FDAMA114 LANDSCAPE ASSESSMENT- ARE US PAYER AND PROVIDER ACCESS DECISION MAKERS RECEPTIVE TO HEALTHCARE ECONOMIC INFORMATION CONSIDERING THE RECENT CHANGES TO FDAMA114
Author(s)
Bower D1, Zhang Y1, Daniel S2, Capuano C1, Suponcic S2, Zan R2
1Navigant Life Sciences, Boston, MA, USA, 2Navigant Life Sciences, Lawrenceville, NJ, USA
OBJECTIVES: Section 114 of the FDA Modernization Act of 1997 (FDAMA114) provides companies with guidelines to share healthcare economic information (HCEI) with formulary decision makers. However, ambiguity in the phrasing of FDAMA114 has caused companies to exercise caution when distributing HCEI. The enactment of the 21stCentury Cures Act in December 2016 aimed to remove this ambiguity in an effort to increase HCEI utilization and standardization, and encourage collaboration in addressing rising healthcare costs. This research identifies four areas of ambiguity within FDAMA114, seeks to understand if the Cures Act provided sufficient clarity, and captures the Payer and Provider Access Decision Maker (ADM) perspective on the credibility and believability of HCEI. METHODS: Secondary research was conducted to identify four phrases in FDAMA114 considered ambiguous to Payer and Provider ADMs. Each identified phrase was analyzed in relation to guidance provided in the Cures Act. Primary research was conducted with Payer and Provider ADMs to understand the extent to which the Cures Act addressed ambiguity in FDAMA114 and impacts the perceived credibility and believability of HCEI. RESULTS: The Cures Act stoked new interest in FDAMA114 by pharmaceutical companies. Specifically, the four primary areas of uncertainty in FDAMA114 identified were acknowledged through changes brought by the Cures Act. However, Payer and Provider ADMs do not recognize a meaningful advancement in reducing the ambiguity around HCEI communications. Moreover, stakeholders acknowledged that the lack of coordination and consistency between pharmaceutical companies further enhances the low perception of credibility and believability around HCEI. CONCLUSIONS: HCEI continues to present an opportunity to utilize a data-driven approach to confronting rising healthcare costs. Even with recent revisions to FDAMA114 through the Cures Act, ambiguity and uncertainty still remain with Payer and Provider ADMs. Furthermore, the pharmaceutical industry must work towards standardization for the communication of HCEI to improve its overall credibility and believability.
Conference/Value in Health Info
2017-05, ISPOR 2017, Boston, MA, USA
Value in Health, Vol. 20, No. 5 (May 2017)
Code
PCN244
Topic
Real World Data & Information Systems
Topic Subcategory
Health & Insurance Records Systems
Disease
Oncology