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Acceptability of Manufacturer-Proposed Utility Values for NICE Cancer Medicine Appraisals: Analysis of Manufacturers’ Information Sources

Published online by Cambridge University Press:  17 March 2022

Shunsuke Takada Open the ORCID record for Shunsuke Takada [Opens in a new window]  and
Mamoru Narukawa
Shunsuke Takada*
Affiliation:
Department of Clinical Medicine (Pharmaceutical Medicine), Graduate School of Pharmaceutical Sciences, Kitasato University, Tokyo, Japan Daiichi Sankyo Co., Ltd., Tokyo, Japan
Mamoru Narukawa
Affiliation:
Department of Clinical Medicine (Pharmaceutical Medicine), Graduate School of Pharmaceutical Sciences, Kitasato University, Tokyo, Japan
*
*Author for correspondence: Shunsuke Takada, E-mail: takada.shunsuke.ai@daiichisankyo.co.jp
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Abstract

Objectives

The National Institute for Health and Care Excellence’s (NICE) method guide for technology appraisals (TAs) encourages medicine manufacturers to use the EuroQol 5 Dimensions (EQ-5D) in relevant clinical trials to obtain utility values; however, the EQ-5D may have low sensitivity when compared to disease-specific measures. This study investigated whether the NICE TA committee’s acceptance of manufacturer-proposed utility values is dependent on the manufacturers’ sources of the utility values.

Methods

Using publicly available data for 2011–2020, we identified 136 single TAs of cancer medicines, the health-related quality-of-life-measures used in relevant clinical trials, manufacturers’ sources of utility values, and the NICE TA committee’s acceptance of these values. Fisher’s exact tests were performed to compare the acceptability of different value sources and reasons for non-acceptance.

Results

The number of appraisals for which the EQ-5D in the relevant clinical trials was the source of the manufacturer-proposed utility values increased continuously over time. The TA committee’s acceptance of values was not dependent on the information source. In cases where a submission for which the information source was the EQ-5D was rejected, the reason was generally related to inappropriate values for the UK population or inappropriate data adjustment, not data reliability.

Conclusions

Our results demonstrated that according with the NICE’s method guide regarding utility values does not guarantee acceptance by the TA committee. Manufacturers must consider in advance possible differences between their clinical trials and clinical practice in the UK and refine plans for EQ-5D measurement in order to obtain convincing evidence.

Keywords

Technology assessmentBiomedicalHealthcare economics and organizationsEnglandQuality-of-life
Type
Assessment
Information
International Journal of Technology Assessment in Health Care , Volume 38 , Issue 1 , 2022 , e25
Copyright
© The Author(s), 2022. Published by Cambridge University Press

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