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.
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?
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.
I congratulate the hon. Lady on securing this important debate. Does she share my concern at news that the Government appear to be ready to leave the European Medicines Agency following the Brexit vote? Many people fear that that will lead to a slowdown in access to new medicines. She talks about the importance of NHS patients getting access to medicines; this could make the situation worse and leave us disadvantaged compared with other countries in Europe.
Breast cancer knows no boundaries, whether class, social or geographic. Anything that reduces access to better forms of treatment is detrimental.
The ability to lead an enriched and longer life as a result of medical advances should not be limited only to those who can afford private healthcare. Those advances should be accessible to us all. This debate will focus particularly on the provision of the breast cancer drug Kadcyla, which is under threat. Most Members will be aware of the lease of life that Kadcyla has brought to thousands of women in England with incurable secondary breast cancer. These women rely on Kadcyla to enrich their lives and to give them extra precious years to live. Indeed, in many ways it is a revolutionary drug. By targeting cancer cells directly, it helps to reduce the number of side effects, boosting women’s quality of life immeasurably. Members who have heard these women talk about their experiences will be humbled to learn of the distress and despair that they face as a result of NICE’s decision to provisionally reject the future use of Kadcyla on the NHS.
Today we are all supporting Breast Cancer Now’s “Keep Kadcyla” campaign to encourage NICE to reverse its decision and enable continued access to the drug, which both improves the quality of life and extends the lives of thousands of women in this country, on the NHS. Since NICE’s decision was announced at the end of December, thousands of people throughout the country have had their views heard. They have signed the petition and contacted their local MPs to ask that we do not give up on women, on the children who are dependent on mothers, and on the families who want that precious extra time with their loved ones. That is why we are all here today: to raise our collective voice in support of these women and defend the treatment that allows them to live their lives.
The focus of much of what I have to say today will be on Kadcyla, but we also need to consider other specific breast cancer drugs, as well as the broader issue of how decisions about access to treatment are made. Unfortunately, we are yet to see any improvements in access to off-patent drugs, some of which can prevent the development of certain cancers, thereby saving countless lives, as well as saving the NHS a great deal of money. Just a few months ago, the front pages of national newspapers highlighted the poor access to vital bisphosphonate drugs, which can prevent women from developing secondary cancer, yet the Government have barely acknowledged the problem of access to such treatment. I look forward to hearing from the Minister about when we can expect tangible results regarding access to off-patent drugs, including bisphosphonates. To be clear, many of the women who today owe their lives to Kadcyla might never have developed secondary breast cancer had they had access to bisphosphonate drugs in the first place.
I will discuss off-patent drugs in my own speech, but on bisphosphonates, which are in the category of repurposed drugs, is my hon. Friend as concerned as I am about the results of the UK-wide survey undertaken by the UK Breast Cancer Group in March last year, which showed that currently only 24% of breast cancer clinicians are offering bisphosphonates to patients? That is something that the Government could urgently address.
I completely agree with my hon. Friend and hope to say a little more about that later in my speech.
This debate is about not just Kadcyla, but the lives of the thousands of women who rely on it to survive, so I want to share the words and experiences of two of my friends whose lives have been transformed by having access to Kadcyla. One of my friends is present today—I went to primary school with her, but I shall not tell the House just how many years ago that might have been. Her name is Samantha, and she said:
“When I got the breast cancer diagnosis, I glibly thought—oh it’s OK I’ll get cured, but sadly about 18 months ago I found out that this wasn’t the case and my cancer had spread to my liver. And that’s when I really knew that my cancer meant business!
And that is where Kadcyla comes in. You see for breast cancer, although I coped and kept going with surgery, chemo and radiotherapy, it was grim. I worked a bit, but regular chemotherapy is not a doddle. Exhaustion and hair loss is just the least of it.
Putting on a brave face and wearing a wig is just a surface issue, getting up vomiting and going to work to deal with the VAT is about the hardest thing I have ever done. It wasn’t simply because I don’t have enough sick pay at work to cover my mortgage, I actually like work—work allows me to make my contribution, and I think that’s pretty near the most important thing, making my life make a difference. And Kadcyla? Well that means that my life isn’t over, it really gives me hope.
There is a big hole where my 45 mm tumour used to be in my liver, and scar tissue and other bits, but I am cancer free without having to take another year off my life. My work is precious; I have kept the business going. Eight people are employed, because I could keep going, and Kadcyla made it possible for me.”
I congratulate my hon. Friend on securing this debate. She certainly makes a powerful speech on behalf of her friend. Does she agree that when NICE looks at the cost-value ratio, stories such as that of her friend, who kept eight people in work, should also be a factor? We should be looking at women’s economic life and economic role, in both the workplace and the home.
I completely agree with my hon. Friend. I appreciate that the equations and calculations are difficult, and I do not underestimate NICE’s work, but it is about life and quality of life, and it is about so many more people than only those who have the cancer.
My friend Leslie said:
“In 2013 my world was turned upside down when I was diagnosed with inflammatory breast cancer, a rare and aggressive kind of cancer that develops in the lymph vessels.
After 15 months’ treatment comprising 8 chemotherapy treatments, a mastectomy, 15 radiotherapy treatments and a year of Herceptin, it appeared that the cancer had gone. However, 4 months later I noticed a rash around the scar tissue of the mastectomy and a biopsy showed that the cancer had recurred in my skin.
My oncologist told me that I was in a very tight corner. Because the cancer had returned so quickly I wasn’t eligible for the usual drug treatments, radiotherapy wasn’t an option because I had recently completed a course, and surgery wasn’t possible because of the location of the cancer. I was told the cancer was incurable and referred to the Royal Marsden. They confirmed that surgery was not feasible because the cancer had spread so quickly over a large area making skin grafts impossible. I was told Kadcyla was my best chance.
I have now been treated with Kadcyla for 22 months and I have been told of others that have been treated for 5 years. Signs of the cancer disappeared very quickly and so far I have remained cancer free. Kadcyla has enabled me to live a reasonably normal life and participate in and contribute to my local community. Kadcyla has been a life saver for me and without it my future was very uncertain. I feel profoundly fortunate to have received it and I am incredulous that such an effective drug will now be denied to other people in my situation.”
I also wish to mention Rosalie, who was featured in Friday’s Evening Standard. She is just 33 and is living with incurable breast cancer. She is a single parent to two children, aged three and six, and is terrified of a future without the option of Kadcyla and terrified of her kids’ growing up alone. These are Rosalie’s own words:
“I hate feeling like a victim. But I have to fight for my kids. They are more important than me feeling vulnerable about going public. I have to fight for life for them.”
Then there is Mani. Members may have seen her last week on the “Victoria Derbyshire” programme when she spoke so eloquently about how Kadcyla had given her hope. She said that it had improved her life both significantly and quickly, enabling her to live a much fuller and richer life, going on holiday and playing an active part in her young daughter’s life.
These are just a few of the many women whose lives have been made possible through access to Kadcyla. I am sure that many hon. Members will share the experiences of their constituents. The hon. Member for Croydon South (Chris Philp) will no doubt talk about the incredible Bonnie Fox, the face of the Keep Kadcyla campaign of Breast Cancer Now. Thanks to the hard work of Bonnie and of Breast Cancer Now, this campaign has seen more than 100,000 people sign the petition, calling for NICE and Roche to come together to reassess the decision and find a solution to keep Kadcyla available.
Bonnie is an incredible advocate for the Keep Kadcyla campaign, inspiring so many others as she leads the case for this treatment. Bonnie says that her inspiration comes from wanting to have as much time as possible with her two-year-old son, Barnaby. These are her own words:
“I already feel cheated being diagnosed with secondary breast cancer at 37 with a baby, so having a drug taken away that would potentially add years to my life and give me more quality time with my son is so cruel.”
I am really grateful to the hon. Lady for giving way again. She will be aware that the Government’s accelerated access review last October recommended that NICE should review its whole health technology assessment processes and methods. Is she concerned that the review of Kadcyla and other drugs under the cancer drugs fund is happening before that review takes place? We might learn the lessons about how the review process needs to improve, but we will not benefit from them.
I agree with the right hon. Gentleman. I am sure that he knows more about this process than I do. It clearly makes sense to consider these unique, unusual first-tier drugs in the light of that reconsideration.
I hope that we will hear the stories of the many women whose lives, having been affected by secondary breast cancer, have been enriched by Kadcyla. The drug Kadcyla matters so much to all these women for one simple reason: it works. It is effective. It has already been available on the NHS for more than two years and, compared with other treatments, its side effects are limited. Today, it is nothing short of a tragedy to know that countless women who thought that Kadcyla would be the next treatment they would receive for their breast cancer are having their lives shortened before their eyes.
I ask Members to imagine this: they are living with breast cancer; there is no cure, but there is something that could give them extra time with the people they love—the people who depend on them. It could be a year, five years or even longer. If they needed the drug today, the NHS would give it to them, but if they needed it in a few months’ time, they may have lost their chance.
My hon. Friend is making a very powerful speech. May I congratulate her on securing this debate, and say how proud I am to be a co-signatory? The phenomenon of there being drugs in the pipeline that would make a vital difference to patients, but which are being held up by conflict between NICE and pharmaceutical companies over pricing or value for money, applies not only to breast cancer but to other cancers, too. My constituent David Innes is one of 20,000 sufferers of chronic lymphocytic leukaemia. He was diagnosed in 2009, when he was 39. He was in Parliament earlier this week, making the same argument, and saying that both parties need to end the logjam and come up with a deal to ensure the availability of these drugs. They need to put patients first. Life is too short not to do so.
I completely agree with my hon. Friend. I wish her constituent, David, all the best.
How can we withdraw a drug from the NHS that is working, especially when we are offering nothing in its place? It seems senseless to me, and it is truly devastating to those for whom it really matters. Of course, as my hon. Friend says, Kadcyla is just one drug that we need to look at. What will happen with other key breast cancer drugs now and in the future? I wish to consider just two more examples. Perjeta is currently available through the cancer drugs fund, but unlike Kadcyla it has not yet been re-appraised, although it will be soon. Perjeta is used for HER2 positive secondary breast cancer patients. In many ways it is even more effective than Kadcyla, as it enables women to live for an additional six months without their breast cancer progressing, and can extend life by an additional six months or more. However, because it is administered with two other drugs—Herceptin and Docetaxel—it would not be considered cost-effective under NICE standards even if the drug manufacturer gave it away for free.
The other drug is Palbociclib, which is used on women with hormone receptor positive and HER2 negative breast cancer. It is a new drug, which is being assessed for the first time by NICE. It is extremely effective and enables women to live for at least an additional 10 months without their breast cancer progressing. However, because women are living longer, robust overall survival data are not yet available. Perversely, that will count against it in the NICE appraisal. Overall survival data are given greater weight than progression-free survival in NICE appraisals, despite the fact that the outcome is the same—a longer, more enriched life.
We are seeing effective treatment after effective treatment being rejected or facing rejection by NICE. I want to know this: is it really right that we have a health service that plans to take away those lifelines? How is the decision to take away these life-extending drugs beneficial for people living with cancer, or for any of us who might one day need access to them? Who makes these decisions, and how can we be sure that they are the right ones?
We have a drug appraisal process, which is certainly valuable and necessary, but I question the factors that constitute that process. It is too easy to assume that the experts must automatically be right. The process is: numbers in, formula used, and then a yes or no answer. Let us not forget that we are talking about people’s lives. The lives of those affected and those for whom this decision is all too real are in the hands of a formula—the NICE appraisal process—and yet this life-changing formula has had little examination for many years. How many of us actually understand what factors are taken into account in these life-or-death decisions? The drug Palbociclib is proving so effective that, at present, it only has data on how long people are living without their breast cancer progressing.
Does my hon. Friend agree that the fact that that drug is routinely available in France, Germany, Austria and Canada shows that our appraisal system is not working in this country.
I agree with my hon. Friend. It is amazing to think that, for this particular drug, it will take longer to get overall survival data because people are living longer without their cancer spreading. That obvious success is seen as a big disadvantage in the NICE appraisal system. The cost of Palbociclib will appear to be much higher in the NICE formula because overall survival data are given much more weight than progression-free survival. That seems illogical to me.
Consider also the criteria for determining end-of-life treatment. If a treatment is end-of-life, it is allowed double the quality-adjusted life year costings of other drugs. End-of-life is considered to be two years, but why not three? How have we ended up with such an arbitrary, fixed figure, especially when the figure in Scotland is three years? There is no cure for secondary breast cancer, but as people start to live longer it will place them at a disadvantage when accessing treatments, because it will be harder for those treatments to become approved, as they are no longer considered under the end-of-life criteria.
Therefore, how can the Minister be sure that the NICE process is still fit for purpose? Will she respond specifically on two suggestions: first, to review the weighting for progression-free survival when overall survival is not available because a treatment is so effective; and secondly, to change the criteria for end-of-life treatment to three years’ survival instead of two?
I want to return to the issue of off-patent treatments. In recent years there have been two private Members’ Bills on the topic, one of which was introduced by my hon. Friend the Member for Torfaen (Nick Thomas-Symonds). We heard many commitments from the then Minister for Life Sciences, but we have not yet seen any improvement in access, which is hugely disappointing. The Minister committed to establishing a working group to investigate what could be done to enable the routine use of such treatments. I believe that the working group is due to conclude its work next month and publish its report. Will the report introduce a clear pathway for off-patent treatments, and will the Minister write to me with the details of the pathway and state explicitly how it will work for bisphosphonate drugs for the prevention of secondary breast cancer?
Breast Cancer Now and others have been disappointed by the extremely patchy availability of this treatment for eligible women. As a result, it recently launched the “43p a day” campaign to highlight the low cost of the treatment and the fact that it would save over 1,000 lives every year in the UK if it was routinely available, not to mention millions of pounds for the NHS.
I congratulate the hon. Lady on securing the debate. I want to put on the record my support for the case she is making and draw the House’s attention to the case of my constituent Bonnie Fox—she is in the Gallery today—who is suffering in the way the hon. Lady has described, and whose life chances would be greatly improved if something more could be done to preserve the availability of Kadcyla. I once again express my support for the case the hon. Lady is so eloquently making.
I thank the hon. Gentleman. He is very lucky to have a constituent as exceptional as Bonnie Fox, who has already been mentioned because of all her work.
As a result of Breast Cancer Now’s campaign, the Minister has said that clinical commissioning groups are responsible for commissioning the treatment for bisphosphonates. What contact has been made with CCGs on the use of this treatment in these circumstances? As I understand it, the treatment presents a challenge to existing commissioning arrangements because it does not fit squarely into either specialised services, which are commissioned by NHS England, or local commissioning by CCGs. Does the Minister agree that if we want genuine progress on the availability of this treatment, we cannot take the path of least resistance and just say, “It’s up to CCGs; CCGs are independent bodies and can make their own decisions.” That is the “do nothing” option.
Treatments do not always fit into the neat categories that we create. This is an old treatment that requires a new approach. It requires our commissioning strategists at NHS England to make a considered decision about how to commission the treatment routinely. Will the Minister agree to meet Ian Dodge, the national director for commissioning strategy, to discuss this specific case with him and will she keep Members here today updated on those discussions? Will she also agree that it is indeed worrying that a treatment that could prevent over 1,000 women getting secondary breast cancer every year is not routinely available?
Finally—I think that everybody will be delighted that I am about to finish—I hope that the Minister will consider meeting some of the women affected by the decision on Kadcyla and the women from Breast Cancer Now who are here today. I would like to thank those women in the Public Gallery for coming here to show their support for this debate en masse. I wish every single one of them well. Access to life-enhancing and life-saving drugs should be a right in the UK, not a decision based on a lottery of access to private healthcare. I sincerely hope that NICE will reverse its decision and give every woman with secondary breast cancer their future back.
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.
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.
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.
I agree, because it is not only about the drugs we are debating today; we have had problems before in relation to NICE. In answer to the question from the right hon. Member for New Forest West (Sir Desmond Swayne), I think that the Minister should look at the procedures and at NICE itself, because otherwise we will keep coming back to this issue time and again. The years I have spent listening to the same issues with different drugs is nobody’s business, to use an expression.
The hon. Gentleman makes an important point. I do not pretend to be an expert on how NICE works, but I hope to bring to the debate the personal experience of my constituent and underline the human effect of these issues. I do not necessarily have a solution, but I hope that the outcome of the debate will be that we not only consider Kadcyla, but take a fresh look at the whole process.
The NICE framework works very well for mass drugs for the entire population or where a whole vaccination is going to work, but for very small numbers of people, such as the 1,200 women who really need this drug, I do not think it is as effective a process. There are two organisations in this negotiation, NICE and Roche, and we must not have Roche seeing its new drugs Perjeta and Kadcyla as a new cash cow as Herceptin goes off-patent in 2017-18. Women’s lives should not be treated as cash cows by this drugs company.
I agree with the hon. Lady. I have not had any personal discussions with Roche; I can only refer to and take at face value the briefing note that it sent me early this morning, which seemed to represent a genuine wish to negotiate with NICE and get the drug down to an acceptable price. I hope the debate is joined in that spirit.
Perhaps it is appropriate to mention now something I was going to bring up later in my speech: one area that needs to be examined is the pharmaceutical price regulation scheme, which is a five-year voluntary contract between the pharmaceutical companies and NICE. If I understand how it is intended to work, the pharmaceutical companies will underwrite any overspend for a particular drug. For various reasons that does not seem to be working in practice. I urge my hon. Friend the Minister to look at that point, which has been made by some in the industry.
In the case of my constituent, Mrs Mears, when her current medication ceases to be effective, Kadcyla is the only option. Although she has responded well to the current treatment, there is every likelihood, and her consultant agrees, that she will respond in a similarly positive way to Kadcyla. There is every chance that she would enjoy the benefits of that drug for a time well in excess of the expected nine months. I would therefore argue that a blanket ban on the drug would be inappropriate. At the very least, there should be some flexibility in the system to make the drug available to people such as my constituent, for whom there is a very high probability that it would have more than the expected benefit. She has responded so well to her existing drug, and if her life could be extended considerably by Kadcyla, that would allow more research to be done on the efficacy of her existing medication, which would be an important body of evidence to add to the appraisal process.
The hon. Member for Mitcham and Morden rightly said that the prescription of drugs should be based solely on clinical need and no other factor, but when I met Mrs Mears, she made one point to me that I could not really answer. Through her life, she worked professionally in the criminal justice system and has done a lot of work saving the public purse money by innovating programmes to reduce youth offending. That value cannot be calculated, but she made the point to me, “At the one point in my life that I need something back from this country, it is being denied to me.” I really could not give an answer to that. I hope that something can be done to make the drug available.
The NICE decision is provisional. I contributed to the consultation and I hope that when NICE meets next—in, I think, early March—it will review the decision.
I know that NHS resources are finite and that there are many competing demands on its budget. The debate on the overall size of the NHS budget must be a matter for another time, but cases such as this illustrate the need to use what resources we have as efficiently as possible. Just before I met Mrs Mears the other week, I happened to see a story in the media that really made my blood boil. I do not pretend to be an expert on the prescription system, but I simply put this on the table. The story reported that the NHS wastes about £80 million per annum by prescribing simple painkillers such as paracetamol, which can be bought in a supermarket for 20p or 30p a packet. Those prescriptions go through the usual prescription system and cost £80 million a year. Surely there is a way of getting around that, perhaps by giving GP practices a stock of basic painkillers. I am not asking for people who get free prescriptions to start paying but, surely, there is a way for doctors to issue them when it is appropriate to do so, and stop this merry-go-round of paperwork that costs many millions of pounds.
The hon. Gentleman is making a very valuable point. Does he agree that one way around this issue would be to have prescribing pharmacists who could give out medications such as those basic painkillers, without the need for the patient even to see their GP, which would also free up valuable GP time?
That sounds an eminently sensible suggestion. As I say, I do not pretend to be an expert on the system, but, surely, something like that could be done. Then the money saved could be added to the cancer drugs fund and make more drugs such as Kadcyla available to people who need them.
I will end my comments, as I know there are many Members who want to contribute. Please let us try to do everything we can in this House to encourage NICE and Roche to look at the overall system and to look in particular at this drug. It means so much to my constituent and to many others up and down the country. I hope that this debate has that effect. I conclude where I started, by congratulating the hon. Member for Mitcham and Morden on securing it.
I begin by thanking the Backbench Business Committee for selecting this very important topic for debate this afternoon. I pay tribute to my hon. Friend the Member for Mitcham and Morden (Siobhain McDonagh) for the passionate but very thoughtful way in which she introduced the debate. I endorse everything that she said. On the drug Kadcyla, she said, quite pithily, that, first, it works and, secondly, it has far fewer side effects than many other cancer drugs. I was also very proud to have backed the “43p a day” campaign that she mentioned.
I declare an interest as the chair of the all-party group on off-patent drugs and should also say that one of my first actions as a Member of this House in 2015 was to become a breast cancer ambassador. I was very proud to do that, as the person who inspired me to come into politics, my grandmother, died of the disease some years ago.
I was lucky enough in my early months in this House to be drawn in the ballot for a private Member’s Bill. I introduced the Off-patent Drugs Bill, and although it was talked out in quite controversial circumstances on 6 November 2015, I was none the less pleased after that to work on a cross-party basis to achieve legislative progress. I pay tribute to the hon. Members for Central Ayrshire (Dr Whitford), for Bury St Edmunds (Jo Churchill) and for Daventry (Chris Heaton-Harris), and to the former Minister for Life Sciences, the hon. Member for Mid Norfolk (George Freeman), for the work that was done in those months to make legislative changes which were incorporated in the Access to Medical Treatments (Innovation) Bill, which received Royal Assent in March last year.
I want to come to the pledges that were made on 29 January 2016 and how things have moved forward since. I say to the Minister that in setting out a number of questions about this matter, I do not necessarily expect them all to be answered in detail in her closing remarks. If there are aspects that she feels she cannot answer in detail, I would be grateful if she wrote to me about them after the debate.
On 29 January 2016, I and others in the House tabled a package of amendments to the Access to Medical Treatments (Innovation) Bill. Some were substantial and went into the Bill. Others were probing amendments designed to extract the promises that I have talked about. The then Minister for Life Sciences said:
“Broadly, the intention of the package of amendments is to introduce off-label repurposed medicines in the Bill, and to put it four square at the heart of the agenda.”
That is precisely what we sought to do that day. He added:
“I wholeheartedly supported the intention of his Bill and its predecessor, but not the mechanism. We now have a mechanism that will work”—
we had spoken that day about the mechanism.
One of the amendments requested an action plan, but the Minister decided he did not want that on the face of the Bill. However, he said:
“let me set out my commitment and that of the Government to pursuing this agenda with time and rigour.” —[Official Report, 29 January 2016; Vol. 605, c. 543.]
I remember very well my hon. Friend’s Bill and the shameful way it was talked out by the professional filibusterers on the Government Benches. However, does he not agree that any action plan needs to look at these things in the round? It should look at the poor post-diagnosis support and information that patients get across other types of cancer, not just breast cancer. It should also look at the limited availability of the effective drugs we have talked about, which do not have side effects, and at the fact that drugs have been de-listed from the Cancer Drugs Fund.
I certainly agree that the pathway has to be comprehensive, and I will come back to it in a moment.
In addition that day, the then Minister for Life Sciences said he would
“explore mechanisms for ensuring NICE can look at evidence and develop evidence-based guidance on off-label medicines, so that doctors are aware of which drugs are being used in an off-label indication…NICE is now looking at ways to collect evidence on repurposed medicines.”
He spoke about the “British National Formulary”, and I am pleased about the progress that has been made on it, which I will come back to in a moment.
We proposed—this would have applied to NHS England—that there should be a new system of national commissioning for repurposed drugs. Again, our amendment was not accepted, but this pledge was given:
“The NHS is hungry to look at all options for promoting off-label and repurposed drug use.” —[Official Report, 29 January 2016; Vol. 605, c. 544-45.]
I hope that that pledge can be repeated by the Minister at the Dispatch Box today. There was also a commitment to consult all relevant stakeholders. Again, I would hope that that is fairly uncontroversial and can be repeated.
Let me come now to where we have got to. When I intervened on my hon. Friend the Member for Mitcham and Morden, I quoted the worrying statistic about bisphosphonates, which really do provide a case in point. They are used to treat osteoporosis, but they are very effective in their secondary form—the repurposed form—where someone has primary breast cancer, and they certainly help to prevent that from spreading to the bone. The statistic that only 24% of clinicians are prescribing bisphosphonates is very worrying, and it does need to be addressed, because there should be no barrier in the system to their being far more widely prescribed than they are.
Let me come to the working group. I understand that it will conclude at the end of next month. I am very grateful for the fact that I will be meeting officials from the Pharmacy and Medicines Directorate in the next few weeks to discuss this issue. However, if there is to be a pathway, I would appreciate it if the Minister was prepared to share it with me in draft form before that meeting, so that comments could be made on it, particularly going back to the pledges made last year.
The “British National Formulary” has begun work. Indeed, I looked up bisphosphonates specifically on BNF Online before I came to the debate. What makes the 24% statistic even more worrying is that BNF Online says:
“The use of bisphosphonates in patients with metastatic breast cancer may reduce pain and prevent skeletal complications of bone metastases.”
That is there already—it is in the prescriber’s bible, if you like—so the Minister really should focus on why it is not filtering through the system in the way that it should.
In addition, there is a pilot licensing scheme that brings together medical research charities and generics manufacturers to license off-patent drugs for their new purposes. If the Minister could comment on whether she is looking for that to become a fully fledged scheme, that would be helpful.
The scheme is an interesting development, because my Bill, in its original form, would actually have put a duty on the Secretary of State for Health to seek licences for drugs in their new indications, and that was the bone of contention between me and the then Minister, who thought that it was too onerous for the Secretary of State to have that duty.
Looking back at that debate, I think the other interesting thing is that a point was made about the EU’s licensing scheme. It was said that any changes could run a coach and horses through that scheme, but given that we will not be members of the European Union by the end of this Parliament, I would be interested to hear how the Minister thinks the end of the Brexit process will affect this issue. If the European licensing scheme was seen by the Minister at the time as posing something of a problem, perhaps she can tell us if she will consider whether the pilot licensing scheme can now become fully fledged and how she sees things developing here in the UK without the European scheme.
I appreciate that I have put a lot of points to the Minister. As I said, I am perfectly happy for her to write to me about them. However, we should not forget the difference that this off-patent drugs agenda can make to people’s lives. Those who face this disease show incredible bravery. For example, we have my hon. Friend the Member for Bristol West (Thangam Debbonaire) in the Chamber with us, and Bonnie Fox, a constituent of the hon. Member for Croydon South (Chris Philp), is in the Public Gallery. We in this House, as legislators, owe a duty to all who suffer from this terrible disease to take all possible steps to make what are extraordinarily cheap drugs as readily available throughout our country as possible.
It is a pleasure to speak in the debate, and I congratulate the hon. Member for Mitcham and Morden (Siobhain McDonagh) on securing it. I was really honoured to be able to back the application to the Backbench Business Committee. I also thank her for her powerful speech, which was very moving.
Fighting cancer is not just a top priority for the NHS but one of the great scientific challenges of our time. Treating our illnesses with science rather than superstition is a relatively new idea in the history of medicine. However, the acceleration of better diagnosis, better treatment and more successful outcomes is keeping more of us alive for longer, and with a better quality of life.
The motion mentions Kadcyla, a treatment that NICE is not currently able to recommend for the treatment of secondary breast cancer, and we await the result of its consultation in March. This treatment is a relative of another medicine, which, in its introduction, was also extremely controversial—Herceptin. After a lot of consideration by NICE and a lot of debate and pressure from this House, Herceptin was approved. It has helped thousands of people—men get breast cancer too—in fighting breast cancer.
Kadcyla is a treatment that could help women who have already been on an Herceptin-based treatment and whose cancer has continued to advance. We must be clear when we talk about secondary, or metastatic, cancer that we are talking about people whose lives will be massively shortened by cancer. Kadcyla gives them and their families more time and a better quality of life. It can add months to the life expectancy of patients whose remaining lives are likely to be measured in only a few months. The hon. Lady movingly talked about some of her friends and some of those in the Public Gallery.
I think we all understand that there are ultimate financial constraints on the NHS, even though spending on it has increased. I really welcome the new cancer drugs fund, which provides patients with much better access to the most promising new cancer treatments, while providing value for the taxpayer.
I was profoundly moved by the case of my constituent, Rosalie Marshall, who sadly is suffering from breast cancer. She told me that she finds it hard to understand why the NHS can spend such significant sums on conditions which, frankly, are not life-threatening and sometimes seem to verge on the cosmetic, and yet not give priority to vital drugs like Kadcyla. Surely something is wrong, and savings could be made in other parts of the NHS that would more than pay for Kadcyla.
Yes, I also get emails on the same subject. We have to remember, though, that there are other considerations such as mental health conditions. Sometimes people do not quite understand why money is being spent on various parts of the NHS, but there are always other reasons behind it. However, I totally agree with my right hon. Friend about drugs like this which seem to make such a difference.
In the case of Kadcyla, there do seem to be questions as to why it cannot be brought into regular use. Some of those questions are for NICE and some are for the manufacturer. Kadcyla is a treatment that has been accepted by a number of European countries, despite the expense. I am reassured to see that many cancer charities accept that NICE has made every effort so far to fund it, and that NICE has been doing its best. However, there remains the question of how NICE’s apparent final position stands up by comparison with other European countries—France and Germany, for instance. France’s equivalent of NICE considered Kadcyla in exactly the same way as NICE has, and has approved it.
Another query is based on the choice of comparator treatment in assessing the quality of Kadcyla as a treatment. There have been concerns that the comparator treatment—Lapatinib and Capecitebine; I hope that Hansard will be able to report that rather better than I can say it—is no longer available on the NHS. The drug’s manufacturer carries the comparison on its own website, with the outcome of a clinical trial codenamed EMILIA. However, it does not seem realistic to base a decision on a drug on a comparison with another drug that is not available on the NHS either. It would help everyone to understand the comparison if it was made with a drug that is generally available.
Can the Minister tell us the status of Roche’s study under the name ESTHER, which is looking at Kadcyla? In the event that NICE does not revise its decision now, will it be open to it to do so when it gets the ESTHER conclusions? That trial is not scheduled to report until 2023, so the immediate concerns about availability remain. However, I recognise that research goes on constantly, and that perhaps the manufacturer will reconsider its position. It is unfortunate that NICE has been subjected to sustained attacks by the manufacturer, Roche, which has risked undermining NICE’s reputation in a most unjustified way. I call on Roche to get round the table with NICE and look again at the pricing of this drug, as it has done with others in the past.
Turning to other treatments, I know that the message is going out to clinical commissioning groups about the options available. Many Members will have had campaign emails relating to bisphosphonates, and I was reassured by the response I had from the Department of Health and the Portsmouth clinical commissioning group that they are being made available. Queen Alexandra hospital in Portsmouth has above-average performance in both treatment times and outcomes, and is becoming, if it is not already, a centre of excellence in cancer treatment.
I know that this is a difficult subject and budgets are limited, but like many others in this House, including those in the Gallery, many of my friends and family have died of breast cancer or are survivors. We need to make sure that we are keeping up with the right drugs to treat them, and that sounds like Kadcyla.
I congratulate my hon. Friend the Member for Mitcham and Morden (Siobhain McDonagh) on securing this debate. She made an extraordinarily powerful and emotive speech. I join her in wishing everybody who is here today in the Public Gallery and everybody who is watching this debate at home all the very best for the future. It is also a pleasure to follow the hon. Member for Milton Keynes South (Iain Stewart), who made a very powerful speech citing the personal testimony of his constituent, whose case he argued eloquently. My hon. Friend the Member for Torfaen (Nick Thomas-Symonds) spoke eloquently about his grandmother being his inspiration for going into politics, and her dying of the disease. We come into politics for many different reasons, the profession of public pain being one. Nye Bevan did not create the NHS in 1948; he created it much earlier when his father died of pneumoconiosis in his arms before the time of the NHS. I hope that I can pronounce the drugs that I am going to mention just as well as the hon. Member for Portsmouth South (Mrs Drummond) did.
We have heard lots of statistics today. Stats, in themselves, are shocking, and it is also important to remind ourselves that behind every statistic there is a human story. The lives of women, all too often young women and mothers, are being cut cruelly short. We have heard many important interventions about access to breast cancer drugs for treatment of secondary breast cancer. At the heart of the motion is also the issue of how we can improve access to innovative new breast cancer drugs and off-patent drugs used for breast cancer. The use of such drugs relates not only to the treatment of breast cancer but to its prevention. I am immensely proud of the fact that my constituency is home to the Nightingale centre— Europe’s first breast cancer prevention centre—and the charity Prevent Breast Cancer. I am a Mancunian MP, so my constituency also benefits from close proximity to the Christie hospital, the largest single-site cancer centre in Europe, treating more than 44,000 patients a year.
The Nightingale centre opened at University Hospital of South Manchester—Wythenshawe hospital—in July 2007. It offers state-of-the-art diagnostic and treatment services to women and men with breast cancer and co-ordinates the NHS breast screening programme for the entire Greater Manchester area. It also provides training facilities aimed at addressing the shortage of breast cancer specialists, and it houses many of the Prevent Breast Cancer researchers who are looking at ways to predict and prevent breast cancer.
In the Prevent Breast Cancer research unit, several drugs that are now out of patent are being repurposed for preventing cancer from coming back. Women with a family history or other factors that make them high risk are known to benefit from these drugs, which prevent the disease. But women in that position find it difficult to obtain these inexpensive, tried-and-tested drugs because they are currently not listed in the “British National Formulary” as specifically licensed for the new purpose of prevention, despite successful clinical trials. There are currently three drugs in that situation: Tamoxifen, Raloxifene and Anastrozole.
Will my hon. Friend give way?
I would be happy to give way, having got the names of those drugs right.
I understand that a new policy is being put together by those in charge of the “British National Formulary”, which will set out how they will get more off-label drugs into the formulary. Does my hon. Friend agree that the sooner that policy is available for us to see the better?
I congratulate my hon. Friend on doing so much work in this area since he came to Parliament. We can only hope that what he says is true; perhaps the Minister can give us more information on that point in her summing up.
The Prevent Breast Cancer research unit has more out-of-patent drugs under investigation for breast cancer prevention which may be even better for the future. As well as doing everything we can to extend the life of women with secondary breast cancer, we must do all we can to prevent breast cancer from occurring in the first place. As we all know, the adage is that prevention is better than cure. For those with secondary cancer, for whom cure is currently out of reach, many people will be striving to achieve that for the next generation.
At the moment, the system is standing in the way. A solution to make those drugs more widely available that would cost very little money indeed would be to ask NICE to list such drugs as approved for the new indication of prevention in the “British National Formulary”—following the evaluation of relevant clinical trials, of course—so that doctors can have confidence in prescribing them. The requirement to obtain a new Medicines and Healthcare Products Regulatory Agency licence for the new indication is expensive and impractical for repurposed medications, because they usually lack a sponsoring pharmaceutical company to champion the new use of the generic drug. I am sure the Minister would agree that such a small change would be transformative in the prevention of breast cancer. I hope that she will ask NICE to consider that change to the way in which drugs are listed in the “British National Formulary” to allow drugs that have been evaluated for a new purpose, such as prevention, to be listed as approved for that purpose.
When we lose someone prematurely to cancer, grief obviously follows. It has been my experience that when we lose someone to breast cancer, the grief is particularly poignant. Tonight, my thoughts and prayers will be with all my constituents who have either succumbed to the disease or are battling it, and with their families who carry the consequences. I lost my cousin Maura Kane to the disease, and my two friends Tom and Claire both lost their mothers to it. I stand in solidarity with my constituent and friend Sheila Higgins, who is battling this disease. She has been like a mother to me for the last two decades. Finally, my parliamentary assistant Suzanne Richards came back to work after Christmas with a clean bill of health. She was diagnosed with a virulent strain last year, but she had world-class treatment at the Wythenshawe and Christie hospitals. Today is her birthday, but it is a birthday that many of us feared she would never see—happy birthday, Suzanne.
I thank the hon. Member for Mitcham and Morden (Siobhain McDonagh) for securing this debate. It is a great pleasure to follow the hon. Member for Wythenshawe and Sale East (Mike Kane). I am sure everyone in the House wishes his assistant a very happy and fulfilling birthday, and many more to come.
Sadly, most families in this country have had some experience of cancer at some point, and we have heard of many compelling examples today. As we debate the difficult topic of the provision of medicines to those who need them, I am very conscious that discussions about prices and the costs of drugs mean nothing, frankly, to the wives, daughters, mothers and grandmothers who simply want to live for the next week, the next month or the next year to see their next birthday or the birthday of a loved one.
I do not underestimate the task facing NICE, but having listened to the speeches today, we must ask why countries such as France and Germany have approved this drug, when NICE drew the initial conclusion it did at the end of last year. I know that the Minister is listening carefully, and I hope that our questions and thoughts on this process will feed into a larger review of how NICE looks at this and other drugs, and of whether the process is as correct and appropriate as it should be. I am a big believer in saying that any system run by human beings can always be made better, and I wonder whether this is such an example.
I want to look at Lincolnshire, the county in which my constituency is situated. I am pleased that we have better than average cancer screening in the county. What worries me, however, is that when it comes to diagnosing the early signs of breast cancer, my local clinical commissioning group ranks third from the bottom in the United Kingdom. That is very significant because, as we all know in this House and beyond it, the earlier the diagnosis of cancer, whether first stage or secondary, the better the chances of successful treatment.
The treatment of secondary breast cancer is particularly relevant to my constituency. I have met representatives from Breast Cancer Care—I say “representatives”, but they are women, mums and wives—and I was incredibly moved to hear the stories of their experiences of living with secondary breast cancer. I commend the vital work that the charity has done, particularly its “Secondary, not second-rate” campaign looking at the barriers preventing the improvement of care for those with secondary breast cancer.
Breast Cancer Care highlighted to me the key point that unless our hospital trusts collect specific data on how many people have been diagnosed with secondary breast cancer, they cannot accurately plan services for those patients. I was shocked to learn that two thirds of hospital trusts in this country do not collect those data. Sadly, my hospital trust—the United Lincolnshire Hospitals NHS Trust—is one of those trusts. I urge my hospital trust and others across the country to start to collect those data, so that the services provided to women with secondary breast cancer can be planned properly and effectively.
The Minister will want to tell the House about the success of the cancer drugs fund. We know that 95,000 people have received the life-extending drugs they need through the fund. However, we must always strive to look at new ways of making sure that patients have access to innovative new medicines, diagnostics and medical technologies, as is happening through the accelerated access review plans.
I also welcome the Government’s commitment to making sure that the prices charged to the NHS are fair and not inflated. I cannot be the only Member who was shocked and pretty disgusted by some of the headlines that have appeared in newspapers recently about the conduct of some companies in massively inflating the price of patent drugs. I am pleased that that loophole will be closed by the Health Service Medical Supplies (Costs) Bill, which is currently in the other place. I urge the Secretary of State to ensure, as I know he is doing, that the Competition and Markets Authority keeps a close eye on the matter. Unfair practices should not conspire against our constituents, neighbours, friends and families when it comes to cancer treatment.
I know that my hon. Friend the Minister has listened carefully to the concerns raised in this informative and engaging debate. I hope that a solution is reached quickly between NICE and Roche if the problem is that the price charged for the drug is simply too high. I join other Members in wishing every single woman in this country who is battling first stage or secondary cancer the very best of luck. I hope those women feel that the debate has done them proud.
I congratulate the hon. Member for Mitcham and Morden (Siobhain McDonagh) on securing the debate. Like other hon. Members, I am here today to represent my constituents’ concerns. I should say from the off that I join the cause to make Kadcyla more available.
When my staff and I were discussing the correspondence about the debate and particular constituency cases, we quickly agreed that this is the worst sort of correspondence that we receive—when people are terminally ill but unable to access the medicines that they need. The subject is particularly acute—I do not think that I am the first Member to struggle to keep a quaver out of my voice—because my mother-in-law died of secondary cancer. These things will stay with us all. None of us can know what ladies who are currently suffering from these diseases are going through, but when we have seen it at second hand, we all want to live in a world where the NHS does not have to practise any rationing.
I want to focus on that point because, as the hon. Member for Coventry South (Mr Cunningham) said, the problem is intractable. I know about some of the great difficulties in bringing forward Abiraterone to help men, in a similar set of circumstances, suffering from prostate cancer. In a sense, I sympathise with the Minister and with NICE because they have an extremely difficult task. While it is easy for all of us to say that of course Kadcyla should be freely available to all those who need it without restriction, I am well aware that the problem is long-standing and applies to many innovative pharmaceuticals.
I also appreciate that it is no comfort whatever to sufferers of various cancers to know that a profit-making pharmaceutical system has a far better record of innovation than the alternative planned systems. I wish the Minister every success in her crucial task of working out how to ensure that innovative medicines come forward at a lower cost and a greater rate.
It is a pleasure to take part in today’s important debate and I thank the hon. Member for Mitcham and Morden (Siobhain McDonagh) for securing it. I am grateful to her for her contribution and the cases that she used to illustrate it. She eloquently put a human face to the problem.
The debate about access to Kadcyla and other breast cancer drugs is of immense interest to the public on both sides of the border. Breast cancer is the most common cancer, which was shown by the many individual constituency cases cited by hon. Members of all parties today.
As has been said, Kadcyla is an effective life-extending treatment, which gives some women with incurable secondary breast cancer up to nine months longer than the alternatives, and has fewer side effects and a cost of around £90,000 per patient. In Scotland, Kadcyla has never been available on the NHS.
The Scottish Medicines Consortium, which makes its decisions independently of Ministers and Parliament, decided in October 2014 not to approve Kadcyla for routine use in Scotland. After considering all the available evidence, it felt that the health benefits were not sufficient in relation to the treatment’s cost. Patients have, therefore, been able to access the drug only in exceptional circumstances through individual patient treatment requests—IPTRs. It is estimated that more than 100 women in Scotland could benefit from Kadcyla annually.
A Kadcyla discount has been offered by the pharmaceutical company Roche and it recently wrote to Scottish Government officials about a patient access scheme. Roche has now resubmitted its application to the SMC, so that it can be considered for routine use in the NHS across Scotland. That is currently being assessed—
Will my hon. Friend join me in hoping for a positive outcome in relation to Kadcyla for our constituents who are affected by secondary breast cancer, to whom this debate means so much?
I thank my hon. Friend for that point and I join her in hoping for a positive outcome. We expect a decision to be made in March with an announcement on 10 April.
The SNP Scottish Government have substantially increased access to new medicines, particularly for cancer, with plenty of reforms and investment in recent years. The Scottish Government will build on recent reforms and make further improvements, in collaboration with patients and NHS staff, by accepting the recommendations of Dr Brian Montgomery’s review. Shona Robison, Cabinet Secretary for Health, Wellbeing and Sport, has announced that the Scottish Government will take forward all 28 of the review’s recommendations. Dr Montgomery was tasked to examine how changes made to the Scottish Medicines Consortium process in 2014 affected access to medicines for rare and end-of-life conditions. His recommendations set out how the process for appraising medicines could be made more open, transparent and robust.
Among the Montgomery recommendations—the House need not worry; I will not list all 28 of them—is to give the SMC an additional decision option of an interim recommendation for use subject to ongoing evaluation, which will allow collection of more data on a medicine’s real-world effectiveness. Another is the introduction of managed access agreements, under which medicine would be provided at a discounted price for a period of time, again to collect real-world data on its effectiveness. Another recommendation is to make greater use of national procurement in NHS National Services Scotland— NSS—to lead negotiations on cost with the pharma industry to get the fairest price possible. Better capturing of patient outcome data in the real world is vital to enable us to determine whether medicines are bringing the expected level of benefits to patients.
Beyond the recommendations of the review, Ms Robison has also announced improvements to the processes for non-routine access to medicines on an individual case-by-case basis. The peer approved clinical system or PACS, piloted in Glasgow in 2015 to handle applications for ultra-orphan medicines, has been successfully rolled out across Scotland. A second tier of PACS will now be introduced to replace and build upon the existing individual patient treatment request system. A new national appeals process will be introduced through the new tier of PACS, and that will include consideration of equity of access with other parts of the UK as a material part of its decision-making process.
In November Gregor McNie, Cancer Research UK’s senior public affairs manager in Scotland, said:
“SMC does a difficult but necessary job to assess whether new cancer drugs should be made available on the NHS. Following the SMC reforms, we’ve been pleased to see a significant increase in the availability of cancer drugs in Scotland and we support the review’s recommendations to make further progress.”
Breast Cancer NOW has said that
“Scottish Government reforms give fresh hope for a medicines system that will put patients and their families first.”
It also said:
“Scotland’s approach to reform is a useful example to the rest of the UK about ways in which the system can be improved.”
I thank my hon. Friend for his words about the flexibility of approach and the need to continue to keep pushing forward to ensure that we allow access to as many of these drugs as possible for the people who are in such need. Will he join me in commending the Scottish Government and the SMC for that approach, and in hoping that it will continue and make a difference?
I do indeed join my hon. Friend in those comments.
A new and ambitious Scottish cancer strategy, launched in 2016, aims to stop anyone dying from breast cancer by 2050, and breast cancer is of course a priority in the Scottish Government’s Detect Cancer Early initiative. We need to do many things to move forward in that direction.
No debate seems complete these days without reference to Brexit, and this issue is no exception. The Health Secretary has stated that the UK will not be in the European Medicines Agency. If so, there could be implications for the way in which medicines are regulated, and marketing authorisations will be required from the Medicines and Healthcare Products Regulatory Agency for the UK. I am in no doubt that the implications will be less efficiency and possibly longer processes for obtaining authorisations, resulting—I fear—in innovative drugs taking longer to reach patients. Some industry leaders predict delays in the region of 150 days, based on the examples of Switzerland and Canada.
According to a piece that appeared last year in the Financial Times, when Sir Michael Rawlins, chair of the MHRA, was asked whether it would be able to take on all the extra work registering new drugs and medical devices currently carried out by the EMA, he said, “Certainly not”. It seems that considerable investment and recruitment will be required to re-establish it as a stand-alone national regulator. I am keen to hear from the Minister how delayed drug access for UK patients will be avoided.
I have listened carefully to the hon. Gentleman, and of course he raises a perfectly reasonable concern, but the campaign director of Vote Leave had, as one of his particular bugbears, the costs associated with the clinical trials directive and its prejudicial effect on innovation in medicines. I hope that the Government can find a better way through than the previous system and that, in leaving the EU, we will not only solve the problem of the EMA but have a better regulatory system afterwards.
I thank the hon. Gentleman for his intervention, and I look forward to hearing the outcome.
In conclusion, with regards to Kadcyla, I hope the company’s resubmission to the Scottish Medicines Consortium is at a fair price to allow it to be considered for approval for use in the NHS in Scotland. It would give people across Scotland the opportunity to benefit from more treatment options and could give them precious extra time with their families and loved ones. The Scottish Government, the SMC and the NHS have worked hard to reform access to new medicines, but we now need pharmaceutical companies to do their bit by bringing forward much fairer prices for new medicines, so that access is as wide as possible for the people of Scotland. Cost-effectiveness is a key marker in ensuring that drugs are routinely available in the NHS, and I take the opportunity to emphasise that point to the pharmaceutical industry in general.
I thank my hon. Friend the Member for Mitcham and Morden (Siobhain McDonagh) for securing this debate, following the very sad news that her friend Samantha Heath, who had been receiving this life-extending treatment, had heard from NICE that it was being taken away from her. I am pleased that she was able to secure this important debate through the Backbench Business Committee.
I also thank all colleagues who have attended the debate and made excellent speeches, sharing with us their experiences and thoughts, including the hon. Members for Milton Keynes South (Iain Stewart), for Portsmouth South (Mrs Drummond), for Louth and Horncastle (Victoria Atkins) and for Wycombe (Mr Baker), my hon. Friends the Members for Torfaen (Nick Thomas-Symonds) and for Wythenshawe and Sale East (Mike Kane) and the hon. Member for Linlithgow and East Falkirk (Martyn Day), who spoke for the SNP. I am sure that the Minister has been given lots to think about, and I look forward to her response shortly. I also thank Breast Cancer Now for its work campaigning on this matter, along with Breast Cancer Care for its continued dedication and its support and advocacy for individuals with secondary breast cancer.
In my contribution, I will first briefly establish the documented and perceived benefits of Kadcyla, and then, building on that, discuss the broader issues around the provision of off-patent drugs, before moving on to present the problems with determining the funding of a drug based principally on its cost-effectiveness as judged by NICE.
Kadcyla’s continued funding through the cancer drugs fund in 2015 was a great success for patients and patient advocates. At the time, the value of the drug was recognised and the concession was made that, despite its high cost, its positive impact was worth the funding it needed. Yet just over a year later, the alterations to the cancer drugs fund have prevented the future funding of this drug, along with, potentially, that of a number of other secondary breast cancer drugs such as palbociclib and Perjeta—I hope that I pronounced those correctly—as it moves towards becoming a funding mechanism for under-researched but innovative drugs with cost and value as a principal driver, and away from its original principle, which was to finance drugs that were too expensive to be recommended by NICE but proved effective in treating cancer patients.
We can all agree that patients have benefited significantly since the introduction of the cancer drugs fund, but the progress that has been made in recent years in improving access to cancer drugs is now at risk. That is unsurprising, given the cash-strapped state of the national health service—we have discussed that in the House recently in the past few weeks—which faces pressures to provide these costly drugs that are developed by large pharmaceutical companies, and is forced to consider costs rather than clinical need. I hope that the Minister will tell us whether those concerns have been assessed, and how she plans to address them. We have heard a number of good suggestions today about how funding may be redirected.
Is not the situation made all the more poignant by the fact that since 2001, the incidence of breast cancer has been rising by 9% every year?
That is a very good point. It may be that more and more people are coming forward and being diagnosed, but, as my hon. Friend says, this will clearly become more of an issue, not less of an issue, in the years to come.
As we have heard today, it is estimated that Kadcyla benefits 1,200 women every year in England alone, and that on average it can increase the length of a woman’s life by six months, although reports suggest that in the case of some women that can stretch into years. Even if it is measured in months, however, the extra time is surely priceless to the women and families involved. I speak from personal experience, as I lost my mother-in-law to secondary breast cancer 20 years ago this year, when my children were very small. I know that she fought for every extra week and day in the end, and that she would have given anything for an extra six months to spend with her grandchildren. We all wanted that little bit longer for her. For all those 1,200 women, that extra time is time with their families. It means seeing their children reach perhaps one more milestone: starting school or university, getting married, or even giving them a grandchild. What is the cost of such moments, such memories, which are so precious and which help families so much with what, ultimately and inevitably, will follow?
The hon. Lady has made a powerful point. In the case of the most aggressive cancers, the period between diagnosis and death can be very short. As she says, any extension of life enabling women to celebrate family events, or anything else, is incredibly important, and we should not lose sight of that.
I agree. What price can be put on those precious months?
I have some investment in this. My own experience of breast cancer treatment over the last two years has left me passionate about the issue of prevention and early diagnosis. Will my hon. Friend join me in not just thanking the breast cancer charities—as she has already done—but calling on all Members to spread the word among all the women they know that they must learn how to examine their breasts? I learnt how to do it from a comic sketch in a television programme: that is how I diagnosed my lump. I want everyone to learn how to do it, and also to learn what they can do to help prevent breast cancer, because, although there is no magic prevention method, there are ways of reducing the risk.
Although we have not so far touched on prevention or early diagnosis, they are vital issues. We have discussed them in the House on many occasions, but they can never be discussed too often, and I am grateful to my hon. Friend for raising them. Let me add that I am happy every day to see her back in this place, and doing so well.
What also stands out with Kadcyla is the reduced side effects, as we have heard, as opposed to alternative breast cancer treatments, the side effects of which can include the inducement of osteoporosis and an increased risk of blood clots. As some colleagues will, sadly, know first-hand or through experiences of family and friends or constituents, the side effects of some cancer treatments can be truly awful, and in some cases are daunting enough to prevent the acceptance of further treatment entirely. It is a common perception that women make the decision to end their treatment much earlier than planned, despite it prolonging their life sometimes. That is because they feel the suffering they are enduring as a result of the treatment is not worth the additional life it is providing to them, because it is all about the quality of that life.
Research conducted by Genentech in the United States on the side effects of Kadcyla found that less than 5% of women taking the treatment suffered any hair loss. Through my work as co-chair of the all-party group on breast cancer, I know that hair loss can be a highly traumatic experience for women undergoing cancer treatment and is one of the most discussed side effects of cancer treatment in general. Given that in this debate we are discussing the treatment of secondary breast cancer, which is ultimately a terminal disease, the best outcome we can offer through treatment is both the extension of life and the preservation of the quality of life enjoyed pre-diagnosis. Therefore, because Kadcyla causes fewer side effects, it represents a treatment that can effectively achieve not only an extension of life, but the preservation of some of that quality of life enjoyed by these women pre-diagnosis. So I look forward to hearing from the Minister about what she is doing to ensure women will benefit from this vital treatment in the future.
I will now move on to how we can better support off-patent drugs, especially for breast cancer. Drug patents typically last for 20 years—although sometimes only 10 years—and at the end of that patent there is very little incentive for the drugs to be licensed for use in another indication. These drugs are still clinically effective in many cases and can be a low-cost effective treatment, but currently the NHS has no method for making them routinely available.
Bisphosphonates are one such example of an off-patent drug that is not being made universally available to patients, despite evidence showing its effectiveness. It is estimated that, if given to the entire eligible population, this drug could prevent one in 10 breast cancer deaths. It is therefore concerning that research conducted by the UK Breast Cancer Group found that only 24% of breast cancer clinicians were offering bisphosphonates to patients. Solving this issue therefore provides an opportunity to improve breast cancer survival rates, and it is something that I hope the Minister will consider carefully.
I want to finish by discussing the cost-effectiveness of drugs. Currently NICE measures cost-effectiveness using quality-adjusted life years—QALY—and one QALY is equal to one year of life in perfect health. As I am sure colleagues will agree, it is almost impossible to objectively measure someone’s quality of life, and there are questions surrounding the morality of attempting to do so, as raised in NICE’s “Social value judgements” paper on the moral evaluation of drugs.
As is so often the case in these debates, a clear cause of the problem lies with how NICE approves drugs. At the last general election, Labour proposed a top-to-bottom reform of NICE, ensuring that drug acceptance and funding is determined solely by clinical need, not with cost or value considerations. This debate shows there is clearly a need to re-address these issues.
As I have already mentioned, Kadcyla patients tend to experience considerably fewer side effects, and this can potentially have a positive impact on their ability to enjoy a higher quality of life post-diagnosis. Because of practicality and cost implications, it is almost impossible for NICE to comprehensively and effectively measure this exact quality of life. However, what we can say, without a doubt, is that these individuals would suffer a lower quality of life without Kadcyla, and this, I believe, deserves more attention and value in the process of drug approval and funding.
The current funding of drugs is becoming based on the cost-effectiveness of a drug, rather than clinical need, yet, as this debate has shown, it should not be the final deciding factor as it disregards very personal reasons for many people who rely upon drug treatments. Kadcyla has benefited many women during their time living with a terminal disease, and has now been pulled, devastatingly, out of their reach.
It is the Minister who has the levers of power to address the problems in the system which is letting these women down. Members from across this Chamber have eloquently made their case to the Minister. I hope she has listened—I am sure she has—and will give these women and their families some reassurances today.
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.
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?
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.
I thank all the Members who contributed to this debate and thank the Minister for her detailed response. Most importantly, I thank the women in the Public Gallery for coming here en masse to show their support for this debate. I wish every single one of them well, and I hope that they will join me for tea afterwards. Perhaps unconventionally, I also invite any hon. or right hon. Members here to join me and those women for tea to thank them for their campaigning efforts and to understand more about their case. I expressly invite Suzanne from the office of my hon. Friend the Member for Wythenshawe and Sale East (Mike Kane)—there is a cake in the Pugin Room with her name on it. Happy birthday, Suzanne.
Question put and agreed to.
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.