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Last Updated: Wednesday, 12 April 2006, 12:43 GMT 13:43 UK
Q&A: The Herceptin judgement
Herceptin
The drug is already used for advanced cancer
The Court of Appeal has decided that a breast cancer patient should receive the drug Herceptin after a long-running legal fight.

The decision could have widespread implications for other cancer patients, and for the provision of drugs in the NHS in general.

What could the ruling mean?

The fact that the law courts have decided that Ms Rogers should be given Herceptin would appear to set a precedent for other hundreds of other cancer patients in a similar position.

But Appeal Court judges said the ruling would not "open the floodgates" as only women who met the clinical criteria for Herceptin would qualify for the drug.

It is estimated that around 5,000 women could be able to get the drug because of the judgement, costing the NHS around 100m a year.

However, their ruling calls into question the role of the National Institute for Health and Clinical Excellence, which is supposed to determine which drugs should be made widely available on the NHS.

It could also affect judgements by local NHS bodies about the many other new treatments which doctors want to provide

What is Herceptin?

It is a drug said to halve the chances of the aggressive HER-2 form of breast cancer returning.

It targets the HER-2 protein, which can fuel the growth of breast tumours. Herceptin prevents this process happening. Around a fifth of breast cancers are HER-2 positive.

It is currently licensed for use in women with advanced breast cancer - where the disease has spread within the breast or to another organ.

Research has suggested it could also benefit women in the early stages if the disease, but it is not currently licensed for use in this group of patients.

However, it has been linked to heart problems.

The cost for one year's treatment with Herceptin is around 20,000.

When will it be licensed for use in early stage breast cancer?

The National Institute for Health and Clinical Excellence (NICE) has said that it will fast-track the review of the drug, but manufacturers Roche still have to submit an application to European licensing authorities before NICE can consider it.

In the meantime, women up-and-down the country are challenging their local NHS trusts when they refuse to fund the treatment.

Trusts can still fund drugs which are awaiting NICE approval, but they tend not to because they argue it is hard to justify the outlay when cash is tight in the health service.

Why did Ann Marie Rogers go to court?

She said she was prescribed the drug by her doctor but has been refused it by local health bosses, and has borrowed 5,000 to fund her treatment.

But she said she cannot pay anymore and accused Swindon Primary Care Trust of putting "money before life".

The PCT denied the move is solely motivated by finances, pointing out the local strategic health authority, in charge of overseeing the trust, has said the drug should not be routinely funded until it is given the seal of approval by NHS advisers NICE.

Why did the High Court rule against Ms Rogers?

Mr Justice Bean ruled that Ms Rogers had not shown that Swindon PCT refusal to fund her treatment was contrary to guidance from the Health Secretary.

He said the PCT was within its rights to decide not to fund Herceptin treatment unless the individual case was exceptional.

The court's task was not to judge the merits of that policy, he said, but to decide whether the policy was arbitrary or irrational, and thus unlawful.

"Accordingly, despite my sympathy with Ms Rogers's plight, I must dismiss the claim for judicial review."

Why did the Court of Appeal over-turn this ruling?

The three judges challenged the idea that a patient could have "exceptional circumstances".

It decided that Ms Rogers should be given the drug as there was no rational basis for giving Herceptin to one breast cancer patient who met the clinical criteria for receiving it, and not another.

What has happened with challenges in the past?

This is the first case to reach the High Court, as previous legal actions by women have resulted in NHS trusts backing down and funding the drug.

Last year, nurse Barbara Clarke, 49, threatened Somerset Coast PCT with a judicial review, but the trust backed down before the case and provided her with the treatment.

And in November, Health Secretary Patricia Hewitt intervened when North Stoke Primary Care Trust refused to fund the drug for mother-of-four Elaine Barber.

Ms Hewitt said she wanted to see the evidence upon which health bosses had made their decision and within a day the trust had reversed the decision, citing Ms Barber's "particular exceptional circumstances".

Evidence collected by the BBC's Panorama programme suggests many trusts are already prescribing it.

A survey of cancer doctors revealed three quarters had been allowed to give it to patients by local health bosses.




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