January 23, 2019

Evaluation of Clinical Compendia Used for Medicare Part D Coverage Determinations for Off-label Prescribing in Dermatology

John S. Barbieri, MD, MBA¹; Kayla St Claire, BA²; Arash Mostaghimi, MD, MPA, MPH³; et alJoerg Albrecht, MD, PhD^4,5

Author Affiliations

JAMA Dermatol. Published online January 23, 2019. doi:10.1001/jamadermatol.2018.5052

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Key Points

Question  Are compendia used for Medicare Part D to make coverage determinations adequate for ensuring that patients have access to necessary off-label dermatology treatments?

Findings  In this cross-sectional study, 73 of 238 (31%) evidence-based treatments were included in either compendium evaluated. Of the 22 diseases evaluated, 10 (45%) had 1 or fewer treatments included in the DRUGDEX Information System and 15 (68%) had 1 or fewer treatments included in the American Hospital Formulary Service Drug Information compendium.

Meaning  The findings suggest that these compendia are inadequate for determining coverage for off-label dermatology treatments and that policies to reduce the reliance on the compendia to ensure that patients can access treatments for their disease should be developed.

Abstract

Importance  When making coverage determinations for off-label prescribing, Medicare Part D recognizes 2 compendia: the American Hospital Formulary Service (AHFS) Drug Information and the DRUGDEX Information System. Deficiencies in the accuracy and completeness of these compendia could result in coverage denials for necessary, effective, evidence-based treatments.

Objective  To evaluate these compendia for dermatologic conditions, with a focus on less common conditions that often require systemic treatment.

Design, Setting, and Participants  This cross-sectional study was conducted from July 1, 2018, through September 30, 2018. To identify diseases for which dermatologists may often need access to off-label systemic treatments, a list of 22 chronic, noninfectious, nonneoplastic diseases with at least 4 systemic therapies (including 1 in the first-line therapies and less than 25% approved by the US Food and Drug Administration) were selected for evaluation. With use of Treatment of Skin Disease, 5th Edition, a list of first-, second-, and third-line medications was created, including the level of evidence for each disease. A search of AHFS and DRUGDEX compendia was performed to evaluate for inclusion of the evidence-based therapies. In addition, the references cited in the compendia to justify inclusion of the therapy were examined qualitatively.

Main Outcomes and Measures  Percentage of treatment options included in each compendium, stratified by level of evidence and position on the therapeutic ladder. Concordance between the 2 compendia was assessed using Cohen κ.

Results  Overall, 73 of 238 treatments (30.7%) evaluated were included in either compendium. Among individual diseases, 10 of 22 (45%) had 1 or fewer treatments included in the DRUGDEX compendium and 15 of 22 (68%) had 1 or fewer treatments included in the AHFS compendium. Discrepancies in which a medication was included in one compendium but not in the other compendium occurred for 53 of the 238 medications (22.3%) evaluated. Literature use did not follow a discernible pattern and was often based on decades-old sources.

Conclusions and Relevance  The findings suggest that treatment options listed in these compendia are incomplete, outdated, idiosyncratic, and unpredictable. To ensure that patients can access treatments for their disease, it appears that policies to reduce the reliance on these compendia for coverage determinations should be developed.

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