Is There a Threshold in France?: First Exhaustive Review of Published Health-Economic Appraisals by the Haute Autorite De Sante (HAS), (French National Authority for Health)

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.

Cost-Utility Analysis of STN1013001, a Latanoprost Cationic Emulsion, versus Other Latanoprost Formulations (Latanoprost) in Open-Angle Glaucoma or Ocular Hypertension and Ocular Surface Disease in France

“…e ICUR of €21.26 per incremental QALY gained, resulting from an incremental QALY gain of 0.348 at an incremental cost of €7.39 for STN1013001, well below the lower limit of the unofficial WTP range (€30,000-€50,000) proposed for France [45] (Table 2).…”

“…Probabilistic sensitivity analysis shows that STN1013001 has a 49.12% probability of being strongly dominant (i.e., less costly and more effective) versus Latanoprost (Figure 4). e probability that STN1013001 is cost-effective versus the lower bound of the last available unofficial acceptability range for QALY gained (€30,000-€50,000) suggested for the French health system equals 100.00% [45] (Figure 5).…”

“…CEAC and CEAF show the probability for STN1013001 to be cost-effective or optimal at the entire informal acceptability range of €30,000-€50,000 per QALY gained [45] to be 100.00%.…”

Cost-effectiveness of Lutetium [177Lu] oxodotreotide versus best supportive care with octreotide in patients with midgut neuroendocrine tumors in France

“…In France, there is no formal willingness-to-pay threshold 31 , with the value of new interventions being considered on an individual basis. However, willingness-to-pay thresholds are often considered to be higher for new interventions used in oncology, end-of-life care or for orphan diseases, for which treatment options are often limited and there is typically a high unmet clinical need.…”

Conflicting findings between the Mitra-Fr and the Coapt trials: Implications regarding the cost-effectiveness of percutaneous repair for heart failure patients with severe secondary mitral regurgitation

“…A 2.5% annual discount was applied for both costs and benefits [21]. Reimbursement thresholds vary within and between states [22] and Cartier-Bechu et al 2016 [23] were unable to deduce a reimbursement threshold that operated in France; we therefore arbitrarily adopted €50,000/QALY as the willingness-to-pay (WTP) threshold.…”