Last Updated : April 18, 2023
Details
FilesGeneric 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:
- 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 | January 26, 2022 |
|---|---|
| Call for patient/clinician input closed | March 18, 2022 |
| Clarification: - Patient input submission received from Lung Cancer Canada, and Lung Health Foundation / The Ontario Lung Association | |
| Submission received | February 24, 2022 |
| Submission accepted | March 10, 2022 |
| Review initiated | March 11, 2022 |
| Draft CADTH review report(s) provided to sponsor for comment | May 30, 2022 |
| Deadline for sponsors comments | June 08, 2022 |
| CADTH review report(s) and responses to comments provided to sponsor | June 30, 2022 |
| Expert committee meeting (initial) | July 13, 2022 |
| Draft recommendation issued to sponsor | July 26, 2022 |
| Draft recommendation posted for stakeholder feedback | August 04, 2022 |
| End of feedback period | August 18, 2022 |
| Clarification: - Reconsideration: major revisions requested by sponsor | |
| Expert committee meeting | December 07, 2022 |
| Final recommendation issued to sponsor and drug plans | December 19, 2022 |
| Final recommendation posted | January 12, 2023 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | January 10, 2023 |
| CADTH review report(s) posted | April 17, 2023 |
Files
Last Updated : April 18, 2023