UK NICE Recommends Erlotinib Use in NSCLC After Price Reduction

Zosia Chustecka

December 01, 2008

December 1, 2008 — Erlotinib (Tarceva, Roche) is now recommended for use in the second-line treatment of non-small-cell lung cancer (NSCLC) by the National Institute for Health and Clinical Excellence (NICE) in the United Kingdom. This means that this use of the drug is now covered by the UK National Health Service. The decision was reached after lengthy deliberations on cost effectiveness, and only after the manufacturer offered to supply the drug at a discounted price.

Details of the deliberations are outlined by NICE researchers in a special report published online November 27 in Lancet Oncology; the final appraisal is available on the NICE website.

The current standard second-line treatment of NSCLC is intravenous docetaxel. The proposal to use oral erlotinib in its place was hampered by a lack of evidence from a direct comparison between the 2 drugs. Instead, data and estimates from several different trials were used, some of which compared docetaxel to best supportive care. The manufacturer argued that these data showed that erlotinib was at least as effective as docetaxel in terms of overall survival, and was better in terms of time to progression and, hence, progression-free survival, but the Committee was not convinced.

A key factor in the cost-effectiveness analysis, according to the NICE researchers, was the risk for severe febrile neutropenia (grade 3 or 4), which is associated with docetaxel therapy but not with erlotinib. When the cost of treating this adverse effect was included in the analysis, the difference between the 2 drugs was roughly £1000 per patient.

"The Committee concluded that the benefits to quality of life of oral administration and lower adverse events were not sufficient to consider erlotinib cost effective without an equivalent overall survival and progression-free survival relative to docetaxel," the NICE researchers write.

At this point, the manufacturer proposed a scheme to equalize costs between the 2 drugs for the UK National Health Service. This scheme discounts the list price of erlotinib to equalize overall treatment costs (including administration, adverse events, and monitoring costs) for those patients who are eligible for docetaxel.

The Committee considered this proposal to be acceptable and issued the recommendation.

Roche has agreed to continue with this discount until results from an ongoing trial, known as TITAN, become available. This trial is comparing erlotinib with chemotherapy (docetaxel or pemetrexed) as second-line therapy for advanced NSCLC, and the results should resolve the uncertainties over survival.

Lancet Oncol. Published online before print November 27, 2008.