1 Recommendations

1.1 Ceritinib is recommended, within its marketing authorisation, as an option for untreated anaplastic lymphoma kinase (ALK)‑positive advanced non-small-cell lung cancer in adults, only if the company provides it with the discount agreed in the patient access scheme.

Why the committee made this recommendation

Most people with untreated ALK‑positive advanced non-small-cell lung cancer are offered crizotinib. Chemotherapy may be offered if the person's ALK mutation status isn't known, and therefore is not a relevant comparator for ceritinib. There are no trials directly comparing ceritinib with crizotinib; the clinical trial compares ceritinib with chemotherapy.

Because the clinical trial has not finished, it is unable to show how much ceritinib prolongs life compared with chemotherapy. But it shows that ceritinib is more effective than chemotherapy at increasing the length of time people live without their disease progressing. An indirect comparison suggests that ceritinib is more effective than crizotinib. Clinical experts support using ceritinib instead of crizotinib.

The most plausible cost-effectiveness estimate for ceritinib compared with crizotinib is around what NICE normally considers acceptable. Therefore ceritinib can be recommended as an option for adults with untreated ALK‑positive advanced non-small-cell lung cancer.

  • National Institute for Health and Care Excellence (NICE)