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Osimertinib for adjuvant treatment of EGFR mutation-positive non-small-cell lung cancer after complete tumour resection (review of TA761)

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1 Recommendations

1.1

Osimertinib is not recommended, within its marketing authorisation, for the adjuvant treatment of stage 1b to 3a non‑small‑cell lung cancer (NSCLC) after complete tumour resection in adults whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations.

1.2

This recommendation is not intended to affect treatment with osimertinib that was funded by the Cancer Drugs Fund before final guidance was published. If this applies, when that funding ends osimertinib will be funded by the company. Osimertinib should be stopped at 3 years, or earlier if there is disease recurrence, unacceptable toxicity or the patient and their NHS healthcare professional consider it appropriate to stop.

Why the committee made these recommendations

This evaluation reviews the evidence for osimertinib for treating NSCLC after complete tumour resection (NICE technology appraisal guidance 761). It also reviews new evidence collected as part of the managed access agreement, which includes evidence from a clinical trial and from people having treatment in the NHS in England.

People with EGFR mutation-positive NSCLC whose tumour has been surgically removed (complete resection) have the option of then having chemotherapy. There are no other options to have in addition to chemotherapy, so if a person does not have osimertinib they would have active monitoring.

A clinical trial comparing osimertinib with placebo shows that people who have osimertinib have less chance of their cancer coming back or getting worse, and live longer. But in the long term it is uncertain whether osimertinib is a cure or just delays the cancer coming back.

Because of the uncertainty in the long-term clinical effectiveness, the most likely cost-effectiveness estimates are above the range that NICE normally considers an acceptable use of NHS resources. So, osimertinib is not recommended for routine use in the NHS.