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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 | EQ-5D or HUI3. It is recommended to use a health-status classification system for which validated, preference-based scores are available in France. In absence of French data, it is possible to use preference-based scores from foreign studies, subject to a critical analysis of their quality. The use of any other method must be duly qualified, and its validity must be demonstrated in France. |
A Methodological Guide: Choices in Methods for Economic Evaluations (HAS, 2012) |
| Germany | IQWiG/G-BA | Note that no cost-utility analysis is required for a G-BA submission. Data should be collected in a clinical setting. No particular utility measure is preferred. For generic index instruments, a validated German version must be used to determine the utility value. A German tariff should be used. Justification for the use of the generic instrument should be stated, and the measure should be comprehensible. Evidence of the instrument’s objectivity, reliability, validity, and responsiveness is required. In addition, disease-specific instruments should be included in clinical studies to determine quality of life. The mapping of disease-specific instruments to generic instruments is discouraged. |
General Methods, Version 5.0 (IQWiG, 2017) |
| Italy | l’Ufficio Coordinamento OsMed e attività HTA | The EQ-5D should be used to measure the utility weights whenever possible. The utility weights should be estimated based on the value set for the Italian population. If EQ-5D utility weights are not available or not suitable for the specific patient population, utility weights based on other instruments can be used. |
Proposta di Linee Guida per la Valutazione Economica Degli Interventi Sanitari [Italian Guidelines for Economic Evaluation] (Italian Association of Health Economics, 2009) |
| Mexico | CENETEC | The EQ-5D is preferred. | Guide for Evaluation Economic for Medical Devices (CENETEC, 2017) |
| Netherlands | ZiN | The EQ-5D-5L should be used and valued using Dutch reference values. Additional questionnaires and methods can be used to measure quality of life to identify the effect to its fullest; however, the EQ-5D-5L should still be administered. |
Guideline for Economic Evaluations in Healthcare (ZiN, 2016) |
| 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 | The EQ-5D with UK tariff is recommended. EQ 5D-5L utility weights should be calculated using the EQ 5D-3L crosswalk algorithm (van Hout et al., 2012). The EQ-5D-Y can be used for children; tariffs are in development. If the EQ-5D is not suitable (Brazier and Longworth, 2011) or data are not available, other generic preference-based instruments can be used (SF-6D, 15D, HUI, AQoL, QWB) and values must then be mapped to EQ-5D values. If only data from disease-specific instruments are available, these must be mapped to predict EQ-5D values according to Longworth and Rowen (2011). |
Guidelines for the Submission of Documentation for Single Technology Assessment (STA) of Pharmaceuticals (NoMA, 2020) |
| 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 | Ministério da Saúde | EQ-5D-5L (recommended or preferred MAUI). Use Portuguese tariffs. |
Portaria (Ordinance) No. 391/2019. Sumário: Aprova os princípios e a caraterização das Orientações Metodológicas para Estudos de Avaliação Económica de Tecnologias de Saúde (Ministério da Saúde, year); Kennedy-Martin et al. (2020) |
| South Korea | HIRA | Direct measures (SG, TTO, Rating Scale) or indirect measures (MAUI, EQ-5D, HUI2, HUI3, SF-6D, QWB). It is recommended to use the Korean EQ-5D tariff. |
Guidelines for Economic Evaluation of Drugs. Revised Guidelines for Economic Assessment (HIRA, 2011) |
| 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] | Calculations based on appraisals of persons in the health condition are preferred over weights calculated from an average of a population estimating the condition depicted for it, i.e., the social tariff from the EQ-5D. | General Guidelines for Economic Evaluations From the Pharmaceutical Benefits Board (TLV, 2003) |
| Thailand | Health Intervention and Technology Assessment Program (HITAP), Ministry of Public Health | EQ-5D-3L (recommended or preferred MAUI) “…due to the validity, reliability, responsiveness, feasibility and availability of the established value set for Thai population.” The Thai value set. Note: The Thailand guideline states that at the time of publication (in 2014), no EQ-5D-5L value set from the Thai population was available (although the guideline noted that HITAP was working on one with the EuroQol Group). Consequently, the EQ-5D-3L is the preferred method used to measure utility. Note, in 2018, the EQ-5D-5L value set for Thailand was published. |
Ministry of Public Health Guidelines for Health Technology Assessment in Thailand (2nd Edition) (2014); Pattanaphesaj et al. (2018); Kennedy-Martin et al. (2020) |
| USA | Second Panel on Cost-Effectiveness in Health and Medicine | To enhance the comparability of results across studies, the use of a generic preference-based measure is recommended. The measure should be fit for purpose, with measurement properties that allow measurement of differences and changes in health across interventions. No specific, generic, preference-based measure is recommended. | Sanders et al. (2016) |
| ICER | In general, the use of generic, preference-based measures is recommended and EQ-5D is preferred. Disease-specific preference-based data should be used if generic measures are considered not to be responsive enough or data are not available. Scenario analyses should be performed to examine the influence on cost-per-QALY findings of lower utilities for individuals with chronic severe conditions. | (ICER, 2020) | |
| UK | NICE | For adults, the EQ-5D using the UK general population value set is recommended. The EQ-5D-5L questionnaire may be used with the EQ-5D-3L crosswalk by van Hout et al. (2012). When EQ-5D data are not available, utility may be estimated by mapping from other health-related quality-of-life measures to the EQ 5D. For children, an alternative health-related quality-of-life measure can be used. The EQ-5D-Y is available for children aged 7-12 years; however, there is no validated UK valuation set. In some circumstances, the EQ-5D may not be the most appropriate measure. To make a case that the EQ-5D is inappropriate, empirical evidence should be provided, demonstrating that key dimensions of health are missing and showing that EQ-5D performs poorly on tests of construct validity and responsiveness. |
Guide to Methods of Technology Appraisal (NICE, 2013); Position Statement on Use of the EQ-5D-5L Valuation Set for England (NICE, 2019) |
| SMC | The preference is for the EQ-5D in randomized, controlled studies of the medicine (or observational studies relevant to the population of interest). The EQ-5D may not be appropriate in all circumstances; those submitting data should provide reasons for their choice of instrument. Alternative methods are allowed if generic utility data are not available (mapped from disease-specific quality of life measure; direct measurement in patients or vignettes valued using TTO or SG; or published data). |
Guidance to Manufacturers for Completion of New Product Assessment Form (SMC, 2018) |