ACCC to MCAC: What Makes a Good Drug Compendium for Off-Label Use?

The Centers for Medicare & Medicaid Services (CMS) is considering adding to the drug compendia used to determine off-label coverage. The Medicare Coverage Advisory Committee (MCAC) recently voted to recommend that CMS consider several desired characteristics when evaluating compendia. A major organization of cancer centers and providers, the Association of Community Cancer Centers (ACCC), disagreed with some of the MCAC-supported traits. ACCC did not support any particular compendium.

Both MCAC and ACCC endorse the following characteristics:

• Extensive breadth of listings
• Quick throughput from application for inclusion to listing
• Detailed description of evidence reviewed for every individual listing
• Use of prescribed published criteria for weighing evidence
• Use of prescribed published process for making recommendations
• Publicly transparent process for evaluating therapies

ACCC advised against using the below MCAC-recommended characteristics (quotes are from ACCC’s written statement to MCAC):

• Net clinical benefit analysis based on potential harm and potential benefit. ACCC stated that this analysis is “impossible to perform meaningfully because individual comorbidities require a different assessment for each patient.”
• Explicit listing and recommendations regarding therapies, including sequential use or combination in relation to other therapies. “Different sequences for different patients are appropriate, and indeed needed,” said ACCC.
• Explicit “equivocal” listing when validated evidence is equivocal. ACCC advocated that a compendium remain silent when evidence is equivocal so that carriers can cover a use on a case-by-base basis, pending further data. Not doing so “could cause carriers to deny coverage” of a use “for all patients.”