ISPOR's Initiative on US Value Assessment Frameworks: An Industry Perspective.

The biopharmaceutical research sector strongly supports the shift to value-driven health care, and is committed to reforms that encourage this shift and enable manufacturers to engage as partners in the process. This includes a substantial, sustained commitment to improving evidence on comparative clinical and cost effectiveness of medicines and other health care interventions, and supporting the development of better frameworks for value assessment. As health care evolves to rewarding value over volume, how value gets defined and demonstrated will be of critical importance. The International Society for Pharmacoeconomics and Outcomes Research’s (ISPOR’s) leadership in launching a Special Task Force (STF) on Value Assessment Frameworks highlights the importance of gaining consensus on better methods for assessing value. We welcome STF’s efforts, and are encouraged by its recommendations to expand upon the range of elements considered in defining value and explore alternative approaches to value element aggregation and decision making [1–7] such as multicriteria decision analysis (MCDA). However, we are disappointed that the STF took the conservative and conventional path to endorse the cost per quality-adjusted life-year (C/QALY) metric as the core component of value assessment. Although we appreciate STF’s proposals for improvements in defining the C/QALY, we are concerned that the countervailing recommendations on the use of thresholds in policy decision making do not reflect fundamental limitations of the metric. The research, patient, and health care communities would be better-served if the STF had focused its efforts on conceptualizing and proposing realistic solutions to value assessment methods that meet the goals of patients and other decision makers rather than attempting to improve upon the C/QALY approach that has been largely rejected by the US society. We call on the STF and leaders of the health outcomes research field to 1) amend endorsement of prevailing methods for value assessment to reflect the substantial limitations of the C/QALY; and 2) advance progress in development of alternative definitions of the C/QALY and, more importantly, of novel and potentially transformative methods that are better aligned with the US health care system.