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.
ABSTRACT
Cognitive impairment is one of the most important problems of modern health care. Currently, according to WHO, more than 55 million people worldwide are living with dementia. Dementia is one of the leading causes of disability and addiction among older people worldwide. Even more significant is the number of patients with mild cognitive impairment who have an increased risk of progression to dementia compared to people of the same age without cognitive impairment. The number of patients with cognitive impairment has also increased due to the consequences of COVID-19. It is necessary to use drugs that not only improve cognitive functions, but also slow down their progression. One of these drugs is cerebrolysin, the effectiveness of which has been confirmed in various types of cognitive impairment. Cerebrolysin, being a preparation from the brain of a pig, belongs to the group of biological drugs. In the production of Cerebrolysin very strict measures are taken to comply with the technology, which ensures the quality and identity of the product from batch to batch. The experience of many years of clinical use of Cerebrolysin testifies not only to its high efficiency, but also to its safety. It should be taken into account that similar substances can be developed in relation to biological products - biosimilars or biosimilars, which can be considered comparable only in case of equivalent pharmacokinetic parameters, efficacy and safety.
Subject(s)
Alzheimer Disease , Biosimilar Pharmaceuticals , COVID-19 , Cognitive Dysfunction , Dementia , Animals , Swine , Biosimilar Pharmaceuticals/therapeutic use , Cognitive Dysfunction/drug therapy , Dementia/drug therapy , Alzheimer Disease/drug therapyABSTRACT
We performed a systematic search and meta-analysis of available literature to determine the safety profile of Cerebrolysin in acute ischemic stroke, filling existing safety information gaps and inconsistent results. We searched EMBASE, PubMed, and Cochrane Databases of Systematic Reviews and Clinical Trials up to the end of February 2021. Data collection and analysis were conducted using methods described in the Cochrane Handbook for Systematic Reviews of Interventions. All safety outcomes were analyzed based on risk ratios (RR) and their 95% confidence intervals. The meta-analysis pooled 2202 patients from twelve randomized clinical trials, registering non-statistically significant (p > 0.05) differences between Cerebrolysin and placebo throughout main and subgroup analyses. The lowest rate of Serious Adverse Events (SAE), as compared to placebo, was observed for the highest dose of Cerebrolysin (50 mL), highlighting a moderate reduction (RR = 0.6). We observed a tendency of superiority of Cerebrolysin regarding SAE in high dose treatment courses for moderate-severe ischemic stroke, suggesting some effect of the agent against adverse events. This comprehensive safety meta-analysis confirms the safety profile for patients treated with Cerebrolysin after acute ischemic stroke, as compared to placebo.
ABSTRACT
Stroke is one of the most common neurological diseases with high morbidity, disability and mortality, which is an urgent medical and social problem. Clinically, stroke, depending on its nature and location, causes a wide range of neurological disorders, including movement disorders, as well as a variety of cognitive and neuropsychiatric disorders. There is an emerging need for new approaches to manage patients with cerebrovascular diseases during the pandemic of COVID-19. Rehabilitation measures for the correction of motor and cognitive impairments are very diverse. The use of drugs stimulating the production of neurotrophic factors is considered as a promising direction of pharmacotherapy. Cerebrolysin promotes significant regression of motor and cognitive impairments in the acute and recovery period of ischemic stroke. Based on the data of clinical studies, Cerebrolysin is included in the guidelines for the rehabilitation of patients with stroke in Canada and Germany.