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    Has all of the relevant evidence been taken into account?

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    Are the summaries of clinical and cost effectiveness reasonable interpretations of the evidence?

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1 Recommendations

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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 who have not had an ALK 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

People with ALK-positive advanced NSCLC who have not had an ALK inhibitor before usually have alectinib or brigatinib. Ceritinib and crizotinib are also ALK inhibitors but are rarely used for untreated NSCLC. Lorlatinib is another ALK inhibitor and is used after alectinib or brigatinib. It is being proposed as an alternative to alectinib or brigatinib as a first treatment.

Clinical trial evidence suggests that lorlatinib improves the amount of time people have before their condition progresses compared with crizotinib, but this is uncertain. Also, crizotinib is not usually used as a first treatment for this condition, so the trial results are not generalisable to the NHS. An indirect comparison suggests that lorlatinib increases how long people live before their condition gets worse compared with alectinib and brigatinib, but this is uncertain. Also, because the clinical trial is ongoing, it is unclear whether this difference will continue and if lorlatinib will improve how long they live.

Because there are many uncertainties in the clinical evidence, the company's economic model is uncertain. So, the cost-effectiveness estimates are very uncertain. They are also all above the range NICE normally considers an acceptable use of NHS resources. So, lorlatinib is not recommended for routine use in the NHS.

Collecting more data through managed access may resolve some of the uncertainty in the clinical evidence. But because of uncertainties in the clinical evidence and the economic model, it is unclear if lorlatinib has the potential to be cost effective. So, lorlatinib cannot be recommended for use with managed access.