AMCP Format 4.1 includes new sections describing the evidence needs of HCDMs for unapproved products nearing the end of the product development pipeline, as well as unapproved uses of existing products for which FDA approval is being sought.
Where We Stand: AMCP supports off‐label use of FDA‐approved drugs when medically appropriate and necessary, but opposes government‐mandated coverage of specific pharmaceuticals, whether for FDA‐approved or off‐label uses.
Partnership Forum: Now more than ever, there is an increased focus on health disparities that occur across a multitude of factors, including socioeconomic status, ethnicity, and race. This forum helped identify potential structural issues within the current formulary and benefit design processes that may have led to racial health disparities or inequality.
This forum identified key actions that can support access to and the appropriate management of treatments for rare diseases within the U.S. health care system.
AMCP webinar that addressed what is currently being seen in the industry and how to effectively support and continue this early, meaningful, and effective exchange of information for pre-approval products.
