'Devastating blow' to kidney cancer sufferers

Patients with advanced kidney cancer will be denied four treatments on the NHS under new guidelines published today.

The National Institute for Health and Clinical Excellence (Nice) issued draft guidance rejecting the drugs Sutent (sunitinib), Avastin (bevacizumab), Nexavar (sorafenib) and Torisel (temsirolimus).

Charities expressed outrage at the decision, saying it left patients only one treatment option - interferon - to which many do not respond.

Professor John Wagstaff, from the South Wales Cancer Institute, said there was "no point" in him accepting referrals for people with advanced kidney cancer as around 75 per cent of them "do not gain any real benefit" from interferon.

The only other option was to make patients comfortable in their last months of life.

Broadcaster James Whale, who lost a kidney to cancer in 2000, said the guidance would "mean an early death sentence for many" if it was not revised.

The draft guidance, which is subject to appeal, rejects the drugs, saying they are not cost effective for patients with advanced and/or metastatic kidney cancer.

The medicines do not cure the cancer but extend a person's life by a matter of months.

Patients already on the therapies should continue until they and their doctors consider it appropriate to stop, the guidance said.

Every year, up to 7,000 people in the UK are diagnosed with kidney cancer.

Of these, around 1,700 patients will be diagnosed with advanced kidney cancer and at any one time around 3,600 people are living with the advanced form.

Professor Peter Littlejohns, clinical and public health director at Nice, said: "The decisions Nice has to make are some of the hardest in public life.

"NHS resources are not limitless and Nice has to decide what treatments represent best value to the patient as well as the NHS.

"Although these treatments are clinically effective, regrettably, the cost to the NHS is such that they are not a cost-effective use of NHS resources.

"Two of the manufacturers have developed proposals which may have the effect of reducing the cost of the drugs. We will be happy to consider these proposals once they have been reviewed and considered suitable for the NHS, by the Department of Health."

Prof Littlejohns said there were no treatments that reliably cured advanced or metastatic kidney cancer.

"The main objective is to relieve physical symptoms and maintain general functions," he said.

"Bevacizumab, sorafenib, sunitinib or temsirolimus have the potential to extend progression-free survival by five to six months, but at a cost of £20,000 - £35,000 per patient per year.

"If these treatments were provided on the NHS, other patients would lose out on treatments that are both clinically and cost effective."

Prof Wagstaff, who is an honorary consultant in medical oncology at the South Wales Cancer Institute in Swansea and director of the Wales Cancer Trials Network, said: "The possibility that we clinicians may be prevented from offering Sutent to our patients is an outrage and a devastating blow to the kidney cancer community.

"If this draft guidance is not overturned, there will be no point in me accepting referrals of patients with metastatic renal cell cancer as three quarters of patients do not gain any real benefit from interferon, leaving only the option of palliative care.

"This decision will mean that the UK will have the poorest survival figures for metastatic renal cell cancer in Europe.

"Sutent produces a remarkable effect on survival for patients. It is now no longer ethical or reasonable for patients to have access to treatment with only interferon."

Mr Whale, who founded the James Whale Fund for Kidney Cancer, said: "The treatment options previously available to us in the kidney cancer community have been limited and inadequate for the majority of patients."

He said the arrival of the drugs had given many families and patients hope for the future.

"I strongly urge Nice to rethink its current draft recommendation," he added.

"If final guidance remains as it currently stands it will certainly mean an early death sentence for many."

Professor Peter Johnson, Cancer Research UK's chief clinician, said: "We are disappointed at Nice's view that although these drugs are clinically effective, their high price means that they are not considered to be value for money for the NHS.

"These drugs have shown a small but definite improvement in an illness where there are few alternative treatments.

"If this decision stands it will be very frustrating for cancer patients and their clinicians.

"This decision once again raises questions about whether Nice's system of appraisal is appropriate for all types of drugs.

"It is often difficult to get unequivocal research data in rarer cancers, such as metastatic kidney cancer, which have a small patient population.

"Although we understand that Nice often has to make difficult decisions, in this case there is a clear separation between what Nice finds to be valuable treatment, and clinical and patient opinion.

"Action is needed to bring these two positions closer together."

Harpal Kumar, chief executive of Cancer Research UK, said: "Possible solutions include looking at the way that pharmaceutical companies are charging the NHS for drugs, and whether appropriate allowances are being made by Nice to compensate for the lack of large scale trials in these areas.

"We also need to ensure that further results are sought and that larger trials, in addition to the nine studies supported by Cancer Research UK, are carried out."



Professor Peter Littlejohns, clinical and public health director at the National Institute for Clinical Excellence, told the BBC today: "I can understand the concern and distress this has caused. We cannot afford all the treatments and therefore decisions should be made using the best evidence.

"We have a very strong ethical framework and I think every patient needs to be taken into account.

"The decision was based on cost effectiveness. We balanced the cost of the drug with the actual length and time of its effectiveness.

"If the drugs were cheaper then the cost effectiveness would be better."

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