JEVTANA, Cabazitaxel Form

Cabazitaxel (Jevtana®) is a microtubule inhibitor. FDA Approved Indication(s) Jevtana is indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC) previously treated with a docetaxel-containing treatment regimen. 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 Jevtana is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Prostate Cancer (must meet all):

1. Diagnosis of metastatic CRPC, as evidenced by disease progression despite bilateral orchiectomy or other androgen deprivation therapy (see Appendix D);
2. Prescribed by or in consultation with an oncologist or urologist;
   3. Age ≥ 18 years;
   4. Previously treated with a docetaxel-containing treatment regimen, unless not a candidate for or are intolerant of docetaxel;
3. At the time of request, member has none of the following contraindications: a. Neutrophil counts of ≤ 1,500/mm3; b. Severe hepatic impairment (total bilirubin > 3 × upper limit of normal);
4. Jevtana is prescribed concurrently with corticosteroid (see Appendix E);
   7. Member will use a gonadotropin-releasing hormone (GnRH) analog concurrently or has had a bilateral orchiectomy;

5. Requests meets one of the following (a or b): a. Dose does not exceed 25 mg/m2 once every 3 weeks; b. 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: 6 months Page 1 of 6

   CLINICAL POLICY
   Cabazitaxel B. Other diagnoses/indications (must meet 1 or 2):

6. 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: 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: HIM.PA.103 for health insurance marketplace and CP.PMN.16 for Medicaid; or
   2. 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: HIM.PA.154 for health insurance marketplace and CP.PMN.53 for Medicaid.
      II. Continued Therapy A. Prostate Cancer (must meet all):
7. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Jevtana for a covered indication and has received this medication for at least 30 days;
8. Member is responding positively to therapy;
   3. Jevtana is prescribed concurrently with corticosteroid (see Appendix E);
   4. Member continues to use a gonadotropin-releasing hormone (GnRH) analog concurrently or has had a bilateral orchiectomy;
9. If request is for a dose increase, request meets one of the following (a or b): a. New dose does not exceed 25 mg/m2 once every 3 weeks; b. 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: 12 months 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: 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: HIM.PA.103 for health insurance marketplace and CP.PMN.16 for Medicaid; or

    2. 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 Page 2 of 6

    CLINICAL POLICY
    Cabazitaxel of business: 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.PMN.53 for Medicaid and HIM.PA.154 for health insurance marketplace or evidence of coverage documents. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration CRPC: castration resistant prostate cancer Dose Limit/ Maximum Dose Varies Appendix B: Therapeutic Alternatives
    This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
    Dosing Regimen Drug Name docetaxel Androgen-deprivation therapy with docetaxel 75 mg/m2 for 6 cycles Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Appendix C: Contraindications/Boxed Warnings • Contraindication(s):
    o Neutrophil counts of ≤ 1,500/mm3 o History of severe hypersensitivity reactions to cabazitaxel or to other drugs formulated with polysorbate 80 o Severe hepatic impairment (total bilirubin > 3x upper limit of normal) • Boxed warning(s): neutropenia and hypersensitivity 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 should be continued in the setting of CRPC while additional therapies are applied. • Examples of androgen deprivation therapy include: o Bilateral orchiectomy (surgical castration) o Luteinizing hormone-releasing hormone (LHRH) given with or without an anti- androgen:  LHRH agonists: Zoladex® (goserelin), leuprolide (Lupron Depot®, Eligard®), and Trelstar® (triptorelin) Page 3 of 6

    CLINICAL POLICY
    Cabazitaxel  Anti-androgens: bicalutamide (Casodex®), flutamide (Eulexin®), nilutamide (Nilandron®), Xtandi® (enzalutamide), Erleada® (apalutamide), Nubeqa® (darolutamide) o LHRH antagonist: Firmagon® (degarelix), Orgovyx™ (relugolix) Appendix E: Concurrent Steroid Therapies • Dexamethasone on the day of chemotherapy • Prednisone daily V. Dosage and Administration
    Indication CRPC Dosing Regimen 20 mg/m2 IV every 3 weeks
    Maximum Dose 25 mg/m2 once every 3 weeks VI. Product Availability
    Single-dose vial: 60 mg/1.5 mL, 45 mg/4.5 mL, 60 mg/6 mL VII.