Drug Access Listing

250 mg tab | 500 mg tab

Multiple^1,2

Special Authorization Drug^1,2: Form

Eligibility²:

• Abiraterone in combination with prednisone for the treatment of patients with mCRPC

Renewal Criteria²:

• Written confirmation that the patient has responded to treatment and there is no evidence of disease progression.

Clinical Notes²:

• Patients must have a good performance status
• Treatment should be discontinued upon disease progression or unacceptable toxicity

Claim Notes²:

• Initial approval period: 1 year
• Renewal approval period: 1 year

1. NLPDP Drug Product Database [3-22]
2. Benefit List Update Bulletin 33 [2-22]

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

Not specified

Special Authorization¹: Form

Eligibility:

• In combination with ADT for the treatment of patients with mCSPC

Renewal Criteria:

• Written confirmation that the patient has responded to treatment and there is no evidence of disease progression

Clinical Notes:

• Patients must be castration sensitive (ie, no prior ADT in the metastatic setting or within six months of beginning ADT).
• Patients must have a good performance status.
• Treatment should be discontinued upon radiographic disease progression or unacceptable toxicity

Claim Notes:

• Requests for abiraterone will not be considered for patients who experience disease progression on apalutamide or enzalutamide
• Initial approval period: 1 year
• Renewal approval period: 1 year

1. Benefit List Update Bulletin 33 [2-22]

​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 PO

Multiple^1,2

Open benefit if beneficiary is ≥ 65 years of age or older.^1,2

Special Authorization Drug can be considered < 65 years of age²: Form

Eligibility²:

• For the treatment of osteoporosis associated with documented fracture
• For the treatment of osteoporosis without documented fracture when a patient has a high 10-year fracture risk (based on age, sex and T-score, see Appendix 1 of Special Authorization Products List for fracture risk table)
• As prophylaxis of corticosteroid induced osteoporosis in patient who will be or have been on systemic corticosteroid therapy for > 3 months

1. NLPDP Drug Product Database [3-22] 
2. NL Special Auth Products [1-16]

Apotex: Access Here

Tablet, PO, 60mg, 240mg

02478374

Special Authorization1: Form

Eligibility2:

• In combination with ADT for the treatment of patients with CRPC who meet all of the following criteria:

• No detectable distant metastases by either CT, MRI or technetium-99m bone scan
• PSADT ≤ 10 months during continuous ADT (ie, high risk of developing metastases)

Renewal Criteria2:

• Written confirmation that the patient has responded to treatment and there is no evidence of radiographic disease progression

Clinical Notes2:

• Castration-resistance must be demonstrated during continuous ADT and is defined as a minimum of three rises in PSA, measured at least one week apart, with the last PSA greater than 2 mcg/L
• Castrate levels of testosterone must be maintained throughout treatment with apalutamide
• Patients must have an ECOG PS of ≤ 2 and no risk factors for seizures
• Treatment should be discontinued upon radiographic disease progression or unacceptable toxicity

Claim Notes2:

• Requests for apalutamide will not be considered for patients who experience disease progression on enzalutamide
• Initial approval period: 1 year
• Renewal approval period : 1 year

**60 mg tablet funded, 240 mg tablet pending provincial funding decision

1. NLPDP Drug Product Database [3-22] 
2. NL Special Auth - Apalutamide [3-21]

Janssen BioAdvance Patient Assistance Program: Access Here

Tablet, PO, 60mg, 240mg

02478374

Eligibility:

• In combination with ADT for the treatment of patients with mCSPC

Renewal Criteria:

• Written confirmation that the patient has responded to treatment and there is no evidence of disease progression

Clinical Notes:

• Patients must be castration sensitive (i.e., no prior ADT in the metastatic setting or within six months of beginning ADT)
• Patients must have a good performance status and no risk factors for seizures
• Treatment should be discontinued upon radiographic disease progression or unacceptable toxicity

Claim Notes:

• Requests for apalutamide will not be considered for patients who experience disease progression on enzalutamide
• Initial approval period: 1 year
• Renewal approval period: 1 year

**60mg tablet funded, 240mg tablet pending provincial funding decision

1. NLPDP Drug Product Database [3-22] 
2. NL Special Auth - Apalutamide [3-21]

Janssen BioAdvance Patient Assistance Program: Access Here

300 mg Tab

02496348

Special Authorization¹: Form

Eligibility²:

• In combination with ADT for the treatment of patients with nmCRPC who meet all of the following criteria:

• No detectable distant metastases by either CT, MRI or technetium-99m bone scan
• PSADT ≤ 10 months during continuous ADT (ie, high risk of developing metastases)

Renewal Criteria²:

• Written confirmation that the patient has responded to treatment and there is no evidence of radiographic disease progression.

Clinical Notes²:

• Castration-resistance must be demonstrated during continuous ADT and is defined as 3 PSA rises at least one week apart, with the last PSA > 2 ng/mL.
• Castrate levels of testosterone must be maintained
• Patients with N1 disease, pelvic lymph nodes < 2cm in short axis located below the aortic bifurcation are eligible for darolutamide
• Patients should have good performance status
• Treatment should be discontinued upon radiographic disease progression or unacceptable toxicity

Claim Notes²:

• Darolutamide will not be funded for patients who experience disease progression on apalutamide or enzalutamide
• Patients receiving darolutamide for the treatment of nmCRPC will be eligible for funding of abiraterone at the time of disease progression to mCRPC. Enzalutamide is not funded for patients who experience disease progression to mCRPC while on darolutamide.
• Either abiraterone or enzalutamide may be used to treat mCRPC in patients who discontinued darolutamide in the non-metastatic setting due to intolerance without disease progression.
• Initial approval period: 1 year
• Renewal approval period: 1 year

1. NLPDP Drug Product Database [3-22] 
2. NL Special Auth – Darolutamide

Bayer Patient Support Programs: Access Here 
Nubeqa Support Services: Access Here

60 mg/ml Syr

02343541

Special Authorization¹: Form

Eligibility¹:

• For the treatment of osteoporosis in male patients who meet the following criteria:

• Have a contraindication to oral bisphosphonates
• High risk for fracture, or refractory or intolerant to other available osteoporosis therapies

Clinical Criteria:

• High fracture risk defined as either: a moderate 10-year fracture risk (10% to 20%) with a prior fragility fracture; or a high 10-year fracture risk (≥ 20%) as defined by either the CAROC tool or FRAX tool
• Refractory is defined as an unsatisfactory response to bisphosphonates is typically defined as a fragility fracture and/or evidence of a decline in BMD below pre-treatment baseline levels, despite adherence for one year

1. NLPDP Drug Product Database [3-22] 
2. NL Special Auth Products [3-18]

ProVital Program: Access Here

120 mg / 1.7 mL Vial

02368153

Special Authorization¹: Form

Eligibility²:

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

• One or more documented bony metastases
• ECOG PS of 0-2

Notes²:

• Approval Period: Indefinite
• Recommended Dose: 1.7 ml every four weeks

1. NLPDP Drug Product Database [3-22] 
2. NL Special Auth Products [4-14]

The VICTORY Program: Access Here 

40 mg Cap

02407329

Special Authorization¹: Form

Eligibility²:

• Patients with mCRPC

Renewal Criteria²:

• Written confirmation that the patient has responded to treatment and there is no evidence of disease progression

Clinical Notes²:

• Patients must have a good performance status and no risk factors for seizures
• Treatment should be discontinued upon disease progression or unacceptable toxicity

Claim Notes²:

• Requests for enzalutamide will not be considered for patients who experience disease progression on apalutamide
• Initial approval period: 1 year
• Renewal approval period: 1 year

1. NLPDP Drug Product Database [3-22] 
2. NL Special Auth - Enzalutamide [10-21]

Expedite^® Patient Assistance Program: Access Here

40 mg Cap

02407329

Special Authorization¹: Form

Eligibility²:

• In combination with ADT for the treatment of patients with nmCRPC

•  PSADT of ≤ 10 months during continuous ADT (ie, high risk of developing metastases)

Renewal Criteria²:

• Written confirmation that the patient has responded to treatment and there is no evidence of disease progression

Clinical Notes²:

• Castration-resistance must be demonstrated during continuous ADT and is defined as a minimum of three rises in PSA, measured at least one week apart, with the last PSA greater than 2 mcg/L
• Castrate levels of testosterone must be maintained throughout treatment with enzalutamide
• Patients must have a good performance status and no risk factors for seizures
• Treatment should be discontinued upon radiographic disease progression or unacceptable toxicity                                                     

Claim Notes²:

• Requests for enzalutamide will not be considered for patients who experience disease progression on apalutamide
• Initial approval period: 1 year
• Renewal approval period: 1 year

1. NLPDP Drug Product Database [3-22]
2. NL Special Auth - Enzalutamide [10-21]

Expedite^® Patient Assistance Program: Access Here

40 mg Cap

02407329

Special Authorization¹: Form

Eligibility²:

• In combination with ADT for the treatment of patients with mCSPC

Renewal Criteria²:

• Written confirmation that the patient has responded to treatment and there is no evidence of disease progression

Clinical Notes²:

• Patients must be castration sensitive (ie, no prior ADT in the metastatic setting or within six months of beginning ADT)
• Patients must have a good performance status and no risk factors for seizures
• Treatment should be discontinued upon radiographic disease progression or unacceptable toxicity

Claim Notes²:

• Requests for enzalutamide will not be considered for patients who experience disease progression on apalutamide
• Initial approval period: 1 year
• Renewal approval period: 1 year.

1. NLPDP Drug Product Database [3-22]
2. NL Special Auth - Enzalutamide [10-21]

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

Metastatic Castration-Resistant Prostate Cancer As monotherapy for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who meet all of the following criteria:

• Deleterious or suspected deleterious germline and/or somatic mutations in the homologous recombination repair (HRR) genes BRCA1, BRCA2 or ATM; and
• Disease progression on prior treatment with androgen-receptor-axis-targeted (ARAT) therapy.

Renewal Criteria: Written confirmation that the patient has responded to treatment and there is no evidence of disease progression.

Clinical Notes:

1. Patients must have a good performance status.
2. Treatment should be discontinued upon disease progression or unacceptable toxicity.

Claim Notes: Approval period: 1 year

Newfoundland Labrador Health and Community Services

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