Hundreds of women may get Herceptin after legal victory

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Hundreds of women who have been denied access to the breast-cancer drug Herceptin may now receive the life-saving treatment after the Court of Appeal ruled that an NHS trust had acted "irrationally and unlawfully" in refusing to prescribe it to a patient.

Ann Marie Rogers, 54, who has three children, burst into tears after three judges yesterday overturned an earlier High Court ruling that Swindon Primary Care Trust had been within its rights to decide not to fund the £20,000 cost of treating her with the drug.

Mrs Rogers has been diagnosed with an early but aggressive form of breast cancer and had described the PCT's decision as a "death sentence". The Court of Appeal ruling could also have implications for hundreds of other women who have been told that they cannot receive Herceptin on the NHS despite having the form of breast cancer that can benefit from the treatment.

Charities and patients have claimed that women with breast cancer are being denied the drug on the grounds of cost, despite claims it can halve the risk of the disease returning.

Jeremy Hughes, the chief executive of Breakthrough Breast Cancer, welcomed the judgment, saying: "We hope this sends a clear message to all PCTs that Herceptin should be prescribed on the basis of clinical need, not cost."

Herceptin has already been licensed for use in women with advanced breast cancer, but studies have shown that it may also be effective in preventing a recurrence of early-stage forms of the disease.

The makers, Roche, have applied for a licence for early-stage treatment with Herceptin and the National Institute for Clinical Excellence has agreed to fast-track its appraisal of which patients should receive it on the NHS, but the two decisions are not expected until later this year.

In the meantime, PCTs have been told to act at their own discretion, leading to widespread disparities in who receives the drug.

Only 10 per cent of eligible patients in some areas are given access to Herceptin, compared to 90 per cent in others. Swindon PCT had a policy of "disregarding" the financial considerations of providing Herceptin but still only agreed to its prescription in "exceptional personal and clinical circumstances".

After Mrs Rogers was told by Swindon PCT that she was not eligible under its prescribing policy, she took out loans to fund the treatment herself.

But after running out of money, she took her fight to the High Court, claiming that the decision to refuse her treatment was in breach of her human rights and contradicted government guidance that the drug should be made available unless there were concerns about its safety.

Sir Anthony Clarke, the Master of the Rolls, along with two other appeal judges, ruled yesterday that the PCT's prescribing policy was "irrational and so unlawful", although they stopped short of ordering the trust to specifically provide Mrs Rogers with Herceptin.

The ruling said: "As we see it, it is now a matter for the PCT to reconsider its policy and to formulate a lawful policy upon which to base decisions in particular cases, including that of the appellant, in the future."

Mrs Rogers is currently receiving the drug on the NHS, pending a new decision by the trust. She said: "I have got my future back. I can start living again. That is what I have been scared of - not having a future. I have got it back now." She added: "I did this for all women battling this dreadful disease. I believe everyone prescribed this treatment by their doctor should be given the same health care wherever they live."

Jan Stubbings, the chief executive of Swindon Primary Care Trust, said: "We welcome the clarity given by the court on the use of Herceptin.

"Following this new judgment we will now revisit our policy taking into consideration the points made by the court. The PCT will continue to treat all patients now and in the future with care and consideration."

But the ruling will still mean that PCTs are not obliged to provide Herceptin to all breast cancer patients who are eligible for it.

There are also concerns that the demand for the drug has outstripped the scientific evidence for its benefits. Ms Stubbings said: "The jury is still out so we need to make sure we do not over-hype Herceptin.

"It is one of many new treatments coming on to the market at the moment."

Elisabeth Cooke, 59: 'When I was refused the drug, it was very worrying'

Elisabeth Cooke was refused Herceptin by North Bristol Primary Care Trust in December last year. Her own High Court challenge was put on hold last month pending the outcome of Anne Marie Rogers' case. Mrs Cooke, from Bristol, who suffers from an aggressive form of breast cancer, said: "There is a whole list of medical criteria you have to meet before you can even be considered for the drug. So when I was refused Herceptin it was very disappointing and very worrying.

"Then we had an appeal in January which was turned down. It was a very anxious time because I need the drug. My oncologist said I needed it and so it was very difficult."

Mrs Cooke and her solicitor, John Watkins, were at the High Court yesterday to hear the ruling. Mr Watkins said: "This is a landmark ruling regarding the provision of healthcare treatment. This decision will affect thousands of people around the country."

Mrs Cooke hopes that North Bristol Primary Care Trust will not waste any more money pursuing its case and will concede and give her the rest of her treatment on the NHS.

However, Mrs Cooke said that she was still worried and added: "Until it's cut and dried there's still a strong element of anxiety that the trust will try to wangle their way out of it. I'm sure if they can find a reason to not come up with the money then they will do so."

"I think the postcode lottery is absolutely disgusting," she said. "The NHS is supposed to provide equity of care throughout the country. I can remember Tony Blair saying that the postcode lottery would cease to exist. If it wasn't for the fact that my union, Unison, have supported me and are paying my legal costs, I wouldn't have been able to have pursued this."

Louise Jack

Restricted treatment

ALZHEIMER'S

The National Institute for Clinical Excellence (Nice) ruled in January that only patients with moderate and severe Alzheimer's should receive drugs such as donepezil, rivastigmine and galantamine, which can slow the disease. Patients with mild forms of the disease should not receive the drugs at all, Nice said, because there was not enough clear evidence of benefit.

However, patients north of the border will be treated at any stage of Alzheimer's after the Scottish Intercollegiate Guidelines Network made its own ruling this month.

NON-HODGKIN'S LYMPHOMA

Studies have shown that MabThera with other chemotherapy drugs, can keep non-Hodgkin's lymphoma sufferers free of the disease for 17 months longer than on standard drugs. However, the Nice backlog means that is not due to be assessed until next year. It is already available in Scotland and through some funding bodies in London.

MULTIPLE SCLEROSIS

The Government said in 2002 that beta interferon drugs should be available to all MS sufferers who could benefit from them. The treatment can prevent relapses and prolong the active life of patients.

However, sufferers are still being denied the drugs.

FERTILITY TREATMENT

Under Nice guidelines, all NHS trusts are supposed to provide at least one cycle of fertility treatment to couples who need it. In reality less than half of the country's trusts offer free treatment to couples.

A third of health authorities are enforcing age restrictions, which vary geographically, while waiting times range from three months to as long as five years.

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