A divorced mother of three has lost a legal battle to force her local health authority to prescribe the drug Herceptin to prevent her breast cancer recurring.
In a case being keenly watched by other cancer patients up and down the country, a High Court judge today ruled that Swindon Primary Care Trust had not acted in an arbitrary or irrational way in deciding to refuse Ann Marie Rogers the treatment, which costs £20,000 a year.
Some primary care trusts (PCTs) in England and Wales routinely supply Herceptin to women who, like Ms Rogers, have already suffered one bout of the aggressive HER-2 form of breast cancer, which constitutes one in five of all breast cancers.
The drug has been found in clinical trials to halve the chances of the cancer recurring, although it is not yet fully licensed to be used in these circumstances.
But other PCTs - including Swindon - have decided to supply Herceptin in what they decide are only exceptional cases, such as when the patient cannot be prescribed the standard, licensed treatment. Swindon felt that Ms Rogers, who worked as a restaurant manager before her cancer treatment made her too ill to continue, was not an exceptional case.
Making her plea for Swindon's decision to be judicially reviewed, Ms Rogers, 54, said that being refused the drug felt like a death sentence.
Her lawyers claimed that the trust had acted in a way that was arbitrary and irrational, and thus in breach of UK domestic law and European human rights law.
They cited guidance from Patricia Hewitt, the Health Secretary, who had tackled the issue when answering a question from MP Charlotte Atkins in a Health Select Committee hearing in December.
Ms Hewitt had suggested that reasons for refusing Herceptin should be "entirely limited" to clinical concerns such as side effects. The Department of Health now says that this opinion has no legal force.
Mr Justice Bean, sitting at the High Court in London, said that he was sympathetic to Ms Rogers's plight, but he disagreed with her lawyers' arguments.
"Ms Rogers has not shown that Swindon PCT’s refusal to fund her treatment with Herceptin is contrary to a direction or guidance from the Secretary of State for Health," he said, in a written ruling.
"Many primary care trusts have a policy of funding Herceptin treatment for early stage breast cancer sufferers who are HER-2 positive, but Swindon’s is not to provide such funding unless the individual case is exceptional.
"The court’s task is not to say which policy is better, but to decide whether Swindon’s policy is arbitrary or irrational and thus unlawful."
The judge granted Ms Rogers permission to appeal.
When she was turned down by her PCT Ms Rogers took out a loan to finance Herceptin treatment privately, but her money has now run out. When she started her legal case last year, the court ordered that Swindon should take over the funding of her treatment for the duration of the legal proceedings.
Today Mr Justice Bean directed that the PCT should continue to treat her with Herceptin until March 31, or until the Court of Appeal gave its judgment, or any further court order was made. Ms Rogers is due have her next treatment tomorrow.
Ruling that Swindon had not acted unlawfully, the judge said: "Accordingly, despite my sympathy with Ms Rogers’s plight, I must dismiss the claim for judicial review."
Ms Rogers said that she was "devastated" by the ruling. Looking harrowed, she stood silently outside the High Court this morning as her solicitor, Yogi Amin, read out a statement.
He said: "Ann Marie has an aggressive form of breast cancer. She feels let down by her health authority. Access to lifesaving breast cancer treatment depends on where you live in England and Wales."
He said that Professor Mike Richards, the Department of Health's "cancer tsar", had condemned the "unacceptably high variations" in access to cancer drugs such as Herceptin.
"He has urged PCTs to provide this treatment to all women who would benefit," added Mr Amin.
Dr Sarah Rawlings, of the Breakthrough breast cancer charity, said: "We're extremely disappointed with today's verdict. We now need clarity over who exactly is allowed to access this drug, prior to licensing and prior to National Institute for Health and Clinical Excellence (NICE) approval.
"It really should be available on the basis of need. We know it’s particularly beneficial to certain types of breast cancer and has the potential to save a thousand lives a year."
Outside the court, Jan Stubbings of Swindon PCT shrugged off questions about a postcode lottery, saying that she could not speak for other trusts, but that Swindon had carefully applied the guidelines in this case.
She said that the trust had received written guidance from Ms Rogers's consultant that she was not an exceptional case. It would be totally unethical for the trust to ignore its guidelines, although, she said, it was quite understandable that she should try to obtain any treatment she thought would help her.
"We did look at effectiveness and efficacy," she said. "What would be exceptional in this case would be perhaps that someone could not tolerate a standard treatment regime. That was not the case in this case.
"This was not an easy decision and it has not been taken lightly." She pointed out that the drug had not yet received a licence for use in these circumstances, or been assessed by NICE for its safety, benefits and cost effectiveness. Herceptin has been linked to side effects such as heart problems.
The PCT also issued a statement, saying that it had "the greatest sympathy" for Ms Rogers and her family, but unless it rigorously applied its own guidelines it would be impossible "to remain open, fair and consistent in our decisions which impact all our 200,000 residents".
The Department of Health said that the situation remained unchanged, and PCTs would continue to decide at a local level when to supply Herceptin. It said that NICE would review Herceptin under a new fast track procedure, so that a decision on whether to approve it for general use could be taken quickly once Herceptin was licensed.
