Alimta drug approval denied

Every year about 2,000 people die of mesothelioma, a cancer of the lining of the lung that arises from exposure to asbestos, which is nearly always terminal. The numbers are expected to peak between 2011 and 2015.

Nice denied approval for the life-extending chemotherapy drug Alimta in June last year, subject to consultation which closed last month. Final guidance is due for publication in September. The uncertainty over NHS funding for chemotherapy treatment (which is still available in parts of the country, including Manchester, Liverpool and certain London boroughs) comes at a time when campaigners are increasingly concerned about the financial security of families blighted by the disease, despite new government proposals for fast-tracking financial support for those diagnosed with the devastating illness.

'No amount of money will ever make up for the suffering and loss to individuals and families caused by mesothelioma,' John Hutton, the Secretary of State for Work and Pensions, said last month. 'But no one should have to worry that they, or their family, will have to wait years before they see a penny of compensation; especially as in many of those cases people don't have years to wait.'

On average, sufferers die within 12 to 18 months of diagnosis. Hutton has promised everyone should get a state benefit within six weeks of making a claim, rather than just those exposed at work, as was once the case.

Ministers had been forced to step in and overrule a judgment by the law lords in the case of Sylvia Barker (reported in The Observer last May), the latest in a series of attempts by insurers to evade liability by deploying technical legal arguments. Five years ago, they attempted to strike out thousands of claims from sufferers by arguing that responsibility couldn't be shared if more than one employer exposed a worker. The Lords overruled that judgment. But last summer insurers did a U-turn, successfully arguing in the Barker case that if there was more than one employer, compensation should be split between them all. As some have now gone out of business or are impossible to track down, this would have meant some families missing out on part or all of their compensation.

Alarmed at this prospect, ministers stepped in to protect ex-workers by amending the Compensation Bill, which was then going through parliament. The new law is now on the statute books and makes negligent employers 'jointly and severally liable', so sufferers can recover full compensation from any employer or insurer. However, the non-availability of Alimta on the NHS seriously compounds the financial problems of sufferers already anxious about challenges over modest levels of compensation paid out. The treatment is available privately at a cost of around £24,000 for the entire course, including hospital costs, although some sufferers have been quoted double that amount.

'People have been contacting us who have remortgaged or sold their homes to pay,' reports Chris Knighton, founder of the Mick Knighton Mesothelioma Research Fund. Her husband died of the disease in 2001, aged 60, after exposure to asbestos while serving in the Royal Navy. He died seven months after diagnosis. 'When I heard that there was a drug being licensed that would give people a better quality of life for longer, I thought it was a lifeline. There was nothing for my husband,' she says.

The charity is funding a study at the Northern Institute for Cancer Research to find out which patients will benefit most from Alimta. 'For a condition where there's no cure, it's so important that it's offered. It's so devastating and cruel for it to be denied,' adds Knighton.

Nick Thatcher, professor of oncology at the Christie Hospital NHS Trust and Wythenshawe Hospital, describes Nice's decision as 'crazy'. 'It's the only proven licensed treatment and isn't that expensive [for the NHS] - only £7,000 for the complete treatment course.'

Nice insists that Alimta is not 'superior to other, far less costly treatment regimens', but Thatcher disagrees. He believes the treatment significantly increases life expectancy, alleviates pain which cannot be lessened by opiates, and helps with breathlessness. 'One in four people on Almita survive two years and more, and generally have a good quality of life,' he says. 'They wouldn't have that with other chemotherapy that's cheaper and not as effective. In terms of social justice, to not treat an industrial disease is extraordinary, especially when the cost is pretty minimal.' Alimta is widely available throughout the EU.

Source - The Observer

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