Regulatory Focus™ > News Articles > Germany’s IQWiG Declines to Recommend Shire’s Elvanse for ADHD

Germany’s IQWiG Declines to Recommend Shire’s Elvanse for ADHD

Posted 05 September 2013 | By

Germany's Institute for Quality and Efficiency in Health Care (IQWiG) has issued a report declining to recommend Shire's Elvanse (Lisdexamfetamine dimesylate) for the treatment of attention deficit/hyperactivity disorder (ADHD). 

The drug has been approved in Germany since March 2013 as part of a comprehensive ADHD treatment program in children aged six years and over when response to previous treatment with the drug methylphenidate was inadequate.  The basis for IQWiG's finding of no added benefit of the drug versus the comparator therapy was apparently the fact that the manufacturer did not present any relevant studies.

In the only study presented, both lisdexamfetamine and the comparator atomoxetine were not evaluated as part of a comprehensive treatment program, which was not consistent with the terms of the drugs' approval. IQWiG also found that the duration of the study - nine weeks - was too short to draw useful conclusions about a chronic, long term condition.

IQWiG's recommendation is part of the overall procedure for early benefit assessments supervised by Germany's Gemeinsamer Bundesausschuss (G-BA). After publication of the manufacturer's dossier and IQWiG's assessment, the G-BA conducts a commenting procedure, which may provide further information and result in a change to the benefit assessment. The G-BA makes the final determination on the extent of a product's added benefit.

IQWiG Report

Read all Breaking News from RegLink

Tags: IQWiG, Germany, Shire

Regulatory Focus newsletters

All the biggest regulatory news and happenings.