Alectinib is recommended, within its marketing authorisation, as an option for the adjuvant treatment of stage 1B (tumours 4 cm or larger) to 3A ALK-positive non-small-cell lung cancer (NSCLC) after complete tumour resection in adults. It is only recommended if the company provides it according to the commercial arrangement.
Why the committee made this recommendation
Usual treatment for stage 1B to 3A ALK-positive NSCLC after surgery (adjuvant treatment) is active monitoring or chemotherapy.
Clinical trial evidence suggests that when people have alectinib after surgery the cancer is less likely to come back than if they have chemotherapy after surgery. But the trial has not been going for long enough to tell if people having alectinib live for longer than those having chemotherapy.
Despite the uncertainties in the clinical evidence, exploratory analyses show that all likely cost-effectiveness estimates are within the range that NICE considers an acceptable use of NHS resources. So alectinib is recommended.
The external assessment group's base case is considered the most likely estimate for decision making. This evaluation used the seventh edition of the Union for International Cancer Control (UICC) and the American Joint Committee on Cancer (AJCC) staging system, because this was used in the clinical trial and marketing authorisation. For all the evidence, see the committee papers.