HT7 - A REVIEW OF EFFICIENCY OPINIONS OF FRENCH ‘HAUTE AUTORITE DE SANTE’ (HAS) IN THE ONCOLOGY FIELD

French health technology assessment requires economic evaluation for drugs for which relative clinical benefit claimed is moderate to important (ASMR III-I) and expenditures expected are significant. A ‘Major’ methodological reservation (MR) from HAS on methodology could affect price negotiations with the Economic Committee (CEPS). Anti-cancer drugs represent almost half of the published efficiency opinions (EOs). The objective was to describe these EOs in terms of methodological reservations and results validity. Analysis was restricted to available EOs in solid tumors and hematology (last access: 30/04/2018). From these EOs, reasons of MR and their classification by HAS (‘Minor’, ‘Important’ or ‘Major’) were collected, as well as incremental cost-effectiveness ratios (ICER) and drivers of uncertainty. Over 21 EOs on anti-cancer drugs, 188 MRs were raised by HAS: 119 ‘Minor’ (61%), 52 ‘Important’ (29%) and 17 ‘Major’ (10%). The median number of MR was 8 per EOs (min-max: 2-17). HAS categories for MR were ‘Modelling’ (40%; including 12 ‘Major’), ‘Cost and health state valuation’ (30%; no ‘Major’), ‘Results presentation and sensitivity analysis’ (16%; including 2 ‘Major’). ‘Major’ and ‘Important’ MRs (N=69) involved the population of analysis (16%), clinical data (16%), survival extrapolation (13%), results presentation (4%) and model validity (1%). In 10 EOs (48%), results were invalidated due to at least one ‘Major’ MR. For the validated ones, the lowest incremental cost-effectiveness ratio (ICER) was €26,088 and the highest was €1,437,359/QALY. Distribution showed a median of €144,784/QALY (Q1–Q3: €106,060–€263,192). Half of validated ICERs were qualified as “very” or “extremely” high with a lowest value of €103,970/QALY. The ICER uncertainty raised by HAS was mainly related to treatment duration and utility inputs. HAS invalidated near half of the economic evaluations of anti-cancer drugs. Within validated ICERs, we observed an extensive range of values varying 54-fold. Three quarters of ICERs were over roughly €100,000/QALY.