The National Institute for Health and Care Excellence (NICE) makes recommendations on whether all new licensed medicines, including medicines for COVID-19, should be routinely funded by the National Health Service, based on an assessment of their costs and benefits. The NICE aims, wherever possible, to publish guidance close to licensing and the NHS in England is legally required to fund medicines recommended by the NICE, normally within three months of final guidance.

The NICE has published guidance that recommends three medicines, paxlovid, xevudy, and roactemra, for the treatment of COVID-19, both in the community and for patients in hospital. This guidance ensures that patients who are at the highest risk of developing severe disease from COVID-19 have access to clinically and cost-effective treatments.

The NICE has started its appraisal of sipavibart, which has been referred to as evusheld 2.0, through its standard processes, and its Appraisal Committee will meet to consider its recommendations in October 2024. The NICE will aim to publish its guidance as close as possible to licensing.

The UK Health Security Agency began the process of testing against the Omicron variant in March 2022. Following the completion of preliminary laboratory work, such testing lasts for approximately three to four weeks.

The Living with Covid Strategy sets out three key objectives to protect the vulnerable, maintain resilience, and continue the transition to managing COVID-19 wherever possible and clinically appropriate, as we do with any other respiratory virus through business as usual public health activities.

Appropriate levels of testing will remain to support diagnosis for clinical care and treatment and to protect very high-risk individuals and settings. Those who are clinically extremely vulnerable and immunocompromised are part of the group who are eligible for COVID-19 treatments in the community, enabling them easy access to anti-viral treatments. High-risk individuals are also part of the priority cohort in line for booster vaccines. The Government will continue to consider the advice of the Joint Committee on Vaccination and Immunisation on future vaccine selection and booster programmes for those at greatest risk.

However, as we learn to live safely with COVID-19, there are actions we should all take to help reduce the risk of catching COVID-19 and passing it on to others. Vaccination remains the most effective way to prevent serious illness from catching COVID-19.

The UK Health Security Agency (UKHSA) continue to evaluate countermeasures for COVID-19 and other diseases working with the Government and industry. We are establishing a Vaccine Development and Evaluation Centre, this will bring together UKHSA’s laboratory based activity, expertise and leadership in vaccine discovery, development and evaluation.

We will work with industry and academic partners to ensure that health security research priorities are addressed and will generate and apply world-leading scientific evidence to inform and optimise vaccination programmes.

The National Institute for Health and Care Excellence (NICE) is the independent, expert body responsible for developing authoritative, evidence-based recommendations for the National Health Service on whether new medicines represent a clinically and cost-effective use of resources. The Government asked NICE to evaluate Evusheld for the prevention of COVID-19 through its technology appraisal programme in August 2022. NICE has been able to expedite the evaluation of Evusheld and released its final draft guidance on 5 May following a consultation on its draft recommendations earlier this year. NICE has unfortunately been unable to recommend Evusheld as a clinically and cost effective use of NHS resources, citing a lack of clinical evidence of its effectiveness against currently circulating variants. NICE has not yet published its final guidance.

The request made by the National Institute for Health and Care Excellence (NICE) to the Department on 8 June 2022 was for the referral of Evusheld for the treatment of COVID-19 for inclusion into its multiple technology appraisal on therapeutics for COVID-19, not Evusheld for prevention. I understand from NICE that an error was made in its response to the freedom of information request, and that a correction will be issued accordingly. I apologise that this happened.

The National Expert Working Group is one of the sources of clinical opinion to develop clinical policies. During this period the RAPID C-19 cross-agency group was also set up to review COVID-19 therapies in response to the pandemic. They would consider evidence and analysis from a number of sources, including the Prophylaxis Oversight Group and the UK Health Security Agency. In addition, the Therapeutics Clinical Review Panel considered evidence for COVID-19 risk to help prioritise cohorts for prophylaxis. This informed thinking within the Department and was subsequently shared with the National Institute for Health and Care Excellence. These groups continued to consider emerging evidence, including published evidence from independent researchers and evidence from the company, after the last meeting of the Expert Working Group.

The report produced by the Independent Advisory Group on potential cohorts eligible for pre-exposure prophylaxis was reviewed by the Therapeutics Clinical Review Panel in April 2022. It was formally submitted to the National Institute for Health and Care Excellence on 13 January 2023.

The National Institute for Health and Care Excellence (NICE) wrote to the Department on 8 June 2022 requesting the referral of Evusheld for the treatment of COVID-19 for inclusion into its multiple technology appraisal on therapeutics for COVID-19. This was different and unrelated to the referral letter sent by the Department to NICE on 10 August 2022, which was for Evusheld for prophylaxis.

Following the referral, NICE has prioritised the appraisal of Evusheld for the prevention of COVID-19 and issued its draft guidance for consultation on 16 February 2023. NICE has been unable to recommend its use to protect against COVID-19 citing the lack of its clinical evidence against current variants and those likely to be circulating in the near future. Stakeholders now have until 9 March 2023 to comment on NICE’s draft recommendations.

The Equalities and Impact Assessment analysed the impact of the decision not to procure Evusheld on all groups with protected characteristics, and the effect of the decision on immunosuppressed patients who are unable to complete vaccination or produce an adequate response to vaccination.

The assessment considered a range of evidence, including the Independent Advisory Group report and OCTAVE study. The Independent Advisory Group report identified a cohort of patients who are unlikely to respond to vaccination and who could potentially benefit from a Pre-exposure Prophylaxis (PrEP) programme. The estimated cohort size is approximately 150,000, although there remains substantial uncertainty attached to these numbers. The Antivirals and Therapeutics Taskforce has also worked with the Therapeutics Clinical Review Panel, Prophylaxis Oversight Group and the Engagement Board, and these organisations consist of scientific experts, including clinicians, pharmacists, evidence assessors and researchers.

The assessment shows that the availability of effective PrEP could particularly benefit those with disabilities. However, the impacts and benefits of a PrEP programme, for patients identified throughout the assessment, would only occur if a suitable prophylactic option existed. Uncertainty remains of the impact of Evusheld as a prophylactic treatment, with RAPID C-19 additionally still unsure if Evusheld would prevent symptomatic COVID-19 caused by current Omicron variants. In line with that advice, the Government will not be procuring Evusheld at this time.

The expert advice used to determine the cohorts eligible for COVID-19 treatment was led by the Therapeutics Clinical Review Panel. The panel periodically reviews new evidence on the definition and revision of eligible cohorts for COVID-19 therapeutics from several sources, including clinical evidence and expert groups. The Independent Advisory Group, led by Professor Iain McInnes, produced a report on the potential cohorts eligible for pre-exposure prophylaxis. This clinical advice was agreed by the panel and has been submitted to the National Institute for Health and Care Excellence (NICE) as part of their Health Technology Evaluation of Evusheld.

The materials submitted to the NICE committee will be published once the process has completed.

The Antivirals and Therapeutics Taskforce are working with COVID-19 antibody testing experts to develop a study, building on existing data and research infrastructure to build evidence for more informed decisions for clinical interventions and the level of protective behaviours based on an individual patient’s risk.

The National Institute for Health and Care Excellence (NICE) is conducting a Health Technology Assessment of Evusheld. This is the routine process for new medicines to be evaluated for clinical and cost effectiveness, which will provide recommendations through NICE’s guidance on the use of Evusheld in the National Health Service. The process includes considering ‘the options for identifying the potentially eligible patients who might benefit from this medicine’, as recommended by RAPID C-19.

The Department has asked the National Institute for Health and Care Excellence (NICE) as the independent expert body to develop guidance for the National Health Service on the clinical and cost effectiveness of Evusheld in its licensed indications for the treatment and prevention of COVID-19. NICE will develop guidance in line with its established methods and processes for health technology evaluation which are published and available at the following link:

https://www.nice.org.uk/process/pmg36/chapter/introduction-to-health-technology-evaluation.

NICE is appraising Evusheld for the treatment of COVID-19 alongside other licensed therapeutics and currently expects to publish final guidance in March 2023. NICE’s final guidance on Evusheld for the prevention of COVID-19 is currently expected in April 2023. The NHS in England is legally required to fund medicines recommended by NICE, usually within three months of final guidance.

The Department has asked the National Institute for Health and Care Excellence (NICE) as the independent expert body to develop guidance for the National Health Service on the clinical and cost effectiveness of Evusheld in its licensed indications for the treatment and prevention of COVID-19. NICE will develop guidance in line with its established methods and processes for health technology evaluation which are published and available at the following link:

https://www.nice.org.uk/process/pmg36/chapter/introduction-to-health-technology-evaluation.

NICE is appraising Evusheld for the treatment of COVID-19 alongside other licensed therapeutics and currently expects to publish final guidance in March 2023. NICE’s final guidance on Evusheld for the prevention of COVID-19 is currently expected in April 2023. The NHS in England is legally required to fund medicines recommended by NICE, usually within three months of final guidance.

The Department has asked the National Institute for Health and Care Excellence (NICE) as the independent expert body to develop guidance for the National Health Service on the clinical and cost effectiveness of Evusheld in its licensed indications for the treatment and prevention of COVID-19. NICE will develop guidance in line with its established methods and processes for health technology evaluation which are published and available at the following link:

https://www.nice.org.uk/process/pmg36/chapter/introduction-to-health-technology-evaluation.

NICE is appraising Evusheld for the treatment of COVID-19 alongside other licensed therapeutics and currently expects to publish final guidance in March 2023. NICE’s final guidance on Evusheld for the prevention of COVID-19 is currently expected in April 2023. The NHS in England is legally required to fund medicines recommended by NICE, usually within three months of final guidance.

The decision not to procure Evusheld for prevention through emergency routes is not based on cost considerations, but rather on independent clinical advice by RAPID C-19 (a multi-agency group) and a UK National Expert Policy Working Group. These groups considered a full range of evidence, including clinical trial data, in vitro analysis and emerging observational studies, as well as the epidemiological context of Omicron and wider policies in the Government’s pandemic response and recovery. Their conclusion is that there is insufficient evidence of benefit to recommend deployment at this time.

The National Institute for Health and Care Excellence (NICE) is now conducting a Health Technology Evaluation of Evusheld, which is the routine process for new medicines to be evaluated for clinical and cost effectiveness and will provide recommendations through NICE’s guidance on the use of Evusheld in the National Health Service.