Added benefit of Lundbeck’s Selincro not proven, says IQWiG

The German Institute for Quality and Efficiency in Health Care (IQWiG) examined in a dossier assessment whether Danish CNS specialist Lundbeck’s (LUND: CO) Selincro (nalmefene) offers an added benefit over the appropriate comparator therapy for people with alcohol dependence, drawing a negative conclusion.

According to the findings, such an added benefit is not proven: In its dossier, the drug manufacturer only presented data for an indirect comparison with the appropriate comparator therapy naltrexone. These data are unsuitable, however. In six out of seven studies on naltrexone, patients and treatment goals differ fundamentally from the ones in the nalmefene studies. In the seventh study, naltrexone was temporarily not used in compliance with the approval, and there were no analyses for relevant periods of time in the study.

The conclusion is in contrast to the UK’s equivalent health cost:benefit agency, the National Institute for Health and Care Excellence (NICE), which last month recommended National Health Service use of Selincro to help reduce alcohol dependence (The Pharma Letter November 26).