Advice

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
Additional notes

This medicine has an EMA conditional marketing authorisation and has been accepted by SMC on an interim basis subject to ongoing evaluation and future reassessment. The company is required to submit an updated SMC submission when the EMA advise that conditional marketing authorisation has been converted to standard marketing authorisation. Further information on the interim accepted decision option is available here.