Question to the Department of Health and Social Care:

To ask His Majesty's Government, further to the Written Answer by Lord Markham on 5 April (HL 5936), what clinical evaluation they have commissioned of pre-exposure prophylaxis after 31 May 2022.

Further to the reply we provided on 5 April, outlined below is the clinical advice commissioned on pre-exposure prophylaxis, including tixagevimab plus cilgavimab (known as ‘Evusheld’) after 31 May 2022.

During June 2022 Ministers received advice on the prophylactic antibody treatment tixagevimab plus cilgavimab (Evusheld), including clinical advice based on the report by the Research to Access Pathway for Investigational Drugs for COVID-19 collaboration (RAPID C-19) of 30 May 2022 regarding Evusheld, along with options for further evaluation by the National Institute for Health and Care Excellence (NICE).

On 28 June, Ministers agreed to refer Evusheld to NICE for a full appraisal of its clinical and cost effectiveness as pre-exposure prophylaxis, with the formal referral letter to NICE sent on 10 August. NICE published the draft scope for the appraisal on 29 July.

RAPID C-19 continued to monitor the available data and were requested to consider observational evidence from other countries. Its report dated 1 September 2022 concluded that, the quality of the data was insufficient to warrant action to progress to consideration of an access policy as an interim measure before NICE technology appraisal, there was uncertainty that tixagevimab plus cilgavimab would prevent symptomatic COVID-19 caused by the current Omicron variants in the vulnerable population who would potentially be eligible for this treatment and there was insufficient evidence to proceed to patient access in the current pandemic context.

The Department also requested advice through the Therapeutics Clinical Review Panel (TCRP) on the potential cohorts for pre-exposure prophylaxis. This advice was commissioned early in 2022 and initially helped inform the advice to ministers on Evusheld before being shared with NICE to support its ongoing appraisal of Evusheld. On 31 January 2023, the Panel considered an updated report taking into account more recent evidence.

The NICE appraisal is ongoing, with draft guidance made available on 16 February 2023 and final draft guidance made available on 5 May 2023. Final guidance is expected on 14 June 2023.