title: Hospital-based health technology assessment in France: A focus on medical devices.
abstract: Hospital-based health technology assessment (HTA) guides decisions as to whether new healthcare products should be made available within hospital structures. Its extension to medical devices (MDs) makes it possible to analyse several relevant aspects of these healthcare products in addition to their clinical value, and such evaluations are of interest to national health authorities, other healthcare establishments and industry. The aim of this work was to formulate several recommendations for a blueprint for hospital-based HTA for MDs in France. Five themes based on the work of the European Adopting hospital-based HTA in the EU (AdHopHTA) project were defined. Each member of the roundtable was then allocated a documentation task based on their experience of the theme concerned, and a literature review was carried out. An inventory of hospital-based HTA was performed and six recommendations aiming to strengthen and improve this approach were put forward: (1) encouragement of the spread of the hospital-based HTA culture and participation in communications and the promotion of this approach to hospital decision-makers; (2) adaptation of hospital-based HTA to the needs of decision-makers, taking into account the financial timetable and strategic objectives of the healthcare establishment; (3) harmonisation of the dossiers requested from industry between healthcare establishments, based on a common core; (4) promotion of the sharing of hospital-based HTA data under certain conditions, with data dissociable from the HTA report and the use of a validated methodology for the literature review; (5) creation of a composite indicator reflecting data production effort and the sharing of HTA activities, to be taken into account in the distribution of funds allocated for teaching, research and innovation missions considered of general interest; (6) the transmission of information directly from local to national level by pioneering centres. This work highlights the major issues at stake in hospital-based HTA and the need to valorise such activities in France.
authors.affiliation: Service de pharmacie, hôpital européen Georges-Pompidou, AP-HP, 20, rue Leblanc, 75015 Paris, France. Electronic address: nicolas.martelli@aphp.fr.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Martelli
authors.affiliation: Medtronic, 92100 Boulogne-Billancourt, France.
authors.forename: Cyril
authors.initials: C
authors.lastname: Puc
authors.affiliation: Johnson et Johnson, 92130 Issy-les-Moulineaux, France.
authors.forename: Karine
authors.initials: K
authors.lastname: Szwarcensztein
authors.affiliation: CHRU de Lille, 59000 Lille, France.
authors.forename: Régis
authors.initials: R
authors.lastname: Beuscart
authors.affiliation: Ministère des Affaires sociales et de la Santé, direction générale de l'offre de soins, 75007 Paris, France.
authors.forename: Hélène
authors.initials: H
authors.lastname: Coulonjou
authors.affiliation: AGEPS, AP-HP, 75005 Paris, France.
authors.forename: Albane
authors.initials: A
authors.lastname: Degrassat-Théas
authors.affiliation: Consultant, 49124 Saint-Barthélemy-d'Anjou, France.
authors.forename: Camille
authors.initials: C
authors.lastname: Dutot
authors.affiliation: SNITEM, 92400 Courbevoie, France.
authors.forename: Anne-Aurélie
authors.initials: AA
authors.lastname: Epis de Fleurian
authors.affiliation: Département de la recherche clinique et du développement, AP-HP, 75475 Paris, France.
authors.forename: Florence
authors.initials: F
authors.lastname: Favrel-Feuillade
authors.affiliation: Service de pharmacie, hôpital européen Georges-Pompidou, AP-HP, 20, rue Leblanc, 75015 Paris, France.
authors.forename: Iliona
authors.initials: I
authors.lastname: Hounliasso
authors.affiliation: Département de la recherche clinique et du développement, AP-HP, 75475 Paris, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Lechat
authors.affiliation: Centre hospitalier Louis-Pasteur, 39108 Dôle, France.
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Luigi
authors.affiliation: Clinique Beau-Soleil, 34070 Montpellier, France.
authors.forename: Laurent
authors.initials: L
authors.lastname: Mairot
authors.affiliation: Johnson et Johnson, 92130 Issy-les-Moulineaux, France.
authors.forename: Thao
authors.initials: T
authors.lastname: Nguyen
authors.affiliation: CHU de Bordeaux, 33404 Talence, France.
authors.forename: Laurent
authors.initials: L
authors.lastname: Piazza
authors.affiliation: 3M France, 95006 Cergy-Pontoise, France.
authors.forename: Christophe
authors.initials: C
authors.lastname: Roussel
authors.affiliation: Hyprevention, 33604 Pessac, France.
authors.forename: Cécile
authors.initials: C
authors.lastname: Vienney
mesh_terms: D003659:Decision Making, Organizational; D004864:Equipment and Supplies; D005602:France; D006801:Humans; D013673:Technology Assessment, Biomedical / Q000458:organization & administration*
keywords: Decision support; Health technology assessment; Healthcare establishment; Medical devices