Alnylam's Amvuttra Tests Faster HTA In England, Wins Praise in Germany For Full Assessment
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.
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NICE, the health technology appraisal body for England and Wales, is asking for views on amendments to its health technology evaluations manual to incorporate its new proportionate approach to appraisals.
NICE, the health technology appraisal body for England, has published an interim process and methods guide for its new proportionate approach to HTAs.
Regulatory reliance is playing an increasingly important role in gaining marketing authorization in the UK following Brexit. Meanwhile, the country’s unique Innovative Licensing and Access Pathway is attracting growing levels of interest, not just from companies but from regulators and health technology appraisal bodies across the world.