Drug Compendia: Practical Strategies to Bridge Evidence and Payer Coverage, Upcoming Webinar Hosted by Xtalks

In this free webinar, understand the role of compendia as a bridge between FDA approvals and payer coverage, especially in cases of off-label use, and clarify common misconceptions around off-label use. The featured speakers will discuss how all companies, particularly small or emerging life sciences companies, can leverage compendia when FDA pathways may be outpaced by innovation or too costly. Attendees will identify key factors that increase success, including the presence of supporting clinical guidelines and published data, and key case studies.

TORONTO, Oct. 23, 2025 /PRNewswire/ -- 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.

Join experts from Avalere Health, Amy Schroeder, Principal Research Scientist; Dr. Laura T. Housman, DrPH, MBA, MPH, Chief Public Health Officer, Senior Vice President & Practice Director, Evidence and Strategy; and Mina Allo, Managing Director, Market Access, for the live webinar on Friday, November 7, 2025, at 11am EST (5pm CET/EU-Central).

For more information, or to register for this event, visit Drug Compendia: Practical Strategies to Bridge Evidence and Payer Coverage.

ABOUT XTALKS

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars and digital content to the global life science, food, healthcare and medical device communities. Every year, thousands of industry practitioners (from pharmaceutical, biotechnology, food, healthcare and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps professionals stay current with industry developments, regulations and jobs. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

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Vera Kovacevic
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