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.
AMCP Webinar that discussed nuances between HEOR and HCEI, payer HCEI needs and associated implications, current manufacturer practices for HCEI communications, and pathways that compliantly enhance the opportunity for information exchange.
Where We Stand: AMCP opposes statutory and regulatory proposals that unduly restrict the ability of pharmacists working within managed care organizations from utilizing tools and services that are essential for the management of a prescription drug benefitFind out about Regulation of the Prescription Drug Benefit.
AMCP supports systems and processes that allow for clinical and economic information to be shared between manufacturers and health care decision-makers proactively and in a timely manner prior to FDA approval. A proactive PIE system would expedite coverage and utilization management policies for emerging therapies, including those granted breakthrough designation, providing earlier access for appropriate patients.
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.
