1.1
Lorlatinib can be used as an option for ALK-positive advanced non-small-cell lung cancer in adults who have not had an ALK inhibitor. Lorlatinib can only be used if the company provides it according to the commercial arrangement.
1 Recommendation
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 healthcare professional consider it appropriate to stop.
What this means in practice
Lorlatinib must be funded in the NHS in England for the condition and population in the recommendations, if it is considered the most suitable treatment option. Lorlatinib must be funded in England within 90 days of final publication of this guidance.
There is enough evidence to show that lorlatinib provides benefits and value for money, so it can be used routinely across the NHS in this population.
NICE has produced tools and resources to support the implementation of this guidance.
Why the committee made these recommendations
This evaluation reviews the evidence for lorlatinib for ALK-positive advanced non-small-cell lung cancer that has not been previously treated with an ALK inhibitor (NICE technology appraisal guidance 909). This does not include everyone who it is licensed for. For this review, the company provided 2 extra years of evidence on how long people have before their cancer gets worse, but no new evidence on how long people live.
Usual first-line treatment in the NHS for ALK-positive advanced non-small-cell lung cancer is alectinib or brigatinib. Crizotinib is also available but is rarely used in the NHS. Lorlatinib is already used after alectinib or brigatinib. It is now being evaluated as a first treatment, as an alternative to alectinib or brigatinib.
Clinical trial evidence shows that, compared with crizotinib, lorlatinib increases how long people have before their cancer gets worse. But, crizotinib is not usually used as a first treatment for this condition, so the trial results do not reflect what happens in the NHS. An indirect comparison suggests that lorlatinib increases how long people have before their cancer gets worse compared with alectinib and brigatinib. But, it is uncertain whether people live longer when they have lorlatinib compared with alectinib and brigatinib as a first-line treatment option.
Because there are uncertainties in the clinical evidence, the cost-effectiveness analyses are also uncertain. But, when considering all the available evidence and economic analyses, the most likely cost-effectiveness estimates are within the range that NICE considers an acceptable use of NHS resources. So, lorlatinib can be used.