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Early access programs for medical devices in France: Overview of recent reforms and outcomes (2015-2022)

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  • Martin, Tess
  • Hervias, Alexandra
  • Armoiry, Xavier
  • Martelli, Nicolas

Abstract

The medical technology sector is characterised by a constant influx of innovations with the potential to revolutionise patient care. In France, there are several pathways for medical devices to enter the market, from diagnosis-related group tariffs to reimbursement lists. However, traditional regulatory pathways can delay market access for innovative technologies. In response, France has established Early Access Programs to expedite patient access to medical devices. This paper looks at three of these Early Access Programs for medical devices. Innovation Funding, introduced in its final version in 2015, provides temporary coverage for innovative devices and facilitates data collection for informed funding decisions. Transitional Coverage (PECT), established in 2021, targets CE-marked devices for rare or serious conditions. Transitional coverage for digital health applications (PECAN), introduced in 2022, covers digital medical devices, either therapeutic or for patient monitoring. Innovation funding has been granted to 16 technologies out of 35 applications (46%) since 2015. 6 technologies out of 11 (64%) applications benefit from PECT. PECAN, in its first year, has granted a telemonitoring solution with a favourable opinion. The French experience could provide valuable lessons for the development of a harmonised European framework to ensure that innovative medical technologies benefit those who need them, while maintaining high safety standards.

Suggested Citation

  • Martin, Tess & Hervias, Alexandra & Armoiry, Xavier & Martelli, Nicolas, 2024. "Early access programs for medical devices in France: Overview of recent reforms and outcomes (2015-2022)," Health Policy, Elsevier, vol. 148(C).
  • Handle: RePEc:eee:hepoli:v:148:y:2024:i:c:s0168851024001568
    DOI: 10.1016/j.healthpol.2024.105146
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    References listed on IDEAS

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    1. Charles M. A. Clark, 2020. "On the Priority of Labor Over Capital," American Journal of Economics and Sociology, Wiley Blackwell, vol. 79(4), pages 1147-1180, September.
    2. Sorenson, Corinna & Kanavos, Panos, 2011. "Medical technology procurement in Europe: A cross-country comparison of current practice and policy," Health Policy, Elsevier, vol. 100(1), pages 43-50, April.
    3. Sorenson, Corinna & Chalkidou, Kalipso, 2012. "Reflections on the evolution of health technology assessment in Europe," Health Economics, Policy and Law, Cambridge University Press, vol. 7(1), pages 25-45, January.
    4. Bernardo B. N. Strassburg & Alvaro Iribarrem & Hawthorne L. Beyer & Carlos Leandro Cordeiro & Renato Crouzeilles & Catarina C. Jakovac & André Braga Junqueira & Eduardo Lacerda & Agnieszka E. Latawiec, 2020. "Global priority areas for ecosystem restoration," Nature, Nature, vol. 586(7831), pages 724-729, October.
    5. Michael Drummond & Carlo Federici & Vivian Reckers‐Droog & Aleksandra Torbica & Carl Rudolf Blankart & Oriana Ciani & Zoltán Kaló & Sándor Kovács & Werner Brouwer, 2022. "Coverage with evidence development for medical devices in Europe: Can practice meet theory?," Health Economics, John Wiley & Sons, Ltd., vol. 31(S1), pages 179-194, September.
    6. Siqiao Li & Ger Koole & Xiaolan Xie, 2020. "An adaptive priority policy for radiotherapy scheduling," Flexible Services and Manufacturing Journal, Springer, vol. 32(1), pages 154-180, March.
    Full references (including those not matched with items on IDEAS)

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