I think NICE’s discussions with NWBio prior to the formal appraisal are a strong indication that the approval of DCVax-L by the MHRA is considered likely, without major objections that currently preclude approval. The government would be very cautious about providing such a neutral and hopeful response if there were actually major barriers.
Answered on 28 April 2025
DCVax-L has not yet been licensed by the Medicines and Healthcare products Regulatory Agency (MHRA) for use in the United Kingdom. The manufacturer has confirmed that it has submitted an application, and it is fully engaged with the Marketing Authorisation process. The National Institute for Health and Care Excellence (NICE) makes recommendations for the National Health Service on whether all new licensed medicines should be routinely funded by the NHS based on an assessment of clinical and cost effectiveness. NICE aims, wherever possible, to issue recommendations on new medicines close to the time of licensing by the MHRA. The NHS is legally required to fund medicines recommended by NICE, normally within three months of the publication of final guidance. NICE is in discussions with the manufacturer of DCVax-L about a potential appraisal, subject to licensing.
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