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The Court of Appeal ruled yesterday that it was illegal for health trusts to discriminate against patients by funding expensive unlicensed drugs case by case.
The ruling means that trusts will now either have to agree to pay for a new drug for any patient whose doctor recommends it — with serious implications for NHS budgets — or refuse the treatment for the entire population it serves.
Dozens of drugs that do not yet have a licence for certain uses — including treatments for life-threatening conditions — which are prescribed by doctors could be affected.
The decision came as Tony Blair and Patricia Hewitt, the Health Secretary, held an emergency meeting at No 10 to address concerns about spiralling health service deficits, which are expected to pass £800 million for the past financial year.
The hearing at the Court of Appeal came after a lengthy legal battle between Ann Marie Rogers, a grandmother from Swindon, and her primary care trust (PCT). The PCT had decided not to pay for Mrs Rogers’s treatment with Herceptin on the ground that she was not an exceptional case. Ruling in favour of Mrs Rogers, the court said that the trust’s policy of judging patients case by case was “irrational and unlawful”.
Health leaders last night gave warning of the unintended uncertainty that the judgment would create for future drug provision.
Gill Morgan, chief executive of the NHS Confederation, representing more than 90 per cent of NHS organisations, said that the decision held “significant implications for the prescription of all unlicensed drugs — not just Herceptin”.
Herceptin is licensed for treatment of women with advanced breast cancer but is unlicensed for treating early-stage sufferers. Swindon PCT had argued that Mrs Rogers, 54, was not an exceptional case deserving of a drug that had neither been licensed in Britain for her condition nor appraised for NHS use. Many of the 300 PCTs in England and Wales follow a similar policy.
Mrs Rogers, who has received Herceptin during her legal battle, will now be allowed to continue taking the drug while Swindon PCT addresses its policy. The trust’s policy was to fund Herceptin without regard to financial considerations in cases in which it was prescribed by a clinician and it was decided that there were exceptional clinical or personal circumstances.
The Court of Appeal ruled that in considering what might be such an exceptional case, personal circumstances “are irrelevant as soon as financial considerations are disregarded”. In a unanimous judgment, the Master of the Rolls, Sir Anthony Clarke, Lord Justice Brooke and Lord Justice Buxton said that the court could not — and should not — order the PCT to provide Herceptin.
Jan Stubbings, the chief executive of Swindon PCT, said that in terms of the law, it had a statutory requirement to balance its books. “The jury is still out, so we need to make sure we do not overhype Herceptin,” she said. “It is one of many new treatments.”
Research suggests that Herceptin, which has been shown to halve the chances of a tumour returning, would be highly beneficial for early-stage sufferers. It targets the HER-2 protein — which can fuel tumour growth — present in about a fifth of sufferers. However, it has been linked to heart problems and, at £20,000 a year, is a severe drain on NHS budgets.
Outside court, Mrs Rogers, 54, said the “humanitarian” ruling had given her back her future. “I feel I’ve taken on the world and beaten it, not just for me but for everyone else.”
Herceptin ruling in full
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