ZYTIGA, Abiraterone Acetate YONSA, Abiraterone Acetate Form

Abiraterone (Zytiga®, Yonsa®) is a selective and irreversible inhibitor of enzyme CYP17.
FDA Approved Indication(s) Zytiga is indicated in combination with prednisone for the treatment of metastatic castration- resistant prostate cancer and metastatic high-risk castration-sensitive prostate cancer. Yonsa is indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Zytiga and Yonsa are medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Prostate Cancer (must meet all):

1. Diagnosis of one of the following (a or b): a. Metastatic prostate cancer; b. Non-metastatic prostate cancer with prostate-specific antigen (PSA) persistence (defined as failure of PSA to fall to undetectable levels) or recurrence (defined as undetectable PSA with a subsequent detectable PSA that increases on 2 or more determinations or that increases to PSA > 0.1 ng/mL) after radical prostatectomy and life expectancy > 5 years (off-label);
2. Prescribed by or in consultation with an oncologist or urologist;
   
   3. Age ≥ 18 years;
   4. For brand Zytiga and brand Yonsa requests: member must use generic abiraterone, unless contraindicated or clinically significant adverse effects are experienced;
   5. Prescribed concurrently with a gonadotropin-releasing hormone (GnRH) analog or member has had a bilateral orchiectomy;
3. If prescribed concurrently with Lynparza® or Zejula®, request is for metastatic castration-resistant prostate cancer;
   • Prior authorization may be required for Lynparza and Zejula

4. For Zytiga requests: prescribed in combination with prednisone or dexamethasone; Page 1 of 7

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   Abiraterone

5. For Yonsa requests: prescribed in combination with methylprednisolone or dexamethasone;
6. Request meets one of the following (a, b, or c): a. Zytiga: Dose does not exceed 1,000 mg once daily, or 1,000 mg twice daily if prescribed concomitantly with a strong CYP3A4 inducer (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, and phenobarbital); b. Yonsa: Dose does not exceed 500 mg (4 tablets) per day, or 500 mg twice daily (8 tablets) if prescribed concomitantly with a strong CYP3A4 inducer (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, and phenobarbital); c. Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Prescribed regimen must be FDA-approved or recommended by NCCN
   Approval duration:
   Medicaid/HIM – 6 months Commercial – 12 months or duration of request, whichever is less B. Other diagnoses/indications (must meet 1 or 2):
7. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
8. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   II. Continued Therapy A. Prostate Cancer (must meet all):

9. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Zytiga or Yonsa for metastatic prostate cancer and has received this medication for at least 30 days;

   2. Member is responding positively to therapy;
   3. For brand Zytiga and brand Yonsa requests: member must use generic abiraterone, unless contraindicated or clinically significant adverse effects are experienced;
   4. If request is for a dose increase, request meets one of the following (a, b, or c):* a. Zytiga: New dose does not exceed 1,000 mg once daily, or 1,000 mg twice daily if prescribed concomitantly with a strong CYP3A4 inducer (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, and phenobarbital);

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   Abiraterone b. Yonsa: New dose does not exceed 500 mg (4 tablets) per day, or 500 mg twice daily (8 tablets) if prescribed concomitantly with a strong CYP3A4 inducer (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, and phenobarbital); c. New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). *Prescribed regimen must be FDA-approved or recommended by NCCN Approval duration:
   Medicaid/HIM – 12 months Commercial – 12 months or duration of request, whichever is less B. Other diagnoses/indications (must meet 1 or 2):

10. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

11. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
    III. Diagnoses/Indications for which coverage is NOT authorized:
    A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid or evidence of coverage documents.
    IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key ADT: androgen deprivation therapy CRPC: castration-resistant prostate cancer CSPC: castration-sensitive prostate cancer Appendix B: Therapeutic Alternatives Not applicable CYP17: cytochrome 17 α‑hydroxylase/C17,20-lyase FDA: Food and Drug Administration LHRH: luteinizing hormone-releasing hormone

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    Abiraterone Appendix C: Contraindications/Boxed Warnings None reported
    Appendix D: General Information • CRPC is prostate cancer that progresses clinically, radiographically, or biochemically despite castrate levels of serum testosterone (< 50 ng/dL). Per the NCCN, androgen deprivation therapy (ADT) should be continued in the setting of CRPC while additional therapies are applied. • Examples of ADT include: o Bilateral orchiectomy (surgical castration) o Luteinizing hormone-releasing hormone (LHRH) agonist given with or without an anti-androgen:  LHRH agonists: Zoladex® (goserelin), Vantas® (histrelin), leuprolide (Lupron Depot®, Eligard®), and Trelstar® (triptorelin)  Anti-androgens: bicalutamide (Casodex®), flutamide, nilutamide (Nilandron®), Xtandi® (enzalutamide), Erleada® (apalutamide) o LHRH antagonist: Firmagon® (degarelix), Orgovyx® (relugolix) • Per the NCCN prostate cancer guidelines the fine-particle formulation of abiraterone (Yonsa) can be used instead of the standard formulation (Zytiga) [Category 2B recommendation] V. Dosage and Administration
    Drug Name Abiraterone (Zytiga) Indication Castration- resistant prostate cancer Castration-naïve prostate cancer Abiraterone (Yonsa) Castration- resistant prostate cancer Dosing Regimen 1,000 mg (four 250 mg tablets or two 500 mg tablets) PO QD in combination with prednisone 5 mg PO BID 1,000 mg (four 250 mg tablets or two 500 mg tablets) PO QD in combination with prednisone 5 mg PO QD 500 mg (four 125 mg tablets) PO QD in combination with methylprednisolone 4 mg PO BID Maximum Dose 1,000 mg QD; 1,000 mg BID if taking a strong CYP3A4 inducer 1,000 mg QD; 1,000 mg BID if taking a strong CYP3A4 inducer 500 mg QD; 500 mg BID if taking a strong CYP3A4 inducer Patients receiving Zytiga or Yonsa should also receive a GnRH analog concurrently or should have had bilateral orchiectomy. VI. Product Availability
    Drug Name Abiraterone (Zytiga) Abiraterone (Yonsa) Availability Film-coated tablet: 500 mg Uncoated tablet: 250 mg (generic available as coated and uncoated) Tablet: 125 mg

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    Abiraterone VII.