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Another Tarceva Injustice in UK being appealed!!!


RandyW

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ZURICH, April 24 (Reuters) - Roche Holding AG will appeal over a British decision against approving its Tarceva as a cost effective treatment for lung cancer, the Swiss drugmaker said on Thursday.

Britain's main cost-effectiveness watchdog -- the National Institute for Health and Clinical Excellence (NICE) -- said that the once-a-day lung cancer pill Tarceva is of limited use and too expensive to be given on the state health service.

NICE confirmed an earlier ruling on Thursday, saying the drug -- also known as erlotinib -- could not be considered an effective use of National Health Service (NHS) resources.

"After considering all the evidence available, the Committee concluded that erlotinib could not be recommended for the treatment of locally advanced or metastatic non-small cell lung cancer," NICE said in a report.

The ruling has left England and Wales, where NICE sets guidelines for medicine use, at odds with Scotland, where Tarceva has been recommended for use, and will add to controversy about access to expensive modern cancer treatments.

"Roche is adamant in its conviction that this latest NICE recommendation is wrong and will be appealing against it," the company said in a statement.

Tarceva -- one of a new generation of targeted drugs that attack only cancer cells and are tolerated much better than traditional chemotherapy -- was licensed and launched in Britain in 2005 at a cost of 1,631 pounds ($3,224) for a month's treatment.

Roche said it has submitted evidence which demonstrates Tarceva is both clinically and cost effective and believes NICE failed to take full account of the data.

"This negative decision clearly demonstrates a disconnect between the Department of Health's Cancer Reform Strategy, which calls for a world class cancer service, and the reality inflicted on lung cancer patients by NICE," the company said. (Reporting by Sam Cage; Editing by Rory Channing/Andrew Hurst)

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CANCER patients across the region could miss out on a life-extending drug because the medicines watchdog appears poised to defy expert opinion and ban it from the NHS.

Despite the backing of every lung cancer specialist in England and evidence that the drug can significantly extend patients' lives, the National Institute for Health and Clinical Effectiveness (Nice) has issued a 'final appraisal determination' not to approve Tarceva for the NHS on the grounds of cost- effectiveness.

This means the watchdog is one step away from preventing NHS consultants from prescribing a drug widely available in Scotland, Europe and the US.

Two months ago - after a campaign by Darlington patient Dave Hill and new evidence from clinical trials - the NHS in the North-East decided to fund Tarceva.

While the drug is fully licensed, it is not generally available to cancer patients in England because local primary care trusts are usually not prepared to fund drugs that have not been vetted by Nice.

But last night's announcement by the watchdog means the North-East NHS is likely to be forced to stop prescribing the drug to dying patients.

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While existing patients are expected to continue to be given Tarceva, the anticipated 'final guidance' from Nice would mean an estimated 50 sufferers a year would be denied the drug in the North-East and about 2,300 in the rest of England, Wales and Northern Ireland.

Costing about £6,700 per six-month course, Tarceva has been welcomed by UK cancer specialists as a way of giving terminally-ill patients more time with their families.

The decision by the North-East NHS followed a campaign by The Northern Echo in support of the late Mr Hill.

The 46-year-old from Darlington fought for months to get access to Tarceva on the NHS. He died six days after his request was granted.

Last night, Mr Hill's widow, Tina, who with her daughter, Chantelle, campaigned on behalf of her husband, said: "I can't believe it. We thought we had won this fight."

At his funeral in February, Mr Hill was praised by a minister who said others would live on because of his legacy.

Poignantly, Mrs Hill has already commissioned stonemasons to remember her husband's drug campaign on his headstone.

"The inscription 'your legend will carry on' is already on it," said Mrs Hill.

Lung cancer patient Jimmy Jenkyns, 55, from South Shields, South Tyneside, who has been on Tarceva for a year, said: "This is absolutely ridiculous. They are taking people's last chance away.

"If I had not been on Tarceva I would not be here talking to you today."

Last night, Roche, which makes Tarceva, announced it will appeal against Nice's latest determination.

A spokesman for Roche said the company had submitted evidence to show that Tarceva was "both clinically and cost effective".

One of the world's leading lung cancer specialists, Professor Nick Thatcher, told The Northern Echo that Tarceva was "unanimously supported" by lung cancer doctors in the UK.

Prof Thatcher said: "We are one of the most heavily taxed countries in Europe, yet our patients can't get a drug which is freely available through the health care systems of France, Italy, Spain and Austria. It is very disappointing."

Mike Unger, chief executive of the Roy Castle Lung Cancer Foundation, said the Nice decision "flies in the face of common sense" and warned that the charity could appeal against the decision and potentially mount a judicial review.

"I know one patient who has had his life extended by Tarceva by four years. The average life expectancy is four months." he added.

"It has saved lives and improved the quality of life immeasurably."

No one from Nice was available for comment.

4:03am Friday 25th April 2008

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... British decision against approving its Tarceva as a cost effective treatment for lung cancer...

This is absolutely ridiculous! Cost effective?

I don't give a flying fig how much Tarceva costs, even if it's the entire budget of the US and European Union combined--not if it gives us extra time with our families. And no one else--from any nation--should give a flying fig either... particularly not the US and UK whose leaders seem to have no problem with spending double digit billions monthly on wars without end!

Arrrrrrrrrggggggghhhhhhhhh!

Carole

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This speaks VOLUMES to Me right here!!

The 46-year-old from Darlington fought for months to get access to Tarceva on the NHS. He died six days after his request was granted.

Last night, Mr Hill's widow, Tina, who with her daughter, Chantelle, campaigned on behalf of her husband, said: "I can't believe it. We thought we had won this fight."

At his funeral in February, Mr Hill was praised by a minister who said others would live on because of his legacy.

Poignantly, Mrs Hill has already commissioned stonemasons to remember her husband's drug campaign on his headstone.

"The inscription 'your legend will carry on' is already on it," said Mrs Hill.

I have been in touch with Deanne to see what is next in their fight and there is a debate scheduled for Tuesday, so far and Roche is of course also appealing this decision!

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