Cost regulators have closed the door to Eli Lilly’s Alimta as a maintenance treatment for non-small cell lung cancer on the National Health Service, after deeming the drug too costly for use in this setting.

Maintenance therapy for NSCLC – which is designed to prolong the period of remission after first-line chemotherapy and boost the chances of being able to receive second-line chemotherapy - is a new approach that is not yet routinely practiced in the UK.

Regulators approved Alimta as the first maintenance therapy for locally advanced or metastatic non-small cell lung cancer earlier this year, based on a Phase III trial which showed that patients with certain subtypes of NSCLC who received the drug plus best supportive care survived for 15.5 months following treatment, compared with 10.3 months for those on best supportive care alone.

But this morning the National Institute for Health and Clinical Excellence has published draft guidance rejecting Alimta (pemetrexed) as a potential maintenance therapy on the NHS, because “many uncertainties in the data and analysis provided by the manufacturer” meant that the appraisal committee could only conclude that “the cost of the drug related to the benefits it brings means [it] would not be a good use of NHS money”.

In the best-case scenario, it was estimated that the ICER (incremental cost-effectiveness ratio) for Alimta is greater than £51,000 per QALY (quality-adjusted life year gained), but “due to the uncertainties in the manufacturer’s economic model, this may be higher”, NICE said, explaining the decision.

Dr Carole Longson, Health Technology Evaluation Centre Director at NICE, said the Institute is “disappointed” that it could not give the go-ahead for the drug in this setting, particularly as it recommended Alimta as a first-line weapon against the disease back in September. But the next step, she said, is for Lilly to “consider the committee’s comments and respond to its concerns”.