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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 International Loge.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

REFERENCES

1. Haute Autorité de Santé (HAS) [Internet]. Medical device assessment in France: Guidebook. 2009. [updated 2009 October]. http://www.has-sante.fr/portail/upload/docs/application/pdf/2010--03/guide_dm_gb_050310.pdf (accessed January 17, 2014).Google Scholar
2. Haute Autorité de Santé (HAS) [Internet]. Guide to the application dossier for inclusion, for modification of the conditions for inclusion and for the renewal of inclusion of a product or service under a brand name on the list referred to in Article L.165–1 to be submitted to the National Committee for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS). 2011. [updated November 8, 2011]. http://www.has-sante.fr/portail/upload/docs/application/pdf/2012--05/guide_fabricant_version_anglaise_maj_20_12__2011vd__2012--05--21_18--04--7_755.pdf (accessed January 19, 2014).Google Scholar
3. Authority for Health (HAS) [Internet]. Business report 2012. 2013. [updated June 27, 2013]. http://www.has-sante.fr/portail/upload/docs/application/pdf/2013--06/ra2012_has.pdf (accessed January 22, 2014).Google Scholar
4. Sorenson, C, Drummond, M, Kanavos, P. Ensuring value for money in health care. The role of health technology assessment in the European Union [Internet] . Copenhagen, Denmark: WHO Regional Office for Europe; c2008. [updated February 24, 2011]. http://www.euro.who.int/__data/assets/pdf_file/0011/98291/E91271.pdf (accessed January 24, 2014).Google Scholar
5. Haute Autorité de Santé (HAS) [Internet]. Guide pour le dépôt d’un dossier auprès de la Commission nationale d’évaluation des dispositifs médicaux et des technologies de santé (CNEDiMTS). 2015. [updated June 26, 2015]. http://www.has-sante.fr/portail/upload/docs/application/pdf/2015--06/guide_fabricant_2015_2105cnedimts_vd.pdf (accessed January 26, 2014).Google Scholar
6. Haute Autorité de Santé (HAS) [Internet]. Parcours du dispositif medical. Guide pratique. (Course of the medical device. Practical Guide). 2009 actualisation 2013. 2013. [updated October 2009]. http://has-sante.fr/portail/upload/docs/application/pdf/2009--12/guide_pratique_dm.pdf (accessed January 28, 2014).Google Scholar
7. Haute Autorité de Santé (HAS) [Internet]. Methodological choices for the clinical development of medical devices- Assessment report. 2013. [updated November 21, 2013]. http://www.has-sante.fr/portail/upload/docs/application/pdf/2014--03/methodological_choices_for_the_clinical_development_of_medical_devices.pdf (accessed February 5, 2014).Google Scholar
8. Stephens, JM, Handke, B, Doshi, JA. International survey of methods used in health technology assessment (HTA): Does practice meet the principles proposed for good research? Comp Eff Res. 2012;2:29–44.Google Scholar
9. Haute Autorité de Santé (HAS) [Internet]. Niveau de preuve et gradation des recommandations de bonne pratique (Level of evidence and grading of recommendations for good practice). 2013. [updated 2013 June 14, 2013]. http://www.has-sante.fr/portail/upload/docs/application/pdf/2013--06/etat_des_lieux_niveau_preuve_gradation.pdf (accessed February 15, 2014).Google Scholar
10. Huot, L, Decullier, E, Maes-Beny, K, Chapuis, FR. Medical device assessment: Scientific evidence examined by the French national agency for health - A descriptive study. BMC Public Health. 2012;12:585.CrossRefGoogle ScholarPubMed