OBJECTIVES : The Transparency Committee (TC) of the French HTA body assess the clinical added value (CAV) of drugs to provide a recommendation to the Ministry of health for reimbursement and pricing decisions. TC’s methodological requirements for appropriate data collections on Health-Related Quality of Life (HRQL) are presented in its guidelines. Our purpose was to analyse how the TC effectively considers HRQL data in its opinions.

METHODS : We analysed clinical trial (CTs) designs and all the TC conclusions on the clinical added value (CAV) of new drug published in 2018. We awarded 1 point for each methodological TC requirement satisfied: randomized double-blind trial, at least one HRQL instrument as key outcome including management of multiple analysis, at least one disease-specific HRQL instrument and clinically relevant minimum difference defined in the protocol for at least one of them, the score ranging from 0 to 4.

RESULTS : The 61 opinions included, contained 152 CTs of which 64 (42%) collected HRQL data. HRQL data were described in all opinion with a score of 3 or 4 (12/64; 7/64), whereas HRQL data were not described in opinions for any of the 10/64 CTs with a score of 0, as well as 12/16 and 11/19 trials with a score of 1 and 2, respectively.

Among 51 CAV analysed, HRQL positive mentions lead to highly positive conclusions (CAV II for 1/1, CAV III for 1/8). When there were only negative critics, the CAV was low (IV 5/10, V 12/32).

CONCLUSIONS : HRQL data were provided in less than 50% of CTs submitted to the TC in 2018. A minority of them (30%) met TC’s requirements in terms of HRQL data collection methodology. When these recommendations were met, HRQL contributed to the evaluation. There may be a link between HRQL positive mentions and higher level of CAV to be further explored.