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NICE ‘yes’ for Selincro

Published on 10/07/14 at 08:08am
selincro image

Lundbeck has received a lift from UK drugs pricing watchdog NICE as it has recommended the firm’s alcohol dependency pill Selincro for use on the NHS.

Taken once a day, Selincro (nalmefene) is designed to reduce the craving for drink in 600,000 alcoholics who NICE estimates should have access to the drug.

It costs £42.42 per pack of 14 tablets, and a consultation is now open until 29 July before final guidance is issued which is expected to happen in November.

Alcohol abuse is a major headache for governments, leading to crime and antisocial behaviour as well as ill-health through medical complications such as liver disease. 

Dependence is a brain disease, with the level of consumption strongly correlated with the risk for long-term morbidity and mortality – and the UK’s Department of Health has consistently warned that many people are unaware they drink at harmful levels.

Approved in Europe 18 months ago, Selincro has reduced alcohol consumption by nearly two thirds after six months in trials involving patients who are high-risk drinkers.

The dual-acting opioid system modulator acts on the brain’s motivational system and is thought to reduce the positive effects of alcohol - therefore reducing the urge to drink.

The European Commission decision was based on three randomised, double-blind, placebo-controlled trials in 2,000 alcohol-dependent patients.

Those taking the drug showed a 40% drop in total consumption within the first month and approximately 60% by six months - an average reduction equal to nearly one bottle of wine per day.

“Alcohol addiction is a serious issue for so many,” says Carole Longson, director of NICE’s Health Technology Evaluation Centre.

“Those who could be prescribed nalmefene have already taken the first big steps in their fight against their addiction by visiting their doctor and taking part in therapy programmes. We are pleased to be able to make draft recommendations which can support people in their fight,” she adds.

It will be available to people who are heavy drinkers but not those who require immediate detoxification: NICE believes Lundbeck’s drug “is clinically and cost-effective for the NHS compared with psychosocial interventions alone”.

Doctors should prescribe ‘continuous’ psychosocial support - focussed on treatment adherence and reducing alcohol consumption - along with the medication, NICE says.

Treatment should only begin if patients continue to have a ‘high drinking risk level’ a fortnight after the doctor has first seen them.

NICE’s technology appraisal guidance is a landmark because it is the first whose recommendations cover both health and social care, since the formalisation of NICE in its latest guise and the Health and Social Care Information Centre Regulations 2013.

Lundbeck has argued there is a significant unmet need because alcohol dependence is under diagnosed: it believes 14 million people in Europe have this addiction although more than 90% of them do not receive treatment at present.

The Danish manufacturer says the trials also suggested Selincro’s efficacy lasted beyond six months and it was generally well tolerated with mild to moderate adverse effects.

Adam Hill

 

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