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Restrictions applied to skin cancer drug

By
WebMD UK Health News
Medically Reviewed by Dr Keith David Barnard
researcher

25th February 2014 – A skin cancer medication should not be given to patients as a first-line treatment, the NHS treatments regulator has ruled.

In preliminary draft guidance, the National Institute for Health and Care Excellence (NICE) says ipilimumab should only be used by the NHS for patients in clinical trials so that the drug's effectiveness in extending life can be tested.

Ipilimumab, which is also known by its brand name Yervoy, is used to treat advanced malignant melanoma where the tumour cannot be removed or has spread to other parts of the body.

Cancer deaths

Malignant melanoma is a rare type of skin cancer. However, although melanoma only makes up 10% of all skin cancer cases, it is responsible for most skin cancer deaths. Around 2,070 people die from melanoma each year in England and Wales.

In 2010, 10,656 people were diagnosed with malignant melanoma in England.

Ipilimumab works by changing immune cells in the body to help the immune system destroy cancer cells.

Guidance issued by NICE in 2012 approved ipilimumab for NHS funding in England and Wales as a second-line treatment after the manufacturer Bristol-Myers Squibb offered a discount on the cost.

Evidence

However, NICE's Appraisal Committee has since decided that the manufacturer has not provided enough evidence to show that the medication when used as a first-line treatment can extend the lives of patients in comparison with other available treatment options.

The Committee concluded that further evidence from ongoing trials would reduce the uncertainty and strongly encouraged recruitment and patient follow-up in these studies.

The draft guidance also states that people currently receiving ipilimumab as part of their NHS care should continue with the treatment until they and their doctor consider it appropriate to stop.

In a statement, Sir Andrew Dillon, chief executive of NICE, says: "There are limited first-line treatment options available for patients with this type of advanced skin cancer. Which is why it is disappointing that the evidence put forward by the company did not conclusively demonstrate the degree to which the regulator approved dose of ipilimumab can extend life when compared with current standard care in the NHS.

"We understand that clinical trials are ongoing that could provide an answer to this important question, and are keen to see the recruitment and continued follow up of patients in these trials encouraged."

Public consultation

The NICE draft guidance is now available for public consultation. Until final guidance is published, NHS bodies must make decisions locally on the funding of specific treatments.

Kate Law, Cancer Research UK’s director of clinical trials, says in a statement: "Drugs like ipilimumab, which harness our understanding of the biology of advanced skin cancer, represent real signs of progress for a disease where treatments are long overdue.

"We look forward to NICE issuing a final decision on the use of this drug as a first line treatment, and look forward to the outcomes of the trials. In the meantime, doctors can apply for their patients to receive the drug if they believe it will benefit them through the cancer drugs fund in England, and through individual patient treatment requests in the rest of the UK."

Reviewed on February 25, 2014

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