title: FACTORS INFLUENCING REIMBURSEMENT OF MEDICAL DEVICES IN FRANCE.
abstract: OBJECTIVE
  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.
authors: MedPass InternationalLoge.pierre@gmail.com.
authors: Pierre
authors: P
authors: Loge
authors: MedPass International.
authors: François
authors: F
authors: Delalande
authors: MedPass International.
authors: Marie-Christine
authors: MC
authors: Reymond
authors: MedPass International.
authors: Sylvia
authors: S
authors: Germain
mesh_terms: D004864:Equipment and Supplies / Q000191:economics*; D005602:France; D006077:Government Agencies; D006801:Humans; D012051:Reimbursement Mechanisms; D013673:Technology Assessment, Biomedical
keywords: Clinical trial; Evidence-based health care; Medical device; Risk-benefit assessment