1.1 Osimertinib is recommended as an option for treating epidermal growth factor receptor (EGFR) T790M mutation-positive locally advanced or metastatic non-small-cell lung cancer (NSCLC) in adults, only if:
their disease has progressed after first-line treatment with an EGFR tyrosine kinase inhibitor and
the company provides osimertinib according to the commercial arrangement.
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
This appraisal reviews the additional evidence collected as part of the Cancer Drugs Fund managed access agreement for osimertinib for treating EGFR T790M mutation-positive locally advanced or metastatic NSCLC for adults whose disease has progressed after treatment with an EGFR tyrosine kinase inhibitor (NICE technology appraisal guidance 416).
EGFR T790M mutation-positive locally advanced or metastatic NSCLC that has progressed after treatment with an EGFR tyrosine kinase inhibitor is usually treated with platinum doublet chemotherapy (PDC).
Evidence from clinical trials suggests that people who take osimertinib live longer than those who have PDC, although there is some uncertainty about the results.
Osimertinib meets NICE's criteria to be considered a life-extending treatment at the end of life. Although the cost-effectiveness estimates for osimertinib are uncertain, they are likely to be within what NICE considers to be an acceptable use of NHS resources. So, osimertinib is recommended.