The National Institute for Health and Care Excellence (NICE) recommends sotrovimab as an option for the treatment of patients with COVID-19 meeting specified clinical criteria and subject to a commercial arrangement agreed with the company. The National Health Service in England is legally required to make funding available for sotrovimab in line with NICE’s recommendations.

The Government secured stocks of sotrovimab on behalf of all nations in the United Kingdom. At current levels of use, driven by the existing access policies, there is sufficient stock held to last until the latter half of 2024. Discussions are ongoing with the manufacturer to ensure that stock is available through normal commercial channels when this Government-owned stock is consumed.

Information on the proportion of hospitals with accident and emergency units that have supplies of Sotrovimab is not held.

The National Institute for Health and Care Excellence (NICE) recommends sotrovimab as an option for the treatment of patients with COVID-19 meeting specified clinical criteria and subject to a commercial arrangement agreed with the company. The National Health Service in England is legally required to make funding available for sotrovimab in line with NICE’s recommendations.

The Government secured stocks of sotrovimab on behalf of all nations in the United Kingdom. At current levels of use, driven by the existing access policies, there is sufficient stock held to last until the latter half of 2024. Discussions are ongoing with the manufacturer to ensure that stock is available through normal commercial channels when this Government-owned stock is consumed.

Information on the proportion of hospitals with accident and emergency units that have supplies of Sotrovimab is not held.

The response on 21 June 2022 referred to data from clinical trials conducted in 2021 that informed the decision to procure these treatments and to make them available on the National Health Service.

This data being referred to in June included, for example, the EPIC-HR trial, for which results showed an 89% reduction in hospitalisation or death from Paxlovid compared to a placebo when administered within three days of symptom onset. Results from the MOVe-Out trial indicate molnupiravir reduces the relative risk of hospitalisation or death by 30% compared to placebo.

A 2021 trial courtesy of Gottlieb et al. showed that among non-hospitalised patients at high risk for COVID-19 progression, a three-day course of remdesivir had an acceptable safety profile and resulted in an 87% lower risk of hospitalization or death than placebo.

Interim analysis of the COMET-ICE showed that a single dose of the monoclonal antibody sotrovimab was found to reduce the risk of hospitalisation and death by 79% in high-risk adults with symptomatic COVID-19 infection. There is, however, uncertainty whether the omicron variant has any impact on sotrovimab’s effectiveness, but the Medicines and Healthcare products Regulatory Agency are working to establish this.

On 28 November 2022, the NHS published Interim Clinical Commissioning Policy: Treatments for non-hospitalised patients with COVID-19 which summarises the evidence base for clinicians to consider. A copy of this document is attached.

Recent guidance from the World Health Organization indicates that Sotrovimab does not neutralise the currently circulating COVID-19 variants and subvariants. NHS England has reviewed the clinical access policy for this drug which may still be considered as a treatment option where other available antiviral treatments are unsuitable.

Sotrovimab will now be prescribed by exception only where its use is supported following a multi-disciplinary team assessment. The revised clinical policy is available at the following link:

https://www.cas.mhra.gov.uk/ViewandAcknowledgment/ViewAlert.aspx?AlertID=103218

Recent evidence suggests that antivirals and neutralising monoclonal antibodies significantly improve clinical outcomes in non-hospitalised patients with COVID-19 who are at high risk of progression to severe disease. Available treatment options for eligible patients are the first line of nirmatrelvir/ritonavir or sotrovimab as clinically indicated; the second line of remdesivir; and the third line, molnupiravir.

These treatments have various safety profiles for patients with a range of characteristics, which ensures safe access. All patients are clinically assessed to ensure they receive the most appropriate treatment according to their health conditions. Therefore, there is no over reliance on one specific treatment path. The Antivirals and Therapeutics Taskforce is working with the RAPID C-19 Collaborative to review further COVID-19 treatments.

Severely obese patients are currently ineligible for treatment with Sotrovimab or other anti-viral medications, unless they meet the existing eligibility criteria.

Patient access to sotrovimab is clinically determined in line with the published clinical access policies. Individuals at highest risk from COVID-19 infection can access this treatment directly from COVID Medicines Delivery Units (CMDUs) or via the RECOVERY trial for patients admitted to hospital with COVID-19. The latest data shows that 24,798 patients who tested positive for COVID-19 have received sotrovimab in England, with the majority of these patients receiving treatment as non-hospitalised patients via a CMDU.

While the information relating to Slough is not held in the format requested, 2,175 patients suitable for treatment have been identified in the Frimley CDMU area, of whom 701 have been triaged for and treated with sotrovimab and 343 have received oral antiviral medication.

Since 16 December 2021, eligible patients in the highest risk cohort in the United Kingdom can access new COVID-19 treatments from COVID Medicines Delivery Units, including molnupiravir, an antiviral treatment, and sotrovimab, a monoclonal antibody treatment. The highest risk cohort was determined by an independent expert group commissioned by Department and the clinical access policy was agreed by the UK Chief Medical Officers.

Evidence suggests that certain health conditions can cause a patient to progress to severe disease and hospitalisation, therefore these patients are most likely to benefit from novel COVID-19 treatments. A process for considering changes to this cohort is being designed using emerging data and considering all factors that might impact eligibility for treatment. Any updates to the policy will be available in due course.