Current NICE-approved first-line treatments for patients with NSCLC who have EGFR activating mutations include platinum-doublet chemotherapy (mainly gemcitabine plus cisplatin or carboplatin in the UK), gefitinib, and pemetrexed plus cisplatin (for adenocarcinoma or large-cell carcinoma only). 

Erlotinib has recently had its license extended to include the first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR activating mutations.  In the European registration Phase III study (EURTAC), erlotinib at a dose of 150mg daily continued until disease progression (or unacceptable toxicity) resulted in a PFS gain of 4.5 months compared to standard chemotherapy; survival data are immature and will be complicated by further treatments received (including crossover from chemotherapy to erlotinib).  A second Phase III study involving Chinese patients demonstrated a larger PFS survival gain of 9.1 months for erlotinib, when compared to gemcitabine and carboplatin (the standard regimen used in China). 

Although these data show the superiority, in terms of both efficacy and safety, of erlotinib over standard chemotherapy for the first-line treatment of people with locally advanced or metastatic NSCLC who have the EGFR-TK mutation, there are no data comparing it to other possible treatment options.  It remains to be seen what advantages, if any, it will have over gefitinib, another small molecule EGFR tyrosine kinase inhibitor which is already NICE approved for this indication.  Estimates suggest that around 5 people per 100,000 population may be eligible for treatment with erlotinib for this indication; this would work out as approximately £77,770 per 100,000 population (Roche will be implementing a discount scheme for this indication, and this estimate does not take this into account).