Drug Access Listing

250 mg tab | 500 mg tab

Not specified

Eligibility:

• mCRPC, in combination with prednisone

• CRPC defined as 3 consecutive rises in PSA ≥1 week apart with the last PSA >2 mcg/L, OR
• Progression or appearance of ≥ 2 lesions on bone scan or in soft tissue, during continuous ADT with castrate testosterone levels (<1.7 nmol/L)

Notes:

• Funded in patients who have experienced disease progression after prior treatment with other ARATs (e.g., enzalutamide) in patients who are unable to tolerate or are not candidates for other therapeutic choices (ie, chemotherapy)

1. SCA Drug 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

250 mg tab | 500 mg tab

Not specified

Eligibility:

• mCSPC, in combination with prednisone and ADT in patients who:

• Had no prior ADT in the metastatic setting or initiated ADT within 6 months in the metastatic setting with no disease progression

•  Abiraterone may continue until disease progression or unacceptable toxicity

Notes:

• Metastatic prostate cancer is interpreted as distant metastatic disease (ie, positive bone scan or metastatic lesions on radiologic imaging for soft tissue; patients with disease limited to regional pelvic lymph nodes only are not eligible)
• Patients who previously received adjuvant ADT in the non-metastatic setting are eligible as long as ADT was completed >1 year prior to initiation of abiraterone
• Patients who received recent docetaxel chemotherapy for the treatment of mCSPC within the past 3 months are eligible if they  have not experienced disease progression
• Patients unable to tolerate abiraterone plus prednisone may be switched to either apalutamide or enzalutamide for treatment of mCSPC if there is no disease progression
• Patients who experience disease progression on abiraterone plus prednisone for treatment of mCSPC are eligible for enzalutamide for treatment of mCRPC if they are unable to tolerate or are not candidates for other therapeutic choices (ie, chemotherapy) provided they have previously not experienced disease progression after prior treatment with other ARATs (e.g., apalutamide, darolutamide) in any setting

1. SCA Drug 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

10 mg PO | 70 mg PO

Multiple

Exception Drug Status Program^1,2

Eligibility^1,2:

• For the treatment of osteoporosis in patients with a 20% or greater 10-year fracture risk (determined by FRAX, CAROC tools)

• The Drug Plan will not require FRAX or CAROC documentation to be included with EDS applications for oral bisphosphonates

OR

• For the treatment of osteoporosis in patients with:

• Pre-existing and/or recent fragility fractures, OR
• Glucocorticoid treatment for a duration of 3 months or longer, OR
• Men on ADT for prostate cancer, OR
• Women on aromatase inhibitor therapy for breast cancer.

OR

For treatment of osteogenesis imperfecta

1. SK Drug Plan
2. Exception Drug Status Program [2-22]

Apotex: Access Here

Tablet, PO, 60mg, 240mg

02478374

STEP special status*

Eligibility1:

nmCRPC in combination with ADT in patients who:

• Have histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell features, or small cell features
• Have no detectable distant metastases by either CT, MRI or technetium-99m bone scan, including any CNS, vertebral or meningeal involvement, but excluding pelvic lymph nodes <2 cm in short axis (N1) located below the common iliac vessels
• Are at high risk of developing metastases (PSADT of ≤ 10 months during continuous ADT)
• Have no risk factors for seizure
• (if applicable) have demonstrated a further rise in PSA measured ≥ 6 weeks after discontinuing treatment with a first generation anti-androgen (e.g., bicalutamide)

Apalutamide may continue until radiographic disease progression or unacceptable toxicity

Notes:

CRPC defined as 3 consecutive rises in PSA ≥1 week apart with the last PSA >2 mcg/L, during continuous ADT with castrate testosterone levels (<1.7 nmol/L)

If biochemical progression (rising PSA) occurs while on apalutamide, appropriate clinical evaluation and/or investigations for metastatic disease should be conducted in a timely manner

If progression to mCRPC occurs during apalutamide treatment for nmCRPC, abiraterone (not enzalutamide) is funded as a subsequent treatment option in patients who are unable to tolerate or are not candidates for other therapeutic choices (ie, chemotherapy)

If apalutamide was discontinued in the nmCRPC setting (e.g., due to intolerance) prior to development of metastatic disease, either abiraterone or enzalutamide is funded as an option for treatment at the time of progression to mCRPC

*STEP (SCA Treatment Evaluation Program) is a special status designation within the Cancer Agency which is an internal registration or approval process to support the ability of the P&T Committee to monitor drug program use when required.

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

1. SCA Drug Formulary [9-23]

Janssen BioAdvance Patient Assistance Program: Access Here 

Tablet, PO, 60mg, 240mg

02478374

Eligibility1:

mCSPC in combination with ADT in patients who had no prior ADT in the metastatic setting or initiated ADT within 6 months in the metastatic setting with no disease progression

Apalutamide may continue until radiographic disease progression or unacceptable toxicity

Notes:

Metastatic prostate cancer is interpreted as distant metastatic disease (ie, positive bone scan or metastatic lesions on radiologic imaging for soft tissue; patients with disease limited to regional pelvic lymph nodes only are not eligible)

Patients who previously received adjuvant ADT in the non-metastatic setting are eligible as long as ADT was completed ≥1 year prior to initiation of apalutamide

Patients who received recent docetaxel chemotherapy for the treatment of mCSPC within the past 3 months are eligible if they have not experienced disease progression

Patients unable to tolerate apalutamide may be switched to either enzalutamide or abiraterone plus prednisone for treatment of mCSPC if there is no disease progression

Patients who experience disease progression on apalutamide for treatment of mCSPC are eligible for abiraterone plus prednisone for treatment of mCRPC if they are unable to tolerate or are not candidates for other therapeutic choices (ie, chemotherapy) provided they have previously not experienced disease progression on abiraterone in any setting

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

1. SCA Drug Formulary [9-23]

Janssen BioAdvance Patient Assistance Program: Access Here 

300 mg PO

Not specified

STEP special status*

Eligibility¹:

• nmCRPC in combination with ADT in patients who:

• Have histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
• Have no detectable distant metastases by either CT, MRI or technetium-99m bone scan, including any CNS, vertebral or meningeal involvement, but excluding pelvic lymph nodes <2 cm in short axis (N1) located below the common iliac vessels
• Are at high risk of developing metastases, defined as PSADT ≤10 months during continuous ADT
• (if applicable) have demonstrated a further rise in PSA, measured ≥ 6 weeks after discontinuing treatment with a first generation anti-androgen (e.g., bicalutamide)

• Darolutamide may continue until radiographic disease progression or unacceptable toxicity

Notes:

• CRPC defined as 3 consecutive rises in PSA ≥1 week apart with the last PSA >2 mcg/L, during continuous ADT with castrate testosterone levels (<1.7 nmol/L)
• If biochemical progression (rising PSA) occurs while on darolutamide, appropriate clinical evaluation and/or investigations for metastatic disease should be conducted in a timely manner
• If progression to mCRPC occurs during darolutamide treatment for nmCRPC, abiraterone is funded as a treatment option
• If darolutamide was discontinued in the nmCRPC setting (e.g., patient choice, intolerance) prior to the development of metastatic disease, either abiraterone or enzalutamide is funded as an option for treatment at the time of progression to mCRPC

*STEP (SCA Treatment Evaluation Program) is a special status designation within the Cancer Agency which is an internal registration or approval process to support the ability of the P&T Committee to monitor drug program use when required.

1. SCA Drug Formulary [3-22]

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

60 mg/ml Pre-filled Syringe

02343541

Exception Drug Status Program^1,2

Eligibility^1,2:

• To increase bone mass in men with osteoporosis who are at 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 CAROC tool or the FRAX tool with a prior fragility fracture, OR
  • High 10-year fracture risk (≥ 20%) as defined by either the CAROC tool or the FRAX tool AND contraindication to oral bisphosphonates
• Contraindication to oral bisphosphonates

• For treatment of osteoporosis in patients with a moderate – high 10-year fracture risk (10% or more) and one of the following:

• Men on androgen deprivation therapy for prostate cancer; OR
• Women on aromatase inhibitor therapy for breast cancer.

Notes^1,2:

• 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. SK Drug Plan 
2. Exception Drug Status Program

ProVital Program: Access Here

-

-

No listing as of Mar. 2022.

-

The VICTORY Program: Access Here

40 mg cap

Not specified

Eligibility:

• mCRPC in patients who:

• Have not previously received and experienced disease progression during apalutamide, enzalutamide or darolutamide used in any prior treatment setting
• Have no risk factors for seizure

Notes:

CRPC is defined as 3 consecutive rises in PSA ≥ 1 week apart with the last PSA >2 mcg/L, or progression or appearance of >2 lesions on bone scan or in soft tissue, during continuous ADT with castrate testosterone levels (<1.7 nmol/L)

1. SCA Drug Formulary [3-22]

Expedite^® Patient Assistance Program: Access Here

40 mg cap

Not specified

STEP special status*

Eligibility:

• nmCRPC in combination with ADT in patients who:

• Have histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell features or small cell features
• Have no detectable distant metastases by either CT, MRI or technetium-99m bone scan, including any CNS, vertebral or meningeal involvement, but excluding pelvic lymph nodes <2 cm in short axis (N1) located below the common iliac vessels
• Are at high risk of developing metastases, defined as PSADT ≤10 months during continuous ADT
• Have no risk factors for seizure
• (if applicable) have demonstrated a further rise in PSA, measured ≥6 weeks after discontinuing treatment with a first generation anti-androgen (e.g., bicalutamide)

• Enzalutamide may continue until radiographic disease progression or unacceptable toxicity.

Notes:

• CRPC is defined as 3 consecutive rises in PSA ≥1 week apart with the last PSA >2 mcg/L, during continuous ADTwith castrate testosterone levels (<1.7 nmol/L)
• If biochemical progression (rising PSA) occurs while on enzalutamide, appropriate clinical evaluation and/or investigations for metastatic disease should be conducted in a timely manner
• If progression to mCRPC occurs during enzalutamide treatment for nmCRPC, abiraterone is funded as a treatment option
• If enzalutamide was discontinued in the nmCRPC setting (e.g., patient choice, intolerance) prior to the development of metastatic disease, either abiraterone or enzalutamide is funded as an option for treatment at the time of progression to mCRPC

*STEP (SCA Treatment Evaluation Program) is a special status designation within the Cancer Agency which is an internal registration or approval process to support the ability of the P&T Committee to monitor drug program use when required.

1. SCA Drug Formulary [3-22]

Expedite^® Patient Assistance Program: Access Here

40 mg cap

Not specified

Eligibility:

• mCSPC in combination with ADT in patients who:

• Have had no prior ADT in the metastatic setting, or initiated ADT within 6 months in the metastatic setting with no disease progression
• Have no risk factors for seizure

Notes:

• Metastatic prostate cancer is interpreted as distant metastatic disease (ie, positive bone scan or metastatic lesions on radiologic imaging for soft tissue; patients with disease limited to regional pelvic lymph nodes only are not eligible)
• Patients who previously received adjuvant ADT in the non-metastatic setting are eligible as long as ADT was completed >1 year prior to initiation of enzalutamide
• Patients who received recent docetaxel chemotherapy for the treatment of mCSPC within the past 3 months are eligible if they have not experienced disease progression
• Patients unable to tolerate enzalutamide may be switched to either apalutamide or abiraterone plus prednisone for treatment of mCSPC if there is no disease progression
• Patients who experience disease progression on enzalutamide for treatment of mCSPC are eligible for abiraterone plus prednisone for treatment of mCRPC if they are unable to tolerate or are not candidates for other therapeutic choices (ie, chemotherapy) provided they have previously not experienced disease progression on abiraterone in any setting

1. SCA Drug Formulary [3-22]

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 (mCRPC) in patients with a deleterious or suspected deleterious germline and/or somatic mutation in the homologous recombination repair (HRR) genes BRCA or ATM, and who have experienced disease progression on or after prior treatment with androgen receptor axis targeted (ARAT) therapy, including patients who have stable brain metastases (if present). 

Note: 

Only documented mutations in BRCA1, BRCA2 and/or ATM that are known to be deleterious or suspected deleterious are eligible for olaparib; mutations described as non-detrimental  (e.g., “variants of uncertain or unknown clinical significance” or “variant, favor polymorphism” or “benign polymorphism”) are not eligible. 

Saskatchewan Cancer Agency Drug Formulary

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