Procurement of Evusheld
Debate between Ben Lake and Robert Jenrick(2 years ago)
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Robert Jenrick
Yes, there is, and I hope I will be able to shed further light on that in my remarks, but given that there is relatively little time, sadly, for this debate, let me set out first the process that we have been through; I hope that that will give some comfort to those in the Chamber and listening to the debate that the issue has been handled in a very rigorous way.
Our regulator, the Medicines and Healthcare products Regulatory Agency, gave conditional marketing authorisation to Evusheld in March 2022, but—this is an important point to note—it did so noting a lack of data regarding how it responds to the omicron variant. The lack of supporting data has been noted by other respected regulatory authorities, including the European Medicines Agency and the Food and Drug Administration in the United States. Although the MHRA licenses drugs, the National Institute for Health and Care Excellence assesses the clinical and cost-effectiveness of them. The normal process would therefore be that NICE proceeds to investigate Evusheld, and that is happening as we speak. As the hon. Member for St Albans said, that process is due to conclude in April next year, but yesterday, I met NICE’s chief executive, Sam Roberts, to review her work and to seek reassurances that her work could proceed at a faster pace, and she has committed to reverting to me as soon as possible with a new timetable.
Ben Lake (Ceredigion) (PC)
I welcome that development. I want to place it on the record that of course the devolved Governments also depend a lot on the advice of RAPID C-19. I am sure that the Welsh Government, along with the others, will welcome an accelerated timetable, if it is possible. I congratulate the Minister on doing that.
Robert Jenrick
I am grateful to the hon. Member for that comment. Given the urgent need—we all agree on that—to protect lives during the pandemic, we also expedited processes by creating RAPID C-19 as a multi-agency initiative made up of the UK’s main healthcare agencies. It was established in 2020, in response to the pandemic, to get treatments, such as Evusheld, to NHS patients quickly and safely. Therefore we did not simply leave the matter in the hands of NICE; we asked RAPID C-19 to review the evidence base for the use of Evusheld and to consider whether the evidence merited patients having access to it ahead of the normal NICE appraisal. The evidence has now been published and is available on gov.uk; any emerging evidence will continue to be kept under review. That includes the Crick data that the hon. Member for St Albans mentioned, which was published in May and in August and is now being reviewed by RAPID C-19, and also the Lancet study that she referenced, which was published on 6 October, relatively recently.
Three types of evidence have been considered. The clinical trial data is generally the strongest source of evidence. However, in this case, the trial was carried out before omicron became dominant, so it does not confirm efficacy for omicron variants. It would be, I think, concerning to deploy a drug on the NHS that had not been considered in the light of omicron.