1 Recommendation

1.1

Osimertinib is recommended, within its marketing authorisation, as an option for the adjuvant treatment of stage 1b to 3a non‑small‑cell lung cancer (NSCLC) after complete tumour resection. It is for adults whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or EGFR exon 21 (L858R) substitution mutations. It is only recommended if:

osimertinib is stopped at 3 years, or earlier if there is disease recurrence or unacceptable toxicity and
the company provides it according to the commercial arrangement.

Why the committee made these recommendations

This evaluation reviews the evidence for osimertinib for treating NSCLC after complete tumour resection. 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. During the managed access period and in the clinical trial, osimertinib was stopped after 3 years, or earlier if the cancer came back or there were severe side effects. So, this is how osimertinib will be used in the NHS.

People with EGFR mutation-positive NSCLC whose tumours have 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 delays the cancer coming back.

The most likely cost-effectiveness estimates are within the range that NICE normally considers an acceptable use of NHS resources. So, osimertinib is recommended for routine use in the NHS.