[Hospital-based health technology assessment in France: how to proceed to evaluate innovative medical devices?].
Innovative medical devices offer solutions to medical problems and greatly improve patients' outcomes. Like National Health Technology Assessment (HTA) agencies, hospitals face numerous requests for innovative and costly medical devices. To help local decision-makers, different approaches of hospital-based HTA (HB-HTA) have been adopted worldwide. The objective of the present paper is to explore HB-HTA models for adopting innovative medical devices in France and elsewhere. Four different models have been conceptualized: "ambassador" model, "mini-HTA" model, "HTA unit" model and "internal committee". Apparently, "HTA unit" and "internal committee" (or a mixture of both models) are the prevailing HB-HTA models in France. Nevertheless, some weaknesses of these models have been pointed out in previous works. Only few examples involving hospital pharmacists have been found abroad, except in France and in Italy. Finally, the harmonization of the assessment of innovative medical devices in France needs a better understanding of HB-HTA practices.
Laboratoire de droit et économie pharmaceutiques, faculté de pharmacie Paris XI, 5, rue Jean-Baptiste-Clément, 92290 Châtenay-Malabry, France; Service pharmacie, hôpital européen Georges-Pompidou, AP-HP, 20, rue Leblanc, 75015 Paris, France. Electronic address: nicolas.martelli@egp.aphp.fr.
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Martelli
Laboratoire de droit et économie pharmaceutiques, faculté de pharmacie Paris XI, 5, rue Jean-Baptiste-Clément, 92290 Châtenay-Malabry, France.
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van den Brink
Délégation à la recherche clinique et innovation, centre hospitalier régional universitaire de Lille, 6, rue du Professeur-Laguesse, 59037 Lille Cedex, France.
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Denies
Délégation à la recherche clinique et innovation, centre hospitalier régional universitaire de Lille, 6, rue du Professeur-Laguesse, 59037 Lille Cedex, France.
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Dervaux
Pharmacie centrale, centre hospitalier régional universitaire de Lille, place de Verdun, 59037 Lille cedex, France.
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Germe
Service pharmacie, hôpital européen Georges-Pompidou, AP-HP, 20, rue Leblanc, 75015 Paris, France.
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Prognon
Service pharmacie, hôpital européen Georges-Pompidou, AP-HP, 20, rue Leblanc, 75015 Paris, France.
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Pineau
D020811:Biomedical Technology / Q000379:methods / Q000592:standards*; D003657:Decision Making; D018795:Device Approval / Q000592:standards; D005602:France; D006077:Government Agencies / Q000458:organization & administration; D006785:Hospitals, University; D006801:Humans; D062069:Inventions; D008962:Models, Theoretical; D010607:Pharmacy Service, Hospital; D013673:Technology Assessment, Biomedical / Q000458:organization & administration; D013675:Technology, High-Cost / Q000592:standards
Dispositif médical; Health economy; Health technology assessment; Hospital pharmacy; Innovation; Medical device; Pharmacie hospitalière; Économie de santé; Évaluation