Last Updated : January 29, 2025
Details
FilesGeneric 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
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:
- 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.
| Call for patient/clinician input open | May 20, 2021 |
|---|---|
| Call for patient/clinician input closed | July 12, 2021 |
| Clarification: - Patient input submission received from Lung Cancer Canada and CanCertainty | |
| Submission received | June 18, 2021 |
| Submission accepted | July 07, 2021 |
| Review initiated | July 08, 2021 |
| Draft CADTH review report(s) provided to sponsor for comment | September 28, 2021 |
| Deadline for sponsors comments | October 07, 2021 |
| CADTH review report(s) and responses to comments provided to sponsor | October 29, 2021 |
| Expert committee meeting (initial) | November 10, 2021 |
| Draft recommendation issued to sponsor | November 22, 2021 |
| Draft recommendation posted for stakeholder feedback | December 02, 2021 |
| End of feedback period | December 16, 2021 |
| Clarification: - Reconsideration: minor revisions requested by sponsor - Reconsideration accepted | |
| Final recommendation issued to sponsor and drug plans | March 17, 2022 |
| Final recommendation posted | April 04, 2022 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | March 31, 2022 |
| CADTH review report(s) posted | June 02, 2022 |
Files
Last Updated : January 29, 2025