lorlatinib (Lorviqua)

following reassessment under the end of life medicine process:

lorlatinib (Lorviqua®) is accepted for use within NHSScotland.

Indication under review: as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) whose disease has progressed after prior treatment with an ALK inhibitor.

In the relevant subgroup of a non-comparative phase I/II study of previously treated patients with ALK-positive advanced NSCLC, lorlatinib was associated with an objective response rate of approximately 40%. This was supported by results of a phase IV, post-approval study in a larger population, in which response rates were consistent with those observed in the phase I/II study.

This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.

SMC previously accepted lorlatinib for use in this indication on an interim basis (SMC2239). This supersedes that advice.