Benlysta And Fampyra Fail to Make Headway As IQWiG Tightens Comparator Screw
This article was originally published in The Pink Sheet Daily
Executive Summary
Germany’s health technology evaluator’s rejection of GSK’s Benlysta and Biogen Idec’s Fampyra could force companies to design separate trials for authorization and HTA assessment.
You may also be interested in...
German End-Of-Year Figures Highlight Potential Danger To Pharma R&D
The German pharmaceutical market has dealt impressively with the government’s cost-cutting measures, but they are beginning to take their toll on R&D and innovation, industry maintains.
German Reimbursement Dossiers Look Trickier After Rejection Of Eisai’s Fycompa
Eisai’s novel epilepsy drug Fycompa will have a tough time qualifying for reimbursement in Germany after the cost-effectiveness regulator IQWiG said the manufacturer did not stick to HTA guidance on comparator selection.
European HTA Highlights: IQWiG Focuses On Indications, Benefits; NICE Still Obsessed With Cost Controls
Germany’s IQWiG is concentrating on product benefits in its reviews, though is still expecting carefully tailored studies from sponsors. But industry’s concern in England continues to focus on NICE’s obsession with saving the NHS money – meaning pharma must make innovation cheaper to succeed.