Breast Cancer Drugs

Siobhain McDonagh Excerpts

Thursday 26th January 2017 Commons Chamber

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

I beg to move,

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

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

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

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

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

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

[Siobhain McDonagh]

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

[Norman Lamb (North Norfolk) (LD)]

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.

[Siobhain McDonagh]

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.

[Nick Thomas-Symonds (Torfaen) (Lab)]

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.

[Siobhain McDonagh]

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.”

[Mary Creagh (Wakefield) (Lab)]

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.

[Siobhain McDonagh]

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.”

[Norman Lamb]

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.

[Siobhain McDonagh]

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.

[Dr Rupa Huq (Ealing Central and Acton) (Lab)]

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.

[Siobhain McDonagh]

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.

[Julie Elliott (Sunderland Central) (Lab)]

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.

[Siobhain McDonagh]

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.

[Chris Philp (Croydon South) (Con)]

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.

[Siobhain McDonagh]

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.

--- Later in debate ---

[Siobhain McDonagh]

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.

Resolved,

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.