Breast Cancer Drugs

Desmond Swayne Excerpts

Thursday 26th January 2017 Commons Chamber

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

I beg to move,

That this House notes the provisional decision not to provide the breast cancer drug Kadcyla for use in the NHS on 29 December 2016; and calls on the National Institute for Health and Care Excellence (NICE) and pharmaceutical company Roche to come together and re-assess this decision to ensure Kadcyla is kept available for patients, and consider how access to both innovative new breast cancer drugs and off-patent drugs used for breast cancer, such as bisphosphonates, can be improved.

I thank the Backbench Business Committee for the swift manner in which it allocated time to have this important debate. I want to put the spotlight on an issue that affects the lives of millions of people—those who are living with breast cancer and their family and friends. I am sure that almost everyone here today will know someone who has had this disease. My own friends have suffered from breast cancer, and I am so pleased that many of them are in the Public Gallery to watch today’s debate. I have received a large amount of communication on this, including as late as last night in a message from a Vivienne Ashley, who cannot be here today but will be watching on TV.

The disease affects people irrespective of their class or job. Many hon. Members have suffered from breast cancer, such as my hon. Friend the Member for Bristol West (Thangam Debbonaire)—also my Whip—who has had a great recovery. An Opposition Member approached me only yesterday to explain that she was receiving treatment, and that although she wanted to be involved in the debate, she felt the issue was too close to her to do so at the moment.

I am sure all Members would agree that we need a health system in which the most effective cancer treatments are available to all patients. Today, I want to let people living with cancer, especially secondary breast cancer, know that we have not given up on them and that we all want an NHS that provides us all with access to the most effective treatments.

[Sir Desmond Swayne (New Forest West) (Con)]

If the deliberations used by the National Institute for Health and Care Excellence, particularly for metastatic breast cancer, take insufficient account of the needs of young families to spend more time with their mothers, is the remedy something that NICE itself can provide by altering the way it goes about those deliberations, or is it something that we in this House and the Government need to do?

[Siobhain McDonagh]

The answer to the right hon. Gentleman’s question is both. There are issues with how NICE assesses new drugs, particularly cutting-edge drugs such as Kadcyla. He will know, because of his involvement in the last Government, that they established the cancer drugs fund. It is not an either/or, but something we all need to come together to discuss, and that people with more scientific knowledge than me might wish to consider.

--- Later in debate ---

[Iain Stewart (Milton Keynes South) (Con)]

I congratulate the hon. Member for Mitcham and Morden (Siobhain McDonagh) on securing this important debate and setting out her case so powerfully. I agree with pretty much everything she said. I know that several Members wish to speak, so I will not detain the House by simply repeating all those points.

My motivation in speaking today comes from a meeting I had at my constituency surgery just a few weeks ago with my constituent Joanna Mears and her husband. Like many other sufferers, they are watching our proceedings from the Public Gallery. Mrs Mears suffers from secondary breast cancer. Although, sadly, her condition is terminal, she is responding well to her existing medication and has already had more than twice the expected benefit span. When the point comes that the medication no longer has that effect, her only remaining option will be Kadcyla. Naturally, she is very concerned about NICE’s decision.

[Sir Desmond Swayne]

This is essentially the same question I asked earlier. I think that we all accept that a mistake has been made and that the decision was wrong. The key question is this: what is the remedy? Does the remedy lie within NICE’s remit, and therefore it could change its procedures and considerations, or does it lie within the statutory framework that Parliament and Government have set for it to work within? We have to come to an answer on that.

[Iain Stewart]

I am grateful to my right hon. Friend for that question. My answer is pretty much the same as that of the hon. Member for Mitcham and Morden. In this specific case, I hope that there is scope for NICE and Roche, the manufacturer of Kadcyla, to sit down and agree some compromise. I received a briefing note from Roche this morning stating that it was willing to do that, so I hope that NICE will respond in kind. Its consultation ended last week. As the hon. Lady said, and as my right hon. Friend rightly points out, there is a broader issue for other drugs. Perhaps it is time to look again at the appraisal system and the cost mechanisms so that we do not keep returning to this debate every time a new drug is identified and there is a question about its affordability under the cancer drugs fund.

--- Later in debate ---

[The Parliamentary Under-Secretary of State for Health (Nicola Blackwood)]

A large number of important and technical points have been raised today, and I will do my best to respond to as many of them as possible, but where I am unable to do so, I hope that colleagues will allow me to write to them. I congratulate the hon. Member for Mitcham and Morden (Siobhain McDonagh) on securing this important debate, and I join Members across the House in paying tribute to the all-party parliamentary group on breast cancer for all its advocacy on behalf of patients and families. The hon. Lady has campaigned tirelessly to improve access to breast cancer drugs on behalf of her constituents, and I share her commitment to ensuring that patients are able to benefit from the latest effective and often cutting-edge cancer drugs and technologies.

Cancer is a truly terrible disease, and as has been made clear by the many moving personal contributions that we have heard today, there are few of us who have not been touched by it. That is why the availability of effective drugs to treat cancer is of such importance to all of us and to so many of our constituents. I particularly want to thank all those who have allowed their personal stories to be shared today, and all who are here in the Public Gallery. These stories remind us powerfully of why we are all here, and their importance cannot be overestimated.

[Sir Desmond Swayne]

There is an all-party group for almost every disease known to man, with the possible exception of rigor mortis. If patients and campaigners are to have confidence in clinical decision makers, there will have to be profound changes. At the moment, people lobby their MPs, who are uniquely unqualified to make these decisions. May I suggest to my hon. Friend that one of the changes might need to involve a thorough review of the framework and guidance under which the National Institute for Health and Care Excellence operates?

[Nicola Blackwood]

My right hon. Friend makes an important point. It has been made by a number of colleagues today, and I shall address it later in my speech if he will allow me.

We want the UK to lead the world in fighting cancer. Survival rates in this country have never been higher, but we must go further. Medicines are a vital weapon in the battle against cancer, but we must not forget the bigger picture. More than half of people receiving a cancer diagnosis will now live 10 years or more; 96% of women diagnosed with breast cancer in England will live for a year after their diagnosis; 86% will live for five years; and 81% are predicted to live for at least 10 years. Improving outcomes for all cancers remains a priority for this Government.

Our mandate to the NHS sets out an ambition to make England one of the most successful countries in Europe at preventing premature deaths from all cancers, and we are working to achieve this through the implementation of the most recent England cancer strategy. As the hon. Member for Bristol West (Thangam Debbonaire) said, early diagnosis and prevention are essential to achieving that aim. The new faster diagnosis standard will speed up the diagnosis of all cancers. The new standard aims to ensure that every patient referred for an investigation with a suspicion of cancer is diagnosed or has cancer ruled out within 28 days. It is also important that we support further clinical research, as this can have a considerable impact on cancer survival rates, and that is exactly why the National Institute for Health Research spent £142 million on cancer research in 2015-16. And of course we must not forget the vital research carried out by the cancer charities, supported by the millions of pounds donated by members of the public each year.

The Government fully understand how important it is that people affected by cancer are able to access new and promising drug treatments, and we firmly believe that clinically appropriate drugs that are established as cost-effective should be routinely available to NHS patients. We all know that these decisions, which can be fiendishly complex, are never easy. We also know from long experience in this place that they should not be made by the arbitrary interventions of politicians. They must be clinically led and made on the basis of the best available evidence. They must also be frequently reviewed when new evidence comes forward. That is why it is right for NICE to play that role in providing independent, evidence-based guidance for the NHS on whether significant new drugs represent a clinically effective and cost-effective use of NHS resources.

If a drug is recommended by NICE, the NHS is legally required to fund it, and over the years many thousands of people in England have benefited from the cancer drugs that NICE has recommended. Those include transformative drugs for cancer, such as Herceptin for breast cancer, pembrolizumab for skin cancer and Zytiga for prostate cancer. Unfortunately, although we would all wish it were not the case, there are cancer drugs that NICE is not able to recommend as clinically effective and cost-effective on the basis of the available evidence, which is exactly why the Government established the cancer drugs fund in England. Since October 2010, we have invested more than £1.2 billion in the CDF, which has helped more than 95,000 people in England to access life-extending cancer drugs that would not otherwise have been available to them.

In July 2016, as colleagues will know, NHS England and NICE introduced a new operating model for the CDF that builds on that and ensures that it is placed on a more sustainable footing for the future. The new operating model is designed to achieve three key objectives: to make sure that patients have faster access to the most promising new treatments; to make sure that taxpayers get good value for money on drug expenditure; and to make sure that pharmaceutical companies are willing to price their products responsibly and can access a new fast-track route to NHS funding for the best and most promising drugs.

As part of the transition to the new operating model, NICE is looking at whether drugs that were previously available through the fund should be funded through baseline funding in the future. NICE has recently been able to recommend two of these drugs for breast cancer, Halaven and Afinitor, as well as a further breast cancer drug, Perjeta. These drugs will now be routinely available to patients. NICE was able to recommend each of these products by taking into account patient access schemes, a mechanism by which companies can improve the cost of drugs to the NHS.

As we are discussing today, NICE also reappraised Kadcyla. As the hon. Member for Mitcham and Morden rightly explained, NICE consulted on the draft guidance but was not able to recommend the drug for routine use because it is too expensive for its benefits. As my hon. Friend the Member for Milton Keynes South (Iain Stewart) rightly said, it is important to stress that NICE has not yet issued its final guidance on Kadcyla and will take stakeholders’ responses to the recent consultation fully into account in developing its final recommendations, which allows time for further negotiation between NICE and Roche. That is why today’s debate has been of value.

I fully appreciate that this is an anxious time for women with breast cancer, but I hope that all here today will appreciate that these are difficult decisions and that NICE must be able to make them free from political interference. I assure the House that, regardless of the appraisal’s outcome, NHS England will continue to fund Kadcyla through the CDF for all patients who have already begun treatment.

The hon. Member for Mitcham and Morden and others raised the importance of access to bisphosphonates for breast cancer patients, as well as the general use of off-patent drugs. The use of off-label and off-patent drugs is common in clinical practice, and there is no regulatory barrier to their prescription. NICE often considers off-label and off-patent drugs in guidance and issues advice to clinicians on new off-label uses of drugs.

The hon. Member for Torfaen (Nick Thomas-Symonds) made an important and informed speech on the issue that proved, in just over 10 minutes, exactly why he is the chair of the APPG. He is right that progress needs to be made in this area. The working group is about to review its latest progress in the next month, and I will certainly take up the issues that he raised with my colleague, the noble Lord O’Shaughnessy, who is responsible for this policy area. I will ask him to respond, especially on sharing the working group’s progress and providing an update regarding the publication of the “British National Formulary”, which the hon. Member for Wythenshawe and Sale East (Mike Kane) also mentioned.

The hon. Member for Torfaen would perhaps like to know that the Association of Medical Research Charities is also working with the Department of Health to facilitate and improve take-up of new robust research findings on repurposed drugs, where appropriate for the patient. I suspect he already knows that, however, given the nature of his speech.

For other colleagues who intervened on this point, bisphosphonates are medicines that are primarily used to prevent or treat osteoporosis. As colleagues clearly know, they are also used for a number of other medical conditions, including reducing the risk of primary breast cancer. That is based on the research in The Lancet in 2015, which found that bisphosphonates can be used to help women who are being treated for early breast cancer after the menopause by reducing the risk of the breast cancer spreading to the bone by 28%.

Bisphosphonates are not licensed for the treatment of breast cancer, but because there is good research evidence that supports their use, they can be prescribed to patients for that purpose when prescribers consider that that meets their clinical needs. There are concerns that access to bisphosphonates and their prescription is variable and that there may be some confusion at a local level as to who is responsible for commissioning them for such use, so I am happy to share NHS England’s advice on these points. While NHS England is, of course, responsible for commissioning specialised services, the manual for specialised services makes it clear that the decision to prescribe bisphosphonates for breast cancer rests firmly with the clinician and patient, subject to funding from the relevant clinical commissioning group.

Members may also be aware that NICE is updating its guideline on the diagnosis and management of early and locally advanced breast cancer. The use of bisphosphonates will be considered as part of the update. The revised guidance is due in 2018. Given the concerns about prescription, my officials have spoken to NICE about the timescale for the guideline, and I am pleased to say that NICE is looking at the feasibility of bringing forward the recommendations on the adjuvant use of bisphosphonates. It will of course be important to consider what the implications might be for the timescale for the remainder of the guideline. I am happy to keep the House updated on that decision.

The Government are not complacent about the availability of breast cancer drugs, and we continually look for measures to drive greater access to innovative new technologies. That is why the Government commissioned the independent accelerated access review, as mentioned by the right hon. Member for North Norfolk (Norman Lamb). Its final report in October set out how the UK can accelerate access to innovative cost-effective drugs, devices and diagnostics for NHS patients and create a more attractive environment for innovators and investors. The Government will respond to the review in the spring, but I acknowledge that NICE must continue to evolve to adapt to changes both in the development of new drugs and in the health and care system. Given the time, and if it is all right, I will respond on some of the details in writing to the hon. Member for Mitcham and Morden. We will continue to work with NICE to ensure that its methods remain fit for purpose.

We must remember that improving outcomes for cancer patients is not just about drugs. That is why we accepted all 96 recommendations in the independent cancer taskforce’s “Achieving world-class cancer outcomes” report. The recommendations represent a consensus of the whole cancer community on what is necessary to transform cancer care across the whole cancer patient pathway, from prevention and early diagnosis to living with and beyond cancer, including dealing with side effects, as was mentioned so movingly by the shadow Minister. We are implementing that through a strategy that was published in May and we hope to see great progress as it is delivered. As was made clear in the speeches of so many in the Chamber, breast cancer affects many people in this country today. We continue to invest so much in cancer services so that more people survive cancer and more people live better with cancer. To do that, they need rapid access to more effective treatment, be it surgery, radiotherapy or drugs. That is what I want to see and that is what this Government will deliver.

I am sure that the whole House will join me in congratulating all who have fought and survived breast cancer. We want to stand alongside everyone who is living with a breast cancer diagnosis, battling treatment and living with the sometimes hidden day-to-day impacts of breast cancer. We remember all those who fought valiantly but lost the battle with breast cancer. We have made much progress in improving care, providing drugs and funding research, but there is much more that we can and must do to fight this disease. I hope that each and every Member here will do what they have been doing today and hold the Government to account as we move on and try to do just that.