The future of Tarceva as a maintenance therapy for non-small cell lung cancer in England and Wales is looking decidedly shaky after cost regulators for the National Health Service turned down the drug.

The National Institute for Health and Clinical Excellence has issued draft guidance in which it rejects the use of Tarceva (erlotinib) as a maintenance therapy in patients with NSCLC whose disease is considered to be stable after first-line treatment with chemotherapy.

Maintenance therapy is designed to prolong the period of remission after first-line chemotherapy and increase the likelihood of being able to receive second-line treatment, but it is a new concept in lung cancer care and one not yet routinely practised in the UK and the Institute is yet to publish final guidance endorsing any drug for this use.

Despite recognising that Tarceva has been shown to offer some clinical benefit, potentially extending life by around 3.3 months according to Roche, the Institute calculated that its cost in the maintenance setting would be at least £59,000 per QALY, well above its ceiling limit.

According to NICE’s chief executive Sir Andrew Dillon, its independent advisory committee felt a number of assumptions in the manufacturer’s economic model were not appropriate, and that the overall cost of Tarceva had been underestimated.

“These issues led the committee to conclude that, on current evidence, the cost of the drug related to the benefits it brings means that erlotinib would not be a good use of NHS money,” he explained, despite a proposed patient access scheme under which Roche as offered to cut the acquisition cost of Tarceva - £1631.53 for a pack of 30 pills - by 14.5% to £1394.96.

However, depending on whether the cost watchdog receives any additional data during the consultation period there could still be hope for the drug - which received a NICE nod as a first-line treatment for the disease in 2008 - in the maintenance setting.

In April this year the Institute published draft guidance recommending Eli Lilly’s rival drug Alimta (pemetrexed) as a maintenance therapy for patients with NSCLC, after having said it was minded not to issue a green light for its use on the NHS.