MCAC to CMS: Advice About Adding a New Compendium for Off-Label Coverage

The Centers for Medicare & Medicaid Services (CMS) has received requests to add to the number of drug compendia used to determine coverage of off-label drugs and biologicals in anticancer chemotherapeutic regimens. The Medicare Coverage Advisory Committee (MCAC) has evaluated the compendia under consideration. It did not explicitly recommend one compendium over another but outlined several characteristics for CMS to consider in its review.

Medicare covers off-label uses of cancer medications when supported by citations in approved drug compendia or by clinical evidence in peer-reviewed literature. One of the three currently approved compendia is no longer published.
MCAC evaluated these six compendia:

• American Hospital Formulary Service (AHFS) - Drug Information (AHFS)—currently approved
• United States Pharmacopeia - Drug Information (USPDI) —currently approved
• DRUGDEX Information System
• Facts & Comparisons
• National Comprehensive Cancer Network (NCCN) Drugs & Biologics Compendium™
• Clinical Pharmacology (by Clinical Pharmacy Associates)

Of the four compendia seeking approval, NCCN’s offering received the highest rating for having adequately stated evidence-based criteria, then adhering to those criteria in making recommendations. DRUGDEX received the second-highest ratings.
MCAC then rated the NCCN, DRUGDEX, and AHFS compendia on the characteristics it supported for CMS consideration in a compendium. Again, NCCN consistently received the top rating, with the exception of once tying with AHFS.