A new skin cancer drug is not suitable for use on the NHS as its benefits are outweighed by its cost and possible side-effects, according to draft guidance by the National Institute for Health and Clinical Excellence (NICE).

Ipilimumab (Yervoy) is designed to treat patients with advanced malignant melanoma - the most serious form of skin cancer - who have already received chemotherapy.

But NICE said the cost of the treatment - around £80,000 per patient - did not justify its potential benefits.

Trials have shown that the drug is only effective in a small number of patients, and can cause severe side effects.

The draft guidance, which is now open to consultation, highlights doubts over clinical evidence submitted by the drug&aposs manufacturer Bristol-Myers Squibb.

NICE chief executive Sir Andrew Dillon said a trial had shown that the drug could potentially be very effective in a small minority of patients with advanced or metastatic melanoma (cancer that has spread).

But, he said the follow-up from the trial had been too short to determine how long the effect lasted.

Trials have suggested that ipilimumab improves survival rates among just 30 per of suitable patients, with only one in ten likely to experience long-term benefits.

In one trial presented at this year&aposs American Society of Clinical Oncology conference in the US, 20.8 per cent of those given ipilimumab, in combination with cancer drug dacarbazine, were still alive after three years. This compared with 12.2 per cent of patients given just dacarbazine.

Sir Andrew 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.

"Unfortunately, no patient characteristics or biomarkers have yet been identified to help identify this small group of people most likely to gain long-term benefit from receiving ipilimumab.

"The drug is also associated with a number of adverse reactions including diarrhoea, rash, fatigue, nausea, vomiting, decreased appetite, and abdominal pain which can significantly affect a patient&aposs quality of life.

"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."

Ipilimumab could still be available to some NHS patients, with health trusts able to make local decisions on funding the treatment.

Once NICE issues its final guidance, this will replace local recommendations. But, the drug may still be available for some patients in exceptional cases, or via the Cancer Drugs Fund.

Sir Andrew said the manufacturer, healthcare professionals and the public would be able to comment on the preliminary NICE guidelines.

"The manufacturer can also consider whether it wishes to reduce the acquisition cost to the NHS of the drug by proposing a patient access scheme. Ipilimumab currently costs around £80k per patient whether the treatment is effective for them or not," he said.

Professor Peter Johnson, chief clinician at Cancer Research UK, said: "It is disappointing that the high cost of Ipilimumab makes it impossible for NICE to recommend its routine use in the NHS. This is a novel and potentially effective treatment for some people with melanoma, but we still do not have a good way to identify those most likely to benefit and those at risk of the occasionally severe side effects."

Source: CRUK