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Mother battles for Herceptin rights

Groundbreaking High Court case to resolve early breast cancer treatment dispute underway

A mother of three, suffering from HER-2 positive early stage breast cancer, has become the first person to legally challenge a local health authority's refusal to finance treatment with the potentially life-saving drug, Herceptin.

Swindon Primary Care Trust (PCT) denied Ann Marie Rogers, 54, the drug made by Swiss firm Roche, because it felt her case was not `exceptional' enough to warrant the costly treatment, which is not licensed for UK patients in the early stages of breast cancer.

Philip Havers QC, Swindon PCT's representative, told London's High Court that while the trust sympathised with Ms Rogers, it had acted ìwholly in line with [official] guidanceî - which states that Herceptin should only be prescribed in exceptional circumstances. He said that in Ms Rogers' case ìno exceptional circumstances, either clinical or personal were demonstratedî.

Ms Roger's legal team labelled the PCT's ruling ìarbitrary and unlawfulî. They highlighted an internal letter from cancer tsar Mike Richards, which said that all women with HER-2 positive early breast cancers are in ìexceptional circumstancesî - his personal view, not government policy. Ms Roger's representative, Ian Wise, told the court that the PCT's `exceptional cases' policy contradicted Health Secretary Patricia Hewitt's directions, and was an abuse of human rights.

Ms Rogers, who once managed a restaurant, has already borrowed ?5,000 for three treatments of Herceptin, but cannot afford further treatment. In an emotional statement to the court she said the refusal of Herceptin was ìa death sentenceî.

Although cancer sufferers have started similar legal challenges in the past, rulings have been avoided when the relevant PCTs reversed their decisions, under considerable pressure from UK Health Secretary, Patricia Hewitt. However, this latest case has avoided Department of Health (DoH) interference and could set a legal precedent.

Advocates of Herceptin, and Roche, claim the treatment can halve the rate of cancer recurrence. Hewitt has previously acknowledged that it has ìthe potential to save as many as a thousand lives a yearî.

Herceptin is already licensed in England and Wales for people in later stages of cancer, but there is growing pressure on the NHS to widen its use. Roche is applying for a licence to cover early stage breast cancer, and although the National Institute for Health and Clinical Excellence (NICE) has pledged to fast track the submission, a decision is not expected until May.

Herceptin treatment costs over £21,000 a year per patient - wider distribution could cost the NHS over £20 million. A NICE licence, therefore, may not be enough to persuade some PCTs to provide the drug. Hewitt has, however, told PCTs that they ìshould not refuse to fund Herceptin solely on the grounds of its costî.

Amid calls to bypass NICE's system of licensing, The Lancet has warned against an over-reaction to media hype. In November last year it stated: ìThe best that can be said about Herceptin's efficacy and safetyÖis that the available evidence is insufficient to make reliable judgements.î

The judge in the case said he would not give an immediate ruling as the case was ìtoo importantî.

30th September 2008

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