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Procurement of Evusheld

Volume 720: debated on Wednesday 12 October 2022

[Relevant Document: e-petition 611884, Fund Evusheld the preventative COVID19 antibody for immunocompromised.]

There has been a lot of interest in this debate. I will call Daisy Cooper to move the motion and then call the Minister to respond. There will not be an opportunity for the Member in charge to have the final say, as is the convention for a 30-minute debate.

I beg to move,

That this House has considered the procurement of Evusheld.

It is a pleasure to serve under your chairship, Sir Gary. I am pleased to have secured this important debate on behalf of the forgotten half a million immunocompromised and immunosuppressed patients in England, and the 18,617 people who have signed the parliamentary e-petition calling on the Government to fund the preventive covid-19 drug Evusheld. I pay tribute to the extraordinary campaigning work of Evusheld for the UK, Blood Cancer UK, Kidney Care UK and many other charities that have given their members a voice. There is clearly significant interest from colleagues across the House, and I will endeavour to take as many short interventions as possible.

Let me be blunt: the Government have got this badly wrong. Some of our most vulnerable people are now in an impossible position, or, as some of them have said, they have been left to rot. People with blood cancer, vasculitis, kidney transplants, multiple sclerosis, long- term conditions and rare diseases and those on immunosuppressant drugs are crying out for the preventive drug Evusheld. Why? For them, the covid infection is just as deadly—in fact, more so—than when we first went into lockdown two and a half years ago. They do not mount a response to covid through the vaccines like the rest of us. Covid is not just a bad cold or an inconvenience, but a killer disease. In a society where people are allowed to walk around with that killer disease without being required to wear a mask, test or isolate, nowhere is safe for the immunocompromised—not inside or out.

I share the passion with which the hon. Lady speaks. Does she agree that it is incredibly important that the clinicians and scientists take this decision through the usual rigorous methods, and not us as politicians?

I welcome that intervention and I do agree. I will outline all the scientific evidence that backs the decision to procure Evusheld and roll it out right now, this side of Christmas.

I congratulate the hon. Lady on securing this timely debate. I was contacted by a constituent ahead of it, who reiterated that as autumn and winter approach, we are even more vulnerable and isolated. Given what we face, I am sure the hon. Lady agrees that it is urgent for Ministers to listen to this debate and set out plans to support immunosuppressed patients and people during the difficult winter ahead.

The hon. Lady is right. I will set out not only that the scientific evidence backs up the case for Evusheld, but that there is strong political consensus for it. Of course, the voices of those affected must be heard.

There is nowhere that is safe for these people: not shops, not schools, not supermarkets, not buses, not even the very GP surgeries and hospitals that they need to visit to manage the conditions that make them vulnerable. They are at extreme risk of hospitalisation and death, and they have been left with no choice but to lock themselves away from family and friends for two and a half years. Many now face a third winter of shielding.

I agree with the hon. Lady’s sentiments. I have a constituent who has been shielding for 30 months—a 26-year-old who is the son of Mrs Rehana Patel. Along with the hon. Lady, I plead that the Government continue to give serious consideration to the use of Evusheld to help those thousands of clinically vulnerable people across my constituency and the rest of the UK.

I thank the hon. Member for his intervention.

Let us move on to the facts. Is Evusheld safe and effective? Yes, it is. The Medicines and Healthcare products Regulatory Agency approved it in March, seven months ago. Is there enough scientific evidence? Yes, there is ample evidence.

The hon. Lady and I have had conversations about this issue and about my own constituents. What I cannot understand is that the RAPID C-19 committee has looked at this 11 times. These are supposed to be experts that are looking at it. She is quite right to want evidence that proves that the committee is wrong. How come we have got into a situation where Government scientists are saying one thing and the rest of the scientific community is saying something completely different?

I thank the right hon. Member for his intervention. That is exactly the question I would like the Minister to answer.

There are two significant problems with the most recent report published last week. First, it effectively says that the RAPID C-19 group looked at the results of a trial run on actual people in December 2021 and concluded that the evidence was so good that they were going to recommend that Evusheld be rolled out to patients. However, in May of this year, they looked at non-clinical data—test tubes, petri dishes and the like—and decided that the results were not good enough. It does not take a rocket scientist to work out that high concentrations of a virus in a petri dish do not translate to tests in real human beings.

I understand that 33 other countries have approved the use of Evusheld, including every G7 member apart from the United Kingdom. What do you think we can learn from the other parts of the world that have approved this important treatment for the immunocompromised?

I am grateful for that question. In fact, Evusheld is now so effective that not only has it been rolled out in 33 countries, but a number of countries, including Japan, Italy, Spain and Israel, have actually put in repeat orders for Evusheld, and the Centers for Disease Control and Prevention in the US has even launched a public drive to increase uptake. In private discussions, both the Minister and his predecessor have indicated to me in meetings that there was some evidence that countries had bought the drug but were not using it.

Let us be clear: the failure of any Government to identify clinically vulnerable patients and distribute the medication to them has nothing to do with the effectiveness of that particular drug. Before we throw stones in glass houses, we should remember that of immunocompromised patients in England who caught covid and were referred for treatment, only 17% actually got it. That failure to distribute is more to do with the fracturing of our health systems; it is not about the effectiveness of this drug.

I thank the hon. Lady for bringing forward this vital debate on behalf of the many constituents who have contacted me and in my capacity as chair of the all-party parliamentary health group. Does she agree that when people feel they are being left to rot, it is not only their physical health that is impacted; their mental wellbeing is crippled in the stage of recovery where they need the most support possible?

The hon. Member is absolutely right. Many people are clinically vulnerable because they have a health condition, and their physical health is getting worse, as it would when someone is stuck at home for two and a half years, but the mental health impact is also incredibly profound. We know that many of our constituents have experienced suicidal thoughts.

I turn now to the advice of the RAPID C-19 oversight group, which has been mentioned. The Government refused to share this advice for some time, and many of us were asking for it. I was pleased to see that this advice was finally published last Thursday on 6 October. I was pretty shocked for two reasons. First, the report actually says that the group looked at real-world data and the impact on people and that data was very strong. Then it looked at the data in a non-clinical setting and decided not to roll it out. That seems absurd to me.

There is a second problem with the evidence that was published last week. It lists the evidence that the group reviewed, and it leaves out one very critical scientific study by the Francis Crick Institute—a study that I believe the Government commissioned themselves. That study was commissioned to look at the effectiveness of a different drug: sotrovimab. That report concluded that sotrovimab was effective, and the Government are using that report to justify why they continue to use sotrovimab. However, the report also concluded that Evusheld was even more effective. So why not buy Evusheld too? Perhaps the Minister can enlighten us.

On the same day the Government published this RAPID group report, The Lancet—the world’s highest-impact general medical journal—carried an article by 19 experts calling on the World Health Organisation to update its guidance on Evusheld, based on the study the Government commissioned. In the article, those experts say that Evusheld should be used for not only preventative, prophylactic use, but treatment. The UK Government are really trailing behind. Can the Minister tell us why the RAPID study ignores this vital piece of research, which they must have known about?

Many of the people we are talking about have already had five or six vaccine jabs, even though they will mount very little, if any, response. The Government say it is important that these people get those vaccines, because they say some response is better than none. Why does that same test not apply to Evusheld? Why is it being singled out and held to an impossible standard?

Let us look at what the Government are proposing, instead of following the science. Ministers have referred Evusheld to NICE for further clinical and cost-effective assessment; apparently, we might hear back in April 2023. That is another delay—another six months of isolation—even though every other covid treatment and vaccine was urgently procured before being appraised. I ask again, why is the Government’s treatment of Evusheld so inconsistent?

My constituent Helen Nash asked me to be here to support the case that the hon. Lady is making. She makes the key point: while the Government did a lot of great work to accelerate the availability of vaccines for the population at large, this particular cohort seems to be subject to a very different set of criteria. That is the great concern. While we must rely on clinical advice, we must also have the same situation for all people, regardless of their status.

I agree with the hon. Gentleman. One of the big concerns that has not been answered by the Government so far is why their approach to this drug is so inconsistent with their approach to others. As I say, Ministers have referred Evusheld to NICE, and it is not at all clear why their treatment of it is so different.

Meanwhile, the Department of Health has proposed that immunocompromised patients have an antibody test, and that those who do not respond well enough could join an Evusheld trial. Let us be clear what that trial would mean in real life. It would require some of the people who have been shielding to stay alive for two and a half years to come out of shielding like the rest of us, but without any protection from covid vaccines, knowing that they might only be given a placebo. It would be like taking lambs to the slaughter. I would be astonished and appalled if that proposal passed anyone’s ethics test. I do not know if the Minister would support one of his loved ones taking part in such a trial, but I certainly would not. Can the Minister therefore tell us why his Department wants to take this dangerous approach instead of the approach suggested by the Drug Safety Research Unit, which has called on the Secretary of State to roll out Evusheld now, for this winter, and to run an observational study of the impact?

Another question that has arisen is whether there are problems with supply. The answer is no. AstraZeneca has dismissed that claim.

The hon. Lady is presenting a powerful case; I congratulate her on securing this important debate. Max Johnson is a 14-year-old heart transplant recipient. He was the key figure in the organ donation campaign that was supported by Members right across the House. Max and his family are being supported by their local MP, the hon. and learned Member for Eddisbury (Edward Timpson), but we have kept in close touch. Max’s life has been turned upside down since the start of the pandemic, with no light at the end of the tunnel of isolation. Does the hon. Lady agree that Max, along with thousands of other people across the country, has the right to a better life and should be allowed access to Evusheld without any further delay?

I completely agree.

I do not know how much a dose of Evusheld costs. I hope that, when the Government enter into negotiations with AstraZeneca, they will get a good price for the taxpayer. However, all Members of this House know what the cost is to our constituents who are affected. They have given up jobs, caring responsibilities and vital moments in their lives—they could not go to weddings, funerals or births. Some of them no longer run vital volunteer-led community services. Some have lost their life, and some are suicidal; they are thinking of taking their life because the psychological torture of prolonged shielding is too much for them to bear.

Those people are getting even more ill, because no one can be locked up for two and a half years without getting problems with their back or knees, or experiencing extreme loneliness and mental ill health. Those are all problems that are piling up for our already overstretched NHS. If those immunocompromised patients get covid, they are far more likely to end up in an intensive care unit, which we know will cost us thousands and thousands of pounds. There is also a risk of variant escape, because several studies show that new variants and virus mutations are more likely in immunocompromised patients. Against that backdrop, Evusheld is the cheap option.

Two years ago, Members stood in this room and begged Health Ministers to change their minds on care home restrictions, which were supposed to protect people but were so tight that some people started dying of neglect. We are at risk of that happening again. The Government changed course after that debate and can do so again today. The people affected by this feel that they do not have a life; it feels like a life sentence. Ministers have it in their gift to give those people their life back, and on behalf of the half a million, I urge the Minister—I beg him—to do it today.

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.

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.

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.

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.

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.

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.

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.

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; 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.[Official Report, 13 October 2022, Vol. 720, c. 1MC.]

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.

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.

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.

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.[Official Report, 13 October 2022, Vol. 720, c. 2MC.] 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.

Sitting suspended.