Why are partnerships on real-world evidence among payers and pharmaceutical companies becoming more prevalent? That’s what National Pharmaceutical Council President Dan Leonard asked participants during a panel discussion he moderated this week at the PCMA Annual Meeting in Rancho Palos Verdes, California. Mr. Leonard was joined by William Fleming, President, Humana Pharmacy Solutions, and Steve Romano, Senior Vice President, Head, Medicines Development Group–Global Primary Care Business Unit, Pfizer Inc, whose companies are collaborating on a data partnership. Through this collaboration, the companies will generate real-world data with the goal of to developing better medicines and helping payers make outcomes-based decisions.
Companies are working together because they are in need of additional data to address health questions that cannot be answered through a randomized controlled trial (RCT). RCTs are experiments in which "subjects in a population are randomly allocated into study and control groups to receive or not to receive and experimental intervention"* such as a new drug or therapy. RCTs are required for Food and Drug Administration drug approval. By contrast, real-world evidence uses observational data such as electronic medical records, claims information and patient surveys, and looks at the effectiveness of a treatment in populations that are very different from those studied in RCTs. These populations differ in age, race, ethnicity, severity of disease, co-morbid conditions, take other medicines, and vary in their levels of compliance. Studying how drugs work in "the real world" and impact patients’ day-to-day lives can help both payers and pharmaceutical companies determine which drug therapies are clinically effective and lower overall health care costs.
Humana and Pfizer are not alone in their partnerships. Geisinger and Merck, HealthCore and AstraZeneca, and Medco Health Solutions/UBC and Sanofi also are collaborating on ways to assess clinical and cost effectiveness through comparative effectiveness research and related "real-world" analyses.
*RW Dubois and SL Kindermann, Demystifying Comparative Effectiveness Research: A Case Study Learning Guide.