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.
Speakers
Amy Schroeder, Principal Research Scientist, Avalere Health
Amy Schroeder offers strategic guidance on issues related to clinical data, clinical practice guidelines, clinical decision support technologies and drug and pharmacopeial compendia.
Amy leads the Clinical SME team of physicians, nurses and pharmacists, and co-leads the technical science work at Avalere Health. She leads primary research projects related to the use of clinical decision support technologies that guide healthcare decisions and offers real-world expertise on inclusion/exclusion criteria and the types of data to track in retrospective claims data analyses. Her insights assist life science clients in understanding the landscape of different cancers, from screening through diagnosis, treatment and survivorship, as well as interpreting real-world patient experience, identifying barriers to accessing critical treatments, and developing strategies to overcome these barriers. Amy also contributed to the content of three clinical drug compendia recognized by CMS and commercial payers and assisted in drafting the first iteration of the NCCN Drugs & Biologics Compendium (NCCN Compendium®).
Message Presenter
Dr. Laura T. Housman, DrPH, MBA, MPH, Chief Public Health Officer, Senior Vice President & Practice Director, Evidence and Strategy, Avalere Health
Laura Housman, MPH, MBA, DrPH, has broad and extensive expertise in strategy, evidence generation, reimbursement and pricing, patient communications, population health and personalized medicine to drive access to innovation across healthcare.
In 2015, Laura founded and led Access Solutions Consulting (ASC), a healthcare advisory firm serving an extensive network of pharmaceutical, medical device and diagnostic companies. Laura has launched and/or commercialized over 30 diagnostic offerings, successfully obtaining coverage and premium pricing from Medicare Administrative Carriers, including the MolDx program; national, regional and Blue Cross Blue Shield commercial plans nationwide; as well as in global markets.
Before joining Avalere Health, Laura held various leadership positions in industry and academia, including at Novartis and Genzyme, where she led a team in Access and Health Outcomes in support of molecular diagnostics and targeted therapies
Message Presenter
Sarah Alwardt, PhD, President, Avalere Health Advisory
As president of Avalere Health Advisory, Sarah Alwardt oversees the firm’s consulting, sales and operational functions. She previously led Avalere Health Advisory’s Evidence & Strategy practice, assisting life sciences companies in understanding barriers to patient access in key markets, generating evidence about patient experiences, values and priorities who could benefit from those products, and evaluating how health inequities affect clients’ businesses. Before joining Avalere Health, Sarah founded and grew Ontada, McKesson’s oncology research division that provides innovative strategies for evidence development. Under her leadership, Ontada published over 200 scientific articles and submitted multiple regulatory applications. Prior to McKesson, Sarah spent 10 years at Humana in leadership roles across research, program and process development. She also worked for five years at Givaudan, four years at Brown-Forman and served for two years as an Adjunct Professor of Chemical Engineering at the University of Louisville.
Message PresenterWho Should Attend?
This webinar will appeal to professionals in the following fields:
- Market Access
- Medical Affairs
- Regulatory Affairs
- Commercial/Launch Strategy
- Clinical Development
- Pharmaceutical Startup
- Policy
- Real World Evidence and HEOR
What You Will Learn
Attendees will:
- 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
- Learn how all companies, particularly small or emerging life sciences companies, can leverage compendia when FDA pathways may be outpaced by innovation or too costly
- Identify key factors that increase success, including the presence of supporting clinical guidelines and published data, and key case studies
Xtalks Partner
Avalere Health
Avalere Health is guided by a single mission to make EVERY PATIENT POSSIBLE. Its Advisory, Medical, and Marketing capabilities move as one, ensuring every patient is identified, supported, treated, and cared for. Equally.
Avalere Health is a global strategic partner, perfectly formed to solve the biggest challenges in health—at pace and at scale. The organization is united across the product lifecycle, uniquely positioned to understand every angle of life, health, and the human condition. Partnering with its clients, its experts are building a world where healthcare is not a barrier. And no patient is left behind. Visit www.avalerehealth.com and follow Avalere Health on LinkedIn.
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