Amcp dossier6/5/2023 ![]() ![]() ![]() Who can receive pre-approval information? Payers, formulary committees, or other similar entities with knowledge and expertise in health care economic analysis, carrying out its responsibilities for the selection of drugs for coverage or reimbursement. Who can deliver pre-approval information? The guidance does not specify who can (or cannot) deliver pre-approval information to payer audiences. What information can be communicated? The guidance and law provides specific guidance as to what can be communicated, including disease information, clinical evidence, stage of development, and limited pricing and anticipated utilization data. When can information be delivered? Anytime before indication approval Key considerations when communicating PIE 2īelow is our guide to some of the key considerations when providing pre-approval information related to the guidance. 2617), which codifies key elements of appropriate pre-approval information exchange. 1 Moreover, the PIE Act of 2022 was signed into law on Decemas part of the Consolidated Appropriations Act, 2023 (H.R. The FDA has provided guidance on communicating pre-approval information, most notably in its guidance on payor communications published in 2018. ![]() Pre-approval Information Exchange (PIE) is the exchange of information between pharmaceutical manufacturers and payers about an unapproved drug, or an unapproved use of an approved drug. What is Pre-approval Information Exchange? Payers increasingly need this information sooner to inform these challenging population-level coverage and access decisions. They rely on available clinical and economic evidence, when available, to plan and budget for future coverage and/or reimbursement for unapproved products and new uses of approved products. Health care payers have the challenge of determining coverage policies for the high number of innovative therapies that come to market. The Food and Drug Administration (FDA) has responded by supporting access to these therapies with fast-track, collaborative new drug and biologic application review processes. She is an invaluable resource for our clients and team members, and OPEN Health is lucky to have the benefit of her leadership,” says Dipen Patel, vice president and executive director of OPEN Health Evidence & Access.The past decade has seen a surge in medical advancement resulting in innovative therapies addressing unmet needs in rare and orphan diseases or demonstrating superior efficacy over existing therapies. “Beth’s reappointment to the AMCP committee is a testament to her expertise in this area. Her term on the committee will extend to the AMCP annual meeting in 2025. The next update will be the first since the AMCP issued guidelines for unapproved product dossiers, approved product dossiers, and unapproved use dossiers. The last update to the format was in December 2019 that was version 4.1, Lesher says. Although AMCP formatting is not required in submissions, it is considered the standard. Serving as a member on the format committee, she says, allows her to apply that experience to updating and improving the AMCP format guidance document.įormally called the Format for Formulary Submissions Guidance on Submission of Pre-approval and Post-approval Clinical and Economic Information and Evidence, it “supports the informed review, assessment, selection, and payment of medical products,” according to the AMCP website. “For the past 20+ years, I have worked on developing and updating AMCP dossiers for our clients,” says Lesher. The invitation to Lesher, a senior director in the Strategic Market Access Center of Excellence, testifies to her specialist expertise, and, by extension, OPEN Health’s, in a critical HEOR and Market Access function. AMCP dossiers are widely used by healthcare decision-makers in evaluating medical products in the United States. OPEN Health’s Beth Lesher, PharmD, BCPS, has been invited to serve a second term on the Academy of Managed Care Pharmacy (AMCP) Format for Formulary Submissions Committee, which issues highly influential guidance on AMCP dossiers. ![]()
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