Canada’s Drug Agency | Drugs, Health Technologies and Systems.

darolutamide

Details

Generic Name:
darolutamide
Project Status:
Received
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
Fee Schedule:
Pending
Indications:
​NUBEQA (darolutamide) is indicated for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC).
  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 open13-Mar-25
Call for patient/clinician input closed06-May-25
Submission received28-Apr-25
Clarification:

Eligible for review through the PACES process

Submission accepted-
Last Updated : April 28, 2025