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.
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.
AMCP has released Version 4.1 of the AMCP Format for Formulary Submissions, which includes two new dossier types for biopharmaceutical manufacturers to share evidence on unapproved products and new indications that are under review by the U.S. Food and Drug Administration (FDA).
Partnership Forum: Industry leaders gather together on September 13-14, 2016 to develope recommendations for biopharmaceutical companies and health care decision makers to more easily communicate information on products awaiting FDA approval.
Press Release: The Academy of Managed Care Pharmacy (AMCP) today released a set of recommendations that would allow biopharmaceutical companies to more easily share health care economic information (HCEI) with entities that make formulary and coverage decisions.