Roche's new lung cancer treatment Tarceva looks set to be refused recommendation from NICE.

Tarceva (erlotinib) is the first next-generation treatment for non-small cell lung cancer (NSCLC) to win marketing approval and has shown it can help prolong the lives of patients with advanced lung cancer, compared to existing treatments.

The cost of the drug is very high and a preliminary NICE ruling has declared that the extra few months of life provided to some patients is not sufficient justification for the expenditure  NICE has calculated that the typical cost for a course of Tarceva treatment will be around £6,800 (assuming 125 days duration).  

NICE has opened up the approval process for consultation and it is expected to make its final recommendation in January 2007.

Tarceva is licensed as a second-line treatment for patients with locally advanced or metastatic NSCLC, who would normally receive Sanofi-Aventis'  intravenous drug Taxotere (docetaxel).

The drug can be used after failure of at least one prior chemotherapy regimen in patients for whom Taxotere is unsuitable, or who have previously received Taxotere  but whose condition has relapsed.

A Roche spokesman said: "We would like to stress that the NICE appraisal is still an on-going process and we welcome the further opportunity to demonstrate the clinical and cost-effectiveness of this innovative lung cancer treatment that both reduces the symptoms of this devastating disease and has been shown to increase one-year survival by 42%."

Ahead of NICE's decision, Tarceva was at the centre of a court battle in July, when a Lancashire man with terminal lung cancer won his fight to force his PCT to prescribe the drug, but the patient, 51-year-old Paul Bould, died just days after winning his case.

pharmafocus@wiley.co.uk