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

Philippe Laramée (), Aurélie Millier, Nora Rahhali, Olivier Cristeau, Samuel Aballéa, Clément François, Ylana Chalem, Mondher Toumi and Jürgen Rehm
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Philippe Laramée: Centre for Addiction and Mental Health
Aurélie Millier: Creativ-Ceutical
Nora Rahhali: Lundbeck SAS
Olivier Cristeau: Creativ-Ceutical
Samuel Aballéa: Creativ-Ceutical
Clément François: Lundbeck SAS
Ylana Chalem: Lundbeck SAS
Mondher Toumi: Université de la Méditerranée
Jürgen Rehm: Centre for Addiction and Mental Health

Applied Health Economics and Health Policy, 2016, vol. 14, issue 4, No 10, 493-505

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

Date: 2016
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DOI: 10.1007/s40258-016-0248-z

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