Drug Access Listing

250 mg tab | 500 mg tab

Multiple

Exceptional Access Program (EAP)1: EAP standard form

Eligibility: patients with mCRPC who have not trialed docetaxel1

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

• Used in combination with prednisone
• Asymptomatic or mildly symptomatic after failure of ADT
• ECOG PS ≤ 1
• Patient must not meet any of the exclusion criteria stated below

Exclusion Criteria1:

• Funding for Zytiga will NOT be approved in patients who meet any ONE (or more) of the following exclusion criteria:

• Patient has viral hepatitis or chronic liver disease;
• Patient has clinically significant heart disease;
• Zytiga is being prescribed for combination use with Jevtana or Xtandi for mCRPC;
• The patient has received prior chemotherapy for mCRPC

Notes:

• Please provide clinical information as objective evidence that the above criteria are met (e.g., castrate testosterone level, PSA levels, evidence of metastatic disease such as presence and location of lesions, surgical procedures related to the condition, and name(s), date, duration of ADT used details of the response to therapy, labwork or clinical confirmation to support that the patient does not meet any of the exclusion criteria
• Approved dosage: 1000 mg once daily will be funded until there is evidence of disease progression
• Duration of Approval: 1 year
• Renewals will be considered in patients with evidence of not having had disease progression while on Zytiga therapy

Eligibility: patients with mCRPC who are requesting Zytiga after a trial of docetaxel1

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

• Zytiga is being used in combination with prednisone
• Cancer has progressed after having received prior docetaxel containing therapy
• ECOG PS ≤ 2
• Patients must not meet ANY of the exclusion criteria for funding stated below

Exclusion Criteria1:

• Funding for Zytiga will NOT be approved in patients who meet any ONE (or more) of the following exclusion criteria:
• Patient has viral hepatitis or chronic liver disease
• Patient has clinically significant heart disease
• Zytiga is being prescribed for combination use with Jevtana or Xtandi for mCRPC
• Patient has already used Zytiga in the pre-docetaxel setting

Notes:

• Requests for patients who initiated Jevtana (cabazitaxel) or Xtandi (enzalutamide) therapy within the 3 months preceding the EAP request for Zytiga and who have not had disease progression, will be considered on a case-by-case basis
• Approved dosage: 1000 mg once daily will be funded until there is evidence of disease progression
• Duration of Approval: 1 year
• Renewals will be considered in patients with evidence of not having had disease progression while on Zytiga therapy

1. ON EAP-Freq Requested [1-22] 
2. CCO-ABIRPRED [5-21]

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

-

-

Not funded by EAP for newly diagnosed hormone-sensitive high-risk metastatic prostate cancer.

1. CCO-ABIRPRED [6-21]

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

Multiple

ODBF listing

1. ODBF [12-21]

Apotex: Access Here

Tablet, PO, 60mg, 240mg

02478374

Exceptional Access Program (EAP)1,2: EAP standard form

Eligibility1:

• High risk nmCRPC in patients who meet all the following criteria:

• Patient using apalutamide (Erleada) in combination with ADT
• No detectable distant metastases as determined by CT, MRI, or technetium99m bone scan;
• Castration resistant disease based on meeting all the following indicia observed while on continuous ADT treatment or post orchiectomy:
  • Castrate serum testosterone levels
  • Biochemical progression defined as three (3) PSA rises at least 1 week apart, with the last PSA > 2ng/mL
• High risk for developing metastatic disease based on a PSADT ≤ 10 months during continuous ADT
• ECOG PS ≤ 2

Exclusion criteria: The following will not be reimbursed1

• The patient received prior chemotherapy for the treatment of prostate cancer, unless it was in the adjuvant or neoadjuvant setting
• The patient has experienced disease progression on prior treatment with enzalutamide or darolutamide used for prostate cancer

Notes:

• The Ministry will fund only one second generation ARI in patients with non-metastatic castrate resistant prostate cancer
• Requests for apalutamide in patients who have initiated another ARI therapy in the nmCRPC setting and who have not experienced disease progression will be considered on a case-by-case basis
• Patients treated with an ARI as part of a clinical trial may be eligible for apalutamide and will be considered on a case-by-case basis
• Approved dosage: 240 mg administered orally once daily
• Renewal criteria: Renewals will be considered in patients without evidence of radiographic disease progression or unacceptable toxicity while on apalutamide therapy
• Duration of initial and renewal approvals: 1 year

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

1. ON EAP-Freq Requested [1-22] 
2. CCO-APAL [12-21]

Janssen BioAdvance Patient Assistance Program: Access Here

Tablet, PO, 60mg, 240mg

02478374

Exceptional Access Program (EAP)1,2: EAP standard form

Eligibility1:

• Patients with mCSPC who meet all the following criteria:

• In combination with ADT (ADT is not required for patients with bilateral orchiectomy)
• Metastatic lesions detected on technetium-99m bone scan, CT, and/or MRI
• Castration sensitive as defined by:
  • Patient being treatment naïve to an ADT, OR
    ADT initiated within the prior 6 months before start of therapy with apalutamide , OR
  • ADT used in the neoadjuvant or adjuvant setting where the patient has been off treatment for 12 months or more prior to start of apalutamide
• Patient has not experienced disease progression with another ARAT (abiraterone, apalutamide, darolutamide, enzalutamide) for CSPC
• Patient has good performance status

• Baseline levels to be provided with initial application1

• Number of metastatic lesions on bone scan and in soft tissues
• Testosterone level 
• Baseline (pre-treatment) PSA level
• Pre-treatment Gleason score (optional)

Exclusion criteria: Patients meeting any of the following will not be funded1

• Patients who have previously experienced disease progression on apalutamide or another ARI used in the setting of prostate cancer
• Apalutamide will not be funded as combination therapy with another ARAT

Notes:

• Patients who have previously progressed on an ARI for prostate cancer will not be eligible for apalutamide in mCSPC. The Ministry will fund only one of apalutamide or enzalutamide in patients with mCSPC.
• Patients treated with enzalutamide or darolutamide as part of a clinical trial may be eligible for apalutamide and will be considered on a case-by-case basis
• Patients who are currently on a treatment regimen with an ARAT for prostate cancer, must meet the initiation criteria if they wish to switch to publicly funded apalutamide for mCSPC
• Time limited funding consideration will be prov ided on a case-by-case basis for those patients who are using docetaxel in combination with ADT as long as there has been no progression and the treatment regimen has not been used for more than 6 months
• Approved Dosage for Initials and Renewals: 240 mg administered orally once daily
• Duration of initial and renewal approvals: 1 year
• Renewal Criteria: Renewals will be considered in patients until disease progression (ie,. PSA elevation in addition to radiographic disease progression, or PSA progression in addition to clinical symptoms associated with cancer progression), development of castration resistant disease, or experiencing unacceptable toxicity while on apalutamide

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

1. ON EAP-Freq Requested [1-22] 
2. CCO-APAL [12-21]

Janssen BioAdvance Patient Assistance Program: Access Here 

300 mg Tab

Not specified

Exceptional Access Program (EAP)1,2: EAP standard form

Eligibility1:

• High risk nmCRPC in patients who meet all the following criteria:

• Patient using darolutamide (Nubeqa) in combination with ADT
• No detectable distant metastases as determined by CT, MRI, or technetium-99m bone scan
• Patient has castrate resistant disease based on meeting all the following indicia observed while on continuous ADT treatment or post orchiectomy:
  • Castrate serum testosterone levels
  • Biochemical progression defined as three (3) PSA rises ≥ 1 week apart, with the last PSA > 2 ng/mL (if the patient has a history of antiandrogen use, the most recent PSA value must be obtained ≥ 4 weeks after anti-androgen withdrawal)
• Patient is at high risk for developing metastatic disease based on a PSADT ≤ 10 months during continuous ADT
• ECOG PS ≤ 2

Exclusion criteria: Patients meeting ≥ 1 below exclusion criteria will not be funded1

• The patient received prior chemotherapy or immunotherapy for the treatment of prostate cancer, unless it was in the adjuvant or neoadjuvant setting completed > 2 years previously
• The patient has experienced disease progression on prior treatment with Erleada (apalutamide) or Xtandi (enzalutamide)
• The patient has a high risk for disease progression by other definitions (such as a high Gleason score 8-10, high PSA level at diagnosis, etc.) AND has not had a PSA progression in the non-metastatic setting

Notes:

• The Ministry will fund only one of Nubeqa (darolutamide) or Erleada (apalutamide) or Xtandi (enzalutamide) in patients with nmCRPC
• While doses may be withheld or reduced to 300 mg twice daily to manage grade 3 toxicities until symptoms improve, treatment doses should be resumed at a dose of 600 mg twice daily
• Requests for Nubeqa in patients who initiated Erleada or Xtandi therapy in the nmCRPC setting and who have not had disease progression will be considered on a case-by-case basis
• Following progression on darolutamide in nmCRPC, the patient would not be eligible for darolutamide, apalutamide or enzalutamide in mCRPC state
• Approved dosage: 600 mg administered orally twice daily.
• Approval duration of initials and renewals: 1 year
• Renewal criteria: Renewals will be considered in patients without evidence of radiographic disease progression or unacceptable toxicity while on Nubeqa therapy

1. ON EAP-Freq Requested [1-22] 
2. CCO-DARO [11-21]

NUBEQA® DART Patient Support Program: 

Toll free:  

1-833-955-3278 

Fax: 

1-877-208-4393 

Email: 

info@dartsupport.ca 

300mg Tab

Not specified

As of March 8, 2024, darolutamide is covered through the Exceptional Access Program(EAP) for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel. 

• No reimbursement criteria listed as of May 2024. 

N/A

NUBEQA® DART Patient Support Program: 

Toll free:  

1-833-955-3278 

Fax: 

1-877-208-4393 

Email: 

info@dartsupport.ca 

60 mg / ml Syr

02343541

Ontario Drug Benefit Formulary - Limited Use

Eligibility: Limited Use Code 515¹

• To increase bone mass in males with osteoporosis who meet the following criteria:

• High risk* for fracture;
• Failed other available osteoporosis therapy (i.e. fragility fracture OR evidence of a decline in bone mineral density below pre-treatment baseline levels) despite adherence for one year.
• *High fracture risk is defined as either:
  • A prior fragility fracture AND a moderate 10-year fracture risk (10% to 20%) based on the CAROC tool or the FRAX tool; OR
  • A high 10-year fracture risk (greater than or equal to 20%) based on the CAROC or FRAX tool; OR
  • Where a patient's 10-year fracture risk based on the CAROC or FRAX tool is less than the thresholds defined above, a high fracture risk based on evaluation of clinical risk factors for fracture

Exclusion Criteria¹:

• Patients receiving Prolia must not be receiving concomitant bisphosphonate therapy

Notes:

• Use of the CAROC or FRAX tool may underestimate fracture risk in certain circumstances and may not include all risk factors
• The recommended dose of PROLIA (denosumab) is a single SC injection of 60 mg, once every 6 months
• Limited use authorization period: indefinite

Eligibility: Limited Use Code 516¹

• To increase bone mass in males with osteoporosis who meet the following criteria:

• High risk* for fracture;
• For whom oral bisphosphonates are contraindicated due to hypersensitivity OR abnormalities of the esophagus (e.g., esophageal stricture or achalasia) OR inability to stand or sit upright for at least 30 minutes
• *High fracture risk is defined as either:
  • A prior fragility fracture AND a moderate 10-year fracture risk (10% to 20%) based on the CAROC tool or the FRAX tool; OR
  • A high 10-year fracture risk (greater than or equal to 20%) based on the CAROC or FRAX tool; OR
  • Where a patient's 10-year fracture risk based on the CAROC or FRAX tool is less than the thresholds defined above, a high fracture risk based on evaluation of clinical risk factors for fracture

Exclusion Criteria¹:

• Patients receiving Prolia must not be receiving concomitant bisphosphonate therapy

Notes:

• Use of the CAROC or FRAX tool may underestimate fracture risk in certain circumstances and may not include all risk factors
• The recommended dose of PROLIA (denosumab) is a single SC injection of 60 mg, once every 6 months
• Limited use authorization period: indefinite

1. ODBF [12-21]

ProVital Program: Access Here

120 mg per vial

Not specified

Exceptional Access Program (EAP)^1,2: Denosumab Form | EAP standard form

Eligibility¹:

• For the treatment of bony metastases in patients with hormone refractory prostate cancer
• Xgeva is considered through CCO for those receiving prostate cancer treatment from a cancer clinic.
• Hormone refractory prostate cancer is determined using the following criteria:

• Patient has an elevated PSA level or evidence of progressive bony disease^a, despite castrate serum testosterone levels (< 1.7 nmol/L or < 50 ng/d)^b
  1. Progressive bony disease is defined as progressive changes in radionucleotide bone scan or clinical signs of disease profession, such as pathologic fracture or increasing bone pain
  2. Patients who have undergone orchidectomy do not need to provide a serum testosterone level in the request submission

Notes:

• Approved dosing: 120 mg subcutaneously every four (4) weeks
• Duration of approval: 1 Year
• Renewals will be considered for patient responding to treatment with Xgeva and who still requires treatment

1. ON EAP-Freq Requested [1-22] 
2. CCO DENO [7-18]

The VICTORY Program: Access Here

40 mg Cap

Not specified

Exceptional Access Program (EAP)1,2: EAP standard form

Eligibility1:

• For the treatment of metastatic castration resistant prostate cancer (mCRPC) in patients meeting the following criteria:

1. Enzalutamide used in combination with ADT (ADT is not required for patients with bilateral orchiectomy), AND
2. Metastatic lesions detected on a bone scan, CT, and/or MRI, AND
3. Patient has castration resistant disease based on meeting the following indicia observed while on continuous ADT treatment or post orchiectomy
   • Castrate serum testosterone levels, AND
   • Biochemical progression defined as three (3) PSA rises at least 1 week apart, with the last PSA greater than 2ng/mL AND/OR radiographic progression of new or pre-existing disease as determined by the detection of 2 or more lesions on bone scan or presence of new soft tissue lesions by RECIST criteria, AND
4. Patient has progressed on a docetaxel-based chemotherapy, OR
5. Patient is using enzalutamide pre-docetaxel for mCRPC and has not previously experienced disease progression on enzalutamide or another second generation ARI (e.g. apalutamide, darolutamide) used for prostate cancer, OR 
6. Patient is using enzalutamide pre-docetaxel for mCRPC and has not previously experienced disease progression on abiraterone used in mCRPC sequenced immediately prior to enzalutamide
7. Patient has good performance status defined as ECOG PS ≤ 2

Exclusion Criteria: Patients meeting any of the following will not be funded1

• Patient has risk factors for seizures
• Enzalutamide will not be funded as combination therapy with another androgen receptor axis targeted therapy or cabazitaxel

Notes:

• Patients who have progressed on treatment with second generation ARI (e.g., apalutamide, enzalutamide, darolutamide) used in prior stages of prostate cancer will not be eligible for enzalutamide in the metastatic castration resistant setting
• Patients treated with apalutamide or darolutamide as part of a clinical trial may be eligible for enzalutamide and will be considered on a case-by-case basis
• Requests for enzalutamide in patients who initiated abiraterone therapy and who have not had disease progression while on abiraterone will be considered on a case-by-case basis
• Approved dosage for initials and renewals: 160 mg administered orally once daily
• Duration of initial and renewal approvals : 1 year
• Renewal criteria: Renewals will be considered in patients who have not experienced disease progression while on enzalutamide therapy

1. ON EAP-Freq Requested [1-22] 
2. CCO_ENZL [12-21]

Xtandi Patient Assistance Program (XPAP): 

Patient Enrolment and Consent Form (English) 

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

40 mg Cap

Not specified

Exceptional Access Program (EAP)1,2: EAP standard form

Eligibility1:

• For the treatment of high risk nmCRPC in patients who meet all the following criteria:

1. Patient using Xtandi in combination with ADT
2. No detectable distant metastases as determined by CT, MRI, or technetium99m bone scan
3. Patient has castrate resistant disease based on meeting all the following indicia observed while on continuous ADT treatment or post orchiectomy:
   • Castrate serum testosterone levels, AND
   • Biochemical progression defined as 3 PSA rises ≥ 1 week apart, with the last PSA > 2ng/mL
4. Patient is at high risk for developing metastatic disease based on a PSADT ≤ 10 months during continuous ADT
5. ECOG PS ≤ 2

Exclusion Criteria1:

• The patient received prior chemotherapy for the treatment of prostate cancer, unless it was in the adjuvant or neoadjuvant setting
• The patient has experienced disease progression on prior treatment with apalutamide or darolutamide
• The patient has risk factors for seizures

Notes:

• The Ministry will fund only one second generation ARI (e.g. apalutamide, darolutamide, or enzalutamide) in patients with nmCRPC
• Patients who have progressed on enzalutamide for nmCRPC will not be eligible for enzalutamide in mCRPC
• Requests for enzalutamide in patients who initiated  another ARI therapy in the nmCRPC setting and who have not had disease progression will be considered on a case-by-case basis
• Approved dosage: 160mg administered orally once daily
• Approval duration: 1 year
• Renewal criteria: Renewals will be considered in patients without evidence of radiographic disease progression or unacceptable toxicity while on enzalutamide therapy

1. ON EAP-Freq Requested [1-22] 
2. CCO_ENZL [12-21]

Xtandi Patient Assistance Program (XPAP): 

Patient Enrolment and Consent Form (English) 

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

40 mg Cap

Not specified

Exceptional Access Program (EAP)1,2: EAP standard form

Eligibility1:

• For the treatment metastatic castration sensitive prostate cancer (mCSPC) in patients who meet all of the following criteria:

1. Enzalutamide is used in combination with ADT (ADT is not required for patients with bilateral orchiectomy), AND
2. Metastatic lesions detected on technetium-99m bone scan, CT, and/or MRI, AND
3. Castration sensitive as defined by the patient being treatment naïve to an ADT, OR ADT initiated within the prior 6 months before start of therapy with enzalutamide, OR ADT used in the neoadjuvant or adjuvant setting where the patient has been off treatment for 12 months or more prior to start of enzalutamide, AND
4. Has not experienced disease progression with another ARAT for CSPC
5. Patient has good performance status

• The following baseline levels are to be provided with the initial application:1
  • Number of metastatic lesions on bone scan and in soft tissues
  • Testosterone level
  • Baseline (pre-treatment) PSA level
  • Pre-treatment Gleason score (optional)

Exclusion Criteria: Patients meeting any of the following will not be funded1

• Patients who have previously experienced disease progression on enzalutamide or another ARI used in the setting of prostate cancer
• Patients who have risk factors for seizures
• Enzalutamide will not be funded as combination therapy with another ARAT

Notes:

• Patients who have previously progressed on a second-generation ARI (e.g. apalutamide, enzalutamide, darolutamide) for prostate cancer will not be eligible for enzalutamide in mCSPC; the Ministry will fund only one of enzalutamide or apalutamide in patients with mCSPC
• Patients treated with apalutamide or darolutamide as part of a clinical trial may be eligible for enzalutamide and will be considered on a case-by-case basis
• Patients who progress on treatment with enzalutamide or apalutamide mCSPC will not be eligible for enzalutamide in the metastatic castration resistant setting
• Patients who are currently on a treatment regimen with an ARAT (e.g. abiraterone or a second-generation ARI) for prostate cancer, must meet the initiation criteria if they wish to switch to publicly funded enzalutamide for mCSPC
• Time limited funding consideration will be provided on a case-by-case basis for those patients who are using docetaxel in combination with ADT as long as there has been no progression and the treatment regimen has not been used for more than 6 months
• Approved dosage: 160 mg administered orally once daily
• Duration of initial and renewal approvals: 1 year
• Renewal Criteria: Renewals will be considered in patients until disease progression (i.e. PSA elevation in addition to radiographic disease progression, or PSA progression in addition to clinical symptoms associated with cancer progression), development of castration resistant disease, or experiencing unacceptable toxicity while on enzalutamide

1. ON EAP-Freq Requested [1-22] 
2. CCO_ENZL [12-21]

Xtandi Patient Assistance Program (XPAP): 

Patient Enrolment and Consent Form (English) 

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

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

Funding effective May 2, 2022 

For the treatment of metastatic castration resistant prostate cancer (mCRPC) in patients meeting all of the following criteria;  

1. Olaparib is used in combination with androgen deprivation therapy (ADT)1; AND 
2. Has documentation of the presence of deleterious or suspected deleterious germline and/or somatic mutations in the BRCA 1, BRCA 2 or ATM genes detected using an approved testing method; AND  
3. Has metastatic lesions detected on a bone scan, computed tomography (CT), and/or magnetic resonance imaging (MRI); AND  
4. Has castration resistant disease based on meeting the following indicia observed while on continuous androgen deprivation therapy (ADT)1 treatment or post orchiectomy:  
   • Castrate serum testosterone levels AND  
   • Biochemical progression defined as three (3) prostate-specific antigen (PSA) rises at least 1 week apart, with the last PSA greater than 2ng/mL AND/OR radiographic progression of new or pre-existing disease as determined by the detection of 2 or more lesions on bone scan or presence of new soft tissue lesions by RECIST criteria; AND 
5. Patient is treatment naïve to olaparib and is using olaparib for mCRPC after experiencing disease progression on an androgen receptor axis targeted therapy (ARAT; e.g. abiraterone, apalutamide, darolutamide, enzalutamide) used at any stage of prostate cancer2; AND  
6. Patient has good performance status.  

1 ADT is not required for patients with bilateral orchiectomy.  

2 Refer to EAP funding criteria for the public funding of individual ARATs in various stages of prostate cancer.  

Renewal Criteria: Renewals will be considered in patients who have not experienced disease progression or unacceptable toxicity while on olaparib therapy.  
 

Exclusion criteria: (Patients meeting any of the following will not be funded.)  

1. Patients who have previously progressed on a Polyadenosine 5-diphosphoribose polymerisation (PARP) inhibitor (including olaparib) for mCRPC will not be funded.  
2. Olaparib will not be funded as combination therapy with another anti-cancer drug for mCRPC (e.g. ARAT, cabazitaxel, or another PARP inhibitor). 

Exceptional Access Program

AstraZeneca Patient Support Program: Access Here

AstraZeneca Patient Assistance Program: Access Here