Qualitative Research on the Acceptance of Evolving Evidence for Hta Body Approval of Innovative Health Technologies in Selected European Countries
Year: 2025
Type: article
Abstract: With increasing efforts of streamlining market access of innovative drugs, current acceptance of health technology assessment (HTA) bodies on non-traditional trial designs is still unclear. The aim of this study was to assess the perspective of drug developers on the acceptance of non-traditional trial designs by HTA bodies in Europe. Eleven semi-structured interviews were conducted with experts to gain insights on their perception of non-traditional trial design acceptance by HTA bodies from the Netherlands, Germany, United Kingdom, Sweden, and France. Future perspectives on and recommendations for facilitating the acceptance of non-traditional trials were provided. All experts highlighted the HTA bodies’ preference for randomized controlled trials over non-traditional trial designs. The degree of acceptance varied between countries. Experts recommended multistakeholder discussions between drug developers and HTA bodies for early scientific advice and re-evaluation of evidence requirements. The EU-HTA regulation was viewed as both a potential opportunity for harmonization and limiting innovative approach. The results of this study highlighted significant variations in the acceptance of non-traditional trial designs by HTA bodies across Europe. Actions are needed to facilitate a more progressive view on non-traditional clinical trial designs to ensure fast patient access to highly innovative treatments.
Source: Figshare
Authors: Reith, E., Maas, L., Joos, A., Heikkinen, I., De Iaco, M., Hiligsmann, M.
Language: English
Subfield: Economics and Econometrics
Domain: Social Sciences
Open Access status: green
OpenAlex ID: W6902323788
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