OBJECTIVES: Quality of life (QoL) is often involved in the evaluation of therapy but not sufficiently exposed. Indeed, between January 1^st, 2018 and March 12^th, 2020, in 196 Transparency Committee (TC) opinions for first or subsequent indications, only 39% described QoL data. The objective was to analyse the frequency of quality of life data in TC opinions as well as the impact on drug assessment.

METHODS: Using the Prismaccess® database, TC opinions for first or subsequent indications since January 1, 2018 were identified. Dossier submissions which mentioned QoL in the study methodology or results were included in the analysis. Assessments regarding line extensions, changes in indication and generics were excluded.

RESULTS: Of the 196 opinions analysed, 116 included QoL data provided by the manufacturer. The TC describes this data in 65.5% of the cases and considered this data in the ASMR in 15.5% of these cases. The main reasons for not considering the submitted QoL data were: exploratory analysis (49% of cases) and failure to manage the multiplicity of analyses (34% of cases). From a total of 196 opinions regarding first or subsequent indications, only 9% were influenced by QoL data.

CONCLUSIONS: Recently, the TC commented on the standard of QoL data submitted by manufacturers, criticizing the absence or low quality of evidence, particularly in files submitted for re-evaluation when real life date must confirm QoL data. This type of data could be appreciated more but needs to be better optimised to have a real influence on the TC assessment.