ABSTRACT
The cost-effectiveness of Cerebrolysin as an add-on therapy for moderate-severe acute ischemic stroke is a topic that remains understudied. This study aims to address this gap by performing a comprehensive cost-utility analysis using both deterministic and probabilistic methods from a payer perspective and within the Romanian inpatient care setting. Quality-adjusted life years (QALYs) were calculated using partial individual patient data from the 2016 Cerebrolysin and Recovery After Stroke (CARS) trial, utilizing three different health state valuation models. Cost data was extracted from actual acute care costs reported by Romanian public hospitals for reimbursement purposes for patients included in the CARS study. Incremental cost-effectiveness ratios were calculated for each treatment arm for the duration of the clinical trial. Deterministic analysis based on sample mean values indicates Cerebrolysin would be cost-effective at a threshold between roughly 18.8 and 29.9 thousand EUR, depending on valuation techniques. Probabilistic sensitivity analysis results indicate an 80% chance probability of cost-effectiveness of Cerebrolysin as an add-on therapy for acute ischemic stroke, considering a willingness-to-pay threshold of 50,000 EUR in a 90-day timeframe after stroke. Further economic evaluations of Cerebrolysin are needed to strengthen these findings, covering a timeframe of at least 12 months after the acute incident, which would account for treatment effects spanning beyond the first 90 days after ischemic stroke. These should be conducted to determine its cost-effectiveness under various care settings and patient pathways. Most importantly, modelling techniques are needed to answer important questions such as the estimates of population gain in QALYs after acute administration of Cerebrolysin and the potential offsetting of direct medical costs as a result of administering the intervention.