The cancer drug lottery

TALKING to Rose Woodward, it is difficult not to feel humble.

The former kidney cancer patient is one of a handful of activists who have spent the last year fighting a guerilla campaign to help desperately ill patients get the life-extending medication they need.

Patients like Barbara Selby from Richmond, North Yorkshire. Barbara, 64, has been pleading with North Yorkshire and York Primary Care Trust to fund a revolutionary new drug called Sutent.

So far the PCT has refused to agree to allow Mrs Selby's consultant oncologist to prescribe Sutent on the NHS, despite evidence that the drug can slow down the progression of otherwise untreatable kidney cancer and buy precious time.

This evidence is so persuasive that Sutent is widely available in western Europe and the United States. In fact, Britain's leading kidney cancer experts - members of the National Cancer Research Network's Renal Cancer Group - have said they are so impressed by the powers of Sutent to prolong the lives of patients that it "should now be made routinely available in the management of the disease in the UK".

The reluctance of many PCTs to fund Sutent is because the National Institute for Health and Clinical Excellence (NICE), the independent body set up by the Government to vet new drugs for the NHS, has not ruled on Sutent and is unlikely to do so until the spring of 2009.

Earlier this week MPs urged NICE to speed up drug evaluations.

BUT until NICE gives a positive ruling on new drugs, PCTs seem to be very reluctant to fund them.

The fact that the drug costs an eye-watering £23,000 a year - a price which includes the first cycle provided free by Pfizer, the company which developed Sutent, as a gesture of goodwill - is probably another reason why PCTs have been dragging their feet.

However, this has not stopped patients in at least 60 out of the 152 English PCTs obtaining supplies of Sutent by resorting to an appeal mechanism which can be used by consultants who feel strongly that an individual patient should be given funding. In most cases this was after Rose Woodward and other members of her Fight For Life Campaign team successfully intervened.

Remarkably, Rose and a handful of like-minded people have been helping desperate cancer patients get access to Sutent for more than a year. In some cases this has involved briefing patients and presenting them with a dossier of documentary evidence, in others Rose and her colleagues have travelled hundreds of miles to help patients make presentations to PCT officials in person.

What drives Rose is her feelings of indignation that patients begging for drugs to extend their lives are being turned down for - in her view - unsound reasons. "I just can't believe there is a treatment available that kidney cancer patients have been waiting for for 25 years and they can't get it. It is just beyond me," she says.

Sutent (also known as Sunitinib) is one of a new type of anti-cancer drug known as a tyrosine kinase inhibitors.

According to Pfizer, tyrosine kinase receptors are involved in two of the processes which allow cancer to grow and spread: proliferation (when a cell divides uncontrollably) and angiogenesis (when new blood vessels form, giving tumours the nutrients and oxygen they need to grow). There is evidence that Sutent can inhibit both these processes, which stops or slows down the growth of the cancer tumours.

Sutent was launched in the UK in August 2006 to treat two types of cancer, advanced kidney cancer and a form of advanced gastrointestinal cancer called GIST.

Following a licence extension granted last January, patients can now be treated with Sutent as a first line treatment when their kidney cancer spreads or returns.

People with advanced kidney cancer - technically known as renal cell carcinoma - can also be given Sutent when they no longer respond to, or are unable to tolerate, the established chemotherapy drug interferon-alpha as a second line treatment.

For patient Barbara Selby, the predicament has been made even more difficult to bear because just a few miles north of where she lives, Sutent is being funded following a U-turn by the North-East and Cumbria Cancer Drug Approvals Group in August.

The group had been holding out against funding applications from kidney cancer patients and their doctors on the grounds that Sutent was not cost-effective enough for the NHS and that NICE had not given a ruling.

But after examining the latest evidence, the group announced that it was lifting its funding ban and that patients living in the North-East and Cumbria could get access to Sutent.

Rose Woodward had hoped that this momentous decision - affecting a cluster of 13 PCTs - might have a knock-on effect further south, but the opposite seems to be happening. "Until recently, we had won all of our appeals on behalf of patients, but they seem to be digging in their heels. The two we have lost included Barbara Selby's appeal in North Yorkshire and one in the Isle of Wight,"

she says.

Barbara's daughter, Clare Whiteside, is considering legal action against North Yorkshire PCT for withholding treatment from her mother, who relies on a single kidney after surgery. She feels desperate at the situation they find themselves in but her mother is adamant that they should not have to fund-raise to pay for Sutent, something more than a dozen patients are doing around the country.

WE have hit a brick wall and we simply don't have the finances to self-fund," says Clare, like her mother is a former NHS nurse.

North Yorkshire and York PCT says it stands by a decision taken by the PCT's High Cost Treatments Board after a review of clinical evidence of the drug's effectiveness.

"I am so angry about this. Having to watch my mum in pain, mentally distressed and unhappy is indescribable,"

says Clare. "More importantly, mum shouldn't have to spend what time she has left in this state of such dismay."