lurbinectedin

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Generic Name:
lurbinectedin
Project Status:
Complete
Therapeutic Area:
metastatic small cell lung cancer (SCLC)
Manufacturer:
Jazz Pharmaceuticals Canada Inc.
Call for patient/clinician input open:
Brand Name:
Zepzelca
Project Line:
Reimbursement Review
Project Number:
PC0281-000
Call for patient/clinician input closed:
Tumour Type:
Lung
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Treatment of adult patients with Stage III or metastatic small cell lung cancer (SCLC) who have progressed on or after platinum-containing therapy.
Submission Type:
Initial
Fee Schedule:
Schedule A
Tumour Type:
Lung
Indications:
​Treatment of adult patients with Stage III or metastatic small cell lung cancer (SCLC) who have progressed on or after platinum-containing therapy.
Recommendation Type:
Do not reimburse
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 openJanuary 26, 2022
Call for patient/clinician input closedMarch 18, 2022
Clarification:

- Patient input submission received from Lung Cancer Canada, and Lung Health Foundation / The Ontario Lung Association

Submission receivedFebruary 24, 2022
Submission acceptedMarch 10, 2022
Review initiatedMarch 11, 2022
Draft CADTH review report(s) provided to sponsor for commentMay 30, 2022
Deadline for sponsors commentsJune 08, 2022
CADTH review report(s) and responses to comments provided to sponsorJune 30, 2022
Expert committee meeting (initial)July 13, 2022
Draft recommendation issued to sponsorJuly 26, 2022
Draft recommendation posted for stakeholder feedbackAugust 04, 2022
End of feedback periodAugust 18, 2022
Clarification:

- Reconsideration: major revisions requested by sponsor

Expert committee meetingDecember 07, 2022
Final recommendation issued to sponsor and drug plansDecember 19, 2022
Final recommendation postedJanuary 12, 2023
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)January 10, 2023
CADTH review report(s) postedApril 17, 2023