Trouble getting off-label meds? Flawed compendia causing coverage denials for dermatologic conditions
A group of researchers reviewed two compendia used to make Medicare Part D coverage determinations for off-label prescribing, and found the compendia “incomplete, outdated, idiosyncratic, and unpredictable” for some chronic dermatologic conditions, according to recent findings published in JAMA Dermatology.
When the Centers for Medicare and Medicaid Services (CMS) developed the Medicare part D program, coverage was a serious concern. At the same time, prescribing had to be limited so a prior authorization process was developed, said Joerg Albrecht, MD, a Chicago-based dermatologist who took part in the study. “In order to standardize the approach between carriers it was felt that all accepted treatment had to be covered. To solve the problem without much burden on the administration, CMS suggested a number of compendia that could serve as a standardized database to assure uniform coverage between carriers.
The CMS regulation may need to be changed more broadly, said lead researcher John S. Barbieri, MD, MBA, because patients are being denied coverage because of these flaws. The patient that sparked interest in this study for Dr. Albrecht had been denied acitretin, which had worked in the past to treat his hidradenitis suppurativa (HS) patients. "It turned out that HS is practically unknown in the compendia. Only one of the two compendia even listed adalimumab, which has an FDA indication. The other compendium did not even list the drug. All other treatments — from rifampin to doxycycline, acitretin to spironolactone and finasteride — would be denied because they are not in either compendium," he said.
To assess the magnitude of the problem, Barbieri and his colleagues evaluated a list of 238 accepted treatments for 22 chronic, noninfectious, nonneoplastic dermatological conditions that had at least four systemic therapies, including one considered first-line, but many not approved by the FDA. Only 73 treatments were listed in either compendium. Additionally, the literature used was often based on decades-old sources. “References were not given if they were older than the early Regan era (1984, to be exact),” said Dr. Albrecht.
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“We were alarmed that over two-thirds of the medications evaluated were not included in these compendia, including half of the medications with the highest evidence grade (double-blind clinical trial),” Barbieri said. “In addition, these compendia disagreed with each other almost a quarter of the time, which suggests that the approach used to develop them is both incomplete and inconsistent,” Barbieri said. Many of the diseases listed are rare, but real,” he said.
The researchers recommend new policies be put in place to better serve patients with rare diseases and diseases with few FDA-approved therapies. These policies should aim to reduce reliance on the compendia so that patients can access much-needed treatments.
The AADA’s Drug Pricing Task Force plans to submit a letter to CMS highlighting several cases of this coverage issue with potential recommendations. If you have experienced adverse coverage determinations due to the compendia, please contact ajohn@aad.org.
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