Added Benefit For Orphans Is ‘Fictitious’ Says German HTA Body
Industry has warned that reforming the system for evaluating orphan drugs could have serious consequences for patient access.
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Alnylam has opted to submit its orphan drug Amvuttra for a full benefit assessment in Germany, rather than an abbreviated process that requires no comparative data. In England, the drug was recommended following a pilot for designing a new and faster approach to health technology appraisals.
Big changes are in store on the drug pricing front in Germany. Further reforms could depend on who is appointed health minister.
The German pharmaceutical industry is calling for “directional correction” to the way implementation of the EU’s Health Technology Assessment Regulation is being developed.