A Trial-Based Predictive Microsimulation Assessing the Public Health ă Benefits of Nalmefene and Psychosocial Support for the Reduction of ă Alcohol Consumption in Alcohol Dependence

Background Alcohol dependence causes considerable harm to patients. ă Treatment with nalmefene, aiming to reduce consumption rather than ă maintain complete abstinence, has been licensed based on trials ă demonstrating a reduction in total alcohol consumption and heavy ă drinking days. Relating these trial outcomes to harmful events avoided ă is important to demonstrate the clinical relevance of nalmefene ă treatment. ă Methods A predictive microsimulation model was developed to compare ă nalmefene plus brief psychosocial intervention (BRENDA) versus placebo ă plus BRENDA for the treatment of patients with alcohol dependence and a ă high or very high drinking risk level based on three pooled clinical ă trials. The model simulated patterns and level of alcohol consumption, ă day-by-day, for 12 months, to estimate the occurrence of ă alcohol-attributable diseases, injuries and deaths; assessing the ă clinical relevance of reducing alcohol consumption with treatment. ă Results The microsimulation model predicted that, in a cohort of 100,000 ă patients, 971 (95 % confidence interval [CI] 904-1038) ă alcohol-attributable diseases and injuries and 133 (95 % CI 117-150) ă deaths would be avoided with nalmefene versus placebo. This level of ă benefit has been considered clinically relevant by the European ă Medicines Agency. ă Conclusions This microsimulation model supports the clinical relevance ă of the reduction in alcohol consumption, and has estimated the extent of ă the public health benefit of treatment with nalmefene in patients with ă alcohol dependence and a high or very high drinking risk level.