Drug Compendia: Practical Strategies to Bridge Evidence and Payer Coverage

For clinical life sciences companies, navigating the “middle space” between regulatory approval, medically appropriate use and widespread payer coverage of drugs, biologics and cell and gene therapies is often one of the most complex and misunderstood aspects of the commercialization journey.

This webinar will explore the often overlooked yet critical role of clinical drug compendia (“compendia”) in bridging that gap.

Since 1993, the Centers for Medicare & Medicaid Services (CMS) has recognized the use of drug compendia to support Medicare Part B coverage determinations for off-label uses, and this practice has expanded into other payer types.

Yet, misconceptions persist, and many stakeholders still view off-label use as inherently illegal or outside the scope of viable patient access.

Compendia offer a well-established, alternative route to support off-label use cases and provide the means to generate and demonstrate real-world evidence. Listing within compendia can support payer coverage, both through payers’ own business decisions and through state legislation that recognizes compendia as a basis for coverage. Still, it may also support provider care decisions and contribute to a more robust eventual FDA label expansion.

In this session, the featured speakers will demystify how compendia function as independent validators of medical necessity and how they interact with regulatory, provider and payer frameworks. The speakers will share how a proactive compendia strategy can accelerate patient access, especially for therapies targeting rare or high-unmet-need populations. They will also explore the strategic value of submission timing to compendia, i.e., before or alongside a first indication, and how to identify supportive guidelines and data sources that improve the likelihood of a successful listing.

Furthermore, the webinar will also highlight a real-world client story, illustrating how one company is thinking about effectively leveraging compendia inclusion to expand patient access and support broader coverage, even in the absence of immediate FDA approval for new indications.

Register for this webinar to learn how drug compendia can support patient access and coverage for off-label use.

Keywords: Centers for Medicare and Medicaid Services, Commercialization/HEOR/Market Access, FDA, FDA Approval, FDA Guidance, Patient Access, Payers, Regulatory, Regulatory Approval, Reimbursement, Underserved Populations