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Oral agents and Outpatient Injections

Saskatchewan

FUNDING:

The Cancer Agency through funding from the government of Saskatchewan pays for all approved cancer drugs for patients with a valid health card and registered with the Cancer Agency. This includes drugs administered by injection or oral cancer treatments taken at home. 

FORMULARIES:

Saskatchewan Drug Plan Formulary: Click Here 
Saskatchewan Cancer Agency (SCA) Drug Formulary: Click Here
Exception Drug Status Program: Click Here

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

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. Saskatchewan Cancer Agency Drug Formulary

Janssen (Janssen BioAdvance Patient Assistance Program):  

https://www.bioadvancemember.ca/s/reimbursement-support?language=en_US

 

Abiraterone (Zytiga) Janssen Inc. mCRPC

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. Saskatchewan Cancer Agency Drug Formulary

Janssen (Janssen BioAdvance Patient Assistance Program):  

https://www.bioadvancemember.ca/s/reimbursement-support?language=en_US

 

Abiraterone Generic mCSPC

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. Saskatchewan Cancer Agency Drug Formulary

JAMP (JAMP Care):  

https://jampcare-support.ca/en/index.html

 

Sentrex Health Solutions: 

https://sentrex.com/patient-programs/ 

 

Pharma-science: 

https://www.pharmascience.com/en/patient-support-programs/

 

Apotex: 

https://www.abirateronesavings.com/  

https://www.apoassist.com/en/

Abiraterone Generic mCRPC

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. Saskatchewan Cancer Agency Drug Formulary

JAMP (JAMP Care):  

https://jampcare-support.ca/en/index.html

 

Sentrex Health Solutions: 

https://sentrex.com/patient-programs/ 

 

Pharma-science: 

https://www.pharmascience.com/en/patient-support-programs/

 

Apotex: 

https://www.abirateronesavings.com/  

https://www.apoassist.com/en/

Alendronate Generic Osteoporosis

10 mg PO | 70 mg PO

Multiple

Exception Drug Status Program1,2

Eligibility1,2:

  • 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. Saskatchewan Cancer Agency Drug Formulary
  2. Exception Drug Status Program [2-22]

Apotex: Access Here

Apalutamide (Erleada) Janssen Inc. nmCRPC

Tablet, PO, 60mg, 240mg

60mg: 02478374 

240mg: 02540185 

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.

  1. Saskatchewan Cancer Agency Drug Formulary

Janssen BioAdvance Patient Assistance Program: Access Here 

Apalutamide (Erleada) Janssen Inc. mCSPC

Tablet, PO, 60mg, 240mg

60mg: 02478374 

240mg: 02540185 

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
  1. Saskatchewan Cancer Agency Drug Formulary

Janssen BioAdvance Patient Assistance Program: Access Here 

Darolutamide (Nubeqa) Bayer mCSPC

300 mg PO 

02496348 

Saskatchewan 

For the treatment of metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel and androgen deprivation therapy (ADT) in previously untreated patients. 

 

Note:  

  • Darolutamide is not funded in patients who have received prior treatment with androgen receptor axis–targeted (ARAT) therapy (e.g., abiraterone, apalutamide, enzalutamide), chemotherapy, or immunotherapy for prostate cancer 

  • Darolutamide is not funded in patients who received androgen deprivation therapy (ADT) in the metastatic setting for more than 6 months or if it has been less than 1 year since completing adjuvant ADT in the non-metastatic setting  

  • Darolutamide is also funded in patients with only regional lymph node metastases  

  • Patients who are unable to tolerate docetaxel may continue with darolutamide and ADT 

Saskatchewan Cancer Agency Drug Formulary

NUBEQA® DART Patient Support Program: 

 

Toll free:  

1-833-955-3278 

 

Fax: 

1-877-208-4393 

 

Email: 

info@dartsupport.ca 

Darolutamide (Nubeqa) Bayer nmCRPC

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. Saskatchewan Cancer Agency Drug Formulary

NUBEQA® DART Patient Support Program: 

Toll free:  

1-833-955-3278 

Fax: 

1-877-208-4393 

Email: 

info@dartsupport.ca 

 

Denosumab (Jubbonti) Sandoz Non-metastatic prostate cancer receiving ADT + high bone fracture risk

60 mg / Syr Injection 

02545411 

Pending 

    

Haven: 

Drug Access Canada - Haven by Sentrex 

Denosumab (Prolia) Amgen mCRPC + Bone mets

-

-

No listing as of Mar. 2022.

-

The VICTORY Program: Access Here

Denosumab (Prolia) Amgen Osteoporosis

60 mg/ml Pre-filled Syringe

02343541

Exception Drug Status Program1,2

Eligibility1,2:

  • 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.

Notes1,2:

  • 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. Saskatchewan Cancer Agency Drug Formulary
  2. Exception Drug Status Program

ProVital Program: Access Here

Denosumab (Wyost) Sandoz mCRPC + high risk of skeletal-related events

Inj. Sol.  
120 mg /1.7mL 

02545764 

Pending  

    

Haven: 

Drug Access Canada - Haven by Sentrex 

Enzalutamide (Xtandi) Astellas mCRPC

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. Saskatchewan Cancer Agency Drug Formulary

Xtandi Patient Assistance Program (XPAP): 

Patient Enrolment and Consent Form (English)

Formulaire D’inscription et de Consentement du Patient (Français)

 

Enzalutamide (Xtandi) Astellas nmCRPC

40 mg capsule

02407329 

FUNDED INDICATIONS and ELIGIBILITY REQUIREMENTS: 

Non-metastatic castration-resistant* prostate cancer (nmCRPC) in combination with androgen deprivation therapy (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 central nervous system, 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 prostate-specific antigen (PSA) doubling time (or PSADT) of ≤10 months during continuous ADT 

  • have no risk factors for seizure 

  • (if applicable) have demonstrated a further rise in PSA, measured at least 6 weeks after discontinuing treatment with a first generation anti-androgen (e.g., bicalutamide) 

 

Enzalutamide may continue until radiographic disease progression or unacceptable toxicity 

 

FUNDING NOTES 

*Castration-resistant prostate cancer is defined as 3 consecutive rises in PSA at least 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 enzalutamide, appropriate clinical evaluation and/or investigations for metastatic disease should be conducted in a timely manner 

 

If progression to metastatic castration-resistant prostate cancer (mCRPC) occurs during enzalutamide treatment for nmCRPC, abiraterone is funded as a subsequent treatment option in patients who are unable to tolerate or are not candidates for other therapeutic choices (i.e., chemotherapy) 

 

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

Saskatchewan Cancer Agency Drug Formulary

Xtandi Patient Assistance Program (XPAP): 

Patient Enrolment and Consent Form (English)

Formulaire D’inscription et de Consentement du Patient (Français)

 

Enzalutamide (Xtandi) Astellas mCSPC

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. Saskatchewan Cancer Agency Drug Formulary

Xtandi Patient Assistance Program (XPAP): 

Patient Enrolment and Consent Form (English)

Formulaire D’inscription et de Consentement du Patient (Français)

 

Leuprolide acetate (ELIGARD) Tolmar Advanced mCRPC/ mCSPC (stage D2)

7.5mg-30mg mg / Syr Injection 

3.75mg = 00884502,

7.5mg = 00836273,

11.25mg = 02239834,

22.5mg = 02230248,

30mg = 02239833 

Public benefit 

    

Haven: 

Drug Access Canada - Haven by Sentrex 

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

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

Orgovyx (Relugolix) Sumitomo Pharma Canada Advanced CRPC/CSPC

120mg tablet 

02542137 

Pending (Positive CDA decision: relugolix | CDA-AMC)  

    

Copay cards available from manufacturer