Scientific Evaluation and Pricing of Medical Devices and Associated Procedures in France

¹ Centre Hospitalier Universitaire La Cavale Blanche, Brest, France
² Medtronic France, Boulogne-Billancourt, France
³ Centre de Pharmacologie Clinique, Clermont-Ferrand, France
⁴ CNAMTS, Paris, France
⁵ General Electric, Vélizy, France
⁶ GlaxoSmithKline, Marly-le-Roi, France
⁷ Agence Technique de l’Information sur l’Hospitalisation, Paris, France
⁸ Direction générale de l’Offre de Soins, Paris, France
⁹ Hôpital Pitié-Salpêtrière, Paris, France
¹⁰ DGCIS, Ivry, France
¹¹ Direction de la Sécurité sociale, Paris, France
¹² Access Conseil, Paris, France
¹³ JMGoehrs Partners, Versailles, France
¹⁴ Abbott Vascular, Rungis, France
¹⁵ Sanofi Aventis, Paris, France
¹⁶ Hôpital Foch, Boulogne-Billancourt, France
¹⁷ Haute Autorité de Santé, Saint-Denis La Plaine, France
¹⁸ Johnson & Johnson, Issy-les-Moulineaux, France

Correspondence and offprints: Frédérique Debroucker, Medtronic France SAS, 27 quai Alphonse le Gallo, CS 30001, 92513 Boulogne-Billancourt Cedex, France. E-mail: frederique.debroucker@medtronic.com

Received: 15 March 2013
Accepted: 7 May 2013

Abstract

Medical devices are many and various, ranging from tongue spatulas to implantable or invasive devices and imaging machines; their lifetimes are short, between 18 months and 5 years, due to incessant incremental innovation; and they are operator-dependent: in general, the clinical user performs a fitting procedure (hip implant or pacemaker), a therapeutic procedure using a non-implantable invasive device (arrhythmic site ablation probe, angioplasty balloon, extension spondyloplasty system, etc.) or follow-up of an active implanted device (long-term follow-up of an implanted cardiac defibrillator or of a deep brain stimulator in Parkinson’s patients).

A round-table held during the XXVIII^th Giens Workshops meeting focused on the methodology of scientific evaluation of medical devices and the associated procedures with a view to their pricing and financing by the French National Health Insurance system. The working hypothesis was that the available data-set was sufficient for and compatible with scientific evaluation with clinical benefit. Post-registration studies, although contributing to the continuity of assessment, were not dealt with. Moreover, the focus was restricted to devices used in health establishments, where the association between devices and technical medical procedures is optimally representative.

An update of the multiple regulatory protocols governing medical devices and procedures is provided. Issues more specifically related to procedures as such, to non-implantable devices and to innovative devices are then dealt with, and the proposals and discussion points raised at the round-table for each of these three areas are presented.