Reproduced through kind permission of The Herald, Glasgow

A drug which offers fresh hope to patients with deadly kidney cancer was rejected by NHS advisers yesterday.

Health boards in Scotland have been told not to fund the treatment Sutent because it fails the cost-effectiveness test.

The announcement by the Scottish Medicines Consortium (SMC), which guides the NHS north of the Border on the use of new medications, has angered doctors and patient representatives.
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They insist for many desperate sufferers with advanced disease the drug is literally a lifeline. The James Whale Fund for Kidney Cancer issued a statement describing its reaction as one of "anger and disbelief".

As there is no official guidance available on whether the treatment should be prescribed in England and Wales, it is thought the SMC ruling will also inform prescribing there.

James Whale, the charity's founder and chairman, said: "By deciding not to fund Sutent, the SMC has effectively issued a death sentence to the 660 patients living with kidney cancer in Scotland. Despite the overwhelming evidence supporting Sutent, doctors will be forced to say no' to patients who need access to this life-saving treatment.

"The decision not to fund Sutent in Scotland will affect the 6600 kidney cancer patients north and south of the Border."

Sutent, the brand name of the drug sunitinib, acts in more than one way - working to kill the tumour and starve it of food and blood.

In the UK it is licensed as both a first and second-line treatment for advanced and spreading kidney cancer - an especially deadly disease. Earlier this year, SMC rejected it as a second-line treatment and yesterday blocked its use as the first line of attack.

Fewer than 5% of patients with advanced kidney cancer survive as long as five years - and many die within months.

The current standard treatment is the immune system protein interferon-alpha, which can produce serious side effects including convulsions and debilitating fatigue.

Research has shown that compared with interferon-alpha, Sutent can lengthen progression-free survival from five to 11 months.

However, supplying one patient with Sutent for a year costs on average £29,500. This is with a price discount of 5% and one free six-week treatment cycle offered by makers Pfizer Ltd to make their drug more cost effective.

Defending its decision, the SMC said the company had not been able to justify the drug's "high cost in relation to its benefits".

Pfizer argues the SMC has not factored the free treatment cycle into its calculations. It also says new trial data shows even greater benefits to patients and there are numerous examples where lives have been extended by two years. The company plans to re-submit a new proposal "at the earliest possible opportunity".

Dr Duncan McLaren, consultant oncologist at Western General Hospital, Edinburgh, said: "As a doctor who treats people with kidney cancer I am naturally disappointed in the SMC's decision and with my patients hope to work with the SMC to find a way to fund this drug on the NHS as quickly as possible.

"Advanced kidney cancer is an extremely difficult disease to treat and does not respond to conventional chemotherapy. For over 20 years we have had to work with drugs that at the most would provide a modest three month improvement. Sutent offers a chance to dramatically improve response rates demonstrating either tumour shrinkage or disease stabilisation."

He added Sutent had less impact on patients' quality of life, allowing them to enjoy time with their families while their condition was controlled. An SMC spokesman said: "We are truly disappointed not to be able to recommend sunitinib at this time. The remit of our organisation is clear - we exist to recommend treatments that offer good value for money to the NHS in Scotland. After analysing the manufacturer's own submission, we feel there are significant uncertainties in evidence and calculations, leading us to conclude that sunitinib's high cost in relation to its benefits has not yet been justified."

He added that new evidence in support of the drug might lead to revised guidance.

© 2007 Herald & Times Group.