1 Recommendations

1.1 Lorlatinib is recommended, within its marketing authorisation, as an option for treating anaplastic lymphoma kinase (ALK)-positive advanced non-small-cell lung cancer (NSCLC) in adults whose disease has progressed after:

  • alectinib or ceritinib as the first ALK tyrosine kinase inhibitor or

  • crizotinib and at least 1 other ALK tyrosine kinase inhibitor.

    It is recommended only if the company provides lorlatinib according to the commercial arrangement.

Why the committee made these recommendations

Advanced ALK-positive NSCLC is usually first treated with an ALK tyrosine kinase inhibitor (alectinib or ceritinib, or crizotinib followed by either brigatinib or ceritinib). People then have either platinum doublet chemotherapy (PDC) or atezolizumab with bevacizumab, carboplatin and paclitaxel (ABCP).

Lorlatinib, another ALK tyrosine kinase inhibitor, has not been compared directly with other drugs. But analyses indirectly comparing lorlatinib with PDC and ABCP suggest that people who take lorlatinib:

  • have longer before their disease progresses and may live longer than people who take PDC

  • have longer before their disease progresses and may live longer than people who take ABCP.

Lorlatinib meets NICE's criteria to be considered a life-extending treatment at the end of life. Although the methods and results of the cost-effectiveness modelling are uncertain, the most likely cost-effectiveness estimates are within what NICE normally considers an acceptable use of NHS resources. Therefore, lorlatinib is recommended.

  • National Institute for Health and Care Excellence (NICE)