Who says Congress can’t get anything done…and with bipartisan support to boot? With impressive speed and purpose, the House and Senate overwhelmingly passed the 21st Century Cures Act in the waning days of the 114th Congress, followed by President Obama’s prompt signature.
While the law has its detractors, the Cures Act does include significant provisions to improve the health of Americans, from prompting new cures for cancer to combating opioid addiction. One provision of particular interest to AMCP takes an important step in creating a value- and outcomes-based health care system that will give patients the medicines they need while ensuring the wise use of health care dollars.
Section 3037 of Cures Act modernizes Section 114 of the Food and Drug Administration Modernization Act (“FDAMA 114” for short) of 1997. FDAMA 114 established a safe harbor for biopharmaceutical manufacturers to share health care economic information (HCEI) with entities that make formulary and coverage decisions, such as health plans. The goal was to assist payers in “evaluating the benefits, other consequences, and costs of competing therapies,” according to lawmakers at the time.
But as I’ve noted before, FDAMA 114 has been little used due to a lack of FDA guidance. That’s why we’re heartened to see Section 3037 address roadblocks that have hindered its use. It does this by:
● Allowing for the communication of HCEI to entities beyond formulary committees, as described in the original FDAMA law. AMCP will seek FDA guidance in 2017 to specify that these entities include population health decision makers (e.g. provider-sponsored health plans, pharmacy benefit managers, accountable care organizations, and integrated delivery networks) and population health decision influencers (e.g. organizations that evaluate HCEI and develop value frameworks or compendia) to align with the modernization of the health care system since enactment of the original law.
● Expanding the ability to communicate HCEI that is not directly related to the label, but that relates to indications in the label, while excluding any analyses of unapproved indications. AMCP will seek guidance in 2017 from FDA to clarify that studies and other data related to the populations studied for the labeled indication may be communicated.
● Explaining that the analyses and studies must be based on competent and reliable scientific evidence (CRSE) and that in some cases include a disclosure that the HCEI is different from the labeled information. AMCP will request that FDA guidance define CRSE as truthful and non-misleading tests, analyses, research, studies, models or other evidence. AMCP will also encourage FDA guidance to include an independent, objective body to develop consensus recommendations on good research practices.
I am proud that AMCP has taken a leadership role on these issues. And we’re pleased that aspects of Section 3037 align with recommendations developed during a recent AMCP partnership forum of diverse stakeholders on clarifying FDAMA 114. But our work is not done. We still need FDA guidance to truly clarify and operationalize FDAMA 114. With these changes in the Cures Act, we believe Congress is signaling that it’s time for the FDA to do its part.
We urge the FDA to adopt the stakeholder recommendations and bring FDAMA 114 into the 21st Century. As the U.S. health care system evolves from a fee-for-service payment system to a system rewarding quality, value and, ultimately, improved patient outcomes, the time for proactive communication has never been greater.