Last Updated : May 13, 2025
Details
Generic Name:
darolutamide
Project Status:
Active
Therapeutic Area:
Metastatic castration-sensitive prostate cancer
Manufacturer:
Bayer Inc.
Call for patient/clinician input open:
Brand Name:
Nubeqa
Project Line:
Reimbursement Review
Project Number:
PC0404-000
Call for patient/clinician input closed:
Tumour Type:
Genitourinary
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC), as per indication. Bayer
requests reimbursement of NUBEQA (in combination with ADT) with criteria
similar to apalutamide + ADT and enzalutamide + ADT in mCSPC.
Submission Type:
Initial
Submission Complexity:
Tailored Review
Fee Schedule:
Schedule B
Indications:
NUBEQA (darolutamide) is indicated for the treatment of patients with
metastatic castration-sensitive prostate cancer (mCSPC).
- 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 | March 13, 2025 |
|---|---|
| Call for patient/clinician input closed | May 06, 2025 |
| Submission received | April 28, 2025 |
| Clarification: Eligible for review through the PACES process | |
| Submission accepted | May 12, 2025 |
| Review initiated | May 13, 2025 |
| Draft CADTH review report(s) provided to sponsor for comment | July 03, 2025 |
| Deadline for sponsors comments | July 10, 2025 |
| CDA-AMC review report(s) and responses to comments provided to sponsor | July 22, 2025 |
| Expert committee meeting (initial) | August 21, 2025 |
| Draft recommendation issued to sponsor | September 03, 2025 To September 05, 2025 |
| Draft recommendation posted for stakeholder feedback | September 18, 2025 |
| End of feedback period | October 03, 2025 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | August 01, 2025 |
Last Updated : May 13, 2025