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

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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.

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Notes

  1. BRENDA therapy consists of six components: Biopsychosocial evaluation, Report to the patient on assessment, Empathic understanding of the patient’s situation, Needs collaboratively identified by the patients and treatment provider, Direct advice to the patient on how to meet those needs, and Assess reaction of the patient to advice and adjust as necessary for best care [16].

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Acknowledgments

Editorial and medical writing support was provided by Stephen Montgomery, Sara Steeves and Saoirse Leonard from Costello Medical Consulting Ltd, Cambridge, UK. This support was funded by Lundbeck SAS.

Author contributions

All authors were involved in the conception and design of all or some component(s) of the research. Acquisition of data was carried out by PL, AM, NR, OC, SA and JR. Modelling and statistical analysis was performed by PL, AM, NR, OC, SA, and JR. All authors participated at all or some step(s) of the review, analysis and interpretation of the outcomes. PL was responsible for development of the manuscript. All authors reviewed and commented on the draft manuscript, and reviewed its intellectual content. All authors approved the final version of the manuscript. PL will act as the overall guarantor.

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Authors and Affiliations

  1. Social and Epidemiological Research Department, Centre for Addiction and Mental Health, Toronto, M5S 2S1, Canada

    Philippe Laramée & Jürgen Rehm

  2. Health Economics and Outcomes Research, Creativ-Ceutical, 75008, Paris, France

    Aurélie Millier, Olivier Cristeau & Samuel Aballéa

  3. Global Analytics, Lundbeck SAS, 92445, Issy-les-Moulineaux Cedex, France

    Nora Rahhali

  4. Global Outcomes Research, Lundbeck SAS, 92445, Issy-les-Moulineaux Cedex, France

    Clément François & Ylana Chalem

  5. Laboratoire de Santé Publique, Faculté de Médecine, Université de la Méditerranée, 13385, Marseille, France

    Mondher Toumi

  6. Dalla Lana School of Public Health, University of Toronto, Toronto, M5T 3M7, Canada

    Jürgen Rehm

  7. Klinische Psychologie und Psychotherapie, TU Dresden, 01187, Dresden, Germany

    Jürgen Rehm

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  1. Philippe Laramée
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Corresponding author

Correspondence to Philippe Laramée.

Ethics declarations

NR and CF are employees of Lundbeck SAS, who funded this work. PL and YC were employees of Lundbeck SAS at the time of the development of this work. AM, OC and SA are employees of Creativ-Ceutical, who were contracted by Lundbeck SAS to undertake some of the work described in this manuscript. JR has received grants, consulting fees/honoraria, travel support and payment for lectures from Lundbeck, outside the work presented in this manuscript. MT declares no conflicts of interest.

This work was funded by Lundbeck SAS. The views presented in this paper are those of the authors, and do not necessarily reflect those of the study funders. Editorial and medical writing support was provided by Costello Medical Consulting Ltd, and was funded by Lundbeck SAS.

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Laramée, P., Millier, A., Rahhali, N. et al. A Trial-Based Predictive Microsimulation Assessing the Public Health Benefits of Nalmefene and Psychosocial Support for the Reduction of Alcohol Consumption in Alcohol Dependence. Appl Health Econ Health Policy 14, 493–505 (2016). https://doi.org/10.1007/s40258-016-0248-z

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