AMCP Forum Issues Recommendations for FDA Guidance on FDAMA Section 114

Alexandria, Va., March 3, 2016 — A diverse group of health care stakeholders participating in an Academy of Managed Care Pharmacy (AMCP) forum reached agreement on a wide range of recommendations to make it easier for pharmaceutical companies to share pharmacoeconomic information with health care organizations that make coverage decisions.

The AMCP Partnership Forum, held March 1-2 in Washington, D.C., sought to clarify Section 114 of the 1997 Food and Drug Administration Modernization Act (FDAMA). Originally established to encourage manufacturers to share “health care economic information” (HCEI) with just managed care pharmacy and therapeutic committees, the nearly 20-year-old law has been underutilized due to uncertainty and lack of guidance from the FDA.

“It’s essential that the potential of Section 114 finally be fully realized,” said AMCP CEO Susan A. Cantrell, RPh, CAE. “The extraordinary advances in medicines and rising concern over pharmaceutical costs make it imperative that health care decision makers have the information they need to evaluate the value of drugs and biologics.”

Forum participants representing pharmaceutical companies, managed care organizations, academia, health care providers and patient advocates agreed to include the following recommendations to the FDA for inclusion in guidance on FDAMA Section 114 that is expected later this year: 

  • Dissemination of information under Section 114 should be expanded to health care decision makers beyond health plan formulary committees, including those making coverage decisions in accountable care organizations and integrated delivery networks, as well as organizations that evaluate pharmacoeconomic information or develop value frameworks and compendia. 
  • HCEI must be truthful and non-misleading, and be based on the expertise of professionals in the relevant area. The HCEI also must be derived and disclosed in a transparent, reproducible and accurate manner. This recommendation stems from a Section 114 requirement that a company support HCEI with “competent and reliable scientific evidence,” not the stricter “substantial evidence” standard required for drug approval. The lower standard has never been fully defined. 

Participants also discussed the types of information, format and processes by which managed care pharmacy and other health care decision-makers seek to receive pharmacoeconomic information from manufacturers. In addition, participants encouraged the FDA, Congress and other stakeholders to find ways that will ensure patients have appropriate access to a full range of information about their medications, and that information related to the medication pipeline is communicated to appropriate stakeholders in a timely manner.

The event was moderated by noted health policy expert Susan Dentzer, incoming President and CEO of the Network for Excellence in Health Innovation.

The Partnership Forum is scheduled to publish its proceedings in the July 2016 issue of AMCP’s Journal of Managed Care & Specialty Pharmacy. Based on the recommendations provided at the Partnership Forum, AMCP will lead the development of a draft guidance document that it will present to the FDA as it develops expected regulations or guidance on FDAMA 114 this year. This information will also be shared with Members of Congress as they consider potential legislative solutions to improve sharing of pharmacoeconomic information.

In addition, AMCP will use this forum to develop educational programing and tools for AMCP members to better understand this provision of law that will become increasingly important in today’s transparent health care environment. AMCP will continue to collaborate with a wide range of organizations to communicate and implement the recommendations from the forum.

“We recognize expanded access to cost effectiveness data is an important component of patient-centered care, and moving forward, we must find ways to expand access to additional entities as the health care paradigm continues to grow and evolve,” Cantrell said.

The Partnership Forum was sponsored by AbbVie, Amgen, Boehringer Ingelheim Pharmaceuticals, Merck & Co., the National Pharmaceutical Council, Pfizer, Pharmaceutical Research and Manufacturers of America, Precision for Value, Takeda Pharmaceuticals and Xcenda.