The decisions by the National Institute for Curbing Expenditure (NICE) underline that new guidance last year for “end of life” treatments will not produce a wave of new approvals for costly drugs that can extend life but where there is not yet evidence of dramatic results.

This year Nice approved Pfizer’s Sutent as a “first line” treatment for kidney cancer. But the institute has now rejected it as a second line treatment – where an initial therapy has failed – and has turned down rival products from Roche, Bayer and Wyeth for first line use.

It has done so in spite of Pfizer, Roche and Bayer agreeing deals with the Department of Health, which effectively cut the price of the drugs to the National Health Service.

The decisions were described as “a bitter blow” by the patients’ charity the Rarer Cancers Forum, which claimed they “went against the spirit” of last year’s amended guidance giving greater weight to end-of-life care.

Roche, whose product Avastin was rejected, was also furious, saying it was “considering all options”, including legal action. It attacked the decision as “illogical” when its product costs broadly the same as Sutent.

Professor Peter Littlejohns, clinical director of Nice, said that in spite of the revised guidance and price cuts “the benefit [from these drugs] was still too small, set against their cost”.

The National Institute for Curbing Expenditure (Nice) has approved the use of Sutent, which costs around £27,000 a year, in its final decision yesterday.

But the body will turn down three other kidney cancer drugs insisting that they are not “cost effective” for the health service.

Nice sparked outrage in August last year when it initially turned down Sutent, claiming it was too expensive.

At the time patient groups and cancer charities accused the body of condemning sufferers to an “early death”.

The drug, which can prolong life for months, is used in the treatment of patients with terminal kidney cancer.

Since its initial draft guidance on the use of the drug Nice has agreed with the labour Government to look more favourably on drugs which prolong life when it makes it decisions.

This, coupled with an offer from Pfizer, the company which makes Sutent, to cut the price, means that the drug will be approved for use on the NHS.

Under the agreement, Pfizer will pay the £3,139 cost of the first six-week cycle of the drug, with the health service paying the rest of the costs.

Three other kidney cancer drugs, Avastin, Nexavar and Torisel, are expected to be rejected because the body has deemed them too expensive for the benefits they provide.

Around 7,000 people are diagnosed with kidney cancer in Britain every year and an estimated 3,600 could be eligible to receive Sutent.

Earlier this year it was announced that the drug, also called sunitinib, would be given to patients in Wales, paid for by the Welsh Executive, even before the Nice announcement.

Prof Robert Hawkins, Cancer Research UK Professor and Director of Medical Oncology at Christie Hospital Manchester, said: “I am delighted that Sutent will be available.

“It will remove a great deal of anxiety and uncertainty for people diagnosed with renal cancer to know that modern, effective treatment is now available to them.”

James Whale, from the James Whale Fund for Kidney Cancer, said: “Finally, we have justice for the kidney cancer community. This positive recommendation from Nice will allow thousands of kidney cancer patients in England and Wales access to this life extending treatment.

“The options previously available to us have been limited and are inadequate for the majority of patients. For some, sunitinib is the only hope.”

From:
http://www.telegraph.co.uk/health/healthnews/5044196/Kidney-cancer-patients-to-get-expensive-drug-on-NHS.html

Health Direct asks how many people have been condemned to an early death by labour’s killer quango whilst it dragged it’s feet over spending NHS money?

The National Institute for Curbing Expenditure (Nice) has issued new guidance recommending that patients with the cancer should be given Sutent, or Sunitinib, following a public outcry.

Last year NICE was accused of condemning sufferers to an “early death” when it recommended that the drug was not “cost effective” for the health service.

However, Nice has revised that guidance after taking into account new rules requiring greater funding for expensive drugs that can help terminally ill patients.

Coupled with an offer from the manufacturers, Pfizer, to make the drug cheaper, Nice said that its new draft guidance was that Sutent should be prescribed on the NHS.

Under the deal, Pfizer, will pay the £3,139 cost of the first six-week cycle of the drug, with the NHS picking up the rest of the bill, expected to be just over £30,000 a year.

In a statement, Nice said that it accepted that the drug was a “clinically effective treatment”.

The organisation has recommended that it be used for patients whose cancer is advanced or has spread to other parts of their body, and who currently have few other treatment options.

However, it still recommends that three other kidney cancer drugs, Avastin, Nexavar and Torisel, are too expensive for the benefits they offer.

Cancer experts said that the new guidance on Sutent would make an “enormous difference” to patients.

Around 7,000 people are diagnosed with kidney cancer in Britain every year and an estimated 3,600 could be eligible to receive Sutent, which is widely available in countries like Germany and France, and last month given to patients in Wales.

Currently patients with the advanced stage of the disease are offered just one drug, Interferon, to which many sufferers do not respond.

Sutent has been shown to increase survival by several months, and in some cases for up to two years, but does not cure the disease.

Andrew Dillon, the chief executive of Nice said: “Having decided that one of these treatments should be recommended for use in the NHS, we felt that it was in the interests of patients to get that advice out as quickly as possible.

“Although this final recommendation is subject to appeal we very much hope it will form the basis of our guidance to the NHS.”

Professor John Wagstaff, from the South West Wales Cancer Institute, said: ‘This really fantastic news for people with kidney cancer… (this will) make an enormous difference for patients and for clinicians.’

Dr David Gillen, medical director, Pfizer Limited, said Sutent had become “the new standard of care in the rest of the world” for kidney cancer patients.

“Not only will this decision have immediate benefits for eligible patients today, but will also pave the way for future treatment advances in kidney cancer,” he said.

In recent months Nice has agreed payment deals to allow a number of expensive drugs to be prescribed on the NHS.

These include Lucentis, which can improve the sight of sufferers of a degenerative eye condition, Tarceva, for lung cancer, and Revlimid, for a rare type of blood cancer.

Nice has previously faced controversy over its advice that Herceptin, the breast cancer drug, could only be used for advanced cases. Following public pressure and legal battles the drug was allowed for early stages of the disease.

The organisation is currently looking at its advice that Aricept, which costs £2.50 a day, be given only to Alzheimer’s patients with advanced stages of the disease.

Final guidance on the use of the four kidney cancer drugs is expected in March.

From:
http://www.telegraph.co.uk/health/healthnews/4449605/Kidney-cancer-patients-should-get-Sutent-on-the-NHS-says-NICE.html

It coincides with the publication of a report which found that more than 1,000 patients have been turned down for cancer drugs in the past two years because of a postcode lottery.

Immediately after the decision on kidney drugs last week, campaigners denounced it as akin to a “death sentence” for thousands of people.

Now experts and patients’ representatives invited to participate in the consultation process have claimed it was “flawed and irrational”.

Charity Kidney UK is expected to make an official complaint that its advice was ignored, while three out of the four patient representatives asked to attend have registered protests.

One patient representative, Bill Savage, a retired management consultant who had a kidney removed, claimed that he and other patients were made to sit through a 101-page Powerpoint presentation focusing solely on the costing of the drugs.

“We were patronised and bullied by a process that marginalised us,” Mr Savage, 61, said.

Kate Spall, who won treatment for 80 patients this year by challenging the priorities of local primary care trusts, drew up advice for Nice with the help of a large number of cancer sufferers, but was so appalled by the process that she declined to be named as a consultee and made a written complaint.

“We waited for our opportunity to contribute – and it never came,” she said.

The four prohibited medicines include Sutent, which can prolong life in kidney cancer patients by up to two years. The draft guidance also rejected Avastin, Nexavar and Torisel.

Nice has said it has sent responses to all complaints but would not comment further.

From:
NHS-drugs-body-Nice-bullied-ignored-and-patronised-patients-say-charities.html

The National Health Service is providing dying cancer patients with drugs that are five times less effective than those available privately and is refusing to treat them if they try to buy medicines themselves.

One drug for kidney cancer, routinely available through public health systems in most European countries but not to British patients, can reduce the size of tumours in 31% of patients, compared with just 6% of those prescribed the standard NHS drug.

The growing row over “co-payments” has prompted the labour government to reconsider the ban. Alan Johnson, the health secretary, has promised a “fundamental rethink” of the policy.

The shift comes as increasing numbers of cancer doctors defy the official Whitehall ban and allow patients to pay for drugs while still receiving NHS care.

Doctors at the Royal Marsden hospital in London and consultants at the NHS trust in Swansea are offering patients NHS care while they pay to receive drugs that will prolong their lives. Recently the Sunday Times revealed that about 16 consultants in Birmingham are ignoring the government guidance.

Research presented at the American Society of Clinical Oncology found that kidney patients taking the new drug Sutent lived six months longer than those prescribed alpha interferon, the NHS treatment.

The failure of the NHS to make more effective drugs available to cancer patients has been condemned as “unethical” by leading doctors.

John Wagstaff, professor of oncology at Swansea University, said: “This has created a very difficult situation for us. Having seen the latest data, I believe it is now pretty unethical to give many patients alpha interferon [rather than Sutent]. We are often forced to prescribe interferon because we do not have access to Sutent [on the NHS], but I am always upfront with the patients. I tell them what I think the most effective treatment is.”

Eight times as many patients in Germany and France receive Sutent as in Britain, according to figures held by Pfizer, the manufacturer. Sutent, which costs about £2,200 a month compared with about £800 for the NHS drug, is one of a number of life-prolonging new drugs at the centre of the co-payments row.

In advanced kidney cancer, when the patient cannot be treated with any other drug, Nexavar, another medicine, can double the period when the disease is held under control.

A trial of Nexavar, comparing the effect of the drug with a placebo, showed it to be so effective that the trial had to be halted early as it was considered unethical not to give it to all the patients in the test. Tumours were prevented from growing for an average of 5.5 months in patients taking Nexavar, against 2.8 months in those taking the placebo. Despite the findings, Nexavar is not routinely funded by the NHS.

Similarly, bowel cancer patients are up to four times as likely to see their tumour shrink if they pay for Erbitux than if they take irinotecan, the NHS-approved drug, alone. A study published in the New England Journal of Medicine in 2004 showed that 23% of patients experienced a reduction in the size of their tumour when they took Erbitux and irinotecan.

Other studies showed that just 5% of patients have the same benefit from taking irinotecan alone. Those taking irinotecan alone had their bowel cancer under control for 4.2 months, but this rose to 8.6 months when Erbitux was added.

Erbitux, costing about £3,000 a month, is funded for bowel cancer in most European countries. Patients in France are 13 times, in Spain 10 times and in Germany nine times more likely to get the drug than Britons.

The drug Avastin offers similar benefits. Research presented earlier this year showed that patients who receive Avastin and routine chemotherapy before surgery are twice as likely to be alive two years later as those who receive only the chemotherapy available on the NHS.

A former fireman who developed liver cancer after 25 years’ service has been told that if he pays for the only drug that can treat his disease his NHS care will be withdrawn.

Barry Humphrey, 59, from North Walsham, Norfolk, was told by NHS doctors that the drug Nexavar was the only available treatment for his advanced liver cancer.

However, consultants at Addenbrooke’s hospital in Cambridge said the drug was not routinely funded by the NHS and told him that if he paid for it he would be billed for the rest of his NHS care.

Humphrey believes his cancer is linked to his time as a fireman. His cancer was caused by cirrhosis of the liver after he contracted hepatitis C. He believes he caught the virus from a casualty while on duty.

Research presented at the American Society of Clinical Oncology found patients with advanced liver cancer survive for an average of 11 months if they take Nexavar, while those denied the drug live for just eight months.

Humphrey’s wife Hazel, 58, who also worked in the fire service, said: “Doctors said this would ‘not be viable’ because we would be deemed as opting out of the NHS and would need to pay for everything.

“I think it is absolutely disgraceful. When people are terminally ill, they want to spend as much time as they possibly can extending their life expectancy.” She said the couple know the drug will not provide a cure but should have the right to spend their savings to prolong her husband’s life.

They plan to sell a flat that they have been renting out to raise the cash for the drug, which costs about £3,000 a month. Humphrey, who has four children, six grandchildren and helps to care for his elderly mother, said: “I think this is morally wrong and indefensible.”

Cambridge University Hospitals NHS Foundation Trust, which runs Addenbrooke’s, said: “We are complying with the national guidance which says we cannot allow co-funding.”

The public’s view

A poll for The Sunday Times shows strong support for allowing co-payment in the National Health Service, with 89% saying that people who buy additional cancer drugs should continue to get free NHS treatment.

Only 5% think allowing co-payment would create a two-tier NHS. Until now this has been the position taken by Alan Johnson, the health secretary.

Ministers had feared that allowing co-payment would upset less well-off patients, but the YouGov poll of nearly 1,800 people shows strong backin
g across the social spectrum and supporters of all three main parties.

From:
http://www.timesonline.co.uk/tol/life_and_style/health/article4138237.ece