NICE Funding Wins For Enhertu & Kesimpta Are Firsts For England
More Data Needed Before Enhertu Can Be Made Routinely Available on NHS
UK health technology assessment body NICE has struck deals with the makers of Enhertu for advanced breast cancer and Kesimpta for relapsing forms of multiple sclerosis.
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The UK conditional approval of Daiichi Sankyo/AstraZeneca’s advanced breast cancer drug Enhertu was issued in accordance with “transitional provisions” that apply to drugs that received a positive opinion from the European Medicines Agency before the end of the Brexit transition period.
Vertex and CRISPR can now get access to the advantages afforded by the European Medicines Agency’s priority medicines scheme for both of the indications they are targeting with their investigational gene therapy, CTX001.
The UK drug regulator, the MHRA, has approved its first product under Project Orbis, the US-led international regulatory collaboration scheme it joined four months ago to speed up access to promising cancer medicines.