Maggie Throup: To date, Evusheld has not been made available to National Health Service patients. Evusheld was granted a conditional marketing authorisation by the Medicines and Healthcare products Regulatory Agency (MHRA) on 17 March 2022. However, the initial positive trial data on Evusheld was published prior to the emergence of the Omicron variant. The UK Health Security Agency is testing the efficacy...
Lord Kamall: We are aware that the United States Food and Drug Administration (FDA) listed an emergency use authorisation for Evusheld in December 2021, which was revised on 24 February 2022. The FDA has modified their dosing regimen according to its available data and consider that a higher dose of Evusheld may be more likely to prevent infection by the Omicron subvariants BA.1 and BA.1.1 than the...
Lord Kamall: The Antivirals and Therapeutics Taskforce engages with other nations on the use, deployment and evaluation of therapeutics and antivirals. We understand that more than 20 countries have procured Evusheld and a proportion have begun to deploy the treatment. AstraZeneca announced positive trial data from the PROVENT trial, which showed Evusheld’s efficacy against developing symptomatic...
Maggie Throup: Evusheld was granted a conditional marketing authorisation by the Medicines and Healthcare products Regulatory Agency on 17 March 2022. However, the initial positive trial data on Evusheld was published prior to the emergence of the Omicron variant. The UK Health Security Agency is currently testing the efficacy of Evusheld against the Omicron variant and the Department and National Health...
Lord Kamall: We understand that the United States of America has increased the suggested dose of Evusheld, in line with in vitro results showing that Evusheld has reduced efficacy against some Omicron subvariants. The Food and Drug Administration’s in vitro data was pseudovirus data, whereas the tests being conducted by the UK Health Security Agency (UKHSA) are based on live virus data. The European...
Lord Markham: The Government has decided not to procure Evusheld at this time for prevention through emergency routes. This is a decision based on independent clinical advice by the multi-agency RAPID C-19 and a United Kingdom national expert policy working group, which considered all available evidence for whether treatments are likely to be effective at preventing symptomatic infection, hospitalisation...
Lord Mendelsohn: To ask Her Majesty's Government, further to the approval of Evusheld by the Medicine and Healthcare products Regulatory Agency on 17 March, when they plan to announce their policy on the provision of Evusheld; and if they are not yet ready to make an announcement, what progress they have made on developing the clinical commissioning policy for Evusheld.
Maggie Throup: Evusheld was granted a conditional marketing authorisation by the Medicines and Healthcare products Regulatory Agency on 17 March 2022. However, the initial positive trial data for Evusheld was published prior to the emergence of the Omicron variant. The UK Health Security Agency has conducted the efficacy of Evusheld against the Omicron variants and initial data for BA.1 and BA.2 has been...
Lord Markham: The National Institute for Health and Care Excellence (NICE) is conducting a Health Technology Evaluation of Evusheld, which will provide guidance on the use of Evusheld in the National Health Service. This evaluation is in development with publication expected in spring 2023. If the NICE recommends its use as a pre-exposure prophylactic is clinically and cost effective, the NHS will make...
Will Quince: On 15 December 2022, we wrote to patient groups and to MPs, to provide an update on COVID-19 treatments this winter. This correspondence did not refer to Evusheld campaigners’ request for a meeting because the purpose of this letter was to provide an update on the Department’s latest position on Evusheld. The Department has met with Evusheld campaigners on multiple occasions and...
Maggie Throup: Evusheld was granted a conditional marketing authorisation by the Medicines and Healthcare products Regulatory Agency (MHRA) on 17 March 2022. However, the initial positive trial data on Evusheld was published prior to the emergence of the Omicron variant. Following its approval, the MHRA had indicated uncertainty on the appropriate dose needed for protection against Omicron. The UK Health...
Lord Markham: The Department has held regular discussions with AstraZeneca on the potential supply, procurement and cost of Evusheld. The Department continues to explore how further data about Evusheld’s effectiveness can be obtained, including encouraging AstraZeneca to continue discussions with the Antivirals and Therapeutics Taskforce on the potential for further research. Clinical advisers have...
Lord Markham: Evusheld received a conditional marketing authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) on 17 March 2022, following trials conducted during the non-Omicron variant wave of the COVID-19 pandemic. The PROVENT study provided data on effectiveness of Evusheld against the alpha, beta, delta and epsilon variants. It was noted that there was a lack of data...
Will Quince: Based on the evidence and after careful analysis and consideration, the UK Government has decided not to procure Evusheld for prevention through emergency routes at this time. However, the UK Government has referred Evusheld to the National Institute for Health and Care Excellence (NICE) for evaluation, which provides evidence-based, rigorous evaluation of the clinical and cost effectiveness...
Maggie Throup: AstraZeneca commissioned the UK Health Security Agency (UKHSA) to undertake testing on the effectiveness of Evusheld against the Omicron variants and initial data for the BA.1 and BA.2 variants has been shared. However, AstraZeneca has not commissioned the UKHSA to initiate testing for the Omicron variant BA.4. After reviewing the data, AstraZeneca can determine whether to commission further...
Lord Markham: The Government has decided not to procure Evusheld for prevention through emergency routes at this time. This is based on independent clinical advice by the multi-agency RAPID C-19 and a United Kingdom national expert policy working group, which concluded that there is insufficient evidence of benefit to recommend deployment. While the Medicines and Healthcare products Regulatory Agency...
Robert Jenrick: The UK Health Security Agency began testing of Evusheld in March 2022, which was completed in May 2022. The decision not to procure Evusheld at this time for prevention through emergency routes is based on independent clinical advice by the multi-agency RAPID C-19 and a national expert policy working group. The decision is based on a range of evidence, including clinical trial data, in vitro...
Lord Markham: 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...
Will Quince: ...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...
Daisy Cooper: To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 20 April 2022 to Question 151279, on Evusheld, when the UKHSA began testing Evusheld’s effectiveness against the covid-19 omicron variant; and whether UKHSA has guidance on how long that testing should take.