A REVIEW OF EFFICIENCY OPINIONS OF FRENCH ‘HAUTE AUTORITE DE SANTE’ (HAS) IN THE ONCOLOGY FIELD
Author(s)
Galasso A1, Medina Diaz A2, Cotte F3, Gaudin A2
1Bristol-Myers Squibb, Princeton, NJ, USA, 2Bristol-Myers Squibb, Rueil-Malmaison, France, 3Bristol-Myers Squibb, RUEIL MALMAISON, France
OBJECTIVES: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
Conference/Value in Health Info
2018-11, ISPOR Europe 2018, Barcelona, Spain
Value in Health, Vol. 21, S3 (October 2018)
Code
HT7
Topic
Economic Evaluation, Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Cost/Cost of Illness/Resource Use Studies, Decision & Deliberative Processes, Pricing Policy & Schemes
Disease
Oncology