Page 6 - CUA Adv Prostate Ca Drug Access List-MAR-2022
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AB

 Group 2*                                                                 AHS Outpatient
                                                                          Cancer Drug
 Eligibility:                                                             Benefit Program
 •  Apalutamide in combination with ADT for the treatment of patients with mCSPC defined   [3-22]
 as:

 Apalutamide   o  No prior ADT in the metastatic setting, OR
 (Erleada)   mCSPC   Oral   Not   o  Within 6 months of beginning ADT for metastatic disease, OR
 specified
 Janssen   o  > 1 year since prior ADT for early-stage disease with good performance status
 •  Patients may receive only one of these agents (apalutamide, enzalutamide, or
 abiraterone) in this setting and switching only if intolerance, not progression
 •  May follow prior docetaxel for mCSPC, if treatment has been within the last 3 months and
 there has been no disease progression (time limited needed)

 Group 2*                                                                 AHS Outpatient
                                                                          Cancer Drug
 Eligibility:                                                             Benefit Program
 Darolutamide   Not   •  Darolutamide in combination with ADT for the treatment of patients with nmCRPC who are  [3-22]
 (Nubeqa)   nmCRPC   Oral   specified   at high risk of developing metastases. High risk defined as:
 Bayer   o  PSADT ≤ 10 months during continuous ADT/post orchiectomy

 •  Patients may receive only one of these agents (darolutamide, apalutamide or
 enzalutamide) in this setting and switching only if intolerant (without progression)
 Special authorization                                                    Alberta Health
                                                                          Drug Benefit List
  Eligibility:                                                            [3-22]
 •  Treatment of osteoporosis in patients who have:
 o  A high 10-year risk (> 20%) of experiencing a major osteoporotic fracture OR
 a  moderate 10-year fracture risk (10-20%) and have experienced a prior fragility
 fracture
 •  AND at least one of the following:
 Denosumab   60 mg / Syr   o  Oral bisphosphonates are contraindicated due to drug-induced hypersensitivity (ie,
 (Prolia)   Osteoporosis   Injection   02343541   immunologically mediated), OR
 Amgen    o  Oral bisphosphonates are contraindicated due to an abnormality of the esophagus
 which delays esophageal emptying, OR
 o  Bisphosphonates are contraindicated due to severe renal impairment (i.e. creatinine
 clearance < 35 mL/min), OR
 o  Demonstrated persistent severe gastrointestinal intolerance to a course of therapy
 with either alendronate or risedronate, OR
 o  Had an unsatisfactory response (defined as a fragility fracture despite adhering to oral
 alendronate or risedronate treatment fully for 1 year and evidence of a decline in BMD
 below pre-treatment baseline level).

                                                                          Alberta Health
                                                                          Drug Benefit List
 Denosumab   mCRPC with   120 mg /                                        [3-22]
 (Xgeva)   Bone mets   Vial   02368153   Not a benefit
 Amgen    Injection









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