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For years, oncologist John DiPersio, MD, PhD, had faced frustrating encounters with insurers that only cover medications through a process called white bagging.

Instead of the traditional buy-and-bill pathway where oncologists purchase specialty drugs, such as infusion medications, directly from the distributor or manufacturer, white bagging requires physicians to receive these drugs from a specialty pharmacy.

On its face, the differences may seem minor. However, as Dr. DiPersio knows well, the consequences for oncologists and patients are not.

White bagging, research showed, leads to higher costs for patients and lower reimbursement for oncology practices. The practice can also create safety issues for patients.

That is why Dr. DiPersio’s cancer center does not allow white bagging.

And when insurers refuse to reconsider the white bagging policy, his cancer team is left with few options.

“Sometimes, we have to redirect patients to other places,” said Dr. DiPersio, a bone marrow transplant specialist at Siteman Cancer Center, Washington University, St. Louis.

In emergency instances where patients cannot wait, Dr. DiPersio’s team will administer their own stock of a drug. In such cases, “we accept the fact that by not allowing white bagging, there may be nonpayment. We take the hit as far as cost.”

Increasingly, white bagging mandates are becoming harder for practices to avoid.

In a 2021 survey, 87% of Association of Community Cancer Centers members said white bagging has become an insurer mandate for some of their patients.

A 2023 analysis from Adam J. Fein, PhD, of Drug Channels Institute, Philadelphia, found that white bagging accounted for 17% of infused oncology product sourcing from clinics and 38% from hospital outpatient departments, up from 15% to 28% in 2019. Another practice called brown bagging, where specialty pharmacies send drugs directly to patients, creates many of the same issues but is much less prevalent than white bagging.

This change reflects “the broader battle over oncology margins” and insurers’ “attempts to shift costs to providers, patients, and manufacturers,” Dr. Fein wrote in his 2023 report.
 

White Bagging: Who Benefits?

At its core, white bagging changes how drugs are covered and reimbursed. Under buy and bill, drugs fall under a patient’s medical benefit. Oncologists purchase drugs directly from the manufacturer or distributor and receive reimbursement from the insurance company for both the cost of the drug as well as for administering it to patients.

Under white bagging, drugs fall under a patient’s pharmacy benefit. In these instances, a specialty pharmacy prepares the infusion ahead of time and ships it directly to the physician’s office or clinic. Because oncologists do not purchase the drug directly, they cannot bill insurers for it; instead, the pharmacy receives reimbursement for the drug and the provider is reimbursed for administering it.

Insurance companies argue that white bagging reduces patients’ out-of-pocket costs “by preventing hospitals and physicians from charging exorbitant fees to buy and store specialty medicines themselves,” according to advocacy group America’s Health Insurance Plans (AHIP).

Data from AHIP suggested that hospitals mark up the price of cancer drugs considerably, charging about twice as much as a specialty pharmacy, and that physician’s offices also charge about 23% more. However, these figures highlight how much insurers are billed, not necessarily how much patients ultimately pay.

Other evidence shows that white bagging raises costs for patients while reducing reimbursement for oncologists and saving insurance companies money.

A recent analysis in JAMA Network Open, which looked at 50 cancer drugs associated with the highest total spending from the 2020 Medicare Part B, found that mean insurance payments to providers were more than $2000 lower for drugs distributed under bagging than traditional buy and bill: $7405 vs $9547 per patient per month. Investigators found the same pattern in median insurance payments: $5746 vs $6681. Patients also paid more out-of-pocket each month with bagging vs buy and bill: $315 vs $145.

For patients with private insurance, “out-of-pocket costs were higher under bagging practice than the traditional buy-and-bill practice,” said lead author Ya-Chen Tina Shih, PhD, a professor in the department of radiation oncology at UCLA Health, Los Angeles.

White bagging is entirely for the profit of health insurers, specialty pharmacies, and pharmacy benefit managers, the middlemen who negotiate drug prices on behalf of payers.

Many people may not realize the underlying money-making strategies behind white bagging, explained Ted Okon, executive director for Community Oncology Alliance, which opposes the practice. Often, an insurer, pharmacy benefit manager, and mail order pharmacy involved in the process are all affiliated with the same corporation. In such cases, an insurer has a financial motive to control the source of medications and steer business to its affiliated pharmacies, Mr. Okon said.

When a single corporation owns numerous parts of the drug supply chain, insurers end up having “sway over what drug to use and then how the patient is going to get it,” Mr. Okon said. If the specialty pharmacy is a 340B contract pharmacy, it likely also receives a sizable discount on the drug and can make more money through white bagging.
 

Dangerous to Patients?

On the safety front, proponents of white bagging say the process is safe and efficient.

Specialty pharmacies are used only for prescription drugs that can be safely delivered, said AHIP spokesman David Allen.

In addition to having the same supply chain safety requirements as any other dispensing pharmacy, “specialty pharmacies also must meet additional safety requirements for specialty drugs” to ensure “the safe storage, handling, and dispensing of the drugs,” Mr. Allen explained.

However, oncologists argue that white bagging can be dangerous.

With white bagging, specialty pharmacies send a specified dose to practices, which does not allow practices to source and mix the drug themselves or make essential last-minute dose-related changes — something that happens every day in the clinic, said Debra Patt, MD, PhD, MBA, executive vice president for policy and strategy for Texas Oncology, Dallas.

White bagging also increases the risk for drug contamination, results in drug waste if the medication can’t be used, and can create delays in care.

Essentially, white bagging takes control away from oncologists and makes patient care more unpredictable and complex, explained Dr. Patt, president of the Texas Society of Clinical Oncology, Rockville, Maryland.

Dr. Patt, who does not allow white bagging in her practice, recalled a recent patient with metastatic breast cancer who came to the clinic for trastuzumab deruxtecan. The patient had been experiencing acute abdominal pain. After an exam and CT, Dr. Patt found the breast cancer had grown and moved into the patient’s liver.

“I had to discontinue that plan and change to a different chemotherapy,” she said. “If we had white bagged, that would have been a waste of several thousand dollars. Also, the patient would have to wait for the new medication to be white bagged, a delay that would be at least a week and the patient would have to come back at another time.”

When asked about the safety concerns associated with white bagging, Lemrey “Al” Carter, MS, PharmD, RPh, executive director of the National Association of Boards of Pharmacy (NABP), said the NABP “acknowledges that all these issues exist.

“It is unfortunate if patient care or costs are negatively impacted,” Dr. Carter said, adding that “boards of pharmacy can investigate if they are made aware of safety concerns at the pharmacy level. If a violation of the pharmacy laws or rules is found, boards can take action.”
 

More Legislation to Prevent Bagging

As white bagging mandates from insurance companies ramp up, more practices and states are banning it.

In the Association of Community Cancer Centers’ 2021 survey, 59% of members said their cancer program or practice does not allow white bagging.

At least 15 states have introduced legislation that restricts and/or prohibits white and brown bagging practices, according to a 2023 report by the Institute for Clinical and Economic Review. Some of the proposed laws would restrict mandates by stipulating that physicians are reimbursed at the contracted amount for clinician-administered drugs, whether obtained from a pharmacy or the manufacturer.

Louisiana, Vermont, and Minnesota were the first to enact anti–white bagging laws. Louisiana’s law, for example, enacted in 2021, bans white bagging and requires insurers to reimburse providers for physician-administered drugs if obtained from out-of-network pharmacies.

When the legislation passed, white bagging was just starting to enter the healthcare market in Louisiana, and the state wanted to act proactively, said Kathy W. Oubre, MS, CEO of the Pontchartrain Cancer Center, Covington, Louisiana, and president of the Coalition of Hematology and Oncology Practices, Mountain View, California.

“We recognized the growing concern around it,” Ms. Oubre said. The state legislature at the time included physicians and pharmacists who “really understood from a practice and patient perspective, the harm that policy could do.”

Ms. Oubre would like to see more legislation in other states and believes Louisiana’s law is a good model.

At the federal level, the American Hospital Association and American Society of Health-System Pharmacists have also urged the US Food and Drug Administration to take appropriate enforcement action to protect patients from white bagging.

Legislation that bars white bagging mandates is the most reasonable way to support timely and appropriate access to cancer care, Dr. Patt said. In the absence of such legislation, she said oncologists can only opt out of insurance contracts that may require the practice.

“That is a difficult position to put oncologists in,” she said.

A version of this article appeared on Medscape.com.

For years, oncologist John DiPersio, MD, PhD, had faced frustrating encounters with insurers that only cover medications through a process called white bagging.

Instead of the traditional buy-and-bill pathway where oncologists purchase specialty drugs, such as infusion medications, directly from the distributor or manufacturer, white bagging requires physicians to receive these drugs from a specialty pharmacy.

On its face, the differences may seem minor. However, as Dr. DiPersio knows well, the consequences for oncologists and patients are not.

White bagging, research showed, leads to higher costs for patients and lower reimbursement for oncology practices. The practice can also create safety issues for patients.

That is why Dr. DiPersio’s cancer center does not allow white bagging.

And when insurers refuse to reconsider the white bagging policy, his cancer team is left with few options.

“Sometimes, we have to redirect patients to other places,” said Dr. DiPersio, a bone marrow transplant specialist at Siteman Cancer Center, Washington University, St. Louis.

In emergency instances where patients cannot wait, Dr. DiPersio’s team will administer their own stock of a drug. In such cases, “we accept the fact that by not allowing white bagging, there may be nonpayment. We take the hit as far as cost.”

Increasingly, white bagging mandates are becoming harder for practices to avoid.

In a 2021 survey, 87% of Association of Community Cancer Centers members said white bagging has become an insurer mandate for some of their patients.

A 2023 analysis from Adam J. Fein, PhD, of Drug Channels Institute, Philadelphia, found that white bagging accounted for 17% of infused oncology product sourcing from clinics and 38% from hospital outpatient departments, up from 15% to 28% in 2019. Another practice called brown bagging, where specialty pharmacies send drugs directly to patients, creates many of the same issues but is much less prevalent than white bagging.

This change reflects “the broader battle over oncology margins” and insurers’ “attempts to shift costs to providers, patients, and manufacturers,” Dr. Fein wrote in his 2023 report.
 

White Bagging: Who Benefits?

At its core, white bagging changes how drugs are covered and reimbursed. Under buy and bill, drugs fall under a patient’s medical benefit. Oncologists purchase drugs directly from the manufacturer or distributor and receive reimbursement from the insurance company for both the cost of the drug as well as for administering it to patients.

Under white bagging, drugs fall under a patient’s pharmacy benefit. In these instances, a specialty pharmacy prepares the infusion ahead of time and ships it directly to the physician’s office or clinic. Because oncologists do not purchase the drug directly, they cannot bill insurers for it; instead, the pharmacy receives reimbursement for the drug and the provider is reimbursed for administering it.

Insurance companies argue that white bagging reduces patients’ out-of-pocket costs “by preventing hospitals and physicians from charging exorbitant fees to buy and store specialty medicines themselves,” according to advocacy group America’s Health Insurance Plans (AHIP).

Data from AHIP suggested that hospitals mark up the price of cancer drugs considerably, charging about twice as much as a specialty pharmacy, and that physician’s offices also charge about 23% more. However, these figures highlight how much insurers are billed, not necessarily how much patients ultimately pay.

Other evidence shows that white bagging raises costs for patients while reducing reimbursement for oncologists and saving insurance companies money.

A recent analysis in JAMA Network Open, which looked at 50 cancer drugs associated with the highest total spending from the 2020 Medicare Part B, found that mean insurance payments to providers were more than $2000 lower for drugs distributed under bagging than traditional buy and bill: $7405 vs $9547 per patient per month. Investigators found the same pattern in median insurance payments: $5746 vs $6681. Patients also paid more out-of-pocket each month with bagging vs buy and bill: $315 vs $145.

For patients with private insurance, “out-of-pocket costs were higher under bagging practice than the traditional buy-and-bill practice,” said lead author Ya-Chen Tina Shih, PhD, a professor in the department of radiation oncology at UCLA Health, Los Angeles.

White bagging is entirely for the profit of health insurers, specialty pharmacies, and pharmacy benefit managers, the middlemen who negotiate drug prices on behalf of payers.

Many people may not realize the underlying money-making strategies behind white bagging, explained Ted Okon, executive director for Community Oncology Alliance, which opposes the practice. Often, an insurer, pharmacy benefit manager, and mail order pharmacy involved in the process are all affiliated with the same corporation. In such cases, an insurer has a financial motive to control the source of medications and steer business to its affiliated pharmacies, Mr. Okon said.

When a single corporation owns numerous parts of the drug supply chain, insurers end up having “sway over what drug to use and then how the patient is going to get it,” Mr. Okon said. If the specialty pharmacy is a 340B contract pharmacy, it likely also receives a sizable discount on the drug and can make more money through white bagging.
 

Dangerous to Patients?

On the safety front, proponents of white bagging say the process is safe and efficient.

Specialty pharmacies are used only for prescription drugs that can be safely delivered, said AHIP spokesman David Allen.

In addition to having the same supply chain safety requirements as any other dispensing pharmacy, “specialty pharmacies also must meet additional safety requirements for specialty drugs” to ensure “the safe storage, handling, and dispensing of the drugs,” Mr. Allen explained.

However, oncologists argue that white bagging can be dangerous.

With white bagging, specialty pharmacies send a specified dose to practices, which does not allow practices to source and mix the drug themselves or make essential last-minute dose-related changes — something that happens every day in the clinic, said Debra Patt, MD, PhD, MBA, executive vice president for policy and strategy for Texas Oncology, Dallas.

White bagging also increases the risk for drug contamination, results in drug waste if the medication can’t be used, and can create delays in care.

Essentially, white bagging takes control away from oncologists and makes patient care more unpredictable and complex, explained Dr. Patt, president of the Texas Society of Clinical Oncology, Rockville, Maryland.

Dr. Patt, who does not allow white bagging in her practice, recalled a recent patient with metastatic breast cancer who came to the clinic for trastuzumab deruxtecan. The patient had been experiencing acute abdominal pain. After an exam and CT, Dr. Patt found the breast cancer had grown and moved into the patient’s liver.

“I had to discontinue that plan and change to a different chemotherapy,” she said. “If we had white bagged, that would have been a waste of several thousand dollars. Also, the patient would have to wait for the new medication to be white bagged, a delay that would be at least a week and the patient would have to come back at another time.”

When asked about the safety concerns associated with white bagging, Lemrey “Al” Carter, MS, PharmD, RPh, executive director of the National Association of Boards of Pharmacy (NABP), said the NABP “acknowledges that all these issues exist.

“It is unfortunate if patient care or costs are negatively impacted,” Dr. Carter said, adding that “boards of pharmacy can investigate if they are made aware of safety concerns at the pharmacy level. If a violation of the pharmacy laws or rules is found, boards can take action.”
 

More Legislation to Prevent Bagging

As white bagging mandates from insurance companies ramp up, more practices and states are banning it.

In the Association of Community Cancer Centers’ 2021 survey, 59% of members said their cancer program or practice does not allow white bagging.

At least 15 states have introduced legislation that restricts and/or prohibits white and brown bagging practices, according to a 2023 report by the Institute for Clinical and Economic Review. Some of the proposed laws would restrict mandates by stipulating that physicians are reimbursed at the contracted amount for clinician-administered drugs, whether obtained from a pharmacy or the manufacturer.

Louisiana, Vermont, and Minnesota were the first to enact anti–white bagging laws. Louisiana’s law, for example, enacted in 2021, bans white bagging and requires insurers to reimburse providers for physician-administered drugs if obtained from out-of-network pharmacies.

When the legislation passed, white bagging was just starting to enter the healthcare market in Louisiana, and the state wanted to act proactively, said Kathy W. Oubre, MS, CEO of the Pontchartrain Cancer Center, Covington, Louisiana, and president of the Coalition of Hematology and Oncology Practices, Mountain View, California.

“We recognized the growing concern around it,” Ms. Oubre said. The state legislature at the time included physicians and pharmacists who “really understood from a practice and patient perspective, the harm that policy could do.”

Ms. Oubre would like to see more legislation in other states and believes Louisiana’s law is a good model.

At the federal level, the American Hospital Association and American Society of Health-System Pharmacists have also urged the US Food and Drug Administration to take appropriate enforcement action to protect patients from white bagging.

Legislation that bars white bagging mandates is the most reasonable way to support timely and appropriate access to cancer care, Dr. Patt said. In the absence of such legislation, she said oncologists can only opt out of insurance contracts that may require the practice.

“That is a difficult position to put oncologists in,” she said.

A version of this article appeared on Medscape.com.

For years, oncologist John DiPersio, MD, PhD, had faced frustrating encounters with insurers that only cover medications through a process called white bagging.

Instead of the traditional buy-and-bill pathway where oncologists purchase specialty drugs, such as infusion medications, directly from the distributor or manufacturer, white bagging requires physicians to receive these drugs from a specialty pharmacy.

On its face, the differences may seem minor. However, as Dr. DiPersio knows well, the consequences for oncologists and patients are not.

White bagging, research showed, leads to higher costs for patients and lower reimbursement for oncology practices. The practice can also create safety issues for patients.

That is why Dr. DiPersio’s cancer center does not allow white bagging.

And when insurers refuse to reconsider the white bagging policy, his cancer team is left with few options.

“Sometimes, we have to redirect patients to other places,” said Dr. DiPersio, a bone marrow transplant specialist at Siteman Cancer Center, Washington University, St. Louis.

In emergency instances where patients cannot wait, Dr. DiPersio’s team will administer their own stock of a drug. In such cases, “we accept the fact that by not allowing white bagging, there may be nonpayment. We take the hit as far as cost.”

Increasingly, white bagging mandates are becoming harder for practices to avoid.

In a 2021 survey, 87% of Association of Community Cancer Centers members said white bagging has become an insurer mandate for some of their patients.

A 2023 analysis from Adam J. Fein, PhD, of Drug Channels Institute, Philadelphia, found that white bagging accounted for 17% of infused oncology product sourcing from clinics and 38% from hospital outpatient departments, up from 15% to 28% in 2019. Another practice called brown bagging, where specialty pharmacies send drugs directly to patients, creates many of the same issues but is much less prevalent than white bagging.

This change reflects “the broader battle over oncology margins” and insurers’ “attempts to shift costs to providers, patients, and manufacturers,” Dr. Fein wrote in his 2023 report.
 

White Bagging: Who Benefits?

At its core, white bagging changes how drugs are covered and reimbursed. Under buy and bill, drugs fall under a patient’s medical benefit. Oncologists purchase drugs directly from the manufacturer or distributor and receive reimbursement from the insurance company for both the cost of the drug as well as for administering it to patients.

Under white bagging, drugs fall under a patient’s pharmacy benefit. In these instances, a specialty pharmacy prepares the infusion ahead of time and ships it directly to the physician’s office or clinic. Because oncologists do not purchase the drug directly, they cannot bill insurers for it; instead, the pharmacy receives reimbursement for the drug and the provider is reimbursed for administering it.

Insurance companies argue that white bagging reduces patients’ out-of-pocket costs “by preventing hospitals and physicians from charging exorbitant fees to buy and store specialty medicines themselves,” according to advocacy group America’s Health Insurance Plans (AHIP).

Data from AHIP suggested that hospitals mark up the price of cancer drugs considerably, charging about twice as much as a specialty pharmacy, and that physician’s offices also charge about 23% more. However, these figures highlight how much insurers are billed, not necessarily how much patients ultimately pay.

Other evidence shows that white bagging raises costs for patients while reducing reimbursement for oncologists and saving insurance companies money.

A recent analysis in JAMA Network Open, which looked at 50 cancer drugs associated with the highest total spending from the 2020 Medicare Part B, found that mean insurance payments to providers were more than $2000 lower for drugs distributed under bagging than traditional buy and bill: $7405 vs $9547 per patient per month. Investigators found the same pattern in median insurance payments: $5746 vs $6681. Patients also paid more out-of-pocket each month with bagging vs buy and bill: $315 vs $145.

For patients with private insurance, “out-of-pocket costs were higher under bagging practice than the traditional buy-and-bill practice,” said lead author Ya-Chen Tina Shih, PhD, a professor in the department of radiation oncology at UCLA Health, Los Angeles.

White bagging is entirely for the profit of health insurers, specialty pharmacies, and pharmacy benefit managers, the middlemen who negotiate drug prices on behalf of payers.

Many people may not realize the underlying money-making strategies behind white bagging, explained Ted Okon, executive director for Community Oncology Alliance, which opposes the practice. Often, an insurer, pharmacy benefit manager, and mail order pharmacy involved in the process are all affiliated with the same corporation. In such cases, an insurer has a financial motive to control the source of medications and steer business to its affiliated pharmacies, Mr. Okon said.

When a single corporation owns numerous parts of the drug supply chain, insurers end up having “sway over what drug to use and then how the patient is going to get it,” Mr. Okon said. If the specialty pharmacy is a 340B contract pharmacy, it likely also receives a sizable discount on the drug and can make more money through white bagging.
 

Dangerous to Patients?

On the safety front, proponents of white bagging say the process is safe and efficient.

Specialty pharmacies are used only for prescription drugs that can be safely delivered, said AHIP spokesman David Allen.

In addition to having the same supply chain safety requirements as any other dispensing pharmacy, “specialty pharmacies also must meet additional safety requirements for specialty drugs” to ensure “the safe storage, handling, and dispensing of the drugs,” Mr. Allen explained.

However, oncologists argue that white bagging can be dangerous.

With white bagging, specialty pharmacies send a specified dose to practices, which does not allow practices to source and mix the drug themselves or make essential last-minute dose-related changes — something that happens every day in the clinic, said Debra Patt, MD, PhD, MBA, executive vice president for policy and strategy for Texas Oncology, Dallas.

White bagging also increases the risk for drug contamination, results in drug waste if the medication can’t be used, and can create delays in care.

Essentially, white bagging takes control away from oncologists and makes patient care more unpredictable and complex, explained Dr. Patt, president of the Texas Society of Clinical Oncology, Rockville, Maryland.

Dr. Patt, who does not allow white bagging in her practice, recalled a recent patient with metastatic breast cancer who came to the clinic for trastuzumab deruxtecan. The patient had been experiencing acute abdominal pain. After an exam and CT, Dr. Patt found the breast cancer had grown and moved into the patient’s liver.

“I had to discontinue that plan and change to a different chemotherapy,” she said. “If we had white bagged, that would have been a waste of several thousand dollars. Also, the patient would have to wait for the new medication to be white bagged, a delay that would be at least a week and the patient would have to come back at another time.”

When asked about the safety concerns associated with white bagging, Lemrey “Al” Carter, MS, PharmD, RPh, executive director of the National Association of Boards of Pharmacy (NABP), said the NABP “acknowledges that all these issues exist.

“It is unfortunate if patient care or costs are negatively impacted,” Dr. Carter said, adding that “boards of pharmacy can investigate if they are made aware of safety concerns at the pharmacy level. If a violation of the pharmacy laws or rules is found, boards can take action.”
 

More Legislation to Prevent Bagging

As white bagging mandates from insurance companies ramp up, more practices and states are banning it.

In the Association of Community Cancer Centers’ 2021 survey, 59% of members said their cancer program or practice does not allow white bagging.

At least 15 states have introduced legislation that restricts and/or prohibits white and brown bagging practices, according to a 2023 report by the Institute for Clinical and Economic Review. Some of the proposed laws would restrict mandates by stipulating that physicians are reimbursed at the contracted amount for clinician-administered drugs, whether obtained from a pharmacy or the manufacturer.

Louisiana, Vermont, and Minnesota were the first to enact anti–white bagging laws. Louisiana’s law, for example, enacted in 2021, bans white bagging and requires insurers to reimburse providers for physician-administered drugs if obtained from out-of-network pharmacies.

When the legislation passed, white bagging was just starting to enter the healthcare market in Louisiana, and the state wanted to act proactively, said Kathy W. Oubre, MS, CEO of the Pontchartrain Cancer Center, Covington, Louisiana, and president of the Coalition of Hematology and Oncology Practices, Mountain View, California.

“We recognized the growing concern around it,” Ms. Oubre said. The state legislature at the time included physicians and pharmacists who “really understood from a practice and patient perspective, the harm that policy could do.”

Ms. Oubre would like to see more legislation in other states and believes Louisiana’s law is a good model.

At the federal level, the American Hospital Association and American Society of Health-System Pharmacists have also urged the US Food and Drug Administration to take appropriate enforcement action to protect patients from white bagging.

Legislation that bars white bagging mandates is the most reasonable way to support timely and appropriate access to cancer care, Dr. Patt said. In the absence of such legislation, she said oncologists can only opt out of insurance contracts that may require the practice.

“That is a difficult position to put oncologists in,” she said.

A version of this article appeared on Medscape.com.

Physicians groups on January 17 hailed a new federal rule requiring health insurers to streamline and disclose more information about their prior authorization processes, saying it will improve patient care and reduce doctors’ administrative burden.

Health insurers participating in federal programs, including Medicare Advantage and Medicaid, must now respond to expedited prior authorization requests within 72 hours and other requests within 7 days under the long-awaited final rule, released on January 17 by the Centers for Medicare & Medicaid Services (CMS). 

Insurers also must include their reasons for denying a prior authorization request and will be required to publicly release data on denial and approval rates for medical treatment. They’ll also need to give patients more information about their decisions to deny care. Insurers must comply with some of the rule’s provisions by January 2026 and others by January 2027. 

The final rule “is an important step forward” toward the Medical Group Management Association’s goal of reducing the overall volume of prior authorization requests, said Anders Gilberg, the group’s senior vice president for government affairs, in a statement. 

“Only then will medical groups find meaningful reprieve from these onerous, ill-intentioned administrative requirements that dangerously impede patient care,” Mr. Gilberg said.

Health insurers have long lobbied against increased regulation of prior authorization, arguing that it’s needed to rein in healthcare costs and prevent unnecessary treatment. 

“We appreciate CMS’s announcement of enforcement discretion that will permit plans to use one standard, rather than mixing and matching, to reduce costs and speed implementation,” said America’s Health Insurance Plans, an insurers’ lobbying group, in an unsigned statement. “However, we must remember that the CMS rule is only half the picture; the Office of the Coordinator for Health Information Technology (ONC) should swiftly require vendors to build electronic prior authorization capabilities into the electronic health record so that providers can do their part, or plans will build a bridge to nowhere.” 

The rule comes as health insurers have increasingly been criticized for onerous and time-consuming prior authorization procedures that physicians say unfairly delay or deny the medical treatment that their patients need. With federal legislation to rein in prior authorization overuse at a standstill, 30 states have introduced their own bills to address the problem. Regulators and lawsuits also have called attention to insurers’ increasing use of artificial intelligence and algorithms to deny claims without human review.

“Family physicians know firsthand how prior authorizations divert valuable time and resources away from direct patient care. We also know that these types of administrative requirements are driving physicians away from the workforce and worsening physician shortages,” said Steven P. Furr, MD, president of the American Academy of Family Physicians, in a statement praising the new rule. 

Jesse M. Ehrenfeld, MD, MPH, president of the American Medical Association, called the final rule “ a major win” for patients and physicians, adding that its requirements for health insurers to integrate their prior authorization procedures into physicians’ electronic health records systems will also help make “the current time-consuming, manual workflow” more efficient.

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

Physicians groups on January 17 hailed a new federal rule requiring health insurers to streamline and disclose more information about their prior authorization processes, saying it will improve patient care and reduce doctors’ administrative burden.

Health insurers participating in federal programs, including Medicare Advantage and Medicaid, must now respond to expedited prior authorization requests within 72 hours and other requests within 7 days under the long-awaited final rule, released on January 17 by the Centers for Medicare & Medicaid Services (CMS). 

Insurers also must include their reasons for denying a prior authorization request and will be required to publicly release data on denial and approval rates for medical treatment. They’ll also need to give patients more information about their decisions to deny care. Insurers must comply with some of the rule’s provisions by January 2026 and others by January 2027. 

The final rule “is an important step forward” toward the Medical Group Management Association’s goal of reducing the overall volume of prior authorization requests, said Anders Gilberg, the group’s senior vice president for government affairs, in a statement. 

“Only then will medical groups find meaningful reprieve from these onerous, ill-intentioned administrative requirements that dangerously impede patient care,” Mr. Gilberg said.

Health insurers have long lobbied against increased regulation of prior authorization, arguing that it’s needed to rein in healthcare costs and prevent unnecessary treatment. 

“We appreciate CMS’s announcement of enforcement discretion that will permit plans to use one standard, rather than mixing and matching, to reduce costs and speed implementation,” said America’s Health Insurance Plans, an insurers’ lobbying group, in an unsigned statement. “However, we must remember that the CMS rule is only half the picture; the Office of the Coordinator for Health Information Technology (ONC) should swiftly require vendors to build electronic prior authorization capabilities into the electronic health record so that providers can do their part, or plans will build a bridge to nowhere.” 

The rule comes as health insurers have increasingly been criticized for onerous and time-consuming prior authorization procedures that physicians say unfairly delay or deny the medical treatment that their patients need. With federal legislation to rein in prior authorization overuse at a standstill, 30 states have introduced their own bills to address the problem. Regulators and lawsuits also have called attention to insurers’ increasing use of artificial intelligence and algorithms to deny claims without human review.

“Family physicians know firsthand how prior authorizations divert valuable time and resources away from direct patient care. We also know that these types of administrative requirements are driving physicians away from the workforce and worsening physician shortages,” said Steven P. Furr, MD, president of the American Academy of Family Physicians, in a statement praising the new rule. 

Jesse M. Ehrenfeld, MD, MPH, president of the American Medical Association, called the final rule “ a major win” for patients and physicians, adding that its requirements for health insurers to integrate their prior authorization procedures into physicians’ electronic health records systems will also help make “the current time-consuming, manual workflow” more efficient.

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

Physicians groups on January 17 hailed a new federal rule requiring health insurers to streamline and disclose more information about their prior authorization processes, saying it will improve patient care and reduce doctors’ administrative burden.

Health insurers participating in federal programs, including Medicare Advantage and Medicaid, must now respond to expedited prior authorization requests within 72 hours and other requests within 7 days under the long-awaited final rule, released on January 17 by the Centers for Medicare & Medicaid Services (CMS). 

Insurers also must include their reasons for denying a prior authorization request and will be required to publicly release data on denial and approval rates for medical treatment. They’ll also need to give patients more information about their decisions to deny care. Insurers must comply with some of the rule’s provisions by January 2026 and others by January 2027. 

The final rule “is an important step forward” toward the Medical Group Management Association’s goal of reducing the overall volume of prior authorization requests, said Anders Gilberg, the group’s senior vice president for government affairs, in a statement. 

“Only then will medical groups find meaningful reprieve from these onerous, ill-intentioned administrative requirements that dangerously impede patient care,” Mr. Gilberg said.

Health insurers have long lobbied against increased regulation of prior authorization, arguing that it’s needed to rein in healthcare costs and prevent unnecessary treatment. 

“We appreciate CMS’s announcement of enforcement discretion that will permit plans to use one standard, rather than mixing and matching, to reduce costs and speed implementation,” said America’s Health Insurance Plans, an insurers’ lobbying group, in an unsigned statement. “However, we must remember that the CMS rule is only half the picture; the Office of the Coordinator for Health Information Technology (ONC) should swiftly require vendors to build electronic prior authorization capabilities into the electronic health record so that providers can do their part, or plans will build a bridge to nowhere.” 

The rule comes as health insurers have increasingly been criticized for onerous and time-consuming prior authorization procedures that physicians say unfairly delay or deny the medical treatment that their patients need. With federal legislation to rein in prior authorization overuse at a standstill, 30 states have introduced their own bills to address the problem. Regulators and lawsuits also have called attention to insurers’ increasing use of artificial intelligence and algorithms to deny claims without human review.

“Family physicians know firsthand how prior authorizations divert valuable time and resources away from direct patient care. We also know that these types of administrative requirements are driving physicians away from the workforce and worsening physician shortages,” said Steven P. Furr, MD, president of the American Academy of Family Physicians, in a statement praising the new rule. 

Jesse M. Ehrenfeld, MD, MPH, president of the American Medical Association, called the final rule “ a major win” for patients and physicians, adding that its requirements for health insurers to integrate their prior authorization procedures into physicians’ electronic health records systems will also help make “the current time-consuming, manual workflow” more efficient.

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

As the saying goes, “The more things change, the more they stay the same.” That is particularly true when it comes to the affordability of drugs for our patients even after the launch of so many Humira biosimilars. And we still have the “musical chairs” game of formulary construction — when the music stops, who knows whether your patient’s drug found a chair to sit on. There seems to be only a few chairs available for the many adalimumab biosimilars playing the game.

Nothing has changed since my testimony before the FDA Arthritis Advisory Committee in July 2016 during the approval hearing of the first Humira biosimilar. Below is a quote from that meeting where I was speaking predominantly about the pharmacy side of drugs.

“I’d like to highlight the term ‘access’ because none of us are really naive enough to believe that just approving a biosimilar gives a patient true, hands-on access to the medication, because even if the biosimilar is offered at a 30% discount, I don’t have any patients that can afford it. This means that access is ultimately controlled by third-party payers.”

My prediction, that approving and launching biosimilars with lower prices would not ensure patient access to the drug unless it is paid for by insurance, is now our reality. Today, a drug with an 85% discount on the price of Humira is still unattainable for patients without a “payer.”
 

Competition and Lower Prices

Lawmakers and some in the media cry for more competition to lower prices. This is the main reason that there has been such a push to get biosimilars to the market as quickly as possible. It is abundantly clear that competition to get on the formulary is fierce. Placement of a medication on a formulary can make or break a manufacturer’s ability to get a return on the R&D and make a profit on that medication. For a small biotech manufacturer, it can be the difference between “life and death” of the company.

Does anyone remember when the first interchangeable biosimilar for the reference insulin glargine product Lantus (insulin glargine-yfgn; Semglee) came to market in 2021? Janet Woodcock, MD, then acting FDA commissioner, called it a “momentous day” and further said, “Today’s approval of the first interchangeable biosimilar product furthers FDA’s longstanding commitment to support a competitive marketplace for biological products and ultimately empowers patients by helping to increase access to safe, effective and high-quality medications at potentially lower cost.” There was a high-priced interchangeable biosimilar and an identical unbranded low-priced interchangeable biosimilar, and the only one that could get formulary placement was the high-priced drug.

Patients pay their cost share on the list price of the drug, and because most pharmacy benefit managers’ (PBMs’) formularies cover only the high-priced biosimilar, patients never share in the savings. So much for the “competitive marketplace” creating lower costs for patients. This is just one of hundreds of examples in which lower-priced drugs are excluded from the formulary. It is unfortunate that the bidding process from manufacturers to PBMs to “win” preferred formulary placement is like an art auction, where the highest bidder wins.
 

Biosimilars and Formulary Construction

For those of us who have been looking into PBMs for many years, it is no surprise that PBMs’ formulary construction has become a profit center for them. Now, with so many adalimumab biosimilars having entered the market, it has become the Wild West where only those with the most money to fork over to the PBMs get preferred placement. Unfortunately, many of the choices that make money for the PBM cost employers and patients more.

How did we get here? In the 1980s and 90s, the price of medications began to increase to the point that many were not affordable without insurance. And who better to construct the list of drugs that would be covered by insurance (formulary) than the PBMs who were already adjudicating the claims for these drugs. The Federal Trade Commission (FTC) realized the power inherent in constructing this list of medications known as the formulary. So when the manufacturer Merck acquired the PBM Medco in the mid-1990s, the FTC stepped in. The FTC surmised that making the drugs and deciding which ones will be paid for created a “conflict of interest” with anticompetitive ramifications.

So, in 1998, William J. Baer, director of the FTC’s Bureau of Competition, said, “Our investigation into the PBM industry has revealed that Merck’s acquisition of Medco has reduced competition in the market for pharmaceutical products … We have found that Medco has given favorable treatment to Merck drugs. As a result, in some cases, consumers have been denied access to the drugs of competing manufacturers. In addition, the merger has made it possible for Medco to share with Merck sensitive pricing information it gets from Merck’s competitors, which could foster collusion among drug manufacturers.” Wow!

These anticompetitive behaviors and conflicts of interest resulting from the Medco acquisition led the FTC to propose a consent agreement.

The agreement would require Merck-Medco to maintain an “open formulary” — one that includes drugs selected and approved by an independent Pharmacy and Therapeutics Committee regardless of the manufacturer. Medco would have to accept rebates and other price concessions and reflect these in the ranking of the drugs on the formulary. Merck would have to make known the availability of the open formulary to any drug maker with an agreement with Medco.

Let’s hope the FTC of 2024 remembers the stance of the FTC in the 1990s regarding anticompetitive behavior involved in formulary construction.
 

Conflicts of Interest

But today it is apparent that crafting formularies that pay only for the drugs that make the most money for the PBM is not a conflict of interest. In its policy manual, Cigna directly tells employers and employees that they are collecting and keeping rebates and fees on medical pharmaceuticals, and they are not for the benefit of the employer or the plan.

And now, in August 2023, CVS launched Cordavis, a subsidiary wholly owned by CVS. Cordavis/CVS has partnered with Sandoz, which makes Hyrimoz, an adalimumab biosimilar. There is a high-priced version that is discounted 5% from Humira, a lower-cost unbranded version that is discounted 80% off the list price of Humira, and a co-branded CVS/Sandoz version of Hyrimoz that is lower priced as well.

It isn’t a surprise that CVS’ Standard and Advanced Commercial and Chart formularies are offering only Sandoz adalimumab biosimilar products. While these formularies have excluded Humira, CVS has entered into an agreement with AbbVie to allow Humira on a number of their other formularies. It can be very confusing.

As stated earlier, in the 1990s, the FTC frowned upon manufacturers owning PBMs and allowing them to construct their own formularies. Here we have CVS Health, mothership for the PBM CVS Caremark, owning a company that will be co-producing biosimilars with other manufacturers and then determining which biosimilars are on their formularies. The FTC knew back then that the tendency would be to offer only their own drugs for coverage, thus reducing competition. This is exactly what the CVS-Cordavis-Sandoz partnership has done for their Standard and Advanced Commercial and Chart formularies. It is perhaps anti-competitive but certainly profitable.

Perhaps the FTC should require the same consent agreement that was given to Merck in 1998. CVS Caremark would then have to open their formularies to all competitors of their co-branded, co-produced Sandoz biosimilar.
 

Summary

It is the same old adage, “The more things change, the more they stay the same.” PBMs are still constructing formularies with biosimilars based on their profitability, with huge differences between gross and net cost. Patients still pay their cost share on the list (gross) price. With the CVS-Cordavis-Sandoz partnership, more vertical integration has led to yet another profit river. Self-funded employers are still getting the wool pulled over their eyes by the big three PBMs who threaten to take away rebates if they don’t choose the preferred formularies. The employers don’t realize that sometimes it is less expensive to choose the lower-priced drugs with no rebates, and that holds true for biosimilars as well.

Let’s hope that the FTC investigates the situation of a PBM partnering with a manufacturer and then choosing only that manufacturer’s drugs for many of their formularies.

We need to continue our advocacy for our patients because the medication that has kept them stable for so long may find itself without a chair the next time the music stops.
 

Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is the CSRO’s Vice President of Advocacy and Government Affairs and its immediate Past President, as well as past chair of the Alliance for Safe Biologic Medicines and a past member of the American College of Rheumatology insurance subcommittee. You can reach her at [email protected].

As the saying goes, “The more things change, the more they stay the same.” That is particularly true when it comes to the affordability of drugs for our patients even after the launch of so many Humira biosimilars. And we still have the “musical chairs” game of formulary construction — when the music stops, who knows whether your patient’s drug found a chair to sit on. There seems to be only a few chairs available for the many adalimumab biosimilars playing the game.

Nothing has changed since my testimony before the FDA Arthritis Advisory Committee in July 2016 during the approval hearing of the first Humira biosimilar. Below is a quote from that meeting where I was speaking predominantly about the pharmacy side of drugs.

“I’d like to highlight the term ‘access’ because none of us are really naive enough to believe that just approving a biosimilar gives a patient true, hands-on access to the medication, because even if the biosimilar is offered at a 30% discount, I don’t have any patients that can afford it. This means that access is ultimately controlled by third-party payers.”

My prediction, that approving and launching biosimilars with lower prices would not ensure patient access to the drug unless it is paid for by insurance, is now our reality. Today, a drug with an 85% discount on the price of Humira is still unattainable for patients without a “payer.”
 

Competition and Lower Prices

Lawmakers and some in the media cry for more competition to lower prices. This is the main reason that there has been such a push to get biosimilars to the market as quickly as possible. It is abundantly clear that competition to get on the formulary is fierce. Placement of a medication on a formulary can make or break a manufacturer’s ability to get a return on the R&D and make a profit on that medication. For a small biotech manufacturer, it can be the difference between “life and death” of the company.

Does anyone remember when the first interchangeable biosimilar for the reference insulin glargine product Lantus (insulin glargine-yfgn; Semglee) came to market in 2021? Janet Woodcock, MD, then acting FDA commissioner, called it a “momentous day” and further said, “Today’s approval of the first interchangeable biosimilar product furthers FDA’s longstanding commitment to support a competitive marketplace for biological products and ultimately empowers patients by helping to increase access to safe, effective and high-quality medications at potentially lower cost.” There was a high-priced interchangeable biosimilar and an identical unbranded low-priced interchangeable biosimilar, and the only one that could get formulary placement was the high-priced drug.

Patients pay their cost share on the list price of the drug, and because most pharmacy benefit managers’ (PBMs’) formularies cover only the high-priced biosimilar, patients never share in the savings. So much for the “competitive marketplace” creating lower costs for patients. This is just one of hundreds of examples in which lower-priced drugs are excluded from the formulary. It is unfortunate that the bidding process from manufacturers to PBMs to “win” preferred formulary placement is like an art auction, where the highest bidder wins.
 

Biosimilars and Formulary Construction

For those of us who have been looking into PBMs for many years, it is no surprise that PBMs’ formulary construction has become a profit center for them. Now, with so many adalimumab biosimilars having entered the market, it has become the Wild West where only those with the most money to fork over to the PBMs get preferred placement. Unfortunately, many of the choices that make money for the PBM cost employers and patients more.

How did we get here? In the 1980s and 90s, the price of medications began to increase to the point that many were not affordable without insurance. And who better to construct the list of drugs that would be covered by insurance (formulary) than the PBMs who were already adjudicating the claims for these drugs. The Federal Trade Commission (FTC) realized the power inherent in constructing this list of medications known as the formulary. So when the manufacturer Merck acquired the PBM Medco in the mid-1990s, the FTC stepped in. The FTC surmised that making the drugs and deciding which ones will be paid for created a “conflict of interest” with anticompetitive ramifications.

So, in 1998, William J. Baer, director of the FTC’s Bureau of Competition, said, “Our investigation into the PBM industry has revealed that Merck’s acquisition of Medco has reduced competition in the market for pharmaceutical products … We have found that Medco has given favorable treatment to Merck drugs. As a result, in some cases, consumers have been denied access to the drugs of competing manufacturers. In addition, the merger has made it possible for Medco to share with Merck sensitive pricing information it gets from Merck’s competitors, which could foster collusion among drug manufacturers.” Wow!

These anticompetitive behaviors and conflicts of interest resulting from the Medco acquisition led the FTC to propose a consent agreement.

The agreement would require Merck-Medco to maintain an “open formulary” — one that includes drugs selected and approved by an independent Pharmacy and Therapeutics Committee regardless of the manufacturer. Medco would have to accept rebates and other price concessions and reflect these in the ranking of the drugs on the formulary. Merck would have to make known the availability of the open formulary to any drug maker with an agreement with Medco.

Let’s hope the FTC of 2024 remembers the stance of the FTC in the 1990s regarding anticompetitive behavior involved in formulary construction.
 

Conflicts of Interest

But today it is apparent that crafting formularies that pay only for the drugs that make the most money for the PBM is not a conflict of interest. In its policy manual, Cigna directly tells employers and employees that they are collecting and keeping rebates and fees on medical pharmaceuticals, and they are not for the benefit of the employer or the plan.

And now, in August 2023, CVS launched Cordavis, a subsidiary wholly owned by CVS. Cordavis/CVS has partnered with Sandoz, which makes Hyrimoz, an adalimumab biosimilar. There is a high-priced version that is discounted 5% from Humira, a lower-cost unbranded version that is discounted 80% off the list price of Humira, and a co-branded CVS/Sandoz version of Hyrimoz that is lower priced as well.

It isn’t a surprise that CVS’ Standard and Advanced Commercial and Chart formularies are offering only Sandoz adalimumab biosimilar products. While these formularies have excluded Humira, CVS has entered into an agreement with AbbVie to allow Humira on a number of their other formularies. It can be very confusing.

As stated earlier, in the 1990s, the FTC frowned upon manufacturers owning PBMs and allowing them to construct their own formularies. Here we have CVS Health, mothership for the PBM CVS Caremark, owning a company that will be co-producing biosimilars with other manufacturers and then determining which biosimilars are on their formularies. The FTC knew back then that the tendency would be to offer only their own drugs for coverage, thus reducing competition. This is exactly what the CVS-Cordavis-Sandoz partnership has done for their Standard and Advanced Commercial and Chart formularies. It is perhaps anti-competitive but certainly profitable.

Perhaps the FTC should require the same consent agreement that was given to Merck in 1998. CVS Caremark would then have to open their formularies to all competitors of their co-branded, co-produced Sandoz biosimilar.
 

Summary

It is the same old adage, “The more things change, the more they stay the same.” PBMs are still constructing formularies with biosimilars based on their profitability, with huge differences between gross and net cost. Patients still pay their cost share on the list (gross) price. With the CVS-Cordavis-Sandoz partnership, more vertical integration has led to yet another profit river. Self-funded employers are still getting the wool pulled over their eyes by the big three PBMs who threaten to take away rebates if they don’t choose the preferred formularies. The employers don’t realize that sometimes it is less expensive to choose the lower-priced drugs with no rebates, and that holds true for biosimilars as well.

Let’s hope that the FTC investigates the situation of a PBM partnering with a manufacturer and then choosing only that manufacturer’s drugs for many of their formularies.

We need to continue our advocacy for our patients because the medication that has kept them stable for so long may find itself without a chair the next time the music stops.
 

Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is the CSRO’s Vice President of Advocacy and Government Affairs and its immediate Past President, as well as past chair of the Alliance for Safe Biologic Medicines and a past member of the American College of Rheumatology insurance subcommittee. You can reach her at [email protected].

As the saying goes, “The more things change, the more they stay the same.” That is particularly true when it comes to the affordability of drugs for our patients even after the launch of so many Humira biosimilars. And we still have the “musical chairs” game of formulary construction — when the music stops, who knows whether your patient’s drug found a chair to sit on. There seems to be only a few chairs available for the many adalimumab biosimilars playing the game.

Nothing has changed since my testimony before the FDA Arthritis Advisory Committee in July 2016 during the approval hearing of the first Humira biosimilar. Below is a quote from that meeting where I was speaking predominantly about the pharmacy side of drugs.

“I’d like to highlight the term ‘access’ because none of us are really naive enough to believe that just approving a biosimilar gives a patient true, hands-on access to the medication, because even if the biosimilar is offered at a 30% discount, I don’t have any patients that can afford it. This means that access is ultimately controlled by third-party payers.”

My prediction, that approving and launching biosimilars with lower prices would not ensure patient access to the drug unless it is paid for by insurance, is now our reality. Today, a drug with an 85% discount on the price of Humira is still unattainable for patients without a “payer.”
 

Competition and Lower Prices

Lawmakers and some in the media cry for more competition to lower prices. This is the main reason that there has been such a push to get biosimilars to the market as quickly as possible. It is abundantly clear that competition to get on the formulary is fierce. Placement of a medication on a formulary can make or break a manufacturer’s ability to get a return on the R&D and make a profit on that medication. For a small biotech manufacturer, it can be the difference between “life and death” of the company.

Does anyone remember when the first interchangeable biosimilar for the reference insulin glargine product Lantus (insulin glargine-yfgn; Semglee) came to market in 2021? Janet Woodcock, MD, then acting FDA commissioner, called it a “momentous day” and further said, “Today’s approval of the first interchangeable biosimilar product furthers FDA’s longstanding commitment to support a competitive marketplace for biological products and ultimately empowers patients by helping to increase access to safe, effective and high-quality medications at potentially lower cost.” There was a high-priced interchangeable biosimilar and an identical unbranded low-priced interchangeable biosimilar, and the only one that could get formulary placement was the high-priced drug.

Patients pay their cost share on the list price of the drug, and because most pharmacy benefit managers’ (PBMs’) formularies cover only the high-priced biosimilar, patients never share in the savings. So much for the “competitive marketplace” creating lower costs for patients. This is just one of hundreds of examples in which lower-priced drugs are excluded from the formulary. It is unfortunate that the bidding process from manufacturers to PBMs to “win” preferred formulary placement is like an art auction, where the highest bidder wins.
 

Biosimilars and Formulary Construction

For those of us who have been looking into PBMs for many years, it is no surprise that PBMs’ formulary construction has become a profit center for them. Now, with so many adalimumab biosimilars having entered the market, it has become the Wild West where only those with the most money to fork over to the PBMs get preferred placement. Unfortunately, many of the choices that make money for the PBM cost employers and patients more.

How did we get here? In the 1980s and 90s, the price of medications began to increase to the point that many were not affordable without insurance. And who better to construct the list of drugs that would be covered by insurance (formulary) than the PBMs who were already adjudicating the claims for these drugs. The Federal Trade Commission (FTC) realized the power inherent in constructing this list of medications known as the formulary. So when the manufacturer Merck acquired the PBM Medco in the mid-1990s, the FTC stepped in. The FTC surmised that making the drugs and deciding which ones will be paid for created a “conflict of interest” with anticompetitive ramifications.

So, in 1998, William J. Baer, director of the FTC’s Bureau of Competition, said, “Our investigation into the PBM industry has revealed that Merck’s acquisition of Medco has reduced competition in the market for pharmaceutical products … We have found that Medco has given favorable treatment to Merck drugs. As a result, in some cases, consumers have been denied access to the drugs of competing manufacturers. In addition, the merger has made it possible for Medco to share with Merck sensitive pricing information it gets from Merck’s competitors, which could foster collusion among drug manufacturers.” Wow!

These anticompetitive behaviors and conflicts of interest resulting from the Medco acquisition led the FTC to propose a consent agreement.

The agreement would require Merck-Medco to maintain an “open formulary” — one that includes drugs selected and approved by an independent Pharmacy and Therapeutics Committee regardless of the manufacturer. Medco would have to accept rebates and other price concessions and reflect these in the ranking of the drugs on the formulary. Merck would have to make known the availability of the open formulary to any drug maker with an agreement with Medco.

Let’s hope the FTC of 2024 remembers the stance of the FTC in the 1990s regarding anticompetitive behavior involved in formulary construction.
 

Conflicts of Interest

But today it is apparent that crafting formularies that pay only for the drugs that make the most money for the PBM is not a conflict of interest. In its policy manual, Cigna directly tells employers and employees that they are collecting and keeping rebates and fees on medical pharmaceuticals, and they are not for the benefit of the employer or the plan.

And now, in August 2023, CVS launched Cordavis, a subsidiary wholly owned by CVS. Cordavis/CVS has partnered with Sandoz, which makes Hyrimoz, an adalimumab biosimilar. There is a high-priced version that is discounted 5% from Humira, a lower-cost unbranded version that is discounted 80% off the list price of Humira, and a co-branded CVS/Sandoz version of Hyrimoz that is lower priced as well.

It isn’t a surprise that CVS’ Standard and Advanced Commercial and Chart formularies are offering only Sandoz adalimumab biosimilar products. While these formularies have excluded Humira, CVS has entered into an agreement with AbbVie to allow Humira on a number of their other formularies. It can be very confusing.

As stated earlier, in the 1990s, the FTC frowned upon manufacturers owning PBMs and allowing them to construct their own formularies. Here we have CVS Health, mothership for the PBM CVS Caremark, owning a company that will be co-producing biosimilars with other manufacturers and then determining which biosimilars are on their formularies. The FTC knew back then that the tendency would be to offer only their own drugs for coverage, thus reducing competition. This is exactly what the CVS-Cordavis-Sandoz partnership has done for their Standard and Advanced Commercial and Chart formularies. It is perhaps anti-competitive but certainly profitable.

Perhaps the FTC should require the same consent agreement that was given to Merck in 1998. CVS Caremark would then have to open their formularies to all competitors of their co-branded, co-produced Sandoz biosimilar.
 

Summary

It is the same old adage, “The more things change, the more they stay the same.” PBMs are still constructing formularies with biosimilars based on their profitability, with huge differences between gross and net cost. Patients still pay their cost share on the list (gross) price. With the CVS-Cordavis-Sandoz partnership, more vertical integration has led to yet another profit river. Self-funded employers are still getting the wool pulled over their eyes by the big three PBMs who threaten to take away rebates if they don’t choose the preferred formularies. The employers don’t realize that sometimes it is less expensive to choose the lower-priced drugs with no rebates, and that holds true for biosimilars as well.

Let’s hope that the FTC investigates the situation of a PBM partnering with a manufacturer and then choosing only that manufacturer’s drugs for many of their formularies.

We need to continue our advocacy for our patients because the medication that has kept them stable for so long may find itself without a chair the next time the music stops.
 

Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is the CSRO’s Vice President of Advocacy and Government Affairs and its immediate Past President, as well as past chair of the Alliance for Safe Biologic Medicines and a past member of the American College of Rheumatology insurance subcommittee. You can reach her at [email protected].

Key clinical point: In patients with psoriatic arthritis (PsA), a high dietary acid load (DAL), evaluated through potential renal acid load (PRAL) and net endogenous acid production (NEAP), was associated with increased disease activity and inflammation.

Major finding: The mean Disease Activity Index for PsA scores were higher in patients with PsA who had high vs low PRAL (19.8 vs 14.0; P = .006) and high vs low NEAP (20.3 vs 13.5; P = .001). In addition, patients in the high vs low PRAL and NEAP groups had significantly higher C-reactive protein levels (P = .024 and P = .020, respectively), indicating increased inflammation.

Study details: Findings are from a cross-sectional study that included 58 patients with overweight or obesity and a diagnosis of PsA.

Disclosures: This study did not disclose any funding. The authors declared no conflicts of interest.

Source: Öteleş S et al. The dietary acid load is associated with disease severity in psoriatic arthritis. Mod Rheumatol. 2023 (Nov 10). doi: 10.1093/mr/road107

Key clinical point: In patients with psoriatic arthritis (PsA), a high dietary acid load (DAL), evaluated through potential renal acid load (PRAL) and net endogenous acid production (NEAP), was associated with increased disease activity and inflammation.

Major finding: The mean Disease Activity Index for PsA scores were higher in patients with PsA who had high vs low PRAL (19.8 vs 14.0; P = .006) and high vs low NEAP (20.3 vs 13.5; P = .001). In addition, patients in the high vs low PRAL and NEAP groups had significantly higher C-reactive protein levels (P = .024 and P = .020, respectively), indicating increased inflammation.

Study details: Findings are from a cross-sectional study that included 58 patients with overweight or obesity and a diagnosis of PsA.

Disclosures: This study did not disclose any funding. The authors declared no conflicts of interest.

Source: Öteleş S et al. The dietary acid load is associated with disease severity in psoriatic arthritis. Mod Rheumatol. 2023 (Nov 10). doi: 10.1093/mr/road107

Key clinical point: In patients with psoriatic arthritis (PsA), a high dietary acid load (DAL), evaluated through potential renal acid load (PRAL) and net endogenous acid production (NEAP), was associated with increased disease activity and inflammation.

Major finding: The mean Disease Activity Index for PsA scores were higher in patients with PsA who had high vs low PRAL (19.8 vs 14.0; P = .006) and high vs low NEAP (20.3 vs 13.5; P = .001). In addition, patients in the high vs low PRAL and NEAP groups had significantly higher C-reactive protein levels (P = .024 and P = .020, respectively), indicating increased inflammation.

Study details: Findings are from a cross-sectional study that included 58 patients with overweight or obesity and a diagnosis of PsA.

Disclosures: This study did not disclose any funding. The authors declared no conflicts of interest.

Source: Öteleş S et al. The dietary acid load is associated with disease severity in psoriatic arthritis. Mod Rheumatol. 2023 (Nov 10). doi: 10.1093/mr/road107

Key clinical point: The risk for late-onset psoriatic arthritis (PsA) was higher in women who attained early natural menopause and had shorter reproductive years.

Major finding: The risk for incident PsA reduced by 46% and 34% in women who reached natural menopause at ≥55 vs <45 years of age and had a reproductive lifespan of ≥38 vs <38 years, respectively (P ≤ .006 for all). The partial population-attributable risk estimated that approximately 1/5of late-onset PsA incidences could be prevented if women went through menopause after the age of 55 years.

Study details: This prospective cohort study included postmenopausal women without psoriatic diseases from the UK Biobank, who were investigated for incident psoriasis (n = 139,572) or PsA (n = 142,329).

Disclosures: This study was supported by the National Natural Science Foundation of China and the Huxiang Youth Talent Supporting Program of Hunan. The authors declared no conflicts of interest.

Source: Xiao Y et al. Age at natural menopause, reproductive lifespan and the risk of late-onset psoriasis and psoriatic arthritis in women: A prospective cohort study. J Invest Dermatol. 2023 (Dec 9). doi: 10.1016/j.jid.2023.11.010

Key clinical point: The risk for late-onset psoriatic arthritis (PsA) was higher in women who attained early natural menopause and had shorter reproductive years.

Major finding: The risk for incident PsA reduced by 46% and 34% in women who reached natural menopause at ≥55 vs <45 years of age and had a reproductive lifespan of ≥38 vs <38 years, respectively (P ≤ .006 for all). The partial population-attributable risk estimated that approximately 1/5of late-onset PsA incidences could be prevented if women went through menopause after the age of 55 years.

Study details: This prospective cohort study included postmenopausal women without psoriatic diseases from the UK Biobank, who were investigated for incident psoriasis (n = 139,572) or PsA (n = 142,329).

Disclosures: This study was supported by the National Natural Science Foundation of China and the Huxiang Youth Talent Supporting Program of Hunan. The authors declared no conflicts of interest.

Source: Xiao Y et al. Age at natural menopause, reproductive lifespan and the risk of late-onset psoriasis and psoriatic arthritis in women: A prospective cohort study. J Invest Dermatol. 2023 (Dec 9). doi: 10.1016/j.jid.2023.11.010

Key clinical point: The risk for late-onset psoriatic arthritis (PsA) was higher in women who attained early natural menopause and had shorter reproductive years.

Major finding: The risk for incident PsA reduced by 46% and 34% in women who reached natural menopause at ≥55 vs <45 years of age and had a reproductive lifespan of ≥38 vs <38 years, respectively (P ≤ .006 for all). The partial population-attributable risk estimated that approximately 1/5of late-onset PsA incidences could be prevented if women went through menopause after the age of 55 years.

Study details: This prospective cohort study included postmenopausal women without psoriatic diseases from the UK Biobank, who were investigated for incident psoriasis (n = 139,572) or PsA (n = 142,329).

Disclosures: This study was supported by the National Natural Science Foundation of China and the Huxiang Youth Talent Supporting Program of Hunan. The authors declared no conflicts of interest.

Source: Xiao Y et al. Age at natural menopause, reproductive lifespan and the risk of late-onset psoriasis and psoriatic arthritis in women: A prospective cohort study. J Invest Dermatol. 2023 (Dec 9). doi: 10.1016/j.jid.2023.11.010

Key clinical point: Poor sleep quality was a very common phenomenon in patients with psoriatic arthritis (PsA) and associated with increased disease activity and higher levels of pain, fatigue, anxiety, and depression.

Major finding: A majority (63%) of patients with PsA experienced poor sleep quality, with factors like higher Disease Activity Index for PsA scores, pain, fatigue, anxiety, and depression (P < .01 for all) associated with poorer sleep quality. Patients with vs without fibromyalgia also reported poorer sleep quality (P < .001).

Study details: Findings are from a single-center cross-sectional study that included 247 patients with PsA.

Disclosures: This study received medical writing/editorial assistance from the Spanish Foundation of Rheumatology. The authors declared no conflicts of interest.

Source: Toledano E et al. SLEEP quality in patients with psoriatic arthritis and its relationship with disease activity and comorbidities: A cross-sectional study. Sci Rep. 2023;13:22927 (Dec 21). doi: 10.1038/s41598-023-48723-z

Key clinical point: Poor sleep quality was a very common phenomenon in patients with psoriatic arthritis (PsA) and associated with increased disease activity and higher levels of pain, fatigue, anxiety, and depression.

Major finding: A majority (63%) of patients with PsA experienced poor sleep quality, with factors like higher Disease Activity Index for PsA scores, pain, fatigue, anxiety, and depression (P < .01 for all) associated with poorer sleep quality. Patients with vs without fibromyalgia also reported poorer sleep quality (P < .001).

Study details: Findings are from a single-center cross-sectional study that included 247 patients with PsA.

Disclosures: This study received medical writing/editorial assistance from the Spanish Foundation of Rheumatology. The authors declared no conflicts of interest.

Source: Toledano E et al. SLEEP quality in patients with psoriatic arthritis and its relationship with disease activity and comorbidities: A cross-sectional study. Sci Rep. 2023;13:22927 (Dec 21). doi: 10.1038/s41598-023-48723-z

Key clinical point: Poor sleep quality was a very common phenomenon in patients with psoriatic arthritis (PsA) and associated with increased disease activity and higher levels of pain, fatigue, anxiety, and depression.

Major finding: A majority (63%) of patients with PsA experienced poor sleep quality, with factors like higher Disease Activity Index for PsA scores, pain, fatigue, anxiety, and depression (P < .01 for all) associated with poorer sleep quality. Patients with vs without fibromyalgia also reported poorer sleep quality (P < .001).

Study details: Findings are from a single-center cross-sectional study that included 247 patients with PsA.

Disclosures: This study received medical writing/editorial assistance from the Spanish Foundation of Rheumatology. The authors declared no conflicts of interest.

Source: Toledano E et al. SLEEP quality in patients with psoriatic arthritis and its relationship with disease activity and comorbidities: A cross-sectional study. Sci Rep. 2023;13:22927 (Dec 21). doi: 10.1038/s41598-023-48723-z

Key clinical point: Adult patients with psoriatic arthritis (PsA) who received biologics, such as interleukin (IL)-12/23, IL-23, and IL-17 inhibitors, or small molecules, such as Janus kinase inhibitors, reported a risk for melanoma and nonmelanoma skin cancer (NMSC).

Major finding: In patients with PsA, the incidence rate of melanoma was 0.09 (95% CI 0.04-0.19) events per 100 patient years (PY) whereas that of NMSC was 0.47 (95% CI 0.28-0.81) events per 100 PY.

Study details: Findings are from a meta-analysis of 19 studies that included 13,739 patients with psoriasis and PsA who were treated with biologics or small molecules tested against an active or placebo comparator.

Disclosures: This study was funded by a research grant from Faculty of Medicine and Health Sciences, Andrzej Frycz Modrzewski Krakow University, Kraków, Poland. P Brzewski declared receiving honoraria or consultation fees from various sources.

Source: Krzysztofik M et al. Risk of melanoma and nonmelanoma skin cancer in patients with psoriasis and psoriatic arthritis treated with targeted therapies: A systematic review and meta-analysis. Pharmaceuticals. 2023;17(1):14 (Dec 21). doi: 10.3390/ph17010014

Key clinical point: Adult patients with psoriatic arthritis (PsA) who received biologics, such as interleukin (IL)-12/23, IL-23, and IL-17 inhibitors, or small molecules, such as Janus kinase inhibitors, reported a risk for melanoma and nonmelanoma skin cancer (NMSC).

Major finding: In patients with PsA, the incidence rate of melanoma was 0.09 (95% CI 0.04-0.19) events per 100 patient years (PY) whereas that of NMSC was 0.47 (95% CI 0.28-0.81) events per 100 PY.

Study details: Findings are from a meta-analysis of 19 studies that included 13,739 patients with psoriasis and PsA who were treated with biologics or small molecules tested against an active or placebo comparator.

Disclosures: This study was funded by a research grant from Faculty of Medicine and Health Sciences, Andrzej Frycz Modrzewski Krakow University, Kraków, Poland. P Brzewski declared receiving honoraria or consultation fees from various sources.

Source: Krzysztofik M et al. Risk of melanoma and nonmelanoma skin cancer in patients with psoriasis and psoriatic arthritis treated with targeted therapies: A systematic review and meta-analysis. Pharmaceuticals. 2023;17(1):14 (Dec 21). doi: 10.3390/ph17010014

Key clinical point: Adult patients with psoriatic arthritis (PsA) who received biologics, such as interleukin (IL)-12/23, IL-23, and IL-17 inhibitors, or small molecules, such as Janus kinase inhibitors, reported a risk for melanoma and nonmelanoma skin cancer (NMSC).

Major finding: In patients with PsA, the incidence rate of melanoma was 0.09 (95% CI 0.04-0.19) events per 100 patient years (PY) whereas that of NMSC was 0.47 (95% CI 0.28-0.81) events per 100 PY.

Study details: Findings are from a meta-analysis of 19 studies that included 13,739 patients with psoriasis and PsA who were treated with biologics or small molecules tested against an active or placebo comparator.

Disclosures: This study was funded by a research grant from Faculty of Medicine and Health Sciences, Andrzej Frycz Modrzewski Krakow University, Kraków, Poland. P Brzewski declared receiving honoraria or consultation fees from various sources.

Source: Krzysztofik M et al. Risk of melanoma and nonmelanoma skin cancer in patients with psoriasis and psoriatic arthritis treated with targeted therapies: A systematic review and meta-analysis. Pharmaceuticals. 2023;17(1):14 (Dec 21). doi: 10.3390/ph17010014

Key clinical point: In pediatric patients, psoriasis vs psoriatic arthritis (PsA) was associated with greater body surface area (BSA) involvement particularly in the extremities, scalp, trunk, genitals, face, skin folds, and nails.

Major finding: The median BSA affected by psoriasis was higher in patients with psoriasis vs PsA (19.7% vs 6.1%; P = .029), with significantly greater disease distribution observed in extremities (75% vs 24%), scalp (61% vs 28%), trunk (58% vs 10%), and genitals (38% vs 10%; P < .05 for all).

Study details: Findings are from a retrospective case-control study that included pediatric patients (age < 18 years) with psoriasis (n = 64) or PsA (n = 29) who were matched by age and sex.

Disclosures: This study did not receive any external funding. The authors declared no conflicts of interest.

Source: Ollech A et al. Pediatric psoriasis with or without arthritis: Does it make a difference? J Clin Med. 2023;13(1):242 (Dec 31). doi: 10.3390/jcm13010242

Key clinical point: In pediatric patients, psoriasis vs psoriatic arthritis (PsA) was associated with greater body surface area (BSA) involvement particularly in the extremities, scalp, trunk, genitals, face, skin folds, and nails.

Major finding: The median BSA affected by psoriasis was higher in patients with psoriasis vs PsA (19.7% vs 6.1%; P = .029), with significantly greater disease distribution observed in extremities (75% vs 24%), scalp (61% vs 28%), trunk (58% vs 10%), and genitals (38% vs 10%; P < .05 for all).

Study details: Findings are from a retrospective case-control study that included pediatric patients (age < 18 years) with psoriasis (n = 64) or PsA (n = 29) who were matched by age and sex.

Disclosures: This study did not receive any external funding. The authors declared no conflicts of interest.

Source: Ollech A et al. Pediatric psoriasis with or without arthritis: Does it make a difference? J Clin Med. 2023;13(1):242 (Dec 31). doi: 10.3390/jcm13010242

Key clinical point: In pediatric patients, psoriasis vs psoriatic arthritis (PsA) was associated with greater body surface area (BSA) involvement particularly in the extremities, scalp, trunk, genitals, face, skin folds, and nails.

Major finding: The median BSA affected by psoriasis was higher in patients with psoriasis vs PsA (19.7% vs 6.1%; P = .029), with significantly greater disease distribution observed in extremities (75% vs 24%), scalp (61% vs 28%), trunk (58% vs 10%), and genitals (38% vs 10%; P < .05 for all).

Study details: Findings are from a retrospective case-control study that included pediatric patients (age < 18 years) with psoriasis (n = 64) or PsA (n = 29) who were matched by age and sex.

Disclosures: This study did not receive any external funding. The authors declared no conflicts of interest.

Source: Ollech A et al. Pediatric psoriasis with or without arthritis: Does it make a difference? J Clin Med. 2023;13(1):242 (Dec 31). doi: 10.3390/jcm13010242

Key clinical point: The risk for uveitis was increased by more than double in patients with psoriatic arthritis (PsA), with past uveitis events and etanercept treatment being significant risk factors.

Major finding: The risk for uveitis was higher in patients with PsA vs matched control individuals without PsA (adjusted hazard ratio 2.38; 95% CI 1.80-3.15). Among patients with PsA, past events of uveitis (adjusted odds ratio [aOR] 136.4; 95% CI 27.38-679.88) and treatment with etanercept (aOR 2.57; 95% CI 1.45-4.57) were associated with an increased risk for uveitis.

Study details: This retrospective matched cohort study included 6147 patients with newly diagnosed PsA and 23,999 matched control individuals without PsA.

Disclosures: This study did not disclose the funding source. The authors declared no conflicts of interest.

Source: Hijazi N et al. The risk factors for uveitis among psoriatic arthritis patients: A population-based cohort study. Clin Rheumatol. 2023 (Dec 11). doi: 10.1007/s10067-023-06834-y

Key clinical point: The risk for uveitis was increased by more than double in patients with psoriatic arthritis (PsA), with past uveitis events and etanercept treatment being significant risk factors.

Major finding: The risk for uveitis was higher in patients with PsA vs matched control individuals without PsA (adjusted hazard ratio 2.38; 95% CI 1.80-3.15). Among patients with PsA, past events of uveitis (adjusted odds ratio [aOR] 136.4; 95% CI 27.38-679.88) and treatment with etanercept (aOR 2.57; 95% CI 1.45-4.57) were associated with an increased risk for uveitis.

Study details: This retrospective matched cohort study included 6147 patients with newly diagnosed PsA and 23,999 matched control individuals without PsA.

Disclosures: This study did not disclose the funding source. The authors declared no conflicts of interest.

Source: Hijazi N et al. The risk factors for uveitis among psoriatic arthritis patients: A population-based cohort study. Clin Rheumatol. 2023 (Dec 11). doi: 10.1007/s10067-023-06834-y

Key clinical point: The risk for uveitis was increased by more than double in patients with psoriatic arthritis (PsA), with past uveitis events and etanercept treatment being significant risk factors.

Major finding: The risk for uveitis was higher in patients with PsA vs matched control individuals without PsA (adjusted hazard ratio 2.38; 95% CI 1.80-3.15). Among patients with PsA, past events of uveitis (adjusted odds ratio [aOR] 136.4; 95% CI 27.38-679.88) and treatment with etanercept (aOR 2.57; 95% CI 1.45-4.57) were associated with an increased risk for uveitis.

Study details: This retrospective matched cohort study included 6147 patients with newly diagnosed PsA and 23,999 matched control individuals without PsA.

Disclosures: This study did not disclose the funding source. The authors declared no conflicts of interest.

Source: Hijazi N et al. The risk factors for uveitis among psoriatic arthritis patients: A population-based cohort study. Clin Rheumatol. 2023 (Dec 11). doi: 10.1007/s10067-023-06834-y

Key clinical point: Functional training (FT) and resistance exercise (RE) improved functional capacity, functional status, disease activity, and muscle strength to a comparable extent in patients with psoriatic arthritis (PsA).

Major finding: FT and RE led to similar improvements in functional capacity measured by the Bath Ankylosing Spondylitis Functional Index (P = .919), functional status measured by the Health Assessment Questionnaire for the Spondyloarthropathies (P = 0.932), disease activity measured by the Bath Ankylosing Spondylitis Disease Activity Index (P = .700), and muscle strength in patients with PsA. No adverse event occurred in either group.

Study details: Findings are from a 12-week, single-blind trial that included 41 patients with PsA who were randomly assigned to undergo FT with elastic bands or RE with weight machines.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Silva DR et al. Effectiveness of functional training versus resistance exercise in patients with psoriatic arthritis: Randomized controlled trial. Adv Rheumatol. 2023;63:58. (Dec 13). doi: 10.1186/s42358-023-00342-y

Key clinical point: Functional training (FT) and resistance exercise (RE) improved functional capacity, functional status, disease activity, and muscle strength to a comparable extent in patients with psoriatic arthritis (PsA).

Major finding: FT and RE led to similar improvements in functional capacity measured by the Bath Ankylosing Spondylitis Functional Index (P = .919), functional status measured by the Health Assessment Questionnaire for the Spondyloarthropathies (P = 0.932), disease activity measured by the Bath Ankylosing Spondylitis Disease Activity Index (P = .700), and muscle strength in patients with PsA. No adverse event occurred in either group.

Study details: Findings are from a 12-week, single-blind trial that included 41 patients with PsA who were randomly assigned to undergo FT with elastic bands or RE with weight machines.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Silva DR et al. Effectiveness of functional training versus resistance exercise in patients with psoriatic arthritis: Randomized controlled trial. Adv Rheumatol. 2023;63:58. (Dec 13). doi: 10.1186/s42358-023-00342-y

Key clinical point: Functional training (FT) and resistance exercise (RE) improved functional capacity, functional status, disease activity, and muscle strength to a comparable extent in patients with psoriatic arthritis (PsA).

Major finding: FT and RE led to similar improvements in functional capacity measured by the Bath Ankylosing Spondylitis Functional Index (P = .919), functional status measured by the Health Assessment Questionnaire for the Spondyloarthropathies (P = 0.932), disease activity measured by the Bath Ankylosing Spondylitis Disease Activity Index (P = .700), and muscle strength in patients with PsA. No adverse event occurred in either group.

Study details: Findings are from a 12-week, single-blind trial that included 41 patients with PsA who were randomly assigned to undergo FT with elastic bands or RE with weight machines.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Silva DR et al. Effectiveness of functional training versus resistance exercise in patients with psoriatic arthritis: Randomized controlled trial. Adv Rheumatol. 2023;63:58. (Dec 13). doi: 10.1186/s42358-023-00342-y