1 Recommendations

1.1 Dacomitinib is not recommended, within its marketing authorisation, for untreated locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer (NSCLC) in adults.

1.2 This recommendation is not intended to affect treatment with dacomitinib that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations

Locally advanced or metastatic EGFR mutation-positive NSCLC is usually first treated with afatinib, erlotinib or gefitinib.

Evidence from a randomised controlled trial suggests that people who take dacomitinib live longer than people who take gefitinib. They also live longer before their disease gets worse. But there is no direct evidence comparing dacomitinib with afatinib, which may be more effective than erlotinib and gefitinib.

There is also uncertainty about the assumptions used in the cost-effectiveness modelling, including about utility values, the treatments used after disease progression, how survival has been extrapolated and the results of the indirect comparisons.

Dacomitinib does not meet NICE's criteria to be considered a life-extending treatment at the end of life. It also does not meet NICE's criteria to be included in the Cancer Drugs Fund. The most plausible cost-effectiveness estimates are above what NICE normally considers an acceptable use of NHS resources. So dacomitinib is not recommended.