Association Between Information Sources of Manufacturer-Proposed Utility Values and the NICE Technology Appraisal Committee's Acceptance
Author(s)
Takada S1, Narukawa M2
1Kitasato University, Shirokane, Minato-ku, 13, Japan, 2Kitasato University, Tokyo, 13, Japan
Presentation Documents
OBJECTIVES: The National Institute for Health and Care Excellence’s (NICE) method guide recommends manufacturers to use utility values from the EuroQol 5 Dimensions (EQ-5D) in relevant clinical trials when they submit evidence to the technology appraisal (TA) program; however, the EQ-5D may have lower sensitivity than disease-specific measures. This study investigated whether the NICE TA committee’s acceptance of manufacturer-proposed utility values (MPUVs) is associated with their information sources.
METHODS: Using publicly available data for 2011–2020, we identified 136 cancer medicine appraisals. We collected the health-related quality-of-life-measures used in relevant clinical trials, the follow-up period of the trials, the information sources of MPUVs, the TA committee’s acceptance of MPUVs. Fisher’s exact tests were performed to assess the association between conformity with the method guide and the TA committee’s acceptability of MPUVs or reasons for non-acceptance.
RESULTS: The number of appraisals for which the EQ-5D in the relevant clinical trials was the source of the MPUVs, which was considered to be in conformity with the method guide, increased continuously over time. The TA committee’s acceptance of MPUVs was not dependent on the conformity with the method guide. In cases where the MPUVs were rejected in spite of their conformity with the method guide, the reason was generally related to the irrelevant values for the UK population or inappropriate data adjustment. When the source of MPUVs was in conformity with the method guide, longer follow-up periods or more frequent EQ-5D measurement in the relevant clinical trials were associated with the TA committee’s acceptance.
CONCLUSIONS: Our results demonstrated that the conformity with the method guide regarding utility values does not guarantee TA committee’s acceptance. Manufacturers should consider in advance possible differences between their clinical trials and clinical practice in the UK and refine plans for EQ-5D measurement to obtain convincing evidence.
Conference/Value in Health Info
Value in Health, Volume 25, Issue 12S (December 2022)
Code
HTA59
Topic
Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes
Disease
STA: Drugs