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FACTORS INFLUENCING REIMBURSEMENT OF MEDICAL DEVICES IN FRANCE

Published online by Cambridge University Press:  12 February 2016

Pierre Loge ,
François Delalande ,
Marie-Christine Reymond  and
Sylvia Germain
Pierre Loge
Affiliation:
MedPass InternationalLoge.pierre@gmail.com
François Delalande
Affiliation:
MedPass International
Marie-Christine Reymond
Affiliation:
MedPass International
Sylvia Germain
Affiliation:
MedPass International
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Abstract

Objectives: This study aims to analyze the key factors considered for the first application of the National Committee for the Evaluation of Medical Devices (CNEDiMTS) for achieving reimbursement through registration in the list of products and services qualifying for reimbursement (LPPR).

Methods: All the appraisals studied on medical devices (MD) for first inclusion in the LPPR during 2011 and 2012 were retrieved from the French National Authority for Health or Haute Autorité de santé (HAS) Web site. A list of relevant factors was analyzed for each included opinion, followed by univariate and multivariate analyses to highlight the key factors that impacted the expected benefit (EB) provided by HAS.

Results: A total of 151 appraisals were included in the study. Of them, 94 (62 percent) were granted with sufficient EB. The manufacturers were mostly from the United States (36 percent), while most of the applicants were from France (84 percent). After adjusting for other retrieved factors, it was observed that MDs complying with the technical standards, requests supported by opinion(s) from previous generation of MD, and the presence of recommendations or guidelines had more probability to obtain a sufficient EB. A lower probability was related to MDs supported by low-quality studies and with no specific health public benefit.

Conclusions: Our results confirmed that manufacturers seeking reimbursement should be aware of the expectations of the health authorities (level of evidence, technical standard, etc.) and foresee their plan of sending requests for funding so that they can provide evidence of good quality.

Keywords

Medical deviceRisk-benefit assessmentEvidence-based health careClinical trial
Type
Assessments
Information
International Journal of Technology Assessment in Health Care , Volume 31 , Issue 6 , 2015 , pp. 399 - 406
Copyright
Copyright © Cambridge University Press 2016 

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References

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