Breast Cancer Drugs

Julie Elliott Excerpts

Thursday 26th January 2017 Commons Chamber

[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.