Nubeqa

Darolutamide

• Brand(s): Nubeqa
• Dosage Form/Strength: 300 mg tablet
• Effective date: June 8, 2021

Initiation Criteria:

For the treatment of high-risk non-metastatic castration resistant prostate cancer (nmCRPC) in patients who meet all the following criteria:

1. Patient using darolutamide (Nubeqa) in combination with androgen deprivation therapy (ADT); AND

2. Has no detectable distant metastases as determined by CT, MRI, or technetium-99m bone scan; AND

3. Patient has castrate resistant disease based on meeting all the following indicia observed while on continuous ADT treatment or post orchiectomy:
   • Castrate serum testosterone levels; AND
   • Biochemical progression defined as three (3) prostate-specific antigen (PSA) rises at least 1 week apart, with the last PSA greater than 2ng/mL (if the patient has a history of antiandrogen use, the most recent PSA value must be obtained at least 4 weeks after anti-androgen withdrawal);

   AND

4. Patient is at high risk for developing metastatic disease based on a prostate-specific antigen doubling time (PSADT) of less than or equal to 10 months during continuous ADT.

5. Has an Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2.

Exclusion Criteria:
Patients meeting one or more of the below exclusion criteria will not be funded.

• The patient received prior chemotherapy or immunotherapy for the treatment of prostate cancer, unless it was in the adjuvant or neoadjuvant setting completed more than 2 years previously.

• The patient has experienced disease progression on prior treatment with Erleada (apalutamide) or Xtandi (enzalutamide).

• The patient has a high risk for disease progression by other definitions (such as a high Gleason score 8-10, high PSA level at diagnosis, etc.) AND has not had a PSA progression in the non-metastatic setting.

Approved Dosage: 600 mg administered orally twice daily.

Notes:

1. The Ministry will fund only one of Nubeqa (darolutamide) or Erleada (apalutamide) or Xtandi (enzalutamide) in patients with non-metastatic castrate resistant prostate cancer.

2. While doses may be withheld or reduced to 300 mg twice daily to manage grade 3 toxicities until symptoms improve, treatment doses should be resumed at a dose of 600 mg twice daily.

3. Requests for Nubeqa in patients who initiated Erleada or Xtandi therapy in the nmCRPC setting and who have not had disease progression will be considered on a case-by-case basis.

4. Following progression on darolutamide in non-metastatic castrate resistant prostate cancer, the patient would not be eligible for darolutamide, apalatumide or enzalutamide in metastatic castrate resistant state.

Renewal Criteria:
Renewals will be considered in patients without evidence of radiographic disease progression or unacceptable toxicity while on Nubeqa therapy.

Approved Dosage: 600 mg administered orally twice daily.

Approval Duration of initials and renewals: 1 year

EAP Drug Request Form:

Standard Form for EAP Drug Requests