Drug Access Listing

250 mg Tab, 500 mg Tab

Multiple¹

Exceptional Drug Status (EDS) Benefits – Part 3 Benefits: will be considered for Pharmacare reimbursement upon an individual prescriber/patient request basis²

Eligibility²:

For patients with histologically confirmed mCRPC with disease progression after prior ADT or with disease progression after prior chemotherapy with docetaxel

1. Manitoba Drug Interchangeability Formulary [2-22] 
2. MB Drug Benefits Bulletin 111 [11-21]

Janssen (Janssen BioAdvance Patient Assistance Program): Access Here   
JAMP (JAMP Care): Access Here 
Sentrex Health Solutions: Access Here 
Pharma-science: Access Here 
Apotex: Access Here 
ApoAssist: Access Here

250 mg Tab, 500 mg Tab

Multiple¹

Exceptional Drug Status (EDS) Benefits – Part 3 Benefits: will be considered for Pharmacare reimbursement upon an individual prescriber/patient request basis¹

Eligibility¹:

• Abiraterone and prednisone in combination with ADT for mCSPC

• Good performance status
• Must be castration-sensitive (ie, no prior ADT for mCSPC or within 6 months of beginning ADT)
• Treatment is continued until disease progression or unacceptable toxicity

1. MB Drug Benefits Bulletin 114 [11-21]

​Janssen (Janssen BioAdvance Patient Assistance Program): Access Here   
JAMP (JAMP Care): Access Here 
Sentrex Health Solutions: Access Here 
Pharma-science: Access Here 
Apotex: Access Here 
ApoAssist: Access Here

10 mg Tab, 70 mg Tab

Multiple¹

Part 1 Benefit – no therapeutic criteria attached to the benefit¹

1. MB Drug Benefits Formulary [3-22]

-

Tablet, PO, 60mg, 240mg

02478374

Exceptional Drug Status (EDS) Benefits – Part 3 Benefits: will be considered for Pharmacare reimbursement upon an individual prescriber/patient request basis1

Eligibility1:

• Apalutamide in combination with ADT 
  • For the treatment of patients with CRPC who have no detectable distant metastases by either CT, MRI or technetium-99m bone scan and who are at high risk of developing metastases.
  • High risk is defined as a PSADT of ≤ 10 months during continuous ADT
  • Should have good performance status and no risk factors for seizures.
  • Treatment should continue until unacceptable toxicity or radiographic disease progression

**60 mg tablet funded, 204 mg table pending provincial funding decision.

1. MB Drugs Benefit Bulletin 106 [3-20]

Janssen BioAdvance Patient Assistance Program: Access Here

Tablet, PO, 60mg, 240mg

02478374

Exceptional Drug Status (EDS) Benefits – Part 3 Benefits: will be considered for Pharmacare reimbursement upon an individual prescriber/patient request basis1

Eligibility1:

• Apalutamide in combination with ADT for mCSPC
  • Must be castration sensitive (ie, no prior ADT or within 6 months of beginning ADT)
  • Good performance status
  • Treatment should be continued until unacceptable toxicity or disease progression

**60 mg tablet funded, 204 mg table pending provincial funding decision.

1. MB Drug Benefits Bulletin 114 [11-21]

Janssen BioAdvance Patient Assistance Program: Access Here

300 mg Tab

02496348

Exceptional Drug Status (EDS) Benefits – Part 3 Benefits: will be considered for Pharmacare reimbursement upon an individual prescriber/patient request basis¹

Eligibility¹:

• Darolutamide in combination with ADT for the treatment of patients with nmCRPC who are at high risk of developing metastases

• High risk is defined as PSADT ≤ 10 months during continuous ADT
• Castration-resistant according to the Prostate Cancer Working Group 2 (PCWG2) criteria which was used in the ARAMIS trial
• Absence of metastases was determined by a negative CT scan and negative bone scan
• Should have good performance status
• Treatment should continue until unacceptable toxicity or radiographic disease progression

1. MB Drug Benefits Bulletin 112 [8-21]

Bayer Patient Support Programs: Access Here

Nubeqa Support Services: Access Here

60 mg/ml Injection

02343541

Exceptional Drug Status (EDS) Benefits – Part 3 Benefits: will be considered for Pharmacare reimbursement upon an individual prescriber/patient request basis¹

Eligibility:

• To increase bone mass in men with osteoporosis who are at a high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy, where the following clinical criteria are met:

• High fracture risk defined as either:
  • moderate 10-year fracture risk (10% to 20%) as defined by either the CAROC tool or (FRAX) tool with a prior fragility fracture; OR
  • high 10-year fracture risk (≥ 20%) as defined by either the CAROC or FRAX
    AND
• Contraindication to oral bisphosphonates

Notes:

• Bisphosphonate failure will be defined as a fragility fracture and/or evidence of a decline in bone mineral density below pre-treatment baseline levels, despite adherence for one year
• Contraindication to oral bisphosphonates will be considered. Contraindications include renal impairment, hypersensitivity, and abnormalities of the esophagus (e.g., esophageal stricture or achalasia).

1. MB EDS [2-22]

ProVital Program: Access Here

120 mg Injection

02368153

Exceptional Drug Status (EDS) Benefits – Part 3 Benefits: will be considered for Pharmacare reimbursement upon an individual prescriber/patient request basis¹

• For the prevention of skeletal-related events (SREs) in patients with CRPC

• One or more documented bony metastases
• ECOG performance status 0-2

1. MB EDS [2-22]

The VICTORY Program: Access Here

40 mg Cap

02407329

Exceptional Drug Status (EDS) Benefits – Part 3 Benefits: will be considered for Pharmacare reimbursement upon an individual prescriber/patient request basis¹

Eligibility:

• For the treatment of histologically confirmed mCRPC with disease progression after prior chemotherapy with docetaxel¹
• For the treatment of histologically confirmed mCRPC with disease progression after prior ADT and no prior chemotherapy²

1. MB Drug Benefits Bulletin 77 [4-14] 
2. MB Drug Benefits Bulletin 85 [1-16]

Expedite^® Patient Assistance Program: Access Here

40 mg Cap

02407329

Exceptional Drug Status (EDS) Benefits – Part 3 Benefits: will be considered for Pharmacare reimbursement upon an individual prescriber/patient request basis¹

Eligibility¹:

• Enzalutamide in combination with ADT for patients with nmCRPC who are at high risk of developing metastases

• High risk is defined as PSADT ≤ 10 months during continuous ADT
• Should have good performance status
• No risk factors for seizures

• Treatment should continue until unacceptable toxicity or radiographic disease progression

1. MB Drug Benefit Bulletin 108 [7-20]

Expedite^® Patient Assistance Program: Access Here

40 mg Cap

02407329

Exceptional Drug Status (EDS) Benefits – Part 3 Benefits: will be considered for Pharmacare reimbursement upon an individual prescriber/patient request basis¹

Eligibility:

• Enzalutamide in combination with ADT for the treatment of mCSPC
  • Patients must be castration-sensitive (ie, no prior ADT in the metastatic setting or within 6 months of beginning ADT)
  • Should have good performance status
  • No risk for seizures
• Treatment should continue until unacceptable toxicity or radiographic disease progression

1. MB Drug Benefits Bulletin 114 [11-21]

Expedite^® Patient Assistance Program: Access Here

Dual-action tablet, PO/ Comprimé à double action, PO: 100mg niraparib/500mg abiraterone acetate

02538563

Pending provincial funding decision

N/A

Janssen BioAdvance Patient Assistance Program: Access Here

100 mg tab | 150 mg tab

100mg: 02475200 | 150mg: 02475219

• Listed on Manitoba List of Oral Oncology Drugs Dispensed at CCMB1
• Funding effective June 1, 2022 (Manitoba Drug Benefit Bulletin #118)2 : As monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) and deleterious or suspected deleterious germline and/or somatic mutations in the homologous recombination repair (HRR) genes BRCA or ATM who have progressed following prior treatment with a new hormonal agent/androgen receptor-axis-targeted therapy (ARAT).

1. MB Oral Onc Drugs [11-21] 
2. MB Bulletin Archive

AstraZeneca Patient Support Program: Access Here
AstraZeneca Patient Assistance Program: Access Here