GovWire

Evusheld

Evusheld is an antibody therapy developed for the pre-exposure prophylaxis (prevention) of COVID-19.

In March 2022, Evusheld was authorised by the Medicines Healthcare Regulatory Agency (MHRA) for prophylaxis. The MHRA summary of product characteristics provides more information on Evusheld, including effectiveness against variants.

Based on the evidence available and after careful analysis and consideration, the UK government decided not to procure Evusheld for prevention through emergency routes.

This was a decision based on independent clinical advice by multi-agency group RAPID C-19 (research to access pathway for investigational drugs) and a UK national expert policy working group. The decision reflected the epidemiological context and wider policies in our pandemic response and recovery. The groups considered the evidence available and concluded that there was insufficient evidence that Evusheld is effective against the current variants.

On 12 August 2022, ministers announced the decision not to procure Evusheld. Steps were then taken to ensure all current evidence had been considered, including the emerging observational studies. The decision to not procure remained in place and in October 2022, the Department of Health and Social Care wrote a letter to patient groups about this decision on Evusheld as a coronavirus (COVID-19) treatment.

Governance process

The following groups considered and reviewed the emerging data relating to Evusheld.

RAPID COVID-19

The research to access pathway for investigational drugs for COVID-19 (RAPID C-19) was a multi-agency initiative set up in response to the coronavirus (COVID-19) pandemic that aimed to get treatments for COVID-19 to NHS patients quickly and safely.

Its membership included the UKs main healthcare agencies, including:

• Medicines and Healthcare products Regulatory Agency (MHRA)

• National Institute for Health and Care Excellence (NICE)

• NHS England (NHSE)

• National Institute for Health and Care Research (NIHR)

• the devolved governments

RAPID C-19 considered the evidence base for Evusheld (tixagevimab plus cilgavimab), starting in February 2021, and kept it under active review, including through monitoring the emerging data.

Expert working group

In parallel to the formation of RAPID C-19, NHSE extended its existing national clinical policy-making process to cover COVID-19 therapeutics. As part of this process, a national expert working group (EWG) was created to support development of a national clinical policy with a focus on clinical effectiveness and eligibility criteria.

An EWG is convened to develop a national clinical policy for a specific drug or sometimes to provide further relevant advice. The EWG is chaired by a senior NHS staff member, and the membership includes UK-wide national experts and frontline clinicians. Officials from the devolved governments are also involved throughout.

EWGs have focused on therapeutic agents but, more recently, have also considered prophylactic agents.

Prophylaxis Oversight Group

In July 2020, the Department of Health and Social Care (DHSC) also established the COVID-19 Prophylaxis Oversight Group (POG) to guide development of pre-exposure and post-exposure prophylaxis for COVID-19 infection.

The POG is formed of a group of independent experts with no vested interests who have the expertise to cover the key issues related to prophylaxis.

The groups responsibilities include to:

• advise on national priorities for prophylaxis

• assist with a co-ordinated national approach to prophylaxis with other relevant stakeholders

• oversee the design and development of platform trials for the study of prophylactic agents

• determine potential trial criteria including the threshold for adverse effects, effect size, patient populations and target product profiles for future prophylaxis trials

• determine how prophylactic trials fit into the COVID-19 trial landscape

• support and oversee the prioritisation of prophylaxis agents through the UK COVID-19 Therapeutics Advisory Panel (UK-CTAP)

The recommendations from these groups fed into the RAPID C-19 report Research to access pathway for investigational drugs for COVID-19 which informed the ministerial decision not to procure Evusheld.

On 6 October, the RAPID C-19 Oversight Group report: review of Evusheld was published.

National Institute for Health and Care Excellence single technology appraisal

Evusheld has now been referred to the National Institute for Health and Care Excellence (NICE) for a single technology appraisal (STA) to evaluate the clinical and cost-effectiveness of Evusheld in preventing COVID-19.

This work is underway as a priority and, following agreement with the manufacturer, NICE has already expedited its appraisal of Evusheld for the prevention of COVID-19 by one month. The current timeline would see the draft guidance published in April 2023. NICE will conduct the appraisal as swiftly as possible while maintaining rigorous and impartial appraisal standards. Further information on the process can be found in the Tixagevimabcilgavimab for preventing COVID-19 [ID6163] project information on the NICE website.