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Drug Nubeqa® (darolutamide) [Bayer HealthCare Pharmaceuticals Inc.]

January 2020

Therapeutic area - Oncology, Oral - Prostate Cancer

Initial approval criteria

  • Patient is ≥ 18 years old; AND
  • Patient has a diagnosis of non-metastatic castration-resistant prostate cancer (nmCRPC); AND
  • Patient has a prostate-specific antigen (PSA) doubling time of ≤ 10 months; AND
  • Patient has a baseline PSA > 2 ng/mL; AND
  • Patient will receive a gonadotropin-releasing hormone analog (GnRH) analog or has had a bilateral orchiectomy; AND
  • Darolutamide will NOT be used in combination with other androgen receptor inhibitors (enzalutamide, apalutamide, etc.); AND
  • Patient will avoid concomitant use with the following drugs or will be closely monitored as clinically appropriate:
    • Combined P-gp and strong or moderate CYP3A4 inducer (rifampin, carbamazepine, St. John’s Wort, etc.,); OR
    • Breast cancer resistance protein (BCRP) substrates (glyburide, statins, prazosin, etc.,)
  • Initial approval is for 6 months

Renewal criteria

  • Patient continues to meet the above criteria; AND
  • Patient demonstrates disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread; AND
  • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: any Grade 3 or higher toxicities or intolerable adverse reactions experienced by the patient, etc.
  • Renewal approval is for 6 months

Quantity limits

  • 120 tablets/30 days


MHCP Provider Call Center 651-431-2700 or 800-366-5411

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