UK cost-effectiveness body the National Institute for Health and Clinical Excellence has firmly closed the door on Eli Lilly’s Alimta for non-small cell lung cancer.

NICE published its draft verdict on the use of Alimta (pemextred) and Roche’s Tarceva (erlotinib) for locally advanced or metastatic NSCLC last year, concluding that there is no evidence the drugs are more cost-effective than the older treatment docetaxel.

Yesterday, the Institute published its final guidance rejecting Alimta, after an appeal by Lilly failed to overturn the recommendations, following suit of the Scottish Medicines Consortium, which issued a red light for the therapy in February.

“The independent Appraisal Committee was not persuaded that the evidence presented provided a robust demonstration of the clinical and cost effectiveness of pemetrexed compared with either docetaxel or best supportive care and therefore concluded that the drug is not an effective use of NHS resources,” explained Andrew Dillon, NICE’s chief executive.

Lilly said it was “extremely disappointed” with the decision, given that “additional costs related to the provision of Alimta for the treatment of non-small-cell lung cancer, and the associated reduction in incidence of life threatening toxicities, are around £500 per month for three or four months."

Last month, Lilly celebrated success after getting the Institute to overturn an earlier decision rejecting Alimta for patients with mesothelioma, a cancer associated with asbestos exposure and mostly affecting the lungs.

NICE’s review of the available evidence last year failed to demonstrate that the drug was better than other, cheaper therapies on the market. But explaining the u-turn at the time, Dr Gillian Leng, implementation director and executive lead for the guidance, said that during the subsequent consultation a number of significant factors came to light, “which, taken together, have enabled the independent appraisal committee to recommend pemetrexed disodium as a treatment option for the majority of people with MPM.”

NICE endorses Tysabri for MS

There was better news for Elan and partner Biogen Idec after NICE issued guidance recommending Tysabri (natalizumab) for the treatment of multiple sclerosis.

The Institute released its final appraisal document recommending the drug last month, opening up a period of consultation for any objections to its guidance, but has now given full consent for doctors to prescribe the treatment on the NHS.

The decision is especially sweet for Elan and Biogen given the rocky road Tysabri has travelled to market. Shortly after being launched in the USA, the drug was quickly pulled back off the shelves in February 2005 after being linked to a rare brain infection and a small number of fatalities. But following a safety review by US regulators, the monoclonal antibody was licensed across Europe in June last year, and placed on NICE’s fast-track programme for approvals in August.