CDA | Evidence Driven
CDA | Evidence Driven

lorlatinib

Details

Files
Generic Name:
lorlatinib
Project Status:
Complete
Therapeutic Area:
ALK-positive locally advanced or metastatic non-small cell lung
Manufacturer:
Pfizer Canada
Brand Name:
Lorbrena
Project Line:
Reimbursement Review
Project Number:
PC0249-000
Tumour Type:
Lung
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Monotherapy for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC)
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Monotherapy for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC)
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.

Key Milestones2

Call for patient/clinician input open20-May-21
Call for patient/clinician input closed12-Jul-21
Clarification:

- Patient input submission received from Lung Cancer Canada and CanCertainty

Submission received18-Jun-21
Submission accepted07-Jul-21
Review initiated08-Jul-21
Draft CADTH review report(s) provided to sponsor for comment28-Sep-21
Deadline for sponsors comments07-Oct-21
CADTH review report(s) and responses to comments provided to sponsor29-Oct-21
Expert committee meeting (initial)10-Nov-21
Draft recommendation issued to sponsor22-Nov-21
Draft recommendation posted for stakeholder feedback02-Dec-21
End of feedback period16-Dec-21
Clarification:

- Reconsideration: minor revisions requested by sponsor

- Reconsideration accepted

Final recommendation issued to sponsor and drug plans17-Mar-22
Final recommendation posted04-Apr-22
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)31-Mar-22
CADTH review report(s) posted02-Jun-22

Files

Recommendation and Reasons View PDF
Clinical and Pharmacoeconomic combined Report View PDF
Patient Group Input Submissions View PDF
Stakeholder feedback on Draft Recommendation View PDF
Last Updated : June 3, 2022