Question to the Department of Health and Social Care:

To ask His Majesty's Government whether the COVID-19 monoclonal antibody Evusheld 2.0 is being treated as a priority for assessment; and whether they have any plans to rollout a programme to be fast-tracked to vulnerable patients.

AZD-3152, which has been referred to as Evusheld 2.0, will be evaluated through the National Institute for Health and Care Excellence’s (NICE) standard appraisal process. The NICE is the independent body responsible for developing evidence-based guidance on whether new medicines should be routinely funded by the National Health Service, based on an assessment of their costs and benefits.

The NICE has formally started its appraisal of AZD-3152, ahead of the Medicines and Healthcare products Regulatory Agency’s (MHRA) decision on whether it should be given a United Kingdom marketing authorisation, and expects to invite stakeholder submissions in April 2024. Timelines for both the NICE’s guidance and licensing depend on data from the SUPERNOVA trial being available. AstraZeneca intends to submit clinical data to the NICE and the MHRA at the same time, with the aim that both organisations are able to reach decisions as close together as possible.

If AZD-3152 is recommended as clinically and cost effective by the NICE, the NHS in England will be under a statutory requirement to fund AZD-3152 for eligible patients, in line with the NICE’s recommendations. There are no plans for the NHS to routinely fund the medicine ahead of it achieving a licence or a positive technology appraisal recommendation from the NICE.