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    Lorlatinib for previously treated ALK-positive advanced non-small-cell lung cancer

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    1 Recommendations

    1.1 Lorlatinib is not recommended, within its marketing authorisation, 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

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

    1.2 This recommendation is not intended to affect treatment with lorlatinib that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

    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 than people who take PDC

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

    The methods and results of the cost-effectiveness modelling are very uncertain, because of limitations in the data and how the treatments are compared indirectly. Lorlatinib meets NICE's criteria to be considered a life-extending treatment at the end of life. But the most likely cost-effectiveness estimates are higher than what NICE normally considers an acceptable use of NHS resources. So lorlatinib is not recommended. Lorlatinib does not meet NICE's criteria to be included in the Cancer Drugs Fund.