Melanoma

Rehman Chishti Excerpts

Wednesday 18th January 2012 Westminster Hall

[Pauline Latham (Mid Derbyshire) (Con)]

It is a pleasure to serve under your chairmanship, Mr Hood, and I am grateful to Mr Speaker for selecting this important topic for debate. According to the British Journal of Cancer, the incidence of the most serious form of skin cancer, melanoma, is expected to rise by 52% in both men and women by 2030. One of the many tragic aspects of advanced melanoma is that, compared with other cancers, it disproportionally affects younger people. Indeed, more than a third of all cases of melanoma affect people who are under the age of 55. With such a high incidence, combined with the aggressive nature of melanoma, treatment options are very important.

I want to draw attention to the new and innovative drug, ipilimumab, also known under the trade name of Yervoy. Ipilimumab works in a new and unique way through a form of immunotherapy. It encourages the immune system to produce more cancer-killing cells. The drug is significant, and it has not been available to patients before.

In July last year, ipilimumab was launched in the UK with a licence approved by the European Medicines Agency. This is the first major advance for treatment of this cancer in 30 years. However, to the disappointment of patients and stakeholders, the National Institute for Health and Clinical Excellence announced on 14 October that it would not be recommending ipilimumab for the treatment of advanced melanoma on the NHS. I was profoundly disappointed to discover that the chief executive of NICE, Andrew Dillon, had deemed that this treatment was not

“a cost effective use of NHS resources.”

In response to that news, I held a stakeholder investigation in the Houses of Parliament and invited patients, carers, clinicians, charities—they included the patient support group, Factor 50, and the Karen Clifford Skin Cancer charity, also known as Skcin—and parliamentarians to come together and discuss their personal concerns about the negative preliminary guidance that was given by NICE.

[Rehman Chishti (Gillingham and Rainham) (Con)]

My hon. Friend mentioned that this disease affects younger people to a greater extent. One of my constituents, who is young and has young children, needs the drug Yervoy, which is expensive. Does she agree that we need to do everything that we can to ensure that those young children can see their mother for a longer period and that her last days are not lost days?

[Pauline Latham]

I completely agree with my hon. Friend, and I will come on to some cases in a moment. It is a very important point.

As well as coming together to share our concerns, the meeting was held to create a report that was submitted to NICE in response to the appraisal consultation document, in anticipation that it would be considered ahead of the NICE technology appraisal meeting, which took place on 16 November. We have had no response so far.

When holding the meeting on advanced melanoma, I was given the opportunity to hear first hand from melanoma patients, who are desperate to receive the drug. Melanoma often strikes at the younger end of the population. More than a third of all cases of melanoma occur in people below the age of 55, and it is the second most common form of cancer in the UK for those aged between 15 and 34. What those statistics on advanced melanoma in the younger population do not show is that many people in that age group will have children and so will face a very aggressive cancer, alongside the knowledge that they face leaving behind their children and family.

The patients whom I met at the meeting all echoed a simple and profound point: they are desperate to stay alive, so that they can be with their children, husbands, wives, partners and families. Given that treatment options for the disease have not advanced for three decades, how can it be fair not to release the drug for use by those patients who could have more time with their families? One young patient—a lady aged only 30—said at the meeting:

“I need to live. I have to live for my children. I just want a few more years so that my boys will remember me.”

Richard Clifford, the founder and trustee of the Karen Clifford Skin Cancer charity—Skcin—said at the meeting that

“median overall survival time after diagnosis is six to nine months. This is tragic because people have little time to prepare themselves and their loved ones for what is inevitably going to occur.”

I could not agree more with his sentiments. There is clearly an unmet need in the treatments available, and I believe that ipilimumab has a place in today’s treatment options, which are already scarce for cases of malignant melanoma. An experienced oncologist from Leeds who has used ipilimumab echoed that view at the meeting:

“It is the first drug that can help people live longer or make them more likely to be active for a meaningful period of time.”

I add a personal plea for help: my brother died from a malignant melanoma 11 years ago this month at the age of 54, one week after his birthday, leaving his wife and two teenage children. I know how debilitating this form of cancer is and how quickly it can spread. Apart from radical surgery, he had very few options in terms of the drugs on offer. As a result of Michael’s illness and death, I see my GP regularly, and I have had several pre-cancerous areas removed before they had the chance to progress to malignancy.

--- Later in debate ---

[Paul Burstow]

In England, one of the opportunities coming up as a result of the Health and Social Care Bill is the transfer of public health responsibilities to local authorities. Alongside the authorities’ other responsibilities for environmental health and trading standards, that brings both enforcement and education opportunities, which will be very important in making the existing regulations even more effective.

Earlier diagnosis is central to the strategy the Government have laid out, because if we catch more cancers earlier they will become more treatable. The SunSmart campaign has a website that provides information about how to spot the symptoms of the disease, and during 2011 it received more than 11,000 visits per month on average, peaking in June, surprisingly, with more than 21,000 visits. With a programme grant from the Department of Health, Cancer Research UK and the British Association of Dermatologists are working together on a toolkit to provide practical online support and training to help GPs with pattern recognition for skin lesions. The toolkit will be piloted early this year, before a planned national roll-out, building on the evidence base.

That leads me on to treatment. Once skin cancer is diagnosed, access to appropriate treatment, delivered to a high standard, is critical. Increasing access to cancer treatments is a goal that all Members who have contributed, or are listening, to the debate share. I pay tribute to my hon. Friend the Member for Mid Derbyshire for her campaigning work on behalf of a number of her constituents and other people, and I would like to set out the current situation in relation to ipilimumab. I am struggling with the pronunciation of that word, and I apologise; I do not in any way wish to denigrate the issue. It is really important to explain where we are, because the drug is being appraised by NICE for use in the treatment of stage 3 and stage 4 malignant melanoma. NICE has a rather difficult job, and my hon. Friend has fairly described the challenge it faces in coming to its judgments. NICE’s role is to provide the NHS with robust, evidence-based guidance on whether a drug should be available, on clinical and cost-effectiveness grounds. I would like to reassure my hon. Friend that NICE recognises that its work has genuine consequences and has an impact on individuals’ lives. It makes a great effort to ensure that clinicians, patients, and anyone with an interest is involved in its work. I will forward my hon. Friend’s speech to NICE and ensure that it sees it.

NICE published its draft guidance on both the clinical and cost-effectiveness of ipilimumab last October. My hon. Friend has explained that the document does not recommend the use of the drug by the NHS, and she has described, in no uncertain terms, the dismay and disappointment that she and others feel on behalf of the families and the sufferers. However, NICE has not yet finalised its guidance to the NHS, and I am sure that Members will appreciate that, because NICE is an independent body, it would not be appropriate for me to dictate to or direct it. What I can tell Members—I hope this will be at least a glimmer of light—is that Bristol-Myers Squibb, the manufacturer of the drug, has proposed a patient access scheme, and the Department has agreed that NICE can consider it. I understand that NICE will now ask its appraisal committee to consider the scheme as part of its reconsideration of the drug.

Until NICE publishes its final guidance, PCTs are responsible for making funds available on the basis of individual needs in their local populations. There is no excuse at this point for PCTs not to do that, and patients have a right under the NHS constitution to expect local decisions about the funding of medicines and treatments to be made rationally, following proper consideration of all the evidence. In addition, where a treatment is not normally funded, PCTs are required to have processes in place to consider exceptional funding requests if a doctor feels that a particular patient’s exceptional clinical circumstances would warrant such funding. To help PCTs make these difficult decisions, the Department has issued a set of core principles that should govern them.

That is the current regime, and when this Government came into office they decided to go further, as part of their coalition programme. We are delivering on a promise in our programme for Government to create a cancer drugs fund. In the first year of the fund we have provided £50 million, and from 2010 through to the end of the fund there will be £600 million. I will say a bit more later about what happens after the fund ends.

[Rehman Chishti]

It is great to hear the Minister saying that we are looking to ensure that people can get new drugs, such as Yervoy. Does he agree that we must also ensure that PCTs, local authorities and the voluntary sector provide excellent palliative care to the terminally ill?

[Paul Burstow]

My hon. Friend makes a very important point. He will know that we received the recommendations of the palliative care review last year, and we are looking forward to making announcements on it in the near future.

The cancer drugs fund means that clinicians in England are now able to prescribe cancer drugs from which they feel patients would benefit, without restrictions simply on cost grounds. That goes back to the absolutely correct point made earlier by my hon. Friend the Member for Gillingham and Rainham (Rehman Chishti) about adding years, months and days to a person’s life, and ensuring that those days are not lost.

Up until last November, 10,000 cancer patients had benefited from the cancer drugs fund and clinical recommendations, with a number of them receiving ipilimumab through the fund. Strategic health authority regional clinical panels are using their clinical judgment. I understand the concern raised by my hon. Friend the Member for Mid Derbyshire about variation, but we are assured that there is consistency between areas, and if there is any evidence to the contrary, I urge her to share it with the Department so that we can pursue that.

On the cancer drugs fund in Wales, the devolved Administration have to make their own judgment about how to prioritise NHS spending, and in contrast to the UK Administration they have decided to reduce spending on the NHS.

My hon. Friend also asked about the future arrangements when the cancer drugs fund finishes. We want to find a way for patients who benefit from drugs provided through the fund to continue to do so, at a cost that represents value to the NHS and to our wider society. We are considering whether it would be sensible, after the fund comes to an end in 2014, to assess some of the drugs, including the one we are debating, under the new value-based pricing arrangements. A final decision has not yet been made on that, but I will certainly write to my hon. Friend as we get to a conclusion.

My hon. Friend drew attention to the potential wider costs of cancers such as melanoma. As we develop our value-based pricing system, it is important that we ensure that those wider costs are taken into account. We want a more systematic and transparent way of working, so that interested parties, including pharmaceutical companies, charities, Members of Parliament and the general public, are clear in advance about what factors can be taken into account and what supporting evidence will be needed.

I thank my hon. Friend for raising this issue. I hope that a glimmer of hope is provided by a new scheme that could allow NICE to re-appraise the drug and come to a different conclusion. We will now wait to see how NICE proceeds. It is absolutely right to use parliamentary opportunities such as this to raise awareness. It is by raising awareness that we will save lives, which is the bottom line.