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AMCP Format Version 4.1 provides manufacturers with additional guidance to communicate evidence about potential new products or new uses to payers in a compliant fashion.
On December 23, 2019, the Academy of Managed Care Pharmacy (AMCP) introduced a new Format for Formulary Submissions. Format Version 4.1 was originally released as a draft in May 2019. The most salient change introduced in this version of the Format has immediate implications for both manufacturers and payers. Specifically, manufacturers are often uncertain how to communicate information about investigational or off-label uses of their products. The new Format offers additional guidance on communicating clinical and health care economic information about unapproved products and unapproved uses for approved products to payers.
However, the new Format stops short of directing manufacturers to proactively communicate information about unapproved products and unapproved uses for approved products. Instead, the new Format encourages manufacturers to follow their own policies and procedures regarding how to convey this off-label information. Note that the guidance is unchanged regarding approved product dossiers, which should still be provided only in response to an unsolicited request.
Payers have increasingly requested more timely delivery of health care economic information about pipeline products to meet budgetary and forecasting needs.
In 2016, the 21st Century Cures Act expanded the provisions in Section 114 of the Food and Drug Administration Modernization Act (FDAMA), which regulates the communication of health care economic information (HCEI) between pharmaceutical manufacturers and US health plans. In 2018, the FDA released final guidance on communication of competent and reliable scientific evidence, including health care economic information, to payers.
Because AMCP dossiers are key to the effective provision of this information to payers, it was necessary to update the Format to align with the new legislation and FDA guidance.
Given that much of the clinical and economic information about products may not be finalized until FDA approval, some specific considerations apply to communicating information about unapproved products (in pre-approval dossiers) and unapproved uses of approved products (in unapproved indication dossiers). Below is a quick guide to the new Format’s recommendations surrounding development of pre-approval and unapproved indication dossiers.
A table including the following information:
In addition to the elements typically provided in product dossiers, include:
Include a factual presentation of clinical evidence for the product that is available at the time of communication; it should be in the form of study summaries and/or evidence tables (per manufacturer discretion)
For unapproved products, information could be provided in a variety of ways, which may include but are not limited to:
The Format acknowledges the challenges associated with providing economic modeling results months in advance of the product approval. Here are a few ways to communicate this information while maintaining confidentiality and flexibility for future updates:
The AMCP Format Version 4.1 provides manufacturers with additional guidance to communicate evidence about potential new products or new uses to payers in a compliant fashion, allowing manufacturers to meet the needs of payers for the information they require to facilitate budgetary and forecasting decisions when they need it most. These recommendations pose a number of challenges-particularly around proactive dissemination of information and the development of preliminary economic models prior to launch – that may necessitate changes to manufacturers’ policies and procedures.
Dave Nellesen, principal, Analysis Group