Last Updated : March 28, 2023
Details
FilesGeneric Name:
darolutamide
Project Status:
Complete
Therapeutic Area:
Metastatic castration-sensitive prostate cancer
Manufacturer:
Bayer Inc.
Brand Name:
Nubeqa
Project Line:
Reimbursement Review
Project Number:
PC0294-000
Tumour Type:
Genitourinary
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
In combination with docetaxel for the treatment of metastatic castration-sensitive prostate cancer (mCSPC) in patients who are chemotherapy-eligible.
Submission Type:
Initial
Fee Schedule:
Schedule A
Tumour Type:
Genitourinary
Indications:
For the treatment of patients with metastatic castration sensitive prostate cancer (mCSPC) in combination with docetaxel.
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 17, 2022 |
|---|---|
| Call for patient/clinician input closed | July 11, 2022 |
| Clarification: - Patient input submission received from Canadian Cancer Society and Canadian Cancer Survivor Network | |
| Submission received | June 16, 2022 |
| Submission accepted | June 30, 2022 |
| Review initiated | July 04, 2022 |
| Draft Canada's Drug Agency review report(s) provided to sponsor for comment | September 26, 2022 |
| Deadline for sponsors comments | October 05, 2022 |
| Canada's Drug Agency review report(s) and responses to comments provided to sponsor | October 28, 2022 |
| Expert committee meeting (initial) | November 09, 2022 |
| Draft recommendation issued to sponsor | November 23, 2022 |
| Draft recommendation posted for stakeholder feedback | December 01, 2022 |
| End of feedback period | December 15, 2022 |
| Final recommendation issued to sponsor and drug plans | January 05, 2023 |
| Final recommendation posted | January 23, 2023 |
| Deadline for sponsor to submit redaction requests on draft Canada's Drug Agency review report(s) | January 19, 2023 |
| Canada's Drug Agency review report(s) posted | March 28, 2023 |
Files
Last Updated : March 28, 2023