New treatments for sickle cell disease, breakthroughs for cystic fibrosis, and personalized approaches to target a patient’s own cancer cells have raised hopes for many patients and families. These hopes are followed by the question, “will my health insurance plan pay for this new treatment?” Health plans, under pressure to manage scarce health care resources, need timely and high-quality evidence to plan for these new treatments and subsequently determine which treatments to cover and for whom. This week, with the release of the AMCP Format for Formulary Submissions - Guidance on Submission version 4.1, biopharmaceutical manufacturers and health plans will have a practical guide to exchange clinical and economic information to inform these decisions.
Since 2000, the Format for Formulary Submissions has enabled biopharmaceutical manufacturers to respond to unsolicited requests for information about existing products, in compliance with the Food and Drug Administration’s (FDA) strict regulations. Consistent with the modernized 2018 FDA Guidance, “Drug and Device Manufacturer Communications with Payors, Formulary Committees and Similar Entities,” the updated Format outlines two new types of dossiers to address the changing needs of payers and population health decision-makers. These two new types of dossiers facilitate the exchange of information about unapproved drugs and therapies and unapproved uses of approved medications, while also streamlining the process of updating that information as new data becomes available.
Until recently, this exchange of information had not kept pace with the growing sophistication of the products available to treat conditions and the ways health care is organized, delivered and reimbursed. According to research surveys, payers desire more, and better, information to inform coverage decisions, but they are often limited by the type and quality of the available information. As reimbursement continues to trend toward a basis on quality and value, rather than volume, clear bi-directional communication channels between biopharmaceutical manufacturers and decision-makers are more important than ever. The updated Format should help to address these challenges.
As the National Pharmaceutical Council and others have commented recently and with previous Format revisions, high-quality evidence, developed over a product's lifecycle, should serve as the foundation for decision-making. This new pathway, along with NPC’s longstanding research, comments, partnerships and activities can help to address barriers to communicating evidence and using high-quality evidence to inform decision-making.