Breast Cancer Drugs

Rupa Huq Excerpts

Thursday 26th January 2017 Commons Chamber

[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.

--- Later in debate ---

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

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.]

[Dr Huq]

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.

[Nick Thomas-Symonds]

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.