NICE, the health technology assessment (HTA) body for England, has recommended interim funding for Daiichi Sankyo/AstraZeneca’s Enhertu (trastuzumab deruxtecan), claiming the move makes England the first country in Europe to commission the advanced breast cancer drug.
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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Pharmaceutical companies are being encouraged to reach out to NICE in relation to its HTA Innovation Lab, which provides a sandbox environment in which the health technology assessment body can test new methods of evaluating “innovative and disruptive” therapies.
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Health technology assessment body NICE said it has taken on feedback about the implications of allowing higher cost-effectiveness thresholds for some medicines after senior health economists offered diverging views on its methods.
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Cell and gene therapy manufacturers must consider the practicalities of their product within the context of a health care system before it comes onto the market to be successful, experts from Novartis, AstraZeneca and England’s National Health Service say.
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The UK branded drug industry is calling for adjustments to be made to the UK voluntary scheme framework for branded medicines, after the payment rate increased to 22.9% for 2025. Meanwhile, the generics industry says the scheme is functioning “as intended” and opposes any changes.
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The European Medicines Agency has recommended five drugs for EU-wide approval , including Averoa’s Xoanacyl for concomitant hyperphosphatemia. Two companies have withdrawn their marketing authorization applications.
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Eli Lilly’ will request a re-examination after the European Medicines Agency declined to recommend its Alzheimer’s disease drug Kisunla for EU approval.
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The new global GCP guideline, ICH E6(R3), enables researchers and clinical trial administrators to tailor their documentation processes, but also opens the door for more scrutiny during GCP inspections.