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Health Technology Assessment (HTA) Utility Measures: Not One-Size-Fits-All
HTA Strategy and Submissions
Are you up to date with HTA recommendations on health utility measurement for your cost-utility model? Many HTA agencies make specific statements about their preferences for health utility measures, but their guidelines change over time. And it can be hard to find the right document.
In our work, we must stay up to date on HTA authority guidelines for health state utility measurement methods across multiple countries. We've developed a summary table of these guidelines that we trust you'll find helpful.
HTA Support
Contact our integrated team of experts for assistance with your utility measurement and technology assessment submission needs:
- Utility research design (trials, observational studies, surveys)
- Instrument/method selection
- Study implementation
- Utility data analysis
- Data incorporation into cost-utility models
| Country | Agency | Guidance | Source |
|---|---|---|---|
| Australia | PBAC | No specific utility instrument is favored. | Guidelines for Preparing Submissions to the Pharmaceutical Benefits Advisory Committee. Version 5.0 (PBAC, 2016) |
| Belgium | Belgian Health Care Knowledge Centre | EQ-5D (recommended or preferred MAUI). “In order to stimulate the use of generic utility instruments and to promote consistency.” Use of Belgian preference values is preferred. | Belgian Guidelines for Economic Evaluations and Budget Impact Analyses, 2nd Edition (Belgian Health Care Knowledge Centre, 2012); Kennedy-Martin et al. (2020) |
| Bulgaria | National Center for Public Health and Analysis | EQ-5D-3L; EQ-5D-5L (recommended or preferred MAUI). “…it [EQ-5D] is commonly used, it allows the greatest comparability of the results of economic analyses.” | Health Technology Assessment Guidelines (National Center for Public Health and Analysis, 2018); Kennedy-Martin et al. (2020) |
| Brazil | DECIT-CGATS | G, TTO, EQ-5D, or SF-6D. | Methodological Guidelines: Economic Evaluation Guideline. Second Edition (Brazilian Ministry of Health, 2014) |
| Canada | CADTH | Health preferences should reflect the general Canadian population and should be obtained from an indirect method of measurement based on a generic classification system (e.g., EQ-5D, HUI, SF 6D). Researchers must justify where an indirect method is not used. Selection of data sources should be based on their fitness for purpose, credibility, and consistency. | Guidelines for the Economic Evaluation of Health Technologies: Canada, 4th Edition (CADTH, 2017) |
| Chile | Ministerio de Salud de Chile | EQ-5D; DALY (recommended or preferred MAUI). There is a Chilean social valuation of EQ-5D health states; national researchers are familiar with DALYs following burden-of-disease studies in Chile. Chilean preferences should be used. | Guía Metodológica Para la Evaluación Económica de Intervenciones en Salud en Chile [Methodological Guide for the Economic Evaluation of Health Interventions in Chile] (Ministerio de Salud de Chile, 2013); Kennedy-Martin et al. (2020) |
| China | No policy-generating agency | Indirect utility methods such as EQ-5D-3L, EQ-5D-5L and SF-6D are preferred, using a value set based on the preference of the Chinese general population. If a value set for China is not available, a value set for a country or region with a similar sociocultural background or a value set that is widely recognized internationally may be used. For children, the EQ-5D-Y is recommended. A direct measure can be performed when there is no applicable instrument for indirect measurement. Commonly used direct methods include SG, TTO, discrete choice experiments, etc. Utilities can be obtained from published studies through systematic literature reviews if utility values are not available through trial utility measurements. Caregiver quality of life and utilities can be considered if the disease or the intervention has a significant effect on caregivers. | Liu et al. (2020) |
| Colombia | IETS [Institute of Health Technology Assessment] | EQ-5D-3L (recommended or preferred MAUI). Preferences from Latino population in US should be used. | Manual Para la Elaboración de Evaluaciones Económicas en Salud [Manual for the Preparation of Economic Evaluations in Health] (IETS, 2014); Kennedy-Martin et al. (2020) |
| Croatia | Agency for Quality and Accreditation in Health Care | EQ-5D (recommended or preferred MAUI). National preferences required. | Croatian Guideline for Health Technology Assessment Process and Reporting (Agency for Quality and Accreditation in Health Care, 2011); Kennedy-Martin et al. (2020) |
| Czech Republic | Státní Ústav pro Kontrolu Léčiv [State Institute for Drug Control] | EQ-5D (recommended or preferred MAUI). “A pharmacoeconomic evaluation always has to apply the same method of measuring quality of life to all (clinical) conditions, as individual methods are not mutually comparable and result in varying partial values of utility.” Preference to use Czech health preferences are preferred; but if not available, use utilities from the UK may be used. | Cost-Effectiveness Analysis Critical Appraisal Procedure (Státní Ústav pro Kontrolu Léčiv, 2017); Kennedy-Martin et al. (2020) |
| France | HAS | • The utility should be estimated using a multi-attribute approach, comprising the collection of health state data from patients via a generic questionnaire and the valuation of health states according to the preferences of the general population. • EQ-5D-5L is recommended (French EQ-5D-5L value set and EQ-5D-5L questionnaire). • Failing that, as a transitional measure, the EQ-5D-3L classification system (French EQ-5D-3L value set and EQ-5D-3L questionnaire) should be used. • If EQ-5D is not available, a mapping approach should be opted for. • Other approaches are not recommended for the base-case analysis of the reference case. These can be subjected to a sensitivity analysis. • Estimating utility through an approach revealing preferences for a hypothetical health state via vignettes or through a visual analogue scale is not acceptable in the base-case and sensitivity analysis. | A Methodological Guide: Choices in Methods for Economic Evaluations (HAS, 2020) |
| Germany | IQWiG/G-BA | • For the calculation of QALYs, the utilities used in the decision-analytic model should be based on valuations by patients. • Utilities based on valuations by the general population are particularly useful if the valuations do not differ from those of patients. • Valuations based on indirect methods should only be used if a validated tariff is available for Germany. • Mapping disease-specific instruments to generic instruments is generally not recommended for the HEE. | General Methods, Version 7.0 (IQWiG, 2023) |
| Italy | The Italian Medicines Agency (AIFA) | • Both generic questionnaire (e.g., EQ-5D-3L, SF-36) and disease-specific instruments will be considered. • Methods for conducting research and identifying information on QOL must be described in detail. Where possible, the use of data is requested referring to the Italian context. • If multiple alternative sources of data are identified, the uncertainty of results will have to be tested as part of the sensitivity analysis. | Linee Guida per la Compilazione del Dossier a Supporto Della Domanda di Rimborsabilità e Prezzo di un Medicinale [Guidelines for submitting Health Economic Evaluations to AIFA for pricing and reimbursement of medicines (Section E and Appendix 2)] (AIFA, 2019) |
| Mexico | CENETEC | The EQ-5D is preferred. | Guide for Evaluation Economic for Medical Devices (CENETEC, 2017) |
| Netherlands | ZiN | • QOL should be measured with the EQ-5D-5L and valued using the Dutch tariff. • The EQ-5D-Y-3L questionnaire is available for children aged 8-12 years. For children under the age of 8 and persons who are mentally or physically unable to indicate their quality of life, a caregiver can complete a proxy version of the EQ-5D. • If EQ-5D-5L is not adequate, alternative questionnaires and other methods can be used. Generic outcome measures are preferable to disease-specific outcome measures. | Guideline for Economic Evaluations in Healthcare (ZiN, 2024) |
| New Zealand | PHARMAC | EQ-5D (recommended or preferred MAUI). “The EQ-5D is widely used internationally and utility weights have been derived from the New Zealand population. Therefore, PHARMAC recommends referring to the EQ-5D Tariff 2 first and using it to describe the health states.” | Prescription for Pharmacoeconomic Analysis. Methods for Cost-Utility Analysis (Version 2.2) (PHARMAC, 2015); Kennedy-Martin et al. (2020) |
| Norway | NoMA | • HRQOL data must be measured using generic preference-based measuring instruments, preferably EQ-5D. • Both EQ-5D-5L and EQ-5D-3L are available for patients 12 years or older. If both versions are used, 5L data should be converted to 3L using the EEPRU data set as described in the literature (NICE, 2019; Hernández Alava et al., 2023). • Use of HRQOL data from the literature must be supported by a systematic literature search and the choice of sources must be justified and discussed. • The EQ-5D-Y can be used for children 8 years or older; tariffs are in development. Average age, age distribution, and age range of the respondents must be submitted. • The EQ-5D with the UK population-based EQ-5D- 3L tariff must be applied until a more relevant and applicable tariff is available. The Norwegian 15D tariff can be applied in scenario analyses. • Other generic preference-based instruments (e.g., SF-6D, 15D, HUI, AQoL, and QWB) can be used if EQ- 5D data are lacking. The values must be mapped to EQ-5D values using validated methods. • To account for changes in morbidity and mortality in the general population with increasing age, utility over time must be age adjusted using the multiplicative method. Lack of age adjustments must be justified. | Guidelines for the Submission of Documentation for Single Technology Assessment (STA) of Pharmaceuticals (NoMA, 2023) |
| Poland | AOTMiT [Agency for Health Technology Assessment and Tariff System] | EQ-5D-3L; EQ-5D-5L (recommended or preferred MAUI). The EQ-5D is recommended; “…since it is commonly used, it allows for the greatest comparability of the results of economic analyses.” Use the Polish 3L value set and crosswalk until 5L value set is available. | Health Technology Assessment Guidelines (Version 3.0) (AOTMiT, 2016); Kennedy-Martin et al. (2020) |
| Portugal | INFARMED – National Authority of Medicines and Health Products | • EQ-5D-5L is the preferred measure, with Portuguese tariffs. • If neither EQ-5D-5L nor mapping algorithm is available, the EQ-5D-3L with the Portuguese tariff can be used. • Other preference-based generic measures can also be used, but their choice must be justified. | Methodological Guidelines for Economic Evaluation Studies of Health Technologies (Perelman, 2019) |
| South Korea | HIRA | • Using generic preference-based measures and using Korean value sets recommended, but not condition-specific measures. • Recommend using an indirect method with patient-level data collected from clinical trials. | Health Insurance Review and Assessment Service. Guidelines on economic evaluation for pharmaceuticals (HIRA, 2021) |
| Spain | Spanish HTA Network | Indirect methods (Spanish recommendations and CATSALUT). Direct or indirect methods (OSTEBA). EQ-5D and SF-6D (CATSALUT). | Methods for Health Economic Evaluations—a Guideline Based on Current Practices in Europe (EUnetHTA, 2015) |
| Sweden | TLV [Swedish Dental and Pharmaceutical Benefits Agency] | • QALY weights should primarily be based on the SG or TTO method. • Alternatively, QALY weights should be based on the Rating Scale method. • The QALY weights can be based either on direct measurements using the above methods or indirect measurements (e.g., EQ-5D). • QALY weights based on the valuations of people in the current health state are preferred over weights calculated from an average of a population that valued a state described for them (for example, the “social tariff” from EQ-5D). | Amendment to the Dental and Pharmaceutical Benefits Agency’s general advice (TLVAR 2003:2) on financial evaluations (TLV, 2017) |
| Thailand | Health Intervention and Technology Assessment Program (HITAP), Ministry of Public Health | • For primary data collection, the EQ-5D-5L using hybrid model is recommended. The Thai EQ-5D-5L value set can be used to derive the utility value. • However, when the EQ-5D-5L is not appropriate to that health state, other utility methods such as SG, TTO, VAS, EQ-5D-3L, HUI, or SF-6D can be employed. • A mapping approach can be applied, but it should not be the first choice. • Societal perspective or general population perspective should be adopted when making policy decision or resource allocation decision. • Other health-utility methods such as a derivation of a utility score from DALYs is not recommended. | Guideline for Health Technology Assessment in Thailand Updated Edition: 2019 (HITAP, 2021) |
| USA | AMCP | Preference estimates should be derived from studies surveying either patients or the general population by using a direct elicitation method or an instrument such as the TTO, SG, EQ-5D, HUI, SF-6D, or QWB. | Guidance on Submission of Pre-Approval and Post- Approval Clinical and Economic Information and Evidence, Version 4.1 (AMCP, 2020) |
| ICER | • Generic classification systems such as the EQ- 5D include measures of health state preferences that reflect those of the general US population are recommended. • Where general population estimates are not available or appropriate, utility estimates from different populations may be used, such as patients with the specific condition under study, those affected by similar symptoms, proxy respondents, or mixed samples. | Value Assessment Framework (ICER, 2023) | |
| UK | NICE | • The EQ-5D using the UK general population value set is recommended to measure HRQOL in adults. • EQ-5D-3L value set is preferred for reference-case analyses. If EQ-5D-5L is used, utility values should be mapped onto the 3L value set. The mapping function developed by the Decision Support Unit (Hernández Alava et al. 2017), using the ‘EEPRU data set’ (Hernández Alava et al. 2020), should be used for reference-case analyses. • EQ-5D-5L value set for England published by Devlin et al. (2018) is not recommended for use. • If not available, EQ-5D data can be sourced from the literature or estimated from another measure by mapping. If EQ-5D is not appropriate, qualitative empirical evidence on the lack of content validity for the EQ-5D is needed and should be derived from a synthesis of peer-reviewed literature and an alternative measure used. In order of preference, alternatives include a generic preference-based measure, condition-specific preference-based measure, vignette valuation, or direct valuation of own health state. • If baseline utility values are extrapolated over long time horizons, adjustment is needed to reflect decreases in HRQOL seen in the general population. • Specific measures of HRQOL in children and young people is not recommended. | NICE health technology evaluations: the manual (NICE, Last updated 31 October 2023) |
| SMC | • A preference (rather than a requirement) for utility estimates from a validated generic utility instrument such as the EQ-5D. • If utility data from generic validated instruments is not available, utilities from 3 other sources are accepted, including 1) Utilities mapped from a disease-specific QOL measure included in a clinical study; 2) Specific surveys for direct measurement of utilities for appropriate disease/condition health states; 3) Values taken from previous studies reported in published literature. • If appropriate data on utilities/QALYs for carers or other groups other than the patients affected is provided as additional evidence, this will need to be presented separately from the primary QALY analysis because it is outside the perspective adopted by the SMC. | Guidance to submitting companies for completion of New Product Assessment Form (NPAF) (SMC, 2022) |
EU HTA guidelines are listed per country in this chart