Vol. 5 No. 11 (2025)
Reimbursement Recommendations

Darolutamide (Nubeqa)

decorative image of the issue cover

Published November 5, 2025

Key Messages

  • Canada’s Drug Agency (CDA-AMC) recommends that Nubeqa be reimbursed by public drug plans for use in combination with androgen deprivation therapy (ADT) for the treatment of metastatic castration-sensitive prostate cancer (mCSPC) if certain conditions are met.
  • A subcommittee of the pan-Canadian Oncology Drug Review Expert Review Committee (pERC) determined that Nubeqa plus ADT demonstrates acceptable clinical value versus other androgen receptor pathway inhibitors (ARPIs) plus ADT in patients with mCSPC. This determination was sufficient for the pERC subcommittee to recommend that Nubeqa plus ADT be reimbursed.
  • Given that Nubeqa is expected to be an alternative to other ARPI plus ADT regimens, acceptable clinical value refers to at least comparable value versus apalutamide plus ADT, enzalutamide plus ADT, and abiraterone acetate and prednisone plus ADT. Evidence from a pivotal phase III clinical trial demonstrated that darolutamide plus ADT resulted in clinically meaningful improvements compared with placebo plus ADT in outcomes that are relevant for the management of mCSPC, including time to progression to more advance disease. Although limited by imprecision, evidence from an indirect comparison suggested similar effects for darolutamide plus ADT versus the other ARPI plus ADT regimens.
  • Nubeqa should only be covered for patients who currently meet the eligibility criteria used by each of the public drug plans for the other ARPI plus ADT regimens used in the treatment of mCSPC.