Page 5 - 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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