What You Need to Know about Compendia

A positive or a negative listing in one or more of the Medicare-approved drug compendia can have a significant impact on whether a pharmaceutical product is covered, ultimately affecting prescribing decisions and patient access.

As such, Xcenda recommends 5 key tasks to help manufacturers consider the impact of the compendia on their pipeline and current brands.

• Understand the history, application, and processes involved with the drug compendia
• Examine compendia listings for indications in development, which can assist in determining the most beneficial Phase 2 studies to initiate
• Conduct a compendia analysis upon publication of Phase 2 and 3 studies to determine if and to which compendia the data should be submitted for review
• Monitor compendia for new, updated, and changed listings for your products and others within relevant disease states
• Compare the compendia listings to what payers are covering

Since Medicare coverage for off-label drug use was first provided through legislation in 1993, the reimbursement landscape has changed, causing numerous governmental agencies and other key stakeholders to review Medicare policies regarding off-label coverage for drugs and biologics. Not surprisingly, coverage changes for off-label use continues to be of great interest to many stakeholders, including physicians, patients, and payers.

Need more information?

• Xcenda’s Compendia White Paper provides an overview of the review processes of various compendia, as well as a landscape assessment of the key players and their processes.
• Xcenda’s reimbursement strategy team provides comprehensive services and expertise with compendia submissions.

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  1. Soares M. “Off-label” indications for oncology drug use and drug compendia: history and current status. J Oncol Practice. 2005;1(3):102-5.