The Institute for Clinical and Economic Review (ICER), in collaboration with the Office of Health Economics (OHE), has released two new white papers to provide guidance to payers and manufacturers on the development and use of real world evidence for drug coverage and formulary decisions. The papers were generated as part of the annual ICER Policy Summit, where life science and payer organizations meet to develop collaborative approaches to addressing key policy issues related to the generation and application of evidence to improve value in the US health care system.
“Both manufacturers and payers share common goals in applying real world evidence to decision-making,” noted Steve D. Pearson, MD, MSc, President of ICER. “However, discussions at our Policy Summit highlighted the need for a common framework to help all parties gain a mutual understanding of how to tailor the entire evidence development process to achieve the best fit with key contextual factors that determine the level of evidentiary certainty decision-makers will require. There is no doubt that real world evidence will play a larger role in coverage and formulary decisions in the future, and we hope these two papers will support payers and the life science industry in their efforts to find common ground in how to maximize the positive role this evidence can play in guiding decisions that will improve patient outcomes and overall value for the health system.”
The first paper, titled Real World Evidence for Coverage Decisions: Opportunities and Challenges, was developed as the background paper for the December 2017 Policy Summit of ICER’s membership program, where leaders from 22 payer and life science organizations convened to share their perspectives on challenges and opportunities for this type of evidence. This paper highlights the challenges associated with wider use of real world evidence, including increased potential for bias, the risks of incomplete data, and the lack of universally accepted methodological standards.
To read more on the guidance on ICER’s website, click here.