The National Institute for Health and Clinical Excellence has barred the entry of Eli Lilly’s lung cancer drug Alimta onto the National Health Service’s treatment menu, because there is a lack of evidence to suggest it is cheaper than currently available therapies, it says. The agency is, however, recommending continued use of the agent in clinical trials.

The company launched Alimta (pemetrexed) in the UK around the close of 2005 to treat the symptoms of mesothelioma - a cancer associated with asbestos exposure and mostly affecting the lungs - and as second-line treatment for non-small cell lung cancer.

Mesothelioma is an aggressive tumour that is often not diagnosed until the advanced stages, at which point patients have an average life expectancy of five months. An estimated 1,700 people in the UK are diagnosed with the illness every year, a figure that is likely to peak at more than 2,000 cases by 2015.

There is currently no standard chemotherapy regimen for the condition. In fact, the Alimta/cisplatin combination is the only chemo-based combo licensed for this indication in the UK. But, according to NICE, a lack of trials comparing chemotherapy with traditional active symptom control or best supportive care methods, in terms of survival and quality of life, means that its actual benefits remain uncertain.

And the drug doesn’t come cheap. A course of Alimta costs about £8,000 for a full course, a spokesperson told PharmaTimes World News. But, according to Lilly, the NICE ruling was made “despite evidence showing that the medicine will have a relatively light budget impact on the NHS, with only an estimated 600 patients annually in the UK being eligible for treatment.”

“This is a major blow for patients with mesothelioma, many of whom were unwittingly exposed to asbestos in their working lives making submarines, ships, boilers, and trains,” remarked Joanna Nakielny, Medical Director of Lilly UK. “This treatment does not save lives, but it can prolong the lives of patients and also improve the quality of the time they have left. Lilly will be formally appealing NICE’s decision.”

And Professor Nick Thatcher, specialist lung Consultant at the South Manchester University Trust Hospital, said that the decision “will remove a very useful treatment option for patients with this resistant cancer. It is contrary to the scientific evidence and is purely based on the value NICE place on a person’s life.”