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.

Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)

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.

Question to the Department of Health and Social Care:

To ask His Majesty's Government what assessment they have made of (1) the level of unmet need of immunocompromised patients for protection against COVID-19, and (2) whether the MHRA has sufficient staff so that it can appropriately prioritise regulatory decisions in support of such patients.

Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)

As set out in the Living with COVID-19 Strategy, the Government and the UK Health Security Agency will continue to communicate to people most vulnerable to COVID-19 about available clinical interventions, including vaccination and treatments, as well as testing and public health advice.

All individuals aged six months old or above who are immunosuppressed were offered a vaccination in the Autumn 2023 COVID-19 vaccination programme, along with those in other clinical risk groups. The immunosuppressed group will be offered a further dose as part of the spring programme announced in February, that is being rolled out in England from mid-April. This follows the Joint Committee on Vaccination and Immunisation’s advice that those who are immunosuppressed are at particular risk of serious disease from COVID-19.

The Medicines and Healthcare products Regulatory Agency (MHRA) is looking at novel and standard ways to develop staff capability and expertise. New assessor capacity is being supplemented with an additional fixed-term resource of appropriately experienced and qualified specialists, to support the training and supervision of new staff. The MHRA also continues to recruit to additional roles in its assessment teams.

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