OBJECTIVES: In Europe, more and more cancer therapies obtain a marketing authorization (MA) based on non-comparative clinical studies. These data have to be submitted to HAS, the HTA body in charge of assessing the reimbursement of medicines in France. The aim of the present study was to analyze the HAS’s opinions for the onco-hematology medicines which clinical trials were not randomized.

METHODS: The HAS’s recommendations published between January 2013 and June 2017 were selected from Prismaccess® database. Regulatory, clinical and evaluation data, such as the SMR (actual benefit) and the ASMR (clinical added value) which influence the reimbursement and the price, were collected to conduct a quantitative descriptive analysis of the HAS’s assessment.

RESULTS: CONCLUSIONS: The distribution of ASMR appears similar whether the clinical data is based on comparative studies or not: 29% of ASMR I to III, 32% of ASMR IV, 39% of ASMR V were granted for all the oncology drugs between 2013-2017.