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Isabelle Adenot1, Dorothée Camus2, Anne-Aurélie Épis de Fleurian2

  • 1HAS, 93210 Saint-Denis, France.

Therapie
|February 12, 2020
PubMed
Summary

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This summary is machine-generated.

Early access schemes in France provide patients with innovative health technologies before mainstream coverage. A new scheme, PRESTO, is proposed to bridge the gap between initial approval and widespread adoption.

Area of Science:

  • Health economics
  • Health policy
  • Medical technology assessment

Background:

  • Innovative health technologies often face delays in mainstream coverage after achieving initial effectiveness.
  • Early patient access is crucial to avoid missed opportunities for patients and the community.
  • Current early access schemes in France are fragmented and not widely known.

Purpose of the Study:

  • To map existing early access schemes for innovative health technologies in France.
  • To identify areas for improvement and adaptation to new European requirements.
  • To propose a new, complementary early access scheme to enhance patient access.

Main Methods:

  • A round table discussion involving stakeholders to dialogue on early access.
  • Mapping of existing French early access schemes, including those not exclusively for early access.
Keywords:
Early accessFundingHealth technologyInnovationMedical deviceTechnology assessment

Related Experiment Videos

  • Analysis of the current landscape and identification of knowledge gaps.

    • Main Results:

    • Several early access schemes exist in France (e.g., forfait innovation, exceptional coverage, RIHN).
    • Other initiatives (Article 51, ETAPES experiments) also facilitate access to non-mainstreamed technologies.
    • Existing schemes are poorly understood, necessitating better communication and integration.

    Conclusions:

    • Early access schemes require better integration into a supportive ecosystem, including streamlined procedures and patient information.
    • There is a need to adapt existing schemes to new European regulations.
    • The proposed PRESTO scheme aims to provide secure and temporary coverage for innovative technologies post-CE marking.