Cost regulators have recommended funding the use of Roche's Tarceva on the National Health Service in England and Wales for the treatment of patients with a certain type of non-small cell lung cancer (NSCLC).

The National Institute for Health and Clinical Excellence has published final draft guidance supporting Tarceva (erlotinib) as an option to treat patients with locally advanced or metastatic EFGR mutation-positive NSCLC.

The decision marks a u-turn from NICE's original stance, which in March 2011 was to reject the drug for use on the NHS to treat NSCLC because of uncertainties in the data in this setting.

But Roche was able to submit further analyses to the Institute's advisory committee which enabled it to recommend Tarceva as a cost effective use of NHS resources.

NICE has already recommended AstraZeneca's Iressa (gefitinib) for the first-line treatment of EGFR mutation-positive NSCLC, which is now the standard of care. 

While there is no trial data that directly compares Tarceva with Iressa, clinical specialists have informed the committee that these drugs are very similar and equally effective, NICE said. 

New patient access scheme

In addition, Roche has agreed a revised patient access scheme with the Department of Health in which it has offered a confidential discount from the list price - £1,631.53 for a pack of 30 (150-mg) tablets.

Roche has welcomed the decision, calling it "positive news" for the 11% or so of patients with NSCLC who have the specific mutation, as Tarceva "nearly doubles the time these patients lived without their disease progressing compared with standard chemotherapy (9.7 months compared with 5.2 months).

Furthermore, it notes that Tarceva is already approved and reimbursed for use in this setting throughout Europe, including in Scotland where it has been endorsed by the Scottish Medical Consortium.

NICE is expected to publish final guidance sometime in June.