Drug Evaluation Committee Introduction to NICE TSD and QOL values Measuring QOL Scores and Using Them in Cost-Effectiveness Analysis
October 2021
In April 2019, a cost-effectiveness evaluation system was introduced for pharmaceuticals and medical devices. As a general rule, the outcome measure used in cost-effectiveness analyses is the Quality-Adjusted Life Year (QALY).A QALY integrates the outcomes of survival and health-related quality of life (QOL). The health-related QOL used to calculate QALYs is limited to that measured by preference-based scales and is referred to as “QOL values” under this system.
This report explains what QOL values—which have been relatively unfamiliar in clinical trials and similar settings—actually are,how they are handled, and the technical challenges involved, based on an overview of the assessment guidelines and Technical Support Documents (TSD) 8 through 12 issued by the UK’s NICE (National Institute for Health and Care Excellence), which has been an early adopter of cost-effectiveness analysis.Finally, as a case study, we present how QOL values are utilized in NICE Technology Appraisals (TA).
Although QOL values are merely one of the input data points used in cost-effectiveness analysis, they remain a contentious topic at NICE, where opinions differ between companies and external evaluation groups regarding their handling, the selection of cited literature, and calculation methods.We hope that this report will serve as a valuable resource for professionals preparing to conduct in-house cost-effectiveness analyses, helping them understand the key issues both in Japan and abroad and providing a solid foundation for calculating QOL values.
Japan Pharmaceutical Manufacturers Association, Data Science Subcommittee
FY2019 Continuing Task Force 5