PCN100 HEALTH-ECONOMIC EVALUATION OF LUNG CANCER DRUGS: DO S AND DON TS IN FRANCE

Abstract

Since the release of the French decree on October 2nd, 2012, requiring economic evaluation for innovant drugs, 97 efficiency opinions were published by the French Health Authority “HAS/CEESP”. Among them, eight dealt with lung cancer. Objectives were to compare the choices made by pharmaceutical manufacturers and the objections raised by the HAS/CEESP, to identify areas of improvement in health economic evaluation of lung cancer in France. We analyzed the eight opinions which evaluated five drugs: alectinib, atezolizumab, nivolumab, osimertinib and pembrolizumab. Evaluation was conducted by the HAS/CEESP between December 2015 and October 2018. In each of the eight opinions, the methodological choices were described and the acceptability level was analysed. Some methodological settings were more frequently accepted and raised no objections as they abided by the HAS recommendations: time horizon, perspective, discount rate and choice of comparators. Other structural choices were more criticized: adoption of a 3-state-partitioned survival model raised an important objection as it simplifies too much the disease management, although considered relevant in lung cancer. Extrapolation of clinical trial data led to objections in all the dossiers. Simulated population was not accepted in two different dossiers requiring confirmation by real world data and utility data used led to several objections (minor/important) with the need to improve the methodological quality of their generation. The HAS/CEESP concluded that: two dossiers did not demonstrate the efficiency; intervention was not efficient in two other dossiers; and for the four remaining dossiers, Incremental Cost-Effectiveness Ratios (ICERs) were between 105,000 and 226,000 €/QALY. These levels of ICERs were qualified as high or very high despite the lack of a willingness to pay threshold in France. The analysis of the objections allowed to highlight the parameters on which pharmaceutical manufacturers need to be more robust and rigorous, for cost effectiveness analysis and budget impact analysis.