OBJECTIVES: After marketing authorization, European HTA agencies may take HRQoL data into account to support reimbursement. We want to explore here how HRQoL have been included into HTA process and what their impact was on reimbursement decisions. METHODS: Initially, we’ve analyzed French HRQoL data on oncology drugs to assess quality, type and impact of these data on the reimbursement opinions made by the French National Autority (HAS). In the second stage, we have performed a qualitative analysis to explore the main similarities and differences across HTA bodies in assessment of HRQoL to support reimbursement. RESULTS: First stage: since 2008, 23 files were assessed by HAS. HRQoL data were available for 11 oncology drugs; for 3 drugs HRQoL data were not taken into account (open trial or missing data). For 5 drugs, no difference in HRQoL (on EORTC QLQ-C30) was observed and in 3 cases, change in HRQoL might have had an impact on final decisions.Second stage: more and more often HRQoL data are included into files submitted for HTA and their quality is gradually improving over time. However, confusion still remains between functional measures and HRQoL. Some countries only consider HRQoL data from randomised clinical trials. For other countries, data from observational studies may also be of interest to provide additional information in real conditions of use. In addition, many countries consider utility measures as one of HRQoL. In all cases, HRQoL remains a secondary endpoint in relative effectiveness assessment (REA) process. CONCLUSIONS: In Europe, the impact of HRQoL on reimbursement decisions could be enhanced if the quality of data increases. Our analysis confirms the interest of the ongoing work on the EUnetHTA guideline that should help assessors of European HTA agencies deal with HRQoL and contribute to the harmonization of HRQoL definitions and use across agencies.