and adding a beta-blocker, a mineralocorticoid receptor antagonist, then swapping out the initial renin-angiotensin system inhibitor for sacubitril/valsartan, and then, on top of all this, adding dapagliflozin or another drug in the same class. It raises questions of what is objectively the best way to introduce all these drugs into patients, and how to do it without subjecting patients to “financial toxicity,” Dr. Allen said during his discussion of the trial’s results.

DAPA-HF was sponsored by AstraZeneca, which markets dapagliflozin (Farxiga). The University of Glasgow received payment from AstraZeneca to compensate for the time Dr. McMurray spent running the study. Dr. Allen has been a consultant to ACI Clinical, Boston Scientific, and Janssen.

[email protected]

SOURCE: McMurray JJV. AHA 19, Late-Breaking Science 1.

PHILADELPHIA – The primary outcome results from the practice-changing DAPA-HF trial gave clinicians strong evidence that the diabetes drug dapagliflozin was equally effective at reducing cardiovascular death and acute exacerbations in patients with heart failure with reduced ejection fraction, whether or not they also had type 2 diabetes. More detailed findings from the 2,605 enrolled patients in DAPA-HF who lacked diabetes (55% of the total study population) have now sealed the deal.

Mitchel L. Zoler/MDedge News

“The relative and absolute reductions in cardiovascular death and hospitalizations or urgent visits for heart failure were substantial, clinically important, and consistent in patients with or without type 2 diabetes,” John McMurray, MD, declared at the American Heart Association scientific sessions as he summarized new trial results that confirmed the initial finding he reported previously.

While the initial report of the DAPA-HF (Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure) by the study’s lead investigator, Dr. McMurray, was limited to the finding that the relative risk reduction for the study’s primary endpoint was a highly statistically significant 25% in heart failure patients with diabetes and an equally strongly significant 27% relative cut among patients without diabetes (N Engl J Med. 2019 Sep 19;doi: 10.1056/NEJMoa1911303), the new data showed that same consistency across the range of outcomes studied in the trial as well as across the range of glycosylated hemoglobin levels that patients had at study entry.

In an analysis that divided the entire study population of 4,744 patients with heart failure with reduced ejection fraction (HFrEF) into tertiles based on their entry blood level of hemoglobin A^1c, patients with a normal level at or below 5.6% had a 26% relative reduction in the study’s primary endpoint, essentially the same response as the 29% relative cut in adverse events in the tertile of patients with a glycosylated hemoglobin level of 5.7%-5.9% and the relative 28% relative reduction in events in patients diagnosed with type 2 diabetes and having a hemoglobin A_1c of 6.0% or greater, reported Dr. McMurray, professor of cardiology at the University of Glasgow. The results also showed a very benign safety profile in the patients without diabetes, similar to patients with diabetes and to placebo, and with no episodes of major hypoglycemia or diabetic ketoacidosis.

“It’s quite impressive that the result was consistent regardless of the level of hemoglobin A_1c,” commented Larry A. Allen, MD, professor of medicine at the University of Colorado in Aurora and designated discussant for the report. Even though the patients without diabetes constituted just over half of the full DAPA-HF enrollment, the comparison of the effect of dapagliflozin in patients with or without diabetes was prespecified in a trial that enrolled a relatively large number of patients into each of the two subgroups by diabetes status. “I think there a good chance dapagliflozin will get an indication” for treating HFrEF patients without diabetes, Dr. Allen suggested in a video interview.

If the DAPA-HF results persuade the U.S. Food and Drug Administration to grant a supplemental indication to dapagliflozin for use in cutting cardiovascular deaths and acute heart failure exacerbations in patients without diabetes, it would pave the way for health insurers to pay for the drug. Right now, even though Dr. Allen and other heart failure physicians have been impressed by the DAPA-HF findings and are eager to add the drug to the list of agents that HFrEF patients routinely receive, he’s been stymied so far by patients’ out-of pocket cost for using dapagliflozin off-label, roughly $500 a month.

“The DAPA-HF results suggest there is strong reason to consider dapagliflozin for patients without diabetes, and for payers to pay for it. I’m not prescribing dapagliflozin to HFrEF patients without diabetes right now; not because of the data, but because of noncoverage. Payers have not yet caught up with the data,” he said, and they likely will continue to not pay for the drug when used by patients without diabetes until a new labeled indication appears for those patients.

The immediate availability of dapagliflozin (Farxiga) and the two other approved members of the sodium-glucose co-transporter 2 inhibitor class of drugs, empagliflozin (Jardiance) and canagliflozin (Invokana), to treat patients with HFrEF, and the prospect of soon having dapagliflozin and possibly the other drugs in this class to treat patients with HFrEF but without diabetes also raises issues of drug sequencing in these patients and the overall number of drugs that HFrEF patients must now take to be on optimized medical therapy, Dr. Allen noted.

The already-existing lineup of medications for HFrEF patients includes starting on an ACE inhibitor or angiotensin receptor blocker and adding a beta-blocker, a mineralocorticoid receptor antagonist, then swapping out the initial renin-angiotensin system inhibitor for sacubitril/valsartan, and then, on top of all this, adding dapagliflozin or another drug in the same class. It raises questions of what is objectively the best way to introduce all these drugs into patients, and how to do it without subjecting patients to “financial toxicity,” Dr. Allen said during his discussion of the trial’s results.

DAPA-HF was sponsored by AstraZeneca, which markets dapagliflozin (Farxiga). The University of Glasgow received payment from AstraZeneca to compensate for the time Dr. McMurray spent running the study. Dr. Allen has been a consultant to ACI Clinical, Boston Scientific, and Janssen.

[email protected]

SOURCE: McMurray JJV. AHA 19, Late-Breaking Science 1.