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Oral agents and Outpatient Injections

New Brunswick

FUNDING:

Take-home cancer drugs are covered by the New Brunswick Drug Plans for eligible beneficiaries. Patients not covered by the New Brunswick Drug Plans may have private insurance coverage.

FORMULARIES:

New Brunswick Drug Plans Formulary: Click Here

Drug
(Brand Name)
Manufacturer
Indication Strength, Route DIN Provincial Funding Eligibility Criteria References Patient Assistance Programs
Abiraterone (Zytiga) Janssen Inc. Generic mCRPC

250 mg tab | 500 mg tab

Multiple

Special Authorization Criteria

Eligibility:

  • Patients with mCRPC

Renewal Criteria:

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

Clinical Notes:

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

Claim Notes:

  • Initial approval period: 1 year
  • Renewal approval period: 1 year
  1. NB Drug Plans Formulary [3-22]

​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

Abiraterone (Zytiga) Janssen Inc. Generic mCSPC

250 mg tab | 500 mg tab

Multiple

Special Authorization Criteria

Eligibility:

  • Abiraterone in combination with ADT for the treatment of patients with mCSPC
  • No prior ADT or are < 6 months of beginning ADT in the metastatic setting

Renewal Criteria:

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

Clinical Notes:

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

Claim Notes:

  • Initial approval period: 1 year
  • Renewal approval period: 1 year
  1. NB Drug Plans Formulary [3-22]

​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

Alendronate Generic Osteoporosis

10 mg Tab | 70 mg PO

Multiple

Regular benefit

  1. NB Drug Plans Formulary [3-22]

Apotex: Access Here

Apalutamide (Erleada) Janssen Inc. nmCRPC

Tablet, PO, 60mg, 240mg

02478374

Special Authorization Criteria

Eligibility:

  • Apalutamide in combination with ADT for the treatment of patients with nmCRPC who meet all 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 Criteria:

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

Clinical Notes:

  • Castration-resistance must be demonstrated during continuous ADT and is defined as a
    ≥ 3 rises in PSA, measured ≥ 1 week apart, with the last PSA > 2 mcg/L
  • Castrate levels of testosterone must be maintained throughout treatment
  • 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 or darolutamide
  • Initial approval period: 1 year
  • Renewal approval period: 1 year

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

  1. NB Drug Plans Formulary [3-22]

Janssen BioAdvance Patient Assistance Program: Access Here

 

Apalutamide (Erleada) Janssen Inc. mCSPC

Tablet, PO, 60mg, 240mg

02478374

Special Authorization Criteria

Eligibility:

  • Apalutamide in combination with ADT for the treatment of patients with mCSPC
  • No prior ADT or are < 6 months of beginning ADT in the metastatic setting

Renewal Criteria:

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

Clinical Notes:

  • Patients must have a good performance status and no risk factors for seizures
  • Treatment should be discontinued upon 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

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

  1. NB Drug Plans Formulary [3-22]

Janssen BioAdvance Patient Assistance Program: Access Here

Darolutamide (Nubeqa) Bayer nmCRPC

300 mg Tab

02496348

Special Authorization Criteria

Eligibility:

  • In combination with ADT for the treatment of patients with nmCRPC
  • PSADT ≤ 10 months during continuous ADT (ie, high risk of developing metastases)

Renewal Criteria:

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

Clinical Notes:

  • Castration-resistance must be demonstrated during continuous ADT and is defined as a
    ≥ 3 rises in PSA, measured ≥ 1 week apart, with the last PSA > 2 mcg/L
  • Castrate levels of testosterone must be maintained throughout treatment
  • Patients must have a good performance status
  • Treatment should be discontinued upon radiographic disease progression or unacceptable toxicity

Claim Notes:

  • Requests for darolutamide 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. NB Drug Plans Formulary [3-22]

NUBEQA® DART Patient Support Program: 

Toll free:  

1-833-955-3278 

Fax: 

1-877-208-4393 

Email: 

info@dartsupport.ca 

 

 

Darolutamide (Nubeqa) Bayer mCSPC

300mg Tab

02496348 

Special Authorization Criteria 

 

Eligibility: 

In combination with docetaxel and androgen deprivation therapy (ADT) for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC) who have had no prior ADT, or are within 6 months of beginning ADT, in the metastatic setting. 

 

Renewal Criteria: 

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

 

Clinical Notes: 

  • Patients must have a good performance status and be eligible for chemotherapy.  

  • Treatment should be discontinued upon disease progression or unacceptable toxicity. 

 

Claim Notes: 

  • Requests will not be considered for patients who are within 1 year of completing adjuvant ADT in the non-metastatic setting. 

  • Patients who experience disease progression on apalutamide or enzalutamide are not eligible. 

  • Approval period: 1 year. 

  1. NB Drug Plans Formulary  

NUBEQA® DART Patient Support Program: 

Toll free:  

1-833-955-3278 

Fax: 

1-877-208-4393 

Email: 

info@dartsupport.ca 

Denosumab (Prolia) Amgen Osteoporosis

60 mg / ml

02343541

Special Authorization Criteria

Eligibility:

  • For the treatment of osteoporosis in 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 Notes:

  • Refractory is defined as a fragility fracture or evidence of a decline in bone mineral density below pre-treatment baseline levels, despite adherence for one year to other available osteoporosis therapies
  • High fracture risk is defined as:
  • Moderate 10-year fracture risk (10% to 20%) as defined by the CAROC tool or the FRAX tool with a prior fragility fracture, OR
  • High 10-year fracture risk (≥ 20%) as defined by the CAROC or FRAX tool
  1. NB Drug Plans Formulary [3-22]

ProVital Program: Access Here

Denosumab (Prolia) Amgen mCRPC + Bone mets

120 mg / 1.7 ml vial

02368153

Special Authorization Criteria

Eligibility:

  • For the prevention of skeletal-related events (SREs) in patients with CRPC
  • ≥ 1 documented bone metastases
  • ECOG PS of 0-2*

* patients who are asymptomatic and those who are symptomatic and in bed less than 50% of the time

  1. NB Drug Plans Formulary  [3-22]

The VICTORY Program: Access Here

Enzalutamide (Xtandi) Astellas mCRPC

40 mg capsule

02407329

For the treatment of patients with metastatic castration-resistant prostate cancer.  

 

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 and no risk factors for seizures. 

  1. Treatment should be discontinued upon disease progression or unacceptable toxicity. 

 

Claim Notes: 

  • Requests for enzalutamide will not be considered for patients who experience disease progression on apalutamide or darolutamide 

  • Approval period: 1 year. 

New Brunswick Drug Plans 

Xtandi Patient Assistance Program (XPAP): 

Patient Enrolment and Consent Form (English

Formulaire D’inscription et de Consentement du Patient (French

 

 

Enzalutamide (Xtandi) Astellas nmCRPC

40 mg capsule

02407329

Non-Metastatic Castration-Resistant Prostate Cancer In combination with androgen deprivation therapy (ADT) for the treatment of patients with non-metastatic castration-resistant prostate cancer who have a prostate-specific antigen (PSA) doubling time of less than or equal to 10 months during continuous ADT (i.e., high risk of developing metastases). 

 

Renewal Criteria: 

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

 

Clinical Notes:  

  1. 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. 

  1. Castrate levels of testosterone must be maintained throughout treatment with enzalutamide. 

  1. Patients must have a good performance status and no risk factors for seizures. 

  1. Treatment should be discontinued upon radiographic disease progression or unacceptable toxicity.  

 

Claim Notes: 

  • Requests for enzalutamide will not be considered for patients who experience disease progression on apalutamide or darolutamide 

  • Approval period: 1 year. 

New Brunswick Drug Plans 

Xtandi Patient Assistance Program (XPAP): 

Patient Enrolment and Consent Form (English

Formulaire D’inscription et de Consentement du Patient (French

 

Enzalutamide (Xtandi) Astellas mCSPC

40 mg capsule

02407329

In combination with androgen deprivation therapy (ADT) for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC) who have had no prior ADT, or are within 6 months of beginning ADT, in the metastatic setting. 

 

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 and no risk factors for seizures. 

  1. Treatment should be discontinued upon disease progression or unacceptable toxicity. 

Claim Notes: 

  • Requests will not be considered for patients who are within 1 year of completing adjuvant ADT in the non-metastatic setting. 

  • Patients who experience disease progression on apalutamide or darolutamide are not eligible. 

  • Approval period: 1 year. 

New Brunswick Drug Plans 

Xtandi Patient Assistance Program (XPAP): 

Patient Enrolment and Consent Form (English

Formulaire D’inscription et de Consentement du Patient (French

 

Niraparib and abiraterone acetate (AKEEGA®) Janssen Inc. mCRPC

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

Olaparib (Lynparza) AstraZeneca mCRPC

100 mg tab | 150 mg tab

100mg: 02475200 | 150mg: 02475219

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 Note: Approval period: 1 year 

NB Drug Plans Formulary

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