Procurement of Evusheld

Robert Jenrick Excerpts

Wednesday 12th October 2022 Westminster Hall

[The Minister of State, Department of Health and Social Care (Robert Jenrick)]

It is a pleasure to speak under your chairmanship, Sir Gary. I thank the hon. Member for St Albans (Daisy Cooper) for securing the debate, and the many hon. Members from across the House who have either intervened on her, or whose presence on behalf of their constituents speaks to the concern and interest across the country.

I come to this debate not merely as a new Minister in the Department of Health and Social Care, but as the Minister who established the shielding programme in spring 2020. I have been involved in these issues, in one way or another, for two and a half years, and care deeply about the individuals who have been shielding since then. Having met many of them, both as a Minister and as a constituency MP, I understand their distress, and the psychological harm that living a cloistered life places on them and their loved ones.

I also approach the issue with the view that the Government should make decisions on covid-19 treatments based on the available evidence and the recommendations of the medical experts at our disposal. That has been the case for all covid-19 treatments, and is, and should be, the case for Evusheld. It is imperative that we deploy only those drugs that we are content are effective. We would be doing a disservice to the public if we deployed drugs through the NHS that, in this grave situation, gave them a false sense of security.

[Caroline Ansell (Eastbourne) (Con)]

rose—

[Dr Luke Evans (Bosworth) (Con)]

rose—

[Robert Jenrick]

I will make one further point, then I will come back to my hon. Friends. That does not mean that there is not a role for Ministers in interrogating the evidence, listening to the voices of those with the contrary view—both in the House and in the public domain—and ensuring that we get all the information that we need before we make informed decisions. That is the approach that I have tried to take in the three weeks in which I have been in post, and will take going forwards.

[Caroline Ansell]

I thank my right hon. Friend for giving way. On behalf of the half a million, and of one very special lady in my constituency, I wanted to ask a question. I have carefully considered the Government’s response. It talks about the risks outweighing the benefits of deploying Evusheld at this point, but I have not really been able to understand what those risks are; I understand the risks of not deploying it, which have been outlined. Could the Minister could speak to that? As the hon. Member for St Albans (Daisy Cooper) described, my constituent is fighting for her career, mental health and relationships, and this debate is very important to her.

[Robert Jenrick]

I hopefully will answer as many of those points as I can in the time available. I will go to my hon. Friend the Member for Bosworth (Dr Evans) next, and then make some progress.

[Dr Luke Evans]

I entirely agree with the point about making sure that we have clinically robust evidence. We saw during covid with ivermectin how poor data influenced a debate that was sparked across the world. That said, one thing we do have control over is how quickly we look at the regulation. Is there anything that the Minister can do to speed up the decision making? That is within his gift.

[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.

[Vicky Foxcroft (Lewisham, Deptford) (Lab)]

Will the Minister give way?

[Robert Jenrick]

I will, but given that I have only five minutes remaining to me, this is the last time I will be able to take an intervention.

[Vicky Foxcroft]

The Minister is making an interesting speech, but I am really inquisitive as to how we are still using vaccines that have not been tested on omicron, yet we are using the excuse of Evusheld not being tested on omicron for those people who are immunocompromised.

[Robert Jenrick]

Before we deploy Evusheld on the NHS and give members of the public the sense of security that comes with that, it is clearly sensible for us to investigate its efficacy in the light of the dominant variant. Otherwise, we would be giving people a false sense of security.

We have looked at in vitro neutralisation studies, which can be completed much more rapidly than clinical trials, that have measured in the lab how a new variant changes the binding efficacy of the therapeutic. These studies show reduced binding with different omicron variants, which means that the clinical efficacy against these variants is expected to be reduced. We have also reviewed the published clinical experience of the use of Evusheld, including the studies emerging from the United States and Israel. There can be difficulties in interpreting some observational studies if, for example, there is not an appropriate control group. The conclusion of the evidence review is that there are uncertainties about efficacy, so a clinical trial has been proposed to look at that. We are working with AstraZeneca on the practicalities of creating an urgent trial that can inform the debate ahead of NICE’s ultimate decision in early 2023.

As was noted, other countries have introduced Evusheld, including, in some cases, before omicron was dominant. Many have decided to double the dose to try to counter the drug’s reduced ability to neutralise the omicron variant. Our experts consider that even at this increased dose, the evidence is still insufficient to demonstrate efficacy, so individuals could be at risk if they changed the protective behaviours that they have undertaken for many months.

The Government recognise that an effective pre-exposure programme for immunosuppressed people would be valuable, but the scientific evidence does not support emergency deployment of Evusheld at this time. To boost the evidence base for future decisions, clinical advisers in the expert groups and my Department have recommended a clinical trial, which could help us to answer outstanding questions on dose, efficacy and duration of protection against different variants. We are working through the practicalities of that trial. We will update colleagues and members of the public as quickly as possible.

We have had great success in generating evidence in clinical trials; last week, initial results from the PANORAMIC trial indicated that early treatment with one drug significantly reduced recovery time, and we will now work in the same way to understand what this evidence means for patient access to the drug. I appreciate the difficulties that immunosuppressed individuals face, particularly if they are concerned about not having protection from covid-19 vaccinations, and so continue with behaviours to avoid covid-19. We all recognise the impact that that has on individuals’ lives and want to improve their quality of life. The Antivirals and Therapeutics Taskforce has ensured that UK patients have the earliest access to antiviral, antibody and anti-inflammatory COVID-19 treatments. NHS patients were often the first in the world to receive safe and effective treatment, both in clinical trials and following regulatory approval of treatments.

Colleagues here and those listening at home have my personal assurance that I will continue to work with expert advisers in the Department, and with RAPID C-19, to ensure that they review all emerging evidence, and to ensure that the NICE process is carried out as swiftly as possible, while ensuring that it is safe and efficacious; we want to ensure that members of the public, who may ultimately receive this drug, have confidence that it does what they think it does.

I am holding a meeting for Members of this House with our expert advisers tomorrow at 11 am. It will give Members the opportunity to ask our experts, including those who have been part of RAPID C-19, any questions and seek further assurances. I am grateful to the hon. Member for St Albans for securing this debate, and for the passionate way in which she expressed the strong feelings of members of the public; I hope to work with her productively in the months ahead.

Question put and agreed to.