, Volume 35, Supplement 1, pp 11–19 | Cite as

International Regulations and Recommendations for Utility Data for Health Technology Assessment

  • Donna RowenEmail author
  • Ismail Azzabi Zouraq
  • Helene Chevrou-Severac
  • Ben van Hout
Review Article


Recommendations and guidelines for the collection, generation, source and usage of utility data for health technology assessment (HTA) vary across different countries, with no international consensus. Many international agencies generate their own guidelines providing details on their preferred methods for HTA submissions, and there is variability in both what they recommend and the clarity and amount of detail provided in their guidelines. This article provides an overview of international regulations and recommendations for utility data in HTA for a selection of key HTA countries: Australia, Canada, France, Germany, the Netherlands, Spain (Catalonia), Sweden and the UK (England/Wales and Scotland). International guidelines are typically clear and detailed for the selection of countries assessed regarding the source description of health states (e.g. generic preference-based measure) and who should provide preference weights for these health states (e.g. general population for own country). Many guidelines specify the use of off-the-shelf generic preference-based measures, and some further specify a measure, such as EQ-5D. However, international guidelines are either unclear or lack detailed guidance regarding the collection (e.g. patients report own health), source (e.g. clinical trial) and usage (e.g. adjusting for comorbidities) of utility values. It is argued that there is a need for transparent and detailed international guidelines on utility data recommendations to provide decision makers with the best possible evidence. Where this is not possible it is recommended that best practice should be used to inform the collection, source and usage of utility values in HTA.



The authors would like to acknowledge Dr. Nick Bansback for comments on an earlier draft, and Prof. Jon Karnon, Ph.D., of The University of Adelaide and Dr. Andrew Lloyd, Ph.D., of Bladen Associates Ltd for their editorial review.

Author contributions

DR extracted and analysed the evidence from the literature, wrote the first draft of the manuscript and made final edits. IA extracted some data, checked the extraction and contributed to the manuscript. HC contributed to the manuscript. BvH checked the extraction and contributed to the manuscript.

Compliance with Ethical Standards

Disclosure statement

This article is published in a special edition journal supplement wholly funded by Takeda Pharmaceutical International AG, Zurich, Switzerland.


This study was funded by an unrestricted grant from Takeda Pharmaceuticals International AG.

Conflict of interest

Ismail Azzabi-Zouraq and Helene Chevrou-Severac are employed by Takeda Pharmaceuticals International AG. Donna Rowen and Ben van Hout have no conflicts of interest.

Supplementary material

40273_2017_544_MOESM1_ESM.xlsx (27 kb)
Supplementary material 1 (XLSX 26 kb)


  1. 1.
    PBAC (Pharmaceutical Benefits Advisory Committee). Guidelines for preparing submissions to the pharmaceutical benefits advisory committee. Australia: Australian Government Department of Health; 2013.Google Scholar
  2. 2.
    CADTH (Canadian Agency for Drugs and Technologies in Health). Guidelines for the economic evaluation of health technologies. Canada: CADTH; 2006.Google Scholar
  3. 3.
    HAS (Haute Autorité de Santé). Choices in methods for economic evaluation. France: HAS; 2012.Google Scholar
  4. 4.
    IQWiG (German National Institute for Quality and Efficiency in Health Care). General methods for the assessment of the relation of benefits to costs. Cologne: IQWiG; 2015.Google Scholar
  5. 5.
    CVZ (College voor zorgverzekeringen). Guidelines for pharmacoeconomic research: evaluation and actualisation. Diemen: CVZ; 2006.Google Scholar
  6. 6.
    Busschbach JV, van Hout BA, de Wit A. BIJLAGE 2: QALY en kwaliteit: van leven metingen. Diemen: Zorginstituut Nederland; 2016.Google Scholar
  7. 7.
    CatSalut. Guia I Recomanacions Per A La Realització I Presentació D’avaluacions Econòmiques I Anàlisis D’impacte Pressupostari De Medicaments En L’àmbit Del Catsalut. Catalonia: CatSalut; 2014.Google Scholar
  8. 8.
    Pharmaceutical Benefits Board. General guidelines for economic evaluations from the Pharmaceutical Benefits Board. Sweden: Pharmaceutical Benefits Board; 2003.Google Scholar
  9. 9.
    NICE (National Institute of Health and Care Excellence). Guide to the methods of technology appraisal. London: NICE; 2013.Google Scholar
  10. 10.
    SMC (Scottish Medicines Consortium) Guidance to manufacturers for completion of new product assessment form (NPAF). Scotland: NHS Scotland; 2016.Google Scholar
  11. 11.
    Sanders G, Neumann P, Basu A, Brock D, Feeny D, Krahn M, et al. Recommendations for conduct, methodological practices, and reporting of cost-effectiveness analyses: second panel on cost-effectiveness in health and medicine. JAMA. 2016;316(10):1093–103.CrossRefPubMedGoogle Scholar
  12. 12.
    Wolowacz SE, Briggs A, Belozeroff V, et al. Estimating health-state utility for economic models in clinical studies: an ISPOR good research practices task force report. Value Health. 2016;19(6):704–19.CrossRefPubMedGoogle Scholar
  13. 13.
    Versteegh M, Knies S, Brouwer W. From good to better: new Dutch guidelines for economic evaluations in healthcare. PharmacoEconomics. 1071;2016:34.Google Scholar
  14. 14.
    Hoefman RJ, van Exel J, Brouwer WBF, PharmacoEconomics. Measuring care-related quality of life of caregivers for use in economic evaluations: CarerQol tariffs for Australia, Germany, Sweden, UK, and US. 2016.Google Scholar
  15. 15.
    Hoefman RJ, Van Exel NJA, Rose JM, et al. A discrete choice experiment to obtain a tariff for valuing informal care situations measured with the CarerQol instrument. Med Decis Mak. 2014;34(1):84–96.CrossRefGoogle Scholar
  16. 16.
    Al-Janabi H, Flynn T, Coast J. Estimation of a preference-based carer experience scale. Med Decis Mak. 2011;31(3):458–68.CrossRefGoogle Scholar
  17. 17.
    Brazier J, Ratcliffe J, Tsuchiya A, Solomon J. Measuring and valuing health for economic evaluation. 2nd ed. Oxford: Oxford University Press; 2017. p. 175–256.Google Scholar
  18. 18.
    Rowen D, Brazier J, Ara R, Azzabi Zouraq I. The role of condition-specific preference-based measures. Pharmacoecon. doi: 10.1007/s40273-017-0546-9.
  19. 19.
    Brazier JE, Rowen D. NICE DSU technical support document 11: alternatives to EQ-5D for generating health state utility values. 2011. Accessed 07 Aug 2016.
  20. 20.
    Burstrom K, Sun S, Gerdtham U, Henriksson M, Johannesson M, Levin L, et al. Swedish experience-based value sets for EQ-5D health states. Quality Life Res. 2014;23:431–42.CrossRefGoogle Scholar
  21. 21.
    Brazier J, Rowen D, Karimi M, Peasgood T, Tsuchiya A, Ratcliffe J. Experience-based utility: are we asking the right questions? Health Economics and Decision Science Discussion Paper, University of Sheffield, UK; 2017.Google Scholar
  22. 22.
    Ara R, Rowen D, Mukuria C. The use of mapping to estimate health state utility values. Pharmacoecon. doi: 10.1007/s40273-017-0548-7.
  23. 23.
    Ara R, Brazier J, Azzabi Zouraq I. The use of health state utility values in decision models. Pharmacoecon. doi: 10.1007/s40273-017-0550-0.
  24. 24.
    Ara R, Brazier J. Estimating health state utility values for comorbidities. Pharmacoecon. doi: 10.1007/s40273-017-0551-z.
  25. 25.
    Brazier J, Ara R, Rowen D, Chevrou-Severac H. A review of generic preference-based measures. Pharmacoecon. doi: 10.1007/s40273-017-0545-x.
  26. 26.
    Ara R, Brazier J, Paisley S, Peasgood T. The identification, review and synthesis of HSUVs from the literature. Pharmacoecon. doi: 10.1007/s40273-017-0547-8.
  27. 27.
    Ara R, Brazier J, Young T. Recommended methods for the collection of HSUV evidence in clinical studies. Pharmacoecon. doi: 10.1007/s40273-017-0549-6.

Copyright information

© Springer International Publishing AG 2017

Authors and Affiliations

  • Donna Rowen
    • 1
    Email author
  • Ismail Azzabi Zouraq
    • 2
  • Helene Chevrou-Severac
    • 2
  • Ben van Hout
    • 1
  1. 1.School of Health and Related Research (ScHARR)University of SheffieldSheffieldUK
  2. 2.Takeda Pharmaceuticals International AGGlattpark-Opfikon (Zurich)Switzerland

Personalised recommendations