Nalmefene for Reducing Alcohol Consumption in People with Alcohol Dependence: An Evidence Review Group Perspective of a NICE Single Technology Appraisal

PharmacoEconomics

Volumn 33, Issue 8, 2015, Pages 833-847

  Stevenson, Matt ^a   Pandor, Abdullah ^a   Stevens, John W ^a   Rawdin, Andrew ^a   Rice, Peter ^b   Thompson, Jez ^c   Morgan, Marsha Y ^d  

^a UNIVERSITY OF SHEFFIELD   (United Kingdom)

^b NHS TAYSIDE   (United Kingdom)

^c Lifeline Project   (United Kingdom)

^d UNIVERSITY COLLEGE LONDON   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ALCOHOL; NALMEFENE; PLACEBO; NALTREXONE; NARCOTIC ANTAGONIST;

ALCOHOL CONSUMPTION; ALCOHOLISM; CLINICAL EFFECTIVENESS; CLINICAL PRACTICE; COMPARATIVE STUDY; COST EFFECTIVENESS ANALYSIS; DRINKING; DRUG MARKETING; ECONOMIC EVALUATION; EVALUATION STUDY; HUMAN; INTERVENTION STUDY; PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; PSYCHOSOCIAL CARE; QUALITY ADJUSTED LIFE YEAR; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; TREATMENT DURATION; UNITED KINGDOM; WITHDRAWAL SYNDROME; ADULT; ANALOGS AND DERIVATIVES; COST BENEFIT ANALYSIS; DRINKING BEHAVIOR; ECONOMICS; MULTIMODALITY CANCER THERAPY; PREVENTION AND CONTROL; SOCIAL SUPPORT;

ADULT; ALCOHOL DRINKING; ALCOHOLISM; COMBINED MODALITY THERAPY; COST-BENEFIT ANALYSIS; HUMANS; NALTREXONE; NARCOTIC ANTAGONISTS; QUALITY-ADJUSTED LIFE YEARS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SOCIAL SUPPORT;

EID: 84938414583     PISSN: 11707690     EISSN: 11792027     Source Type: Journal    
DOI: 10.1007/s40273-015-0272-0     Document Type: Review

References (41)

1. National Institute for Health and Care Excellence (NICE). Guide to the processes of technology appraisal. London: National Institute for Health and Care Excellence; 2014. https://www.nice.org.uk/article/pmg19/resources/non-guidance-guide-to-the-processes-of-technology-appraisal-pdf. Accessed 23 Mar 2015.
2. Stevenson M, Pandor A, Stevens J, Rawdin A, Wong R, Morgan MY, et al. Nalmefene for reducing alcohol consumption in people with alcohol dependence: a single technology appraisal. Sheffield: School of Health and Related Research (ScHARR); 2014.
3. National Institute for Health and Care Excellence (NICE). Nalmefene for reducing alcohol consumption in people with alcohol dependence: evaluation report. NICE; 2014.
4. National Collaborating Centre for Mental Health. Alcohol-use Disorders. The NICE Guideline on Diagnosis, assessment and management of harmful drinking and alcohol dependence. National Clinical Practice Guideline 115. NICE; 2011.
5. American Psychiatric Association. Diagnostic and statistical manual of mental disorders: DSM-IV-TR. Washington, DC: American Psychiatric Association; 2000.
6. World Health Organisation (WHO). The ICD-10 classification of mental and behavioural disorders: clinical descriptions and diagnostic guidelines. Geneva: World Health Organisation; 1992.
7. Burge SK, Schneider FD. Alcohol-related problems: recognition and intervention. Am Fam Phys. 1999;59:361–70.
8. Leshner AI. Addiction is a brain disease, and it matters. Science. 1997;278:45–7.
9. World Health Organisation (WHO). International Guide for monitoring alcohol consumption and related harm. Geneva: World Health Organisation; 2000.
10. Drummond C, Oyefeso A, Phillips T, Cheeta S, Deluca P, Perryman K, et al. Alcohol needs assessment research project (ANARP). London: Department of Health; 2005.
11. Fuller E, Jotangia D, Farrell M. Alcohol misuse and dependence. Adult psychiatric morbidity in England, 2007. Results of a household survey. Leeds: NHS Information Centre for Health and Social Care; 2009.
12. McManus S, Meltzer H, Brugha T, Bebbington P, Jenkins R. Adult psychiatric morbidity in England, 2007: results of a household survey. Leeds: NHS Information Centre for Health and Social care; 2009.
13. Alcohol Concern. Statistics on alcohol. London: Alcohol Concern; 2014.
14. National Institute for Health and Care Excellence (NICE). ESNM29: Alcohol dependence: nalmefene. National Institute for Health and Care Excellence (NICE). London: NICE; 2013.
15. Lundbeck A. Nalmefene (Selincro) [summary of product characteristics]. www.ema-europa.eu. 2013. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002583/WC500140255.pdf. Accessed 1 Apr 2014.
16. Lundbeck. Clinical study report 12014A. Lundbeck; 2012.
17. Mann K, Bladstrom A, Torup L, Gual A, van den Brink W. Extending the treatment options in alcohol dependence: a randomized controlled study of as-needed nalmefene. Biol Psychiatry. 2013;73:706–13.
18. van den Brink W, Aubin HJ, Bladstrom A, Torup L, Gual A, Mann K. Efficacy of as-needed nalmefene in alcohol-dependent patients with at least a high drinking risk level: results from a subgroup analysis of two randomized controlled 6-month studies. Alcohol Alcohol. 2013;48:570–8.
19. Lundbeck Clinical study report 12023A. Lundbeck; 2012.
20. Gual A, He Y, Torup L, van den Brink W, Mann K. A randomised, double-blind, placebo-controlled, efficacy study of nalmefene, as-needed use, in patients with alcohol dependence. Eur Neuropsychopharmacol. 2013;23:1432–42.
21. Lundbeck. Clinical study report 12013A. Lundbeck; 2012.
22. van den Brink W, Sorensen P, Torup L, Gual A. Long-term efficacy, tolerability, and safety of nalmefene as-needed in alcohol-dependence: a randomised, double-blind, placebo-controlled study. Presented at the 35th Annual Scientific Meeting of the Research Society on Alcoholism; San Francisco, California, USA 23–27 June 2012.
23. van den Brink W, Sorensen P, Torup L, Mann K, Gual A, The SENSE Study Group. Long-term efficacy, tolerability and safety of nalmefene as-needed in patients with alcohol dependence: a 1-year, randomised controlled study. J Psychopharmacol. 2014;28:733–44.
24. European Medicines Agency (EMA). Selincro (nalmefene) assessment report. EMA/78844/2013. London: EMA; 2012.
25. Heinala P, Alho H, Kiianmaa K, Lonnqvist J, Kuoppasalmi K, Sinclair JD. Targeted use of naltrexone without prior detoxification in the treatment of alcohol dependence: a factorial double-blind, placebo-controlled trial. J Clin Psychopharmacol. 2001;21:287–92.
26. Hernandez-Avila C, Song C, Kuo L, Tennen H, Armeli S, Kranzler H. Targeted versus daily naltrexone: secondary analysis of effects on average daily drinking. Alcohol Clin Exp Res. 2006;30:860–5.
27. Kranzler H, Armeli S, Tennen H, Blomqvist O, Oncken C, Petry N, et al. Targeted naltrexone for early problem drinkers. J Clin Psychopharmacol. 2003;23:294–304.
28. Kranzler H, Tennen H, Armeli S, Chan G, Covault J, Arias A, et al. Targeted naltrexone for problem drinkers. J Clin Psychopharmacol. 2009;29:350–7.
29. Brookes S, Whitley E, Peters T, Mulheran P, Egger M, Davey Smith G. Subgroup analyses in randomised controlled trials: quantifying the risks of false-positives and false-negatives. Health Technol Assess. 2001;5:1–56.
30. Sun X, Briel M, Busse J, You J, Aki E, Mejza F, et al. Credibility of claims of subgroup effects in randomised controlled trials: systematic review. BMJ. 2012;344:e1553.
31. Babor T, Steinber K, Anton R, et al. Talk is cheap: measuring drinking outcomes in clinical trials. J Stud Alcohol. 2000;6:55–63.
32. Maisto S, Sobell M, Mitch Cooper A, Sobell L. Test–retest reliability of retrospective self-reports in three populations of alcohol abusers. J Behav Assess. 1979;1:315–26.
33. Maisto S, Conigliaro J, Gordon A, McGinnis K, Justice A. An experimental study of the agreement of self-administration and telephone administration of the Timeline Followback interview. J Stud Alcohol Drugs. 2008;69:468–71.
34. Sobell L, Sobell M. Alcohol timeline followback (TLFB). Arlington: American Psychiatric Publishing Inc; 2008.
35. European Medicines Agency (EMA). Guideline on the development of medicinal products for the treatment of alcohol dependence. London: EMA; 2010.
36. Taylor C, Brown D, Duckitt A, Edwards G, Oppenheimer E, et al. Patterns of outcome: drinking histories over ten years among a group of alcoholics. Br J Addict. 1985;80:45–50.
37. Anderson P, Baumberg B. Alcohol in Europe: a public health perspective. London: Institute of Alcohol Studies; 2006.
38. The University of Sheffield. Modelling to assess the effectiveness and cost-effectiveness of public health related strategies and interventions to reduce alcohol attributable harm in England using the Sheffield Alcohol Policy Model, version 2.0. NICE; 2009.
39. National Institute for Health and Care Excellence (NICE). Alcohol-use disorders: preventing harmful drinking (PH 24). London: NICE; 2010.
40. Wallace P, Coste F, Chalem Y, François C. Naturalistic disease management study of patients with alcohol dependence in primary care settings in the UK (STREAM). Poster presented at ISPOR annual European conference, Dublin, Ireland 2013.
41. National Institute for Health and Care Excellence (NICE). Alcohol dependence—nalmefene [ID660]: final appraisal determination document. London: NICE; 2014.