Hospital-based health technology assessment of innovative medical devices: insights from a nationwide survey in France

Tess Martin (1, 2) , Alessandra Guercio (1) , Hélène Besseau (2) , Laure Huot (3, 4) , Pascale Guerre (5, 4) , Jamal Atfeh (4) , Laurent Piazza (6) , Judith Pineau (1) , Brigitte Sabatier (1) , Isabelle Borget (7, 8, 9, 10) , Nicolas Martelli (2, 1)

1 HEGP - Hôpital Européen Georges Pompidou [APHP]
2 Université Paris-Saclay
3 RESHAPE - Inserm U1290 - UCBL1 - Research on Healthcare Performance
4 HCL - Hospices Civils de Lyon
5 P2S - Parcours santé systémique
6 CHU Bordeaux
7 CESP - Centre de recherche en épidémiologie et santé des populations
8 IGR - Institut Gustave Roussy
9 U1018 (Équipe 2) - Oncostat
10 SBE - Service de biostatistique et d'épidémiologie

Objectives To better understand the process of hospital acquisition of innovative medical devices (MDs) and the hospital-based health technology assessment (HB-HTA) pathways in France, an in-depth study based on a quantitative approach is needed. The aim of the present study was to assess through a national survey how HB-HTA is currently implemented in French hospitals and to identify its level of formalization. Methods A quantitative online survey was conducted among hospitals performing HB-HTA in France, with a focus on the acquisition of innovative MDs for individual use. The survey, conducted between March and June 2022, was developed by a scientific board composed of members of the French-speaking Society for HB-HTA. Results Sixty-seven out of 131 surveyed hospitals with HB-HTA activities responded, including 29 university hospitals, 24 nonprofit private hospitals, and 14 local hospitals. Sixty-one respondents (91 percent) reported the existence of a process dedicated to evaluating innovative MDs; of these, 16 declared that their hospitals had a formalized unit with HB-HTA activity. These units were more frequently found in larger hospitals with more than 500 inpatient beds (n = 16, p = 0.0160) and in university hospitals (n = 12, p = 0.0158). No hospital reported any collaboration with HAS, the French national HTA agency. Conclusion A diverse range of HB-HTA organizations with different structural levels exist in France for MD procurement linked to the category of hospitals. The study highlights the need for recognition of HB-HTA activity at the regulatory level in France and for direct collaboration between HTA activities performed at local and national levels.

Mots clés: hospital-based HTA; medical devices; procurement; therapeutic innovations; hospital-based HTA

Domaines: Santé publique et épidémiologie

Tess Martin, Alessandra Guercio, Hélène Besseau, Laure Huot, Pascale Guerre, et al.. Hospital-based health technology assessment of innovative medical devices: insights from a nationwide survey in France. International Journal of Technology Assessment in Health Care, 2023, 39 (1), ⟨10.1017/S0266462323000521⟩. ⟨hal-04229548⟩