In 1997 section 114 of the Food, Drug and Cosmetic Act (FDAMA 114) sought to provide direction for the dissemination of Health Care Economic Information (HCEI) by drug manufacturers to formulary committees. Unfortunately, the direction was vague, and thus companies were hesitant to the extent that they could move forward without further clarification.
It took 18 years, but in May of 2015, the 21st Century Cures Act was approved, which contained a provision (Section 3037) which amended FDAMA 114 and expanded the permissible scope of drug manufacturer’s promotion of HCEI.
In the wake of the Cures Act, the FDA on January 18, 2017, released its long-await draft guidance on the proactive communication of HCEI to payors and formulary committees. The draft guidance is thorough in its scope and contains important changes that affect key stakeholders in medical affairs, HEOR, access teams, compliance and legal.
The timing of this comes at a critical point as payors are looking for real-world HCEI evidence and evidence-based value rationale from the field medical and account team. And as a result of new laws and state mandates, population health decision makers are under strict evaluation timelines evaluate their plan designs, formularies and rates 12-18 months before the beginning of the intended plan year.
Manufacturers who provide timely HCEI to Payors will have a competitive advantage.
DMH offers a variety of training programs specifically designed around the FDA’s new draft guidance. Below is a list of our most popular workshops.