AMCP Partnership Forum Builds Infrastructure and Methodologies to Utilize Patient Reported Outcomes

Alexandria, Va., Nov. 2, 2018 — A multimodal approach is needed to engage individuals in sharing patient reported outcomes (PROs) that can be used to advance objectives in value-based care and drug development, according to attendees of the Academy of Managed Care Pharmacy’s (AMCP) Partnership Forum last week on “Building the Foundation for Patient Reported Outcomes: Infrastructure and Methodologies.”

Many health care stakeholders see the potential of PROs — such as self-reported changes in a disease state — to improve patient care and further the adoption of value-based care models. In addition, the U.S. Food and Drug Administration (FDA) is expected soon to issue new draft guidance on incorporating PROs into the drug development and approval process. However, incorporating PROs within drug development and delivery of care has been difficult, in part due to the fragmented nature of the U.S. health care system.

Addressing this challenge head on, attendees at the Oct. 25 Forum identified specific methods and infrastructure around collecting and using PROs in practice. Foremost, attendees agreed that gathering PRO data must be convenient to patients and gathered in multiple ways, including at the doctor’s office, through home surveys, via social media, through wearable Fitbit-type devices, and using “gamification” methods. 

To obtain PROs, providers also must ensure that patients understand the clinical insights that may be gained from sharing their information, as well as the benefits of being fully engaged in their care. This requires a strong educational component. Furthermore, enlisting the help of patient advocacy groups, is crucial to moving PROs forward.

The recommendations came from attendees who represented a wide range of stakeholder, including patients, payers, providers, government and biopharmaceutical companies. A formal proceedings document, to be released early next year, will present all of the Forum suggestions, and serve as a basis for comments on the FDA’s forthcoming PRO guidance. Attendees agreed this guidance will serve as the impetus for AMCP and other stakeholders to build the infrastructure and methodology around collecting and using PROs. 

“Patient reported outcomes represent a sea change in how we look at and measure value in health care,” said AMCP CEO Susan A. Cantrell, RPh, CAE. “Results from this Forum will advance this promising concept, and will have the potential to directly improve patient care. AMCP looks forward to providing these recommendations to FDA as it develops its guidance around the use of PROs.”

The Forum was a follow-up to last year’s Forum on the role that PROs can play in defining health-care value. That event resulted in consensus on two overarching issues: (1) the importance of PROs in improving patient care and implementing value-based payment models, and (2) the need for strong organizational systems to fully adopt and use PROs in health care decision-making.

The October event was support by Allergan, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Merck, Novo Nordisk, Pharmaceutical Research and Manufacturers of America (PhRMA), Sanofi, Takeda and Xcenda, a part of AmerisourceBergen.