Cancer Medicines: Appraisals

Tracey Crouch Excerpts

Tuesday 13th June 2023 Westminster Hall

[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.

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[Andrew Gwynne (Denton and Reddish) (Lab)]

It is a pleasure, as ever, to serve under your chairmanship, Mrs Harris, and to respond to this debate on behalf of the shadow Health and Social Care team.

I begin by congratulating the hon. Member for Strangford (Jim Shannon), who I call my hon. Friend, on securing this important debate, and I thank him for his tireless work campaigning on such issues.

Also, I pay tribute to my hon. Friend the Member for Mitcham and Morden (Siobhain McDonagh) for the powerful case that she put to the Minister in respect of brain tumours generally and specifically the glioblastoma manifesto. I very much hope that the Minister is able to take up her challenge, because the inequalities in outcomes that she laid out are unacceptable. In the year 2023, we should not be looking at a situation in which there have been zero improvements in life expectancy from cancers such as glioblastoma since 2005-06 when we have seen dramatic improvements in the other areas that she mentioned. We owe it to Baroness McDonagh—Margaret McDonagh—and to others such as Tessa Jowell to ensure that we see improvements in this area, too.

As for the hon. Member for Chatham and Aylesford (Tracey Crouch), she said herself that she has been on the cancer treadmill, and it is lovely to see her back in her place and up to her old usual tricks. We welcome her.

[Tracey Crouch]

I just want to say that I was never not in my place; I was fortunate enough to go through cancer treatment during covid, when we were all working under a hybrid procedure. Actually, that experience has helped to form some of the contributions that I have made to the Procedure Committee about how we in this place support people who are going through significant illnesses.

[Andrew Gwynne]

Absolutely—the virtual Parliament hid a multitude of sins. I know that as somebody who struggled with long covid through that period. Many people would not have known just how ill I was, because I just appeared on a screen. However, it is nice to see the hon. Lady in person; I should put it like that. And she was entirely right to say that cancer touches us all, which is why we can all cite personal experiences of it. I lost my mum to ovarian cancer when I was 19; she was just 50. I lost my dad last year to rectal cancer. I am not alone; we all have people, including close family members and friends, who we have lost to cancer.

I also pay tribute to the hon. Member for Midlothian (Owen Thompson), who responded on behalf of the SNP, for his contribution to the debate and to the right hon. Member for Dwyfor Meirionnydd (Liz Saville Roberts), for her intervention.

I am sure that I speak for everybody from all parties in the House when I say that ensuring that patients have quick access to the most innovative and effective treatments is an absolute priority. This country has a proud history of medical innovation, a reputation that we should try not only to protect but to enhance, as we have already heard today.

We are talking today about the appraisal process for cancer patients, which, as we have also heard, has changed markedly over recent years in several areas. We have seen increased focus on targeted treatments and immunotherapies, as well as reform of the cancer drugs fund in 2016, a move that was taken to improve people’s access to cancer drugs while allowing NICE to collate more information on potential areas of clinical uncertainty.

In a recent report, the Association of the British Pharmaceutical Industry highlighted that 78% of medicines have been able to exit the cancer drugs fund with a positive recommendation, with most of them spending about two and a half years in the CDF process. It also recognised improvements as a result of the relaunched CDF, but raised concerns that the CDF has

“perhaps been overly relied upon”

in order to

“delay making routine recommendations.”

It states that

“a new balance may need to be struck between NICE and manufacturers in considering which treatments should enter the CDF to resolve genuine uncertainty surrounding long-term clinical outcomes and for how long.”

Given that NICE recently set out specific circumstances when committees may be able to accept a higher degree of uncertainty in routine commissioning decisions, can the Minister set out whether his Department has assessed the ABPI’s findings and whether more can be done to improve access to innovative treatments for patients via routine commissioning? That links to a wider point that I wish to raise on clinical research and trials.

Clinical trials provide an opportunity for the NHS, businesses and brilliant researchers to work together for the benefit of everyone. Unfortunately, however, in recent years the UK trials industry has collapsed. The number of commercial trials in the United Kingdom decreased by 41% between 2017 and 2021. Worryingly, the UK has dropped from fourth to 10th in the global rankings, behind Spain, France and Italy. Of most concern is that in 2020-21, the NHS lost £447 million in revenue due to a drop-off in clinical commercial trial activity. Those figures should seriously worry the Minister. They risk putting patients at a disadvantage for all kinds of innovative treatments, including cancer medicines.

In Labour’s recent health mission, we committed to putting Britain right at the front of the queue for new medicines and vaccines. Alongside our pledge to spend 3% of GDP on research and development across the public and private sectors, we want our clinical trials to be more competitive, efficient and accessible. Making those ambitions a reality means tackling unnecessary bureaucracy in how trials are set up and reducing the administrative burden on everyone involved in the clinical trial, including the NHS. Will the Minister set out how his Government plan to reverse the drop-off in clinical research and trials—a drop-off that is costing our NHS financially and clinically?

Finally, I want to touch on the issue of patient access to innovative medicines, including for cancer patients. In 2021, in its “Life Sciences Vision”, the Government committed to identifying and addressing “unwarranted variation” in the uptake of innovative medicines. But in February this year, in the innovation scorecard commissioned on behalf of the Department of Health and Social Care, it was found that a number of areas were still falling short of the NICE recommended levels of new medicine uptake.

Will the Minister provide an update on what work he is doing to improve regional variation in uptake of innovative medicines so that no matter where someone lives, they can access the treatment they need when they need it. Will he also commit to improving the data collected as part of the innovation scorecard to include information on cancer medicines so that we can meaningfully assess uptake and isolate areas for improvement where necessary? That is something that the life sciences sector has called for, so I would welcome more information on that from the Minister.

In conclusion, Labour is wholly committed to ensuring that cancer patients in this country receive access to the very best medicine and care. That means ensuring that appraisals for cancer medicines remain fit for purpose and adapt in line with evolving technologies and scientific advancements. It also means turbocharging clinical trials and tackling the unacceptable gaps in access to cutting-edge treatment. In his response, I hope that the Minister will meet the ambition set out by the Labour party and that we can work together towards making Britain a world leader in cancer care and treatment, because we owe it to all those people on the treadmill right now.

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[Will Quince]

The answer to both is yes, and yes. If the right hon. Lady would write to me with the details, I will certainly raise the issue and meet to discuss radioisotopes specifically.

NHS England is working very closely with the independent sector to ensure that we are using all the available capacity to us to deliver both diagnoses and treatment as quickly as possible. The Government announced the major conditions strategy on 24 January, which is important for cancer as it draws on previous work on cancer. Over 5,000 submissions were provided as part of our call for evidence last year, and we will continue to work closely with stakeholders, the public and patients—whose voice should never be forgotten, as the hon. Member for Strangford rightly points out—and the NHS in the coming weeks to identify the actions we need to take as part of the strategy that will have the most impact.

Specifically on NICE appraisals, the hon. Member raised several concerns about the way in which cancer medicines are appraised. Members will know that NICE is rightly independent of Government. It is an expert body that makes evidence-based recommendations to the NHS on whether new medicines should be routinely funded by the NHS on the basis of on assessment of clinical and cost effectiveness. Those recommendations then develop, mainly for the NHS in England, but as was mentioned, they are usually adopted by the NHS in Wales and in Northern Ireland. Scotland has its own system. This is a difficult matter to raise, but it is important to point out that every pound that we spend on a new medicine is money that is not available for other services, and the NICE appraisal process ensures that NHS funds are spent in a way that provides the greatest health benefit to society. That is a hugely difficult job, which NICE does with great professionalism.

Again, it is important to point out that NICE appraises all new medicines and that its approval rate for cancer medicines has consistently been around 90%–I think that the latest figure is 92%. It is absolutely right that when NICE recommends a medicine for the NHS, it is available for patients and NHS England is required to fund that drug or treatment. I know that the NHS in Northern Ireland and in Wales has adopted a similar model.

NICE’s methods and processes for assessing new medicines are internationally respected, and they have evolved over time to ensure that they reflect best practice and keep pace with advances in medical science. As my hon. Friend the Member for Chatham and Aylesford (Tracey Crouch) pointed out—I will come on to this in some detail— NICE concluded a comprehensive review of its appraisal methods and processes last year, which it carried out with a high level of ambition and transparency. As she pointed out, changes include the introduction of a new severity modifier, which will give NICE more flexibility to recommend medicines for more severe diseases at higher prices. The severity modifier replaces the previous flexibility for end-of-life treatments.

My hon. Friend raised some concerns about that, and I always listen very carefully to what she says on this and many other issues, especially given her personal experience and campaigning. She is right to say that the situation is hugely complex, and her point about data is a really good one, because decisions need to be informed by good-quality data. I would be happy to meet her to discuss how we can ensure that we are collecting data not just on a regional basis, but nationally, so that we can make sure that NICE is making informed decisions. As she rightly points out, we need to ensure that patients and their voices are always at the heart of all the decisions made by not just the Government, but NICE. I would be happy to meet her to discuss that in greater detail.

On the broader point about whether the introduction of a severity modifier in place of an end-of-life modifier will affect cancer drugs specifically, analysis was carried out by NICE in developing the modifier. It indicated that the vast majority of cancer medicines that would have been eligible for the end-of-life modifier would also be eligible for a weighting under the severity modifier. I am happy to meet my hon. Friend and any other Members who would like to meet NICE to discuss this issue further.

[Tracey Crouch]

I think it is very important that the Minister also meets the pharmaceutical companies, because there is a counterclaim to the statistic from NICE that he has just given. The pharmaceuticals say that, actually, a significant percentage—I cannot remember off the top of my head what it is—of drugs would not pass the test. My plea to him is to sit down with all interested parties and not just listen to NICE’s statistics on this issue.

[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.