Woman loses Herceptin court case
pharmafile | February 16, 2006 | News story | |Â Â Â
Breast cancer patient Ann Marie Rogers has lost her court battle to be prescribed Herceptin on the NHS, in what could be a landmark ruling for access to the drug.
Mrs Rogers took Swindon PCT to court over its refusal to fund treatment of her early stage breast cancer, claiming it was acting unlawfully in denying treatment.
But Mr Justice Bean has ruled against the claim, despite support for the case from breast cancer charities and government cancer czar Prof Mike Richards.
Making his ruling, the judge acknowledged that there were different opinions on whether or not to prescribe Herceptin to patients with early-stage breast cancer.
"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," he said, confirming that the PCT had not acted unlawfully.
"Accordingly, despite my sympathy with Ms Rogers' plight, I must dismiss the claim for judicial review."
Roche's Herceptin has been hailed as a wonder drug, with the latest trials showing potentially life-saving results in the early stages of the aggressive HER2 positive form of breast cancer, from which Mrs Rogers suffers.
The trials show a 50% increase in the chance of remaining cancer free if Herceptin is taken in combination with standard treatment, compared to standard treatment alone.
But Roche has not yet submitted this evidence to regulators, and is not expected to gain approval for this licence until later this year.
Despite this, the government has said PCTs should prescribe Herceptin wherever it is appropriate, and not use the high cost of the drug as a reason not to prescribe.
The government's position has brought it into conflict with a number of PCTs, but Swindon is the first to face a court case over Herceptin access.
Speaking after the ruling, Jan Stubbings, a spokeswoman for Swindon PCT, said the ruling had vindicated the trust's actions.
"If something has not been approved as a treatment, and has not been through the licensing process, its safety and benefit haven't been absolutely checked."
She added: "This wasn't an economic decision."
Mrs Rogers is to appeal against the ruling, but her solicitor Yogi Amin, of Irwin Mitchell, said: "Mrs Rogers is bitterly disappointed by the decision. It has come as a shock.
"She felt it was common sense that a policy to refuse to provide treatment, where other authorities are providing it, should be struck down."
He added: "It's an ordeal for her. This legal fight is something she is forced to do. She is fighting for her life."
The government lent its support to the case through evidence given in court by cancer czar Prof Mike Richards. He said all women with HER2 breast cancer who were eligible for Herceptin should be considered (in the language of PCT drug rationing) 'exceptional' and should therefore be prescribed the drug.
Despite this support, Amin called for action from the health secretary Patricia Hewitt. He said Hewitt had built up the hopes of hundreds of breast cancer sufferers up and down the country by indicating Herceptin should be more widely available, but had not enforced the policy. Amin urged the government to issue a mandatory directive to PCTs to resolve the matter.
Breast cancer charities have echoed this demand, saying the health secretary must act to end the confusion and inequalities in access across the country.
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