In the JournalsPerspective

Flaws found in compendia for dermatology conditions

John Barberi
John S. Barbieri

The two compendia that Medicare Part D recognizes to make coverage determinations for off-label prescribing were “incomplete, outdated, idiosyncratic, and unpredictable” for some chronic dermatologic conditions, according to findings recently published in JAMA Dermatology.

“When we were hearing clinicians were having trouble getting [off-label] medications for their patients, we were concerned that this issue could negatively impact their care,” John S. Barbieri, MD, MBA, of the department of dermatology at the University of Pennsylvania told Healio Primary Care Today.

“Since Medicare Part D coverage determinations for off-label prescribing are largely determined based on these compendia (the American Hospital Formulary Service and the DRUGDEX Information System), we were worried that issues with the quality of these compendia could be causing the coverage denials, which prompted us to study whether these compendia are adequate,” he added.

Barbieri and 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 not all approved by the FDA.

Researchers found only 73 treatments listed in either compendium. In addition, 15 conditions had one or fewer treatments included in the American Hospital Formulary Service compendium and 10 conditions had one or fewer treatments included in the DRUGDEX compendium. They also found the literature did not follow a distinguishable pattern and was sometimes based on information that was more than 30 years old.

“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). In addition, these compendia disagreed with each other almost a quarter of the time, which suggests that the approach used to develop these compendia is both incomplete and inconsistent,” Barbieri said as he discussed the results. He added it is possible the flaws they found extend to other medical specialties with less common illness and frequent off-label prescribing.

Barbieri said short-term, feasible solutions are practically nonexistent, and that even long-term solutions face barriers.

“One option would be to develop compendia specific to the unique challenges of managing dermatologic illnesses, as has been done in oncology. However, given that there are over 3,000 unique diagnoses managed by dermatologists, it may be challenging to create such a supplemental compendium,” he said.

Barbieri added other possible solutions include requiring Medicare Part D to consider evidence clinicians provide during the appeal of the prior authorization process or allow an expert panel to review appeals. – by Janel Miller

Disclosures: Barbieri reports no relevant financial disclosures. Please see the study for all other authors relevant financial disclosures.

 

John Barberi
John S. Barbieri

The two compendia that Medicare Part D recognizes to make coverage determinations for off-label prescribing were “incomplete, outdated, idiosyncratic, and unpredictable” for some chronic dermatologic conditions, according to findings recently published in JAMA Dermatology.

“When we were hearing clinicians were having trouble getting [off-label] medications for their patients, we were concerned that this issue could negatively impact their care,” John S. Barbieri, MD, MBA, of the department of dermatology at the University of Pennsylvania told Healio Primary Care Today.

“Since Medicare Part D coverage determinations for off-label prescribing are largely determined based on these compendia (the American Hospital Formulary Service and the DRUGDEX Information System), we were worried that issues with the quality of these compendia could be causing the coverage denials, which prompted us to study whether these compendia are adequate,” he added.

Barbieri and 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 not all approved by the FDA.

Researchers found only 73 treatments listed in either compendium. In addition, 15 conditions had one or fewer treatments included in the American Hospital Formulary Service compendium and 10 conditions had one or fewer treatments included in the DRUGDEX compendium. They also found the literature did not follow a distinguishable pattern and was sometimes based on information that was more than 30 years old.

“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). In addition, these compendia disagreed with each other almost a quarter of the time, which suggests that the approach used to develop these compendia is both incomplete and inconsistent,” Barbieri said as he discussed the results. He added it is possible the flaws they found extend to other medical specialties with less common illness and frequent off-label prescribing.

Barbieri said short-term, feasible solutions are practically nonexistent, and that even long-term solutions face barriers.

“One option would be to develop compendia specific to the unique challenges of managing dermatologic illnesses, as has been done in oncology. However, given that there are over 3,000 unique diagnoses managed by dermatologists, it may be challenging to create such a supplemental compendium,” he said.

Barbieri added other possible solutions include requiring Medicare Part D to consider evidence clinicians provide during the appeal of the prior authorization process or allow an expert panel to review appeals. – by Janel Miller

Disclosures: Barbieri reports no relevant financial disclosures. Please see the study for all other authors relevant financial disclosures.

 

    Perspective
    Daniel D. Bennett

    Daniel D. Bennett

    The responsibility of ensuring compendia are up-to-date is not an easy one, so while I am not surprised by the results of this study, it is still troubling.

    Many dermatological conditions are rare. Some have few, if any, FDA approved-treatment options. Treatments that are FDA-approved are often newer biologics that are quite expensive. Thus, paying for them out-of-pocket is impossible for most patients. Compounding these patients’ woes are that alternative, less expensive treatments are not always included in the compendia, and that most patients enrolled in Medicare are restricted in their ability to take advantage of drug assistance programs. In addition, CMS refuses to budge from its rule that a drug must be FDA-approved for the specific indication before it is included in the compendia. All of this often puts patients with dermatological needs between a rock and hard place when seeking treatment for their condition.

    The authors propose that physicians should be allowed to support the evidence of a particular drug for a particular patient on a case-by-case basis to resolve my aforementioned concerns. This is a great idea. But allowing this to occur likely involves legislative or regulatory action, which can take years to come to fruition. To know that there will be restricted, or sometimes no treatment options available in the interim for some patients, is quite worrisome.

    • Daniel D. Bennett, MD
    • Vice chair of clinical affairs
      department of dermatology
      University of Wisconsin at Madison

    Disclosures: Bennett reports no relevant financial disclosures.