Compendia and anticancer therapy under Medicare

Area of Science:

• Health policy
• Oncology
• Pharmacology

Background:

• Medicare was initially directed to use three compendia to identify medically accepted, unlabeled uses of anticancer drugs.
• Two of the original compendia ceased publication, necessitating an update to the approved list.
• Concerns about experimental treatments being outside Medicare benefits prompted a review of compendia.

Purpose of the Study:

• To revise the list of acceptable compendia for identifying unlabeled anticancer drug uses under Medicare.
• To establish a publicly transparent process for evaluating and selecting compendia.

Main Methods:

• The Centers for Medicare & Medicaid Services (CMS) utilized regulatory authority to create a transparent process for revising the compendia list.
• CMS reviewed five requests in 2008.
• The Medicare Improvements for Patients and Providers Act of 2008 mandated transparency and conflict of interest evaluations.

Main Results:

• The National Comprehensive Cancer Network Drugs and Biologics Compendium, DRUGDEX, and Clinical Pharmacology were added to the list of approved compendia.
• DrugPoints was not added, and American Medical Association Drug Evaluations (AMA-DE) was removed.
• The updated process ensures compendia have transparent evaluation methods and address conflicts of interest.

Conclusions:

• CMS successfully implemented a transparent process to update Medicare's list of compendia for anticancer drug uses.
• New compendia were added, and outdated ones removed, aligning with statutory requirements for transparency and conflict of interest management.
• This ensures Medicare coverage for medically accepted, unlabeled uses of anticancer therapies is based on reliable, unbiased information.