Melanoma

Wednesday 18th January 2012 Westminster Hall

16:15

[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.

[Jeremy Lefroy (Stafford) (Con)]

I congratulate my hon. Friend on raising this important issue. As someone with very fair skin, I have had to have skin removed and examined, so I understand the potential consequences and the worry that people go through. Does she agree that we need more education about the consequences for fair-skinned people and, indeed, everyone of too much exposure to the sun and the overuse of sunbeds?

[Pauline Latham]

Yes, and I thank my hon. Friend for bringing that up. Sunbeds are still a problem, particularly among young women who think that having a tan makes them look healthier.

[Jim Shannon (Strangford) (DUP)]

I congratulate the hon. Lady on bringing this matter before the House. Skin cancer is the deadliest cancer in Northern Ireland, and that is very worrying. The hon. Member for Stafford (Jeremy Lefroy) mentioned sunbeds. People under the age of 35 who use sunbeds increase their possibility of getting skin cancer. What does the hon. Lady think can be done? Does she think that councils need to do more? Councils have control of sunbeds, so perhaps they need to say, “No more.”

[Pauline Latham]

Yes, I would like that to happen. Looking tanned does not mean that someone is healthy. In fact, tanning increases the risk of malignant melanomas, which are rapid killers, and I would like councils to have the strength to say, “No.”

It may be expensive to prescribe the drug, but it is the first advance in treatment for a long time, and if used, may offer the opportunity of more trials to refine it, which could lead to its becoming even more effective. For young people with melanomas, it is a lifeline, even if they only survive for a relatively short time. Let us not forget the possibility that agencies, such as social services, and welfare benefits can cost the country huge sums if the remaining parent has to give up their career to look after a young family. Patients with this aggressive disease are expected to have a median overall survival time of six to nine months, but in trials, 46% of patients taking ipilimumab were still alive after a year, and in some cases, patients can live even longer.

At the stakeholder’s meeting on 8 November, we heard from a patient called Ian. He seemed well, spoke eloquently and raised many important points on access to treatment, which I urge hon. Members to read in the report that we submitted to NICE—I am happy to provide a copy. Sadly, before 21 December 2011, Ian became very unwell and was ultimately bedridden. The short time between Ian attending the meeting in November and his death a week ago demonstrates the aggressive nature of advanced melanomas.

Lack of access to the drug is still a major concern to all melanoma patients and, of course, to their families and friends. It is very distressing for them to know that there is a drug on the market that has been proven to prolong the lives of sufferers, if even for only a few months or years, yet they cannot access it through the normal channels. I acknowledge that ipilimumab is available in some parts of England through the cancer drugs fund, but it is not available in all areas, and the fund does not even exist in Wales—yet another example of inequality from the cancer drugs fund and another illustration of a postcode lottery.

[Chris Skidmore (Kingswood) (Con)]

On my hon. Friend’s point about a postcode lottery and regional variation, I think that she will be interested in figures that I recently obtained through a parliamentary question. They break down the number of registrations of newly diagnosed cases of melanoma—skin cancer—by local authority and region. I would happily give her a copy. In my region of Avon, Somerset and Wiltshire, there has been an explosion of newly diagnosed cases of skin cancer, from 254 in 1999 to 455 in 2008—an increase of 79%. The huge variation across the country shows that this is not just about the future, but that we have a problem now that we must urgently tackle.

[Pauline Latham]

Yes, I agree. I thank my hon. Friend for raising that point, because although we are talking about a big increase by 2030, he is right that melanomas are affecting more and more people, particularly the young, and they are usually a death sentence.

What will happen to those patients in areas covered by the cancer drugs fund who can access ipilimumab through the fund when funding ends in 2014? That further illustrates why it is imperative that NICE recommends ipilimumab, so that it is available across England and Wales to all patients who could benefit from it. The Minister knows that my concerns about access to treatments for other cancers—for example, Avastin as second-line treatment for bowel cancer via the cancer drugs fund—are well versed through parliamentary questions and speeches in the Chamber. I remain equally determined to ensure the availability to cancer patients of other life-prolonging drugs, such as ipilimumab.

Alongside Factor 50 and Skcin, I urge in the strongest possible terms that the Department of Health, the manufacturers and NICE work together, so that ipilimumab is available to appropriate patients across England and Wales. There are huge concerns that, without a positive decision on ipilimumab, patients will lose out on a lifeline to have those extra months or even years with their loved ones.

16:28

[The Minister of State, Department of Health (Paul Burstow)]

I congratulate my hon. Friend the Member for Mid Derbyshire (Pauline Latham) on securing the debate and bringing this important issue to the attention of the House today, and on the way she set out the issue and spoke of her experiences and of those whom she represents. She powerfully made the case for the drug and, more generally, for the need to raise awareness in order to educate people and to ensure they take the right steps better to protect themselves from melanomas.

I want to make it clear that the Government’s commitment to improving outcomes for cancer patients, including people with malignant melanoma—the most serious form of skin cancer, as my hon. Friend said—remains unwavering. Our cancer outcomes strategy, which we published just a year ago, sets out our aims for delivering health care outcomes as good as those anywhere in the world. Our ambition is to reduce significantly the number of deaths from preventable and avoidable cancers. The strategy sets out actions to tackle preventable cancer incidence, improve the quality and efficiency of cancer treatment and services, improve patients’ experience of care, and improve the quality of life for cancer survivors.

I will start with prevention, to which some reference has already been made, because it is the really important aspect of this issue. Cancer Research UK has been running the SunSmart campaign on behalf of the Department of Health for a number of years. It is a national campaign that provides information and advice about skin cancer and sun protection, and it has a particular focus on young people aged 16 to 24, for the very reasons that my hon. Friend rightly mentioned. Its major activity in 2011 was a bespoke marketing partnership with T4 on the Beach, which is a popular music festival, I am told. At the event, about 3,225 people in the target audience were directly engaged by the campaign, and the evaluation showed that those who saw the T4 SunSmart campaign were more likely to report that they would wear sunscreen in the future—72%, compared with 52%. Clearly, there are lessons to learn from that for future campaigns in this area.

In reference to the intervention by my hon. Friend the Member for Stafford (Jeremy Lefroy), my hon. Friend the Member for Mid Derbyshire talked about sunbeds, and I draw her attention to the Sunbeds (Regulation) Act 2010, which came into force last April, making it an offence for sunbed businesses in England and Wales to permit people under the age of 18 to use sunbeds on their commercial premises. To reinforce that, we have been working with Cancer Research UK through the Department-funded “R UV Ugly?” campaign to raise awareness of the dangers of sunbeds and the benefits of skin checks. The campaign is being run in partnership with the company sk:n, which is providing free ultraviolet scans in its clinics across the UK.

That brings me on to early diagnosis, which is the next step in the process.

[Jim Shannon]

I intervened earlier on the hon. Member for Mid Derbyshire (Pauline Latham), regarding councils sometimes needing to be more aware of what they can do. Has the Minister any intention of asking councils to be more proactive in preventing sunbed use? That is perhaps a key question.

[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.