1.1 Osimertinib 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 osimertinib 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 osimertinib live longer than people who take erlotinib or gefitinib. They also live longer before their disease gets worse. But there is no direct evidence comparing osimertinib with afatinib, which may be more effective than erlotinib and gefitinib.
Osimertinib does not meet NICE's criteria to be considered a life-extending treatment at the end of life. The most plausible cost-effectiveness estimates are above what NICE normally considers an acceptable use of NHS resources. So osimertinib is not recommended.
Although some of the clinical uncertainty could be addressed through collecting further data from the clinical trial, osimertinib does not meet NICE's criteria to be included in the Cancer Drugs Fund because it does not have the potential to be cost effective at the price offered.