Drug Evaluation Committee Introduction to NICE TSD and QOL values Measurement of QOL values and use of QOL values for cost-effectiveness analysis
Data Science Subcommittee
October 2021
A cost-effectiveness evaluation system was introduced for pharmaceuticals and medical devices in April 2019. In principle, the effectiveness indicator used for cost-effectiveness analysis is the Quality-Adjusted Life Year (QALY), which integrates survival and health-related Quality Of Life (QOL) outcomes. The health-related quality of life used to calculate QALYs is limited to that measured on a preference-based scale and is referred to as a "quality of life value" under this system.
In this report, we will explain what QOL values are, how they are handled, and the technical issues involved, which have been unfamiliar in clinical trials, etc., based on the evaluation guidelines published by the National Institute for Health and Care Excellence (NICE) in the U.K., which was an early adopter of cost-effectiveness evaluation. The presentation will include an overview of TSD 8 through TSD 12 of the Technical Support Document (TSD) and the evaluation guidelines issued by the National Institute for Health and Care Excellence (NICE) in the U.K., which was an early adopter of cost-effectiveness evaluation. Finally, as a case study, the use of QOL values in NICE Technology Appraisal (TA) will be presented.
QOL values are only one of the input data for cost-effectiveness analysis, but they are also handled in NICE between companies and external evaluation groups, However, it is one of the topics that is often a point of contention at NICE, with companies and external evaluation groups having differing opinions on its handling, selection of references, calculation methods, and so on. For those in charge of preparing for their own cost-effectiveness analysis, we hope that this report will be used effectively as a knowledge base for understanding the issues in Japan and abroad, and will serve as a stepping stone for calculating QOL values.
Data Science Subcommittee, Japan Pharmaceutical Manufacturers Association
2019 Ongoing Task Force 5
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