NEW VALUE FRAMEWORKS IN THE UNITED STATES: INSIGHTS FROM PAYERS, CONSIDERATIONS FOR MANUFACTURERS, AND IMPLICATIONS FOR OTHER REGIONS OF THE WORLD
Prior to mid-to-late 2015, there was little interest in the application of formal value assessments in the United States (US), despite efforts to implement healthcare reform at the national level. This fundamentally changed in 2015 with the release of several US-focused value constructs, including the Memorial Sloan Kettering Cancer Center (MSKCC) DrugAbacus, American Society of Clinical Oncology (ASCO) Value Framework, and the Institute for Clinical and Economic Review (ICER) Evidence Reports. Each has since refined and released – formally or informally – updated tools and methodologies. Moreover, many manufacturers, payers, and other stakeholders have garnered at least one year of tangible experience with drugs that have been evaluated using these methodologies. The MSKCC DrugAbacus and ASCO’s net health benefit (NHB) evolved specifically in response to the rising cost of oncology therapies, whereas the ICER framework is more broadly applicable, with the goal of informing population level policy decisions. ICER conducted its first evaluation of oncology drugs in an assessment of multiple myeloma therapies earlier this year, thereby further underscoring the impact of these therapies. The specific enduring implications of these value constructs on stakeholder decision-making remains to be determined; however, it is evident that the landscape has been transformed. We will present these constructs, discuss the strengths and weaknesses of each, share perspectives regarding how pharma and US payers view value constructs, and examine implications for other regions of the world.