following a full submission assessed under the end of life process:
lorlatinib (Lorviqua®) is accepted for use within NHSScotland on an interim basis subject to ongoing evaluation and future reassessment.
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:
- alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy; or
- crizotinib and at least one other ALK TKI
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 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.
This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.
Medicine details
- Medicine name:
- lorlatinib (Lorviqua)
- SMC ID:
- SMC2239
- Indication:
As monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive advanced non-small cell lung cancer (NSCLC) whose disease has progressed after:
- alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy; or
- crizotinib and at least one other ALK TKI.
- Pharmaceutical company
- Pfizer Ltd
- BNF chapter
- Malignant disease and immunosuppression
- Submission type
- Full
- Status
- Interim acceptance
- Date advice published
- 09 March 2020
The wording of the Marketing Authorisation has been simplified: as monotherapy for the treatment of adult patients with ALK-positive advanced NSCLC whose disease has progressed after prior treatment with an ALK TKI. SMC will not review the minor change in wording at this time; implementation of the simplified indication in the interim is at the discretion of Health Boards. SMC will request a submission for reassessment of lorlatinib when the relevant clinical data are available. Further information on the interim accepted decision option is available here.