Cancer Medicines: Appraisals

Siobhain McDonagh Excerpts

Tuesday 13th June 2023 Westminster Hall

[Siobhain McDonagh (Mitcham and Morden) (Lab)]

It is a pleasure to serve under your chairmanship, Mrs Harris. I thank the hon. Member for Strangford (Jim Shannon), who is the closest thing this House has to a national treasure, for securing a debate that is so important to me.

This debate is about appraisals for cancer medicines. As with any debate about cancer in the House of Commons, there will be Members who have a personal connection to the issue. I will not spend a lot of time explaining my family’s situation, but for me this debate is different. It is not like the other debates that we take part in as parliamentarians. For some, we are experts in the field; for others, we are explaining the experiences of our constituents; and for others, we are speaking about what we have heard from stakeholders. My contribution is grounded in the year and seven months I spent caring for my sister, experiencing what the NHS treatment is like at first hand, and suffering as it became clear that over the past 40 years there has been no improvement in the treatment of glioblastoma—a brain tumour. The drug used to treat glioblastoma today, temozolomide, is the same drug that has been used for the past 20 years. That is not a national policy challenge; it is a frustration that I have lived.

When a person is diagnosed with a glioblastoma, they get six weeks’ radiotherapy, followed by six months’ chemotherapy with temozolomide if they can manage it. The drug was introduced in 2005, and it is called the gold-standard treatment in our NHS. That is a bastardisation of the English language. It is not a gold standard. It is not even a plastic standard. Although there are other treatments and drugs on the market for other cancers, the 3,200 people who are diagnosed with glioblastoma each year have had almost no improvement at all. The average life expectancy for someone diagnosed with a glioblastoma is nine months—do not believe the figures that suggest it is 18 months. The five-year survival rate is only 12.9%—just 1% better than the five-year survival rate in 2010.

For other cancers, the story is very different. For someone diagnosed with lung cancer in 2010, the five-year survival rate was 10.3%—not dissimilar to the survival rate for glioblastoma. The difference is that by 2020, the five-year survival rate for lung cancer had doubled to 21%. For some undiagnosed with breast cancer in 2010, the survival rate was 83.2%. By 2020, the five-year survival rate was all the way up to 85.9%. The five-year survival rate for bowel cancer has gone from 58% in 2010 to 60% in 2020.

I do not in any way mean to take attention away from those cancers. I am absolutely delighted that survival rates have increased, that there is innovation and that there are trials across the board. However, when I meet constituents who have had a cancer diagnosis for something other than a brain tumour, I regularly hear that they have had access to experimental trials. I appreciate that that is because I have a south London constituency and we are close to the brilliant Royal Marsden. When it comes to brain tumours, it is not that there are only a few trials; there are zero, with not many on the horizon. There are many reasons why survival rates have not changed for brain tumours in 20 years, but one is in the title of this debate: there are nowhere near enough appraisals for new brain tumour drugs and nowhere near enough clinical trials.

I will give an insight into how difficult it is to get a new drug on the market for glioblastoma. When my sister’s brilliant oncologist, Dr Paul Mulholland, set up a new clinical trial, he could not get the pharmaceutical companies to give him the drugs he needed. As a result, he had to rely on me, a Member of Parliament with no medical training, to write to the pharmaceutical chief executives asking them to donate to his trial. We were successful. We met senior members in four drug companies, and Roche was absolutely brilliant in its response. But why did it take a letter from somebody like me to get the drugs for a new clinical trial, instead of the other pharmaceutical companies responding to Europe’s expert on brain tumours? It completely baffles me, but I suppose that is the world we live in.

This experience tells me that the market is not working. It tells me that because only 3,200 people are diagnosed with a glioblastoma every year, it is not profitable for the pharmaceutical companies to invest in glioblastoma treatments. The market is very small, so it is not worth their while. As policymakers, it is our job to see where the market is working and where it is not. As legislators, it is our job to change, cajole and, ultimately, legislate to make sure that it does work. That has simply not been happening with glioblastoma, for which there has been no improvement in 40 years.

The drug companies will not change on their own. Unless we demand that they invest in those drugs, nothing will ever change; it will go on and on. Believe me, I do not want my worst enemy to go through what we have over the last 18 months. After speaking to some of the experts in the field and having conversations with all the main brain tumour charities, we have been able to develop a four-point manifesto that will make a real difference. As it happens, it will not cost very much either. I would be very grateful if the Minister could respond to that point.

On a personal level, I understand that the Minister is standing down at the next election. He has a year to 18 months to leave a real mark on this area of work. I ask him personally to be up to that challenge, to stand up to the status quo and the establishment in the medical profession and pharmaceutical companies, and to consider our glioblastoma manifesto.

First, we need a target of getting 200 glioblastoma patients into clinical trials each year on a drug that has the potential to change the course of the disease. That would be 1,000 patients over the lifetime of a Parliament. With those trials, we can begin to understand what works and what does not.

Secondly, the NHS should trial on brain tumours every drug that gets licensed to deal with other tumours, as long as there are not indications that it would be dangerous. Repurposing those drugs would be a cheap way to make a huge difference. It is sometimes the only way that makes a difference. The reason for melanoma survival rates of 90% at five years is precisely that: the use of a drug licensed for another cancer purpose.

Thirdly, the NHS should ensure that every neuro-oncology multidisciplinary team has a medical oncologist who is a core member and is required to attend meetings to discuss patients, so that brain tumour patients are not left in a corner of the ward because there is no specialist arguing for them. Unless a neuro-oncologist is in the room, we will not benefit from their ideas or expertise.

Fourthly, the NHS should require that every young—or not so young—doctor, training to be a medical oncologist should go through a mandatory course on brain tumours. At the moment, there is no compulsory training. Doctors have to take two courses on bowel cancer as part of their training, but nothing on brain tumours. Believe me, they do not take that option. The reason that there is nobody on those wards and the research infrastructure is not there is because nobody is required to do the course.

Fantastic work is being done in the world of cancer. There are improvements in some areas with some fantastic successes, which we should celebrate. However, we should have our eyes wide open when we are not making any progress. We should be able to take stock and say, “This is not working; we need to try something new.” In 2018, after Tessa Jowell sadly passed away from a glioblastoma, £40 million of Government funding was promised to fund research into brain tumours, but the infrastructure of treating glioblastoma is so poor that there have not been enough bids to allocate that funding. As of January, just £15 million of the promised £40 million had been awarded; the field is in such a dire situation that we cannot even spend the money that has been specifically allocated to brain tumours.

This is about trying something different. I do not care whether it is Labour, the Conservatives, the Lib Dems, the DUP or the SNP—I will get behind anyone with the political will to make a change. Einstein famously said:

“The definition of insanity is doing the same thing over and over again and expecting different results.”

I think we are getting to that point with the treatment of glioblastoma. It is time to break the mould, take a risk and try something different.

[Tracey Crouch (Chatham and Aylesford) (Con)]

I think this is my first time speaking under your chairmanship, Mrs Harris; I am sure it will be a great pleasure. I congratulate the hon. Member for Strangford (Jim Shannon) on securing this important debate, and on his excellent speech setting out the issues with the new NICE methods and processes for cancer drugs. The hon. Member for Mitcham and Morden (Siobhain McDonagh) described him as a national treasure. As a Minister, I was once in charge of national treasures; I feel I lost the opportunity to enshrine his legacy in a Bill before Parliament, during whose passage I am sure he would have intervened.

The hon. Member for Strangford set out an interesting problem, and, like him, I am grateful for the briefing I have received on the matter. I am humbled to follow the hon. Member for Mitcham and Morden. I have been on the cancer treadmill, and I think that, as patients, people become incredibly compliant; they do as they are told. It is often much harder for those who love someone who has cancer. They fight for better treatment and care on behalf of their loved one because it is all that they feel they can do, as the hon. Lady set out.

We need to do so much more on rarer cancers, particularly brain cancers. I quickly googled global survival rates for glioblastoma; the survival rate in the US is 26%, compared with 10% in the UK as the hon. Member for Mitcham and Morden set out. That shows that factors such as access to drugs can make a significant difference to outcomes. I am sure that the Minister heard very much what she said, and many people who are suffering from brain tumours will be grateful for her contribution.

I have no intention of becoming the poster girl for all things cancer. In some cases, I still find talking about my experience of the disease quite hard, but I wanted to speak in this debate because I also find it infuriating that we lag behind so many countries on many cancer-related areas, including access to medicine. However, I want to give some good news on cancer targets from my area. It is extremely worrying for anyone to read front-page news of missed targets, backlogs, delays and so on at the start of their cancer journey, but in Kent and Medway we are fortunate to have one of the top performing alliances in the country for meeting the 62-day standard, with both Maidstone and Tunbridge Wells NHS Trust and Medway NHS Foundation Trust reaching 85%. In fact, MTW, which is where I was treated, has consistently met its targets for the last three years, having kept all its cancer services open during the pandemic. The improvements are generally down to achieving more rapid diagnoses by triaging referrals and sending as many patients as possible straight to their diagnostic test.

A lot of evidence links early diagnosis with better outcomes. Despite having top-notch treatments available on the NHS, the UK still lags behind Europe and the US. There may be many reasons, but my view and that of many others is that the main push should be for diagnosing patients as early as possible to improve outcomes. However, we really cannot afford to get into a situation where we do not have access to the latest treatments; otherwise, outcomes may worsen. There is a conundrum, which can be summarised as: methods and processes versus cost versus data—and it is really hard to squish that triangle into a circle. I met two pharmaceutical companies to learn about this issue. Although I am not naive to its aims, I was struck by the disadvantage that the changes to NICE’s methods and processes could leave UK cancer patients with.

The hon. Member for Strangford outlined the background to the changes so I will not repeat them in great detail, but in summary, in 2022 NICE changed the way it reviews disease severity as part of its assessment process. It introduced the severity modifier and removed the end-of-life criteria, which gave a higher value weighting to medicines for terminal illnesses. That change is likely to negatively impact cancer medicines in particular. Capacity issues, cost containment measures and other commercial environment factors are steadily combining to create a life sciences sector that is disincentivised to focus on cancer innovations or invest in the UK. That in turn will pose challenges to achieving the Government’s ambitions to accelerate access to oncology medicines and meet the policy targets set out in the “Life Sciences Vision” and the NHS long-term plan.

What worries me is that big, global oncology conferences take place—like the recent American Society of Clinical Oncology conference in Chicago—which are brilliantly reported in our newspapers, with references to breakthrough drugs for x cancer sending shivers of hope down the spines of people like me and many others, when the truth is that very few of those drugs will reach our NHS due to NICE methods.

That is when I see the other side of the argument, at least to some extent. We should really be congratulating whoever does the procurement negotiations with pharma to drive down the cost to the NHS so that investment can be made in other areas of cancer, such as diagnostics, although that can be stretched only so far before companies pull their drugs from the market. It is about finding a sweet spot that works well for both.

Data is another challenge. There is a lack of outcome data available to NICE in the full assessment of some medicines. The problem for pharmaceutical companies is that this data is hard to come by. Outside of a clinical trial, they have little or no access to outcome data from the use of the drug in the real world, and if it is expensive, it is hard to prescribe it without a NICE recommendation in the first place—thus we have come full circle due to a lack of evidence and, of course, the increasing cost.

[Siobhain McDonagh]

Does the hon. Lady agree that it seems crazy that in a system as universal as the NHS there should not be access to outcome data? To give just one example, South West London Elective Orthopaedic Centre at Epsom Hospital is the largest hip and knee replacement centre outside of America. It is the lowest for blood risks, and has the lowest infection rates and quickest turnaround. It has its own small charity and keeps the data, making £1 million a year from it. That could go some way towards paying for the latest cancer drugs.

[Tracey Crouch]

I entirely agree. Data sharing will help cancer outcomes full stop, not just in the example she gives. If my GP sent me for a breast screening, for example, the person doing the screening could not currently see whether I have had a cervical screening. Having the conversation about screening for other cancers while having some form of cancer screening is an important aspect of long-term survival rates, so I completely agree with the hon. Lady.

It appears that NICE, through changes to its methods and processes, has probably got stricter on the level of evidence it requires before it will make a recommendation, so that it ensures that there is a survival benefit to the things it recommends, all of which is a potential reason that we should collect and share data better across the NHS. We could allow pharma better access to anonymised NHS data, and some trusts already do so with strict governance in place. Working together in this way would allow us to access the actual impact of a drug when it is used outside of a trial and allow NICE to make a real-world evidence-based recommendation, which would be particularly helpful for rarer cancers such as glioblastoma.

We have to get over the clinical reticence of not using a drug before it has a NICE recommendation, otherwise we will never get the real-world data. Some 80% of cancer drugs recommended by NICE were only recommended if the price to the NHS was reduced, so, given that in the UK clinicians tend not to prescribe without a positive NICE recommendation, the pharmaceutical companies essentially have to drop the price to get the recommendation for the drug to be on the market. In all those points, it is forgotten that at the centre of this is a cancer patient just wanting to get the best possible treatment to live for as long as possible.

We all want positive outcomes for cancer. NICE has committed to keeping its new methods under review. During this time, it is essential that flexibility is maintained when considering disease severity so as to ensure timely and ongoing patient access. Pharmaceutical companies want to be at the forefront of developing life-enhancing, cancer-beating drugs for the market. There has to be a sensible way forward, but at the moment it feels like the changes may have made things worse for current and future cancer patients hoping for breakthrough life-enhancing treatments.

I know the Minister to be a sensible and reasonable person. I hope he will take renewed vigour from what he has heard so far in the debate and will sit down with all the interested parties to see how we can go forward, because without doing so, I fear that on this issue—coupled with others around screening, diagnosis and access on to pathways—we will continue to lag behind other countries in beating cancer.

--- Later in debate ---

[Will Quince]

My hon. Friend is absolutely right, and I regularly meet the pharmaceutical industry, not least because of VPAS, which I will come on to discuss because it has been raised by a number of Members. While I understand the concern, it is absolutely right that assessment of clinical and cost effectiveness reflect up-to-date clinical pathways, evidence and evaluative methods and processes. However, my hon. Friend is absolutely right to say that we should also hear and understand the views and concerns of the pharmaceutical industry so that we have a rounded, balanced view and the full picture, to make sure that there are no unintended consequences because of the action that is being taken.

The hon. Member for Strangford mentioned non-uniform pricing and VPAS, so let me come on to that specifically. The tricky thing is that the negotiations for the next VPAS are currently under way. Given that there are ongoing discussions, it would not be appropriate for me to go into too much detail, because of the commercial sensitivity. It would also be inappropriate to set up a working group to review NHS England’s policy on non-uniform pricing. What I would say is that if changes were made to the wording in the next VPAS on commercial flexibilities, they would be reflected in an updated commercial framework for new medicines.

The hon. Members for Strangford and for Denton and Reddish raised clinical trials. We are doing a huge amount of work in that space because I recognise some of the issues and challenges that the hon. Member for Denton and Reddish set out. That is why we commissioned the O’Shaughnessy review into clinical trials, and why we accepted Lord O’Shaughnessy’s recommendations in full. We should take a step back for one moment and look at the work that we did as a country and an industry on clinical trials, particularly relating to covid. We basically shut down huge numbers of clinical trials to focus on a vaccine. To be fair, this country absolutely led the way in that, and we should be very proud of what we did, but we have not been fast enough in switching clinical trials back on and we have lost some of our competitive edge in relation to other countries, as the hon. Gentleman pointed out. The reality is that it is a race; clinical trials are globally competitive, and other countries, including Spain, have seized the advantage and are fighting hard for market share. We have to make sure we are a competitive place. That is about clinical trials but also our regulatory environment.

The hon. Member for Midlothian (Owen Thompson) made good points about the MHRA. We are absolutely looking at its processes and procedures, and we are putting an extra £10 million into it over the next two years to ensure it is a world-class regulator that is one of the fastest and most effective and efficient. It is already highly respected, but we must ensure that it does things at the right speed. That is very much on my radar, and as I said we are accepting the recommendations.

The hon. Member for Denton and Reddish also raised the cancer drugs fund. Since 2016, NICE has been able to recommend medicines for use through the Government’s £340 million cancer drugs fund, which enables patients to receive promising new treatments for a time-limited, managed access period while further evidence is being collected. That is then considered by NICE when determining whether a medicine should be routinely funded by the NHS. Since that fund was created in 2016, it has helped more than 91,000 patients in England, and more in other places, to access innovative medicines.

[Siobhain McDonagh]

Those 91,000 did not include people suffering from a glioblastoma. We are not anywhere near NICE. We have not got that far. The drugs are not there. There is nothing. None of this works for people with glioblastoma. I do not want to mislead the Minister into thinking that I care only about my sister, Margaret. I draw hon. Members’ attention to early-day motion 1233, in my name, to commend the life of Laura Nuttall, a young woman diagnosed with a glioblastoma aged 18. She died on 22 May. I want to pass on all our condolences to her mum, Nicola, her sister, Gracie, and her father. Laura was a shining light and an ambassador for the Brain Tumour Charity. Although she was told that had only a year to live, she managed to live for four and a half years and secured a 2:1 in her degree. Laura highlighted that brain tumours are the greatest killer of people under the age of 40, who are being let down.

[Will Quince]

I totally take the hon. Lady’s point when she says that it is not all about her sister, Margaret— I know that from her contributions. Often in this place, we draw on our personal experiences, which enable us to bring to life powerfully and emotively what others are experiencing. I thank her for sharing Laura’s experience, and I send my condolences to Laura’s friends and family.

The hon. Lady is absolutely right that the cancer drugs fund can bring forward only innovative medicines that have gone through the clinical trials process. I will be very happy to work with her and meet her again to discuss how we get more research in this space. That is the key to so much, in relation to tacking brain tumours.

The hon. Member for Strangford spoke about the challenges presented by combination therapies. The commercial framework also recognises that realising the full potential health benefits from combination drug therapies can be challenging, given the requirement for commercial confidentiality and the need to maintain competition. Having said all that, NHS England has a proven ability to negotiate commercial agreements that secure combination treatments for patients. Just last month, deals were struck to enable NICE to recommend Keytruda and Lenvima for hundreds of women with advanced endometrial cancer. Progress is being made, but again, I would be happy to discuss the issue further.

Again, I thank the hon. Member for Strangford for securing this important debate and for his continued interest in the appraisal of cancer medicines and access to cancer treatments for NHS patients. I also thank other Members who have made such powerful contributions.

If one message comes across, Mrs Harris, I hope that Members are assured that the Government and I remain firm in our commitment to making the most promising and effective new cancer treatments available to NHS patients. The hon. Member for Denton and Reddish said that this is not a political issue, and I agree. It would be impossible to find anyone in the House who does not want to ensure that patients across the United Kingdom get access to the most innovative and cutting-edge medicines for cancer and other diseases, as quickly as possible. We all have a common endeavour there.

It is important to acknowledge the huge role that NICE has played, with its world-leading health technology assessment. It has enabled NHS patients to be at the forefront of access to new cancer treatments, in a way that also represents value for the taxpayer. I recognise the point that has been well made today, that we must always seek to improve and to go further and faster. I look forward to working with all Members present and others across the House to achieve that.