In the Pipeline

The cost-effectiveness agency for England and Wales has issued new draft guidance saying that it is not yet able to recommend erlotinib for the first-line treatment of advanced or metastatic EFGR mutation-positive non–small cell lung cancer.

The National Institute for Health and Clinical Excellence stressed that the draft guidance for erlotinib (Tarceva, Roche) was in early stages, however, and that it had asked its manufacturer for more information. Specifically, NICE said it needed cost-effectiveness comparisons with its currently recommended treatment for the same patient group, gefitinib (Iressa, AstraZeneca and Teva).

Both erlotinib and gefitinib are both oral medications that work by interrupting the signaling of endothelial factor growth receptor.

The Scottish Medicines Agency, which advises the National Health Service in Scotland, in January recommend erlotinib for advanced or metastatic EFGR-positive NSCLC. That recommendation was based on clinical evidence from a phase III open-label trial in European patients (N = 173) with advanced or metastatic NSCLC and activating mutations of EGFR. Patients were randomized to receive either erlotinib or platinum-based chemotherapy (ASCO 2011 Abstract 7503).

At the most recent follow-up evaluated by the Scottish agency, median progression-free survival was 9.7 months in the erlotinib group and 5.2 months in the chemotherapy group (hazard ratio, 0.37 [95% confidence interval: 0.27-0.54]; P less than .0001).

The Scottish reviewers also considered evidence from a Chinese study (N = 155) of similar design comparing erlotinib monotherapy with platinum-based chemotherapy (Lancet Oncology 2011;12:735-42). Median progression-free survival was 13.7 months vs. 4.6 months for erlotinib and gemcitabine/carboplatin (HR, 0.164; P less than .0001).

In a news release, NICE did not mention the clinical evidence supporting erlotinib, saying only that it requires "further sensitivity analyses that look at how the cost-effectiveness of erlotinib changes depending on how many patients are able to continue taking erlotinib and gefitinib after 60 days of treatment." Gefitinib is supplied to the NHS at a fixed cost of £12,200 for each patient who is able to continue treatment for 2 months or more. No costs are incurred for patients who take gefitinib for less than 2 months.

Erlotinib is administered as tablets in a standard dose of 150 mg/day. A pack of 30 tablets currently costs £1,631.53; however, erlotinib’s manufacturer has agreed to a discounting scheme that is currently held in confidence by NICE.

02/16/12