ISPOR Europe Research Poster:

Access to Coverage with Evidence Development Schemes for Medical Devices and Procedures in England, France, Germany, Spain, and the USA

Authors: Heather Wellam, Michelle James, Kimrin Pannu, Helena Grant, Clare Foy, Adam Brown

Presenter: Adam Brown

Presentation Time: Tuesday 19th November, 10.30am–1.30pm

In this short video, Heather Wellam (Senior Consultant – Market Access) introduces the research:

Request a copy of our poster:

Complete the form to request a copy of our research poster.

    Keep me up to date with the latest news and events.

    References for our poster:

    1. Mtech Access. Market access stakeholders and processes for medical devices in key European markets and the USA. 2nd Edition. Available from: https://mtechaccess.co.uk/medtech-market-access-europe/. Accessed: October 2024.
    2. Sertkaya A, DeVries R, Jessup A, Beleche T. Estimated Cost of Developing a Therapeutic Complex Medical Device in the US. JAMA Netw Open. 2022;5(9).
    3. York Health Economics Consortium. Coverage with Evidence Development. Available from: https://yhec.co.uk/glossary/coverage-with-evidence-development. Accessed: October 2024.
    4. ISPOR. Accelerating Access to Medical Technologies: An Overview of the NICE Early Value Assessment Pilot Project in the UK. 2023. Available from: https://www.ispor.org/docs/default-source/euro2023/isporeurope23sohta186poster130461-pdf.pdf?sfvrsn=574bdf0b_0. Accessed: October 2024.
    5. NICE. Early Value Assessment (EVA) for medtech. Available from: https://www.nice.org.uk/about/what-we-do/eva-for-medtech#:~:text=EVA%20aims%20to%20support%20issues,that%20benefit%20from%20digital%20innovation. Accessed: October 2024.
    6. NICE. Early value assessment interim statement 2022. Available from: https://www.nice.org.uk/process/pmg39/resources/early-value-assessment-interim-statement-pdf-72286784283589. Accessed: October 2024.
    7. NICE. Early Value Assessment Programme: Early value assessment guidance consultation document. 2023. Available from: https://www.nice.org.uk/guidance/gid-hte10021/documents/draft-guidance#:~:text=Early%20value%20assessment%20(EVA)%20guidance,to%20address%20national%20unmet%20need. Accessed: October 2024.
    8. HAS. Innovation funding: HAS assessment principles. Available from: https://www.has-sante.fr/upload/docs/application/pdf/2021-10/forfait_innovation_guide_principe_evaluation.pdf. Accessed: October 2024.
    9. HAS. Search for a guideline. Available from: https://www.has-sante.fr/jcms/p_3135026/en/search-for-a-guideline-an-assesment. Accessed: October 2024.
    10. G-BA. Studies to test new examination and treatment methods. Available from: https://www.g-ba.de/studien/erprobung/. Accessed: October 2024.
    11. G-BA. Testing new examination and treatment methods. Available from: https://www.g-ba.de/themen/methodenbewertung/bewertung-erprobung/erprobungsregelung/. Accessed: October 2024.
    12. Canclini EM. Los estudios de monitorización del Sistema Nacional de Salud premiados a nivel internacional. 2023. Available from: https://enotas.astursalud.es/-/los-estudios-de-monitorizaci%C3%B3n-del-sistema-nacional-de-salud-premiados-a-nivel-internacional. Accessed: October 2024.
    13. Federici C, et al. Coverage with evidence development schemes for medical devices in Europe: characteristics and challenges. Eur J Health Econ. 2021;22(8):1253-73.
    14. Ministerio de Sanidad. Instruction document of the Spanish Agency of Medicines and Medical Devices for conducting clinical trials in Spain. 2021. Available from: https://www.aemps.gob.es/investigacionClinica/medicamentos/docs/Instrucciones-realizacion-ensayos-clinicos-EN.pdf?x19374. Accessed: October 2024.
    15. ISCIII. Monitoring Studies. Available from: https://www.isciii.es/QuienesSomos/CentrosPropios/AETS/EvaluacionTecnologiasSanitarias/Paginas/Estudios-de-monitorizaci%c3%b3n.aspx. Accessed: October 2024.
    16. Serrano-Aguilar P, et al. Postlaunch evidence-generation studies for medical devices in Spain: the RedETS approach to integrate real-world evidence into decision making. International Journal of Technology Assessment in Health Care. 2021;37(1).
    17. CMS. Fact Sheet: Notice with Comment – Transitional Coverage for Emerging Technologies (CMS-3421-NC). Available from: https://www.cms.gov/newsroom/fact-sheets/notice-comment-transitional-coverage-emerging-technologies-cms-3421-nc. Accessed: October 2024.
    18. Federal Register. Medicare Program; Transitional Coverage for Emerging Technologies. 2023. Available from: https://www.govinfo.gov/content/pkg/FR-2023-06-27/pdf/2023-13544.pdf. Accessed: October 2024.
    Return to our ISPOR Europe virtual booth