Products Outside the General Reimbursement Systems – A Swedish and Norwegian Comparison

Abstract

Objectives: To assess the publicly available French health-economic opinions, an exhaustive retrospective analysis was conducted on Incremental Cost-Effectiveness Ratios (ICERs) and methodological objections delivered by the HAS. MethOds: An electronic database was built to extract and analyze all health-economic relevant information from the publicly available opinions published by the HAS/CEESP (Comité d'Evaluation Economique et Santé Publique) on their website. This database was structured based on the following items: structural choices, results, sensitivity analysis, cost-effectiveness ratio and methodological objections. Our analysis was performed from December, 2014 (published date of the first economic opinion) until June 8th, 2016. A hypothetical threshold of 50,000 euros per Quality Adjusted Life Year gained (€ /QALY) was used for the ICER analysis cut-off. Results: Currently, 18 health-economic opinions have been published in which: 16 studies express results in cost per QALY. Among these studies, 4 were completely invalidated, leading to the exclusion of the corresponding ICERs. These exclusions were due to various reasons such as: lack of uncertainty investigation, wrong comparator and weakness of input data. From a collective perspective, the ICERs ranged from 5,866€ /QALY up to 191,661€ /QALY. Half of them (6/12) were below the hypothetical threshold of 50,000 € /QALY. cOnclusiOns: From this wide spread of ICERs, it clearly indicates that at this stage, no threshold could be deducted for France. 6 drugs reported an ICER superior to 50,000€ /QALY, and finally access to the reimbursement system. Two products did not obtain the reimbursement in France with ICERs inferior to 30,000€ /QALY (respectively 24,413€ /QALY and 29,797€ /QALY), due to unsatisfactory safety data. To conclude, the willingness to pay of the French Health Care system is not limited by any threshold. The health-economic appraisal on the methodology plays an important role in the pricing negotiations.