Delivering Value in the Biopharmaceutical Industry

The afternoon of the FDA/CMS Summit is focusing on payor and how biopharma products can deliver greater value via the use of comparative effectiveness research. Comparative effectiveness research is analysis that compares the relative values of treatments across the health care sector.  Often included in these analyses are biopharmaceuticals, devices, clinical procedures, diagnostic tests and other medical services. The first panel addressed the question, with the wealth of data available regarding the use of biopharmaceuticals, how can payers (both public and private) use this information to make more informed coverage decisions?

Nathan White (Executive Director of Reimbursement Strategy Development at InVentiv Health), discussed the value equation as he saw it: Safety + Efficacy + Comparative Cost / Clinical Effectiveness.  He asked, whose responsibility is it to demonstrate value? AHRQ, NIH, PCORI, payers, patients/providers and the biopharma industry. He believes that all of the parties have a responsibility to provide information that ultimately leads to the value proposition of a molecule.  He emphasized that the patient is potentially the most important player in this paradigm.  Patient reported outcome are one of the most important factors because we can learn a lot of things that are not part of a randomized clinical trial.  The purpose of patient reported outcomes focus on the overall  assessment to health and quality of life. 

The key point of the discussion was how to gather inputs from patients and how to ensure the sharing of information across all sectors to ensure that clinical effectiveness properly evaluates treatments.  Stakeholders in the health care system should have access to objective, scientifically based, and relevant information on the comparative clinical effectiveness of: different diagnostics, therapies, drugs, procedures, healthcare delivery processes (including health benefit design) and health policies for specific patients and populations.

While the focus of the discussion was on medications, it is important to remember that comparative effectiveness research is beyond medications. An inclusive comparative effectiveness research community examines all aspects of health care, including hospital care, and health care provider services.  Comparative effectiveness research should focus on improving the science and practice of medicine in a way that does not impeded access to care and diminish patient outcomes for the sake of cost.