Manufacturer Engagement and Revision Outcomes in the “Phase Contradictoire” of the HTA Process in France: A Descriptive Analysis

OBJECTIVES: The "Phase Contradictoire" in France is crucial to the Health Technology Assessment (HTA) process, allowing manufacturers to request a hearing session with the Transparency Commission (TC) to discuss the draft assessment "Projet d’Avis" before the final report is issued. During the hearing, manufacturers are granted 15 minutes to adduce arguments in favor of draft assessment revision.

METHODS: Publicly available TC meeting transcripts on the Haute Autorité de Santé (HAS) website were screened to identify sessions corresponding to hearings. The researchers then examined the manufacturer's motive for revision and the outcome of the hearing.

RESULTS: In total, 1059 TC reports with published transcripts were identified between 2018 and 2022. Manufacturers requested a hearing in 15% of cases, with the majority (90.4%) seeking revision of the Clinical Benefit (SMR) and/or the Clinical Added Value (ASMR) level, followed by Public Health Impact (8.2%) and Clinical Comparators (5.7%). The success rate of manufacturers in overturning the initial assessment was 28%. Success rate was slightly higher for SMR revision compared to ASMR (30.4% vs. 24.3%). A draft assessment of Insufficient or weak to moderate SMR was upgraded in 25% and 38% of cases, respectively. Most ASMR hearings were about upgrading ASMR V (67%) or ASMR IV (31.7%), with a success rate of 25.4% and 23%, respectively.

CONCLUSIONS: Manufacturers appear to rarely request a hearing with the TC. The relatively low success rate of hearing sessions reveals consistency in the assessment process and value perception by the TC members. Nonetheless it is worth noting that unlike appeals made to the National Institute for Clinical Excellence (NICE), hearings in France take place with the same TC members who issued the draft assessment.