AMCP Partnership Forum: Building the Foundation for Patient-Reported Outcomes-Infrastructure and Methodologies.

Abstract

Section 3002 of the 21st Century Cures Act, which was signed into law in December 2016, requires the FDA to develop one or more sets of new guidances regarding the collection of patient experience data. To explore how patient-reported outcomes (PROs) can support value-based care and discuss challenges to using PROs more widely, the Academy of Managed Care Pharmacy (AMCP) convened a stakeholder forum in 2017 on PROs and the role they can play in defining the value of health care interventions. This forum achieved consensus on the importance of PROs in improving patient care through implementing value-based payment models and the need for strong organizational systems to fully adopt and use PROs in health care decision making. To explore strategies to build on these findings and implement them in practice, AMCP convened a second forum on October 25, 2018, in Orlando, FL, to focus on identifying specific methods and infrastructure to support the ideal use of PROs in practice. In light of the FDA's plans to propose new guidance for incorporating PROs in the regulatory process, this forum focused on the following: (a) describing the current state of using PROs for FDA regulatory and value-based coverage decisions; (b) defining a process for collecting and sharing PROs with the FDA and managed care organizations for value-based decisions; (c) identifying the necessary infrastructure needed to support the ideal use of PROs; and (d) identifying the health information technology strategies needed to support PRO use across managed care stakeholders. Strategies for the development and implementation of PROs were discussed throughout the forum, including a focus on appropriate activities to address the needs of patients, health care providers, managed care organizations, and life science companies and researchers. Health care leaders representing health plans, integrated delivery systems, pharmacy benefit managers, employers, national associations of health care professionals, patient advocacy organizations, health infrastructure technology companies and biopharmaceutical companies participated in the forum. The AMCP forum was supported in collaboration with Allergan, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Merck, Novo Nordisk, PhRMA, Sanofi, Takeda, and Xcenda. DISCLOSURES: The AMCP Partnership Forum and the development of the proceedings document were supported by Allergan, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Merck, Novo Nordisk, PhRMA, Sanofi, Takeda, and Xcenda.