Place of patient-reported outcomes &amp; experiences measurements (PROMS/PREMS) in the assessment and pricing of Health technologies in France

Roussel, Christophe; Chassany, Olivier; Durand‐Zaleski, Isabelle; Josseran, Anne; Alter, Lise; Auquier, Pascal; Bourguignon, Sandrine; Cachoux, Joude; Desforges, Claire; Fernandez, Judith; Gaudin, Anne-Françoise; Germe, Anne-Françoise; Haenel, Estelle; Olivier, Patrick; Maillard, Nicolas; Naïditch, Nicolas; Nguyen, Thao; Péan, Clarisse; Rumeau-Pichon, Catherine; Sales, Jean-Patrick; Schmidely, N.; Tuppin, Philippe; Vray, Muriel

doi:10.1016/j.therap.2022.01.016

Cited by 8 publications

(3 citation statements)

References 14 publications

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“…Some sources highlight the absence of clear methodologies and regulatory mechanisms guiding the integration of patient data in HTA processes (22). In response to this challenge, a French working group convened in 2021 to address the role of Patient-Reported Outcome & Experiences Measurements (PROMs/PREMs) in the evaluation and pricing of health technologies in France (23). This working group provided recommendations aimed at improving the collection and utilization of PROMs/PREMs data, in HTA and HB-HTA French processes.…”

Section: Discussionmentioning

confidence: 99%

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

Martin,

Guercio,

Besseau

et al. 2023

Int J Technol Assess Health Care

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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.

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Section: Discussionmentioning

confidence: 99%

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

Martin,

Guercio,

Besseau

et al. 2023

Int J Technol Assess Health Care

View full text Add to dashboard Cite

show abstract

“…For a product that is a fourth-line treatment in oncology, that is, after all other treatments have failed? These examples and also the results of the GIENS workshop 2021 16 provide a basis for questioning a universal threshold for all PRO measures.…”

Section: Patient-centered Perspectivementioning

confidence: 91%

“…19 When patient experience data are included in the drug label based upon a rigorous review by health authorities, we advocate to consider respective methods, for example, to use the same definition of a PRO response for HTA assessments as is customary such as in France. 16 Supplementary analyses can be provided to deal with uncertainties.…”

Section: Regulatory Perspectivementioning

confidence: 99%