AMCP Format 4.1 Includes Needed Preapproval Information

By AMCP CEO Susan A. Cantrell, RPh, CAE

Managed care pharmacy professionals practice in a world where diseases can emerge and spread quickly, and breakthrough innovations are fast-tracked at FDA. Despite clinical challenges and the complexity of efficacy, safety, economic, and quality-of-life data on new drugs and biologics, we must be ready to make timely recommendations to formulary committees, evaluate population-level impact of expensive new products, and support prior authorization decisions. Those are the normal expectations our health systems and patients have of us.

AMCP has been working hard for several years to help members be ready when drugs are approved or off-label indications emerge. The first prong of our effort was to update the popular AMCP Format for Formulary Submissions. Introduced at Nexus 2019, AMCP Format 4.1 features new sections describing the evidence needs of health care decision makers (HCDMs) for unapproved products nearing the end of the product development pipeline, as well as unapproved uses of existing products for which FDA approval is being sought.

Launched in 2000, the AMCP Format has become the primary tool for manufacturers to share safety, efficacy, and value data with HCDMs as they consider products for coverage and formulary placement.

During conferences, conversations, and webcasts, managed care pharmacy professionals and our industry colleagues have been telling us that updating the AMCP Format to encompass preapproval information is exactly what they have needed in today’s fast-paced world.

AMCP Format 4.1 takes into consideration the current FDA regulations governing the information that can be provided by manufacturers.

Those regulations go only so far, though, and they are subject to change based on judicial decisions or regulatory winds. For that reason, AMCP continues to spearhead efforts to codify these regulations through Congressional action; we want to be sure that this information remains available and that companies know the law permits them to respond to our requests.

Introduced into the last Congress by Rep. Brett Guthrie (R–KY) as the Pharmaceutical Information Exchange (PIE) Act, the legislation we are advocating would create a safe harbor for communications about unapproved products and off-label uses between biopharmaceutical manufacturers and HCDMs, including payers, formulary committees, or managed care pharmacy professionals who are responsible for the selection of drugs for coverage, reimbursement, or other population-based health care management. AMCP looking for legislative vehicles in the current Congress to reintroduce this important legislation.

AMCP supports passage of PIE legislation to remove any doubts or concerns about the legality of proactive, bidirectional communications. We strongly believe the ability to appropriately share data earlier will help shift the United States health care system to a focus on value and promotion of good outcomes.

The new AMCP Format and our continued efforts in Congress are just the latest AMCP efforts on behalf of managed care pharmacy professionals. Today would be a great time to take a close look at the full scope of AMCP Format 4.1 and to let us know what we can do next!