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Draft guidance consultation

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1 Recommendations

1.1

Lorlatinib should not be used for untreated ALK-positive advanced non-small-cell lung cancer 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 healthcare professional consider it appropriate to stop.

What this means in practice

Lorlatinib is not required to be funded in the NHS in England for untreated ALK-positive advanced non-small-cell lung cancer. It should not be used routinely in the NHS in England.

This is because there is not enough evidence to determine whether lorlatinib is value for money.

Why the committee made these recommendations

This evaluation reviews the evidence for lorlatinib for untreated ALK-positive advanced non-small-cell lung cancer (NICE technology appraisal guidance 909).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 treatment for untreated ALK-positive advanced non-small-cell lung cancer is alectinib or brigatinib. Crizotinib is also available, but 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 lorlatinib makes people live longer compared with alectinib and brigatinib.

Because there are uncertainties in the clinical evidence, the cost-effectiveness analyses are also uncertain. Taking into account the available cost-effectiveness estimates, and the additional evidence needed to inform decision making, the committee could not conclude that lorlatinib was a cost-effective use of NHS resources. So, lorlatinib should not be used in the NHS.

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