European Expedited Programs & Harnessing HTA
European regulators are exploring their interactions with health technology appraisal bodies to improve expedited programs that aim to get medicines to patients more quickly.
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The rate at which investigational drugs were accepted onto the European Medicines Agency’s priority medicines scheme dropped in 2021. Meanwhile, more much-needed treatments that had been developed under the scheme went on to win EU marketing approval.
The German pharmaceutical industry is calling for “directional correction” to the way implementation of the EU’s Health Technology Assessment Regulation is being developed.
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.