The first new skin cancer treatment since the 1970s has been rejected by the NHS’s rationing body, in a decision branded a “death sentence” for patients.Clinical trials had shown that half of those who were given the drug were still alive a year later, twice as many as those given an alternative treatment.
The drug, called ipilimumab, works by teaching the immune system how to tackle melanomas and was widely seen as an important advance on “old-fashioned” chemotherapy.
But in draft guidance NICE- the National Institute for Curbing Expenditure has recommended that NHS trusts do not prescribe the treatment, because it costs about £80,000 per patient and because it had doubts over the research data.
It means that unless the manufacturer cuts the price, the only way that the growing number of advanced melanoma sufferers can access the drug is by applying to the Government’s Cancer Drugs Fund.
The decision comes after a provocative academic report claimed that some expensive cancer drugs are “futile” as they cost a lot and cause toxic side-effects yet only give dying patients a few more weeks to live.
In a joint statement, the support group Factor 50 and charity SKCIN said: “The breakthrough that patients and clinicians throughout the UK have been waiting for has arrived in the form of this drug.”
“Standard treatments that have been available since the 1970s are ineffective and to deny this drug to patients, many of whom are young and with very young families, has undoubtedly handed them down a death sentence.”
“To have come so close to a breakthrough and to be told no at this stage is truly devastating.”
Dr Pippa Corrie, Consultant Medical Oncologist at Cambridge University Hospitals NHS Foundation Trust, added: “Licensing of this drug for use in the UK marked a step change in melanoma patient care, and whilst the Nice decision is predictable, it is disappointing.
“It is essential that we all work to avoid any negative impact on facilitating patient access to this drug. Our patients have waited too long already.”
Rates of skin cancer are rising faster than any other type of the disease in Britain and it affects teenagers and young adults more than any other group.
Almost 12,000 people now develop the most serious kind, malignant melanoma, every year and about 2,000 will die after it spreads across the body.
For the past 30 years the only treatment has been a type of chemotherapy called dacarbazine which is not seen as particularly effective and leaves patients tired and at greater risk of infection.
The new treatment, marketed by Bristol-Myers Squibb as Yervoy, is taken in just four injections, one every three weeks and is said to have fewer side-effects.
In a trial on patients who had undergone prior therapy for skin cancer, 46 per cent who took the new drug were still alive after a year compared with 25 per cent who had not taken it.
In addition, 24 per cent were still alive at two years compared with 14 per cent of those who did not take the drug, and the median survival was 10.1 months compared with 6.4 months among those who did not take it.
But Nice, which assesses whether or not new treatments should be widely available on the NHS in England and Wales, has recommended against its use.
Sir Andrew Dillon, its chief executive, said: “We need to be sure that new treatments provide sufficient benefits to patients to justify the significant cost the NHS is being asked to pay.”
He said the evidence showed that ipilimumab was only effective for a “small percentage” of patients, it was not clear how long its effects last, and that it was linked to “a number of adverse reactions”.
“The Committee considered all these factors and concluded that, on the basis of the evidence provided so far, ipilimumab could not be considered a cost-effective use of NHS resources.”
But he added that the decision is open to public consultation while the manufacturer can offer to cut the cost.
Amadou Diarra, European Vice President and General Manager at Bristol-Myers Squibb UK, said: “We are fully committed to demonstrating that Yervoy represents real value for money to the NHS, and we will be submitting further evidence the hope that Nice will reconsider this decision so that all patients with metastatic melanoma can access this potentially life-extending treatment.”