AMCP Welcomes Comments on Format for Formulary Submissions

Topic(s):

Formulary Management , Formulary & Utilization Management

AMCP Format public comment period facilitates an exchange of information between manufacturers and health care decision-makers to inform formulary and coverage decisions.

(Update 7/3/23: The public comment period was June 1–30, 2023, and is now closed.)

Alexandria, VA., June 1, 2023 — AMCP (Academy of Managed Care Pharmacy) opened the public comment period for its updated version of the Format for Formulary Submissions (AMCP Format), which describes the evidence and information required by health care decision-makers from manufacturers to support formulary and coverage policy decisions. Since its creation by AMCP in 2000, the Format has been adopted by manufacturers and payers as the standard for communicating clinical and economic evidence and information about new drugs. The public comment period will be open until June 30, 2023.

“A standardized exchange of information between manufacturers and health care decision-makers is crucial to helping patients access the therapies they need in a timely and efficient manner,” said AMCP CEO Susan Cantrell, MHL, RPh, CAE. “AMCP’s industry-leading Format has been expanded this year to help guide manufacturers to communicate clinical and economic evidence to health care decision-makers regarding important developments related to the Pre-Approval Information Exchange Act (PIE Act) and the growing use of prescription digital therapeutics (PDTs). The new Format also includes real-world evidence requirements and revisions to inputs on health disparities to support equitable use of new interventions and better understand costs to patients. We are encouraged by the growing use of AMCP’s Format over the years and encourage health care decision-makers and manufacturers to continue using this vital tool to help inform important decision-making across America’s health care system.”

AMCP Format version 5.0 incorporates the following revisions:

The digital therapeutics additions focus on definitions related to digital therapeutics, as well as important and unique product information considerations for the formulary evaluation of digital therapeutics.
The health disparities updates include the request for explaining the diversity of study participants in clinical trials, addressing barriers to the equitable use of new interventions, and the economic model inclusion of patient costs.
Minor proposed revisions to sections including real-world evidence requirements.
A proposal for a pre-approval information exchange (PIE) Deck Guidance appendix.
Suggested updates to encourage brevity and hyperlinking to streamline dossiers.

To review the AMCP Format and to submit a comment, follow the link here.

About AMCP

AMCP is the professional association leading the way to help patients get the medications they need at a cost they can afford. AMCP’s diverse membership of pharmacists, physicians, nurses, biopharmaceutical professionals, and other stakeholders leverage their specialized expertise in clinical evidence and economics to optimize medication benefit design and population health management and help patients access cost-effective and safe medications and other drug therapies. AMCP members improve the lives of nearly 300 million Americans served by private and public health plans, pharmacy benefit management firms, and emerging care models. Visit www.amcp.org.