Manufacturers should communicate pre-approval information that is unbiased, factual, and accurate. What type of pre-approval information can manufacturers communicate? The guidance does not apply to dissemination of health care economic information to other audiences, such as healthcare providers making individual patient prescribing decisions. 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. 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.
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