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Real World Evidence for Coverage Decisions: Opportunities and Challenges


  • Hampson, G.
  • Towse, A.
  • Dreitlein, B.
  • Henshall, C.
  • Pearson, S.


OHE Research Paper 18/01 - This paper sets out the potential opportunities and important challenges and limitations that must be addressed in considering options for using RWE to inform insurer coverage decisions. The primary purpose of developing the paper was to stimulate discussion at the 2017 ICER Policy Summit meeting. A [separate paper]( available that summarises the authors reflections and proposed ways forwards based on the discussions that were had at the meeting. RWE is already utilised for multiple purposes in the US and globally. The focus of the 2017 ICER Policy Summit was on RWE for HTA assessments and payer coverage decisions - both initial decisions and reassessments – and the majority of the paper focuses on this. Acceptance of an expanded future role for RWE is not universal, particularly if it is seen as reducing the amount of RCT evidence available. Among the challenges associated with RWE explored in this paper are - bias and confounding; incomplete data; data mining; access to data; and the lack of universally accepted methodological standards. Current uses of RWE can be strengthened by increasing the quality and credibility of RWE (via national registries, data repositories and strict protocols) and establishment of appropriate governance arrangements. Key opportunities for the future include use of innovative study designs that combine benefits of collecting data from real world settings while incorporating best practice methods (i.e. randomisation methods from traditional RCTs); real time monitoring of patients; and the development of adaptive regulatory pathways linked to coverage with evidence development.

Suggested Citation

  • Hampson, G. & Towse, A. & Dreitlein, B. & Henshall, C. & Pearson, S., 2018. "Real World Evidence for Coverage Decisions: Opportunities and Challenges," Research Papers 001997, Office of Health Economics.
  • Handle: RePEc:ohe:respap:001997

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    References listed on IDEAS

    1. Marta O. Soares & Jo C. Dumville & A. E. Ades & Nicky J. Welton, 2014. "Treatment comparisons for decision making: facing the problems of sparse and few data," Journal of the Royal Statistical Society Series A, Royal Statistical Society, vol. 177(1), pages 259-279, January.
    2. ., 2017. "Local housing standard for a living wage," Chapters, in: Living Wages Around the World, chapter 5, pages 113-147, Edward Elgar Publishing.
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    Cited by:

    1. Elsa Bouée-Benhamiche & Philippe Jean Bousquet & Salah Ghabri, 2020. "Economic Evaluations of Anticancer Drugs Based on Medico-Administrative Databases: A Systematic Literature Review," Applied Health Economics and Health Policy, Springer, vol. 18(4), pages 491-508, August.
    2. Qiu, Tingting & Hanna, Eve & Dabbous, Monique & Borislav, Borisov & Toumi, Mondher, 2020. "Regenerative medicine regulatory policies: A systematic review and international comparison," Health Policy, Elsevier, vol. 124(7), pages 701-713.
    3. Elisabeth M. Oehrlein & Jennifer S. Graff & Jason Harris & Eleanor M. Perfetto, 2019. "Patient-Community Perspectives on Real-World Evidence: Enhancing Engagement, Understanding, and Trust," The Patient: Patient-Centered Outcomes Research, Springer;International Academy of Health Preference Research, vol. 12(4), pages 375-381, August.
    4. Melissa H. Roberts & Gary T. Ferguson, 2021. "Real-World Evidence: Bridging Gaps in Evidence to Guide Payer Decisions," PharmacoEconomics - Open, Springer, vol. 5(1), pages 3-11, March.
    5. Jorge Mestre-Ferrandiz & Néboa Zozaya & Bleric Alcalá & Álvaro Hidalgo-Vega, 2018. "Multi-Indication Pricing: Nice in Theory but Can it Work in Practice?," PharmacoEconomics, Springer, vol. 36(12), pages 1407-1420, December.

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    More about this item


    Value; Affordability; and Decision Making;
    All these keywords.

    JEL classification:

    • I1 - Health, Education, and Welfare - - Health

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