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Developing an evidence-based methodological framework to systematically compare HTA coverage decisions: A mixed methods study

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  • Nicod, Elena
  • Kanavos, Panos

Abstract

Health Technology Assessment (HTA) often results in different coverage recommendations across countries for a same medicine despite similar methodological approaches. This paper develops and pilots a methodological framework that systematically identifies the reasons for these differences using an exploratory sequential mixed methods research design. The study countries were England, Scotland, Sweden and France. The methodological framework was built around three stages of the HTA process: (a) evidence, (b) its interpretation, and (c) its influence on the final recommendation; and was applied to two orphan medicinal products. The criteria accounted for at each stage were qualitatively analyzed through thematic analysis. Piloting the framework for two medicines, eight trials, 43 clinical endpoints and seven economic models were coded 155 times. Eighteen different uncertainties about this evidence were coded 28 times, 56% of which pertained to evidence commonly appraised and 44% to evidence considered by only some agencies. The poor agreement in interpreting this evidence (κ=0.183) was partly explained by stakeholder input (ns=48 times), or by agency-specific risk (nu=28 uncertainties) and value preferences (noc=62 “other considerations”), derived through correspondence analysis. Accounting for variability at each stage of the process can be achieved by codifying its existence and quantifying its impact through the application of this framework. The transferability of this framework to other disease areas, medicines and countries is ensured by its iterative and flexible nature, and detailed description.

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  • Nicod, Elena & Kanavos, Panos, 2016. "Developing an evidence-based methodological framework to systematically compare HTA coverage decisions: A mixed methods study," Health Policy, Elsevier, vol. 120(1), pages 35-45.
    • Handle: RePEc:eee:hepoli:v:120:y:2016:i:1:p:35-45
    DOI: 10.1016/j.healthpol.2015.11.007
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    References listed on IDEAS

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    1. Carroll, Christopher & Kaltenthaler, Eva & FitzGerald, Patrick & Boland, Angela & Dickson, Rumona, 2011. "A thematic analysis of the strengths and weaknesses of manufacturers’ submissions to the NICE Single Technology Assessment (STA) process," Health Policy, Elsevier, vol. 102(2), pages 136-144.
    2. Fischer, Katharina Elisabeth, 2012. "A systematic review of coverage decision-making on health technologies—Evidence from the real world," Health Policy, Elsevier, vol. 107(2), pages 218-230.
    3. Banta, David, 2003. "The development of health technology assessment," Health Policy, Elsevier, vol. 63(2), pages 121-132, February.
    4. Nicod, Elena & Kanavos, Panos, 2012. "Commonalities and differences in HTA outcomes: A comparative analysis of five countries and implications for coverage decisions," Health Policy, Elsevier, vol. 108(2), pages 167-177.
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    Cited by:

    1. Degtiar, Irina, 2017. "A review of international coverage and pricing strategies for personalized medicine and orphan drugs," Health Policy, Elsevier, vol. 121(12), pages 1240-1248.
    2. Anderson, Michael & Drummond, Michael & Taylor, David & McGuire, Alistair & Carter, Paul & Mossialos, Elias, 2022. "Promoting innovation while controlling cost: The UK's approach to health technology assessment," Health Policy, Elsevier, vol. 126(3), pages 224-233.
    3. Fontrier, Anna-Maria & Visintin, Erica & Kanavos, Panos, 2022. "Similarities and differences in Health Technology Assessment systems and implications for coverage decisions: evidence from 32 countries," LSE Research Online Documents on Economics 112969, London School of Economics and Political Science, LSE Library.
    4. Maynou, Laia & Cairns, John, 2018. "What is driving HTA decision-making? Evidence from cancer drug reimbursement decisions from 6 European countries," LSE Research Online Documents on Economics 90877, London School of Economics and Political Science, LSE Library.
    5. Elena Nicod, 2017. "Why do health technology assessment coverage recommendations for the same drugs differ across settings? Applying a mixed methods framework to systematically compare orphan drug decisions in four Europ," The European Journal of Health Economics, Springer;Deutsche Gesellschaft für Gesundheitsökonomie (DGGÖ), vol. 18(6), pages 715-730, July.
    6. Elena Nicod & Michela Meregaglia & Amanda Whittal & Sheela Upadhyaya & Karen Facey & Michael Drummond, 2022. "Consideration of quality of life in the health technology assessments of rare disease treatments," The European Journal of Health Economics, Springer;Deutsche Gesellschaft für Gesundheitsökonomie (DGGÖ), vol. 23(4), pages 645-669, June.
    7. Belousova, Olga A. & Groen, Aard J. & Ouendag, Aniek M., 2020. "Opportunities and barriers for innovation and entrepreneurship in orphan drug development," Technological Forecasting and Social Change, Elsevier, vol. 161(C).
    8. Fischer, Katharina Elisabeth & Heisser, Thomas & Stargardt, Tom, 2016. "Health benefit assessment of pharmaceuticals: An international comparison of decisions from Germany, England, Scotland and Australia," Health Policy, Elsevier, vol. 120(10), pages 1115-1122.
    9. Olina Efthymiadou, 2023. "Health technology assessment criteria as drivers of coverage with managed entry agreements: a case study of cancer medicines in four countries," The European Journal of Health Economics, Springer;Deutsche Gesellschaft für Gesundheitsökonomie (DGGÖ), vol. 24(7), pages 1023-1031, September.
    10. Maynou, Laia & Cairns, John, 2019. "What is driving HTA decision-making? Evidence from cancer drug reimbursement decisions from 6 European countries," Health Policy, Elsevier, vol. 123(2), pages 130-139.
    11. Aris Angelis & Ansgar Lange & Panos Kanavos, 2018. "Using health technology assessment to assess the value of new medicines: results of a systematic review and expert consultation across eight European countries," The European Journal of Health Economics, Springer;Deutsche Gesellschaft für Gesundheitsökonomie (DGGÖ), vol. 19(1), pages 123-152, January.
    12. Anna-Maria Fontrier & Erica Visintin & Panos Kanavos, 2022. "Similarities and Differences in Health Technology Assessment Systems and Implications for Coverage Decisions: Evidence from 32 Countries," PharmacoEconomics - Open, Springer, vol. 6(3), pages 315-328, May.
    13. Mills, Mackenzie & Kanavos, Panos, 2022. "How do HTA agencies perceive conditional approval of medicines? Evidence from England, Scotland, France and Canada," Health Policy, Elsevier, vol. 126(11), pages 1130-1143.
    14. Nicod, Elena & Annemans, Lieven & Bucsics, Anna & Lee, Anne & Upadhyaya, Sheela & Facey, Karen, 2019. "HTA programme response to the challenges of dealing with orphan medicinal products: Process evaluation in selected European countries," Health Policy, Elsevier, vol. 123(2), pages 140-151.

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