German HTA slams cagey Chiesi disclosure on Glybera bad news
This article was originally published in Scrip
Executive Summary
The G-BA, the body in charge of Germany's AMNOG health technology appraisals, is "bewildered" that it learned about a potentially damming EMA risk benefit report on Chiesi/uniQure's gene therapy Glybera from the US Security and Exchange Commission and not the company responsible for the drug. The G-BA was due to publish a resolution declaring that the orphan drug has additional therapeutic value on 16 April, but has instead decided to suspend the process.
You may also be interested in...
Lack Of Industry Involvement In EU HTA Scoping Process Exacerbates ‘Unworkable’ Timelines
Scientific advice could help companies make up for the lack of involvement in scoping, but slots are in short supply.
German HTA Queries Polivy Benefits Amid Lack Of Evidence
Roche’s lymphoma drug Polivy could face pricing challenges in Germany as it undergoes a full benefit assessment.
Germany Confirms No Reimbursement Status For ‘Lifestyle’ Drug Wegovy
In Germany Novo Nordisk’s obesity drug Wegovy will remain excluded from reimbursement for obesity, unlike Rhythm’s Imcivree.