Sacituzumab Govitecan-hziy (Trodelvy) Form

Sacituzumab govitecan-hziy (Trodelvy®) is a Trop-2-directed antibody and topoisomerase inhibitor conjugate. FDA Approved Indication(s) Trodelvy is indicated for the treatment of adult patients with
• Unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease • Unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting • Locally advanced or metastatic urothelial cancer (mUC) who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PDL1) inhibitor ____ This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. 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 Trodelvy is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Breast Cancer (must meet all):

1. Diagnosis of unresectable or metastatic breast cancer;

   2. Prescribed by or in consultation with an oncologist;
   3. Age ≥ 18 years;
   4. Documentation of one of the following (a or b):
      a. Triple negative (i.e., estrogen receptor-, progesterone receptor-, and human epidermal growth factor receptor 2 [HER2]-negative) disease; b. Hormone receptor (HR)-positive, HER2-negative disease;
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   CLINICAL POLICY Sacituzumab Govitecan-hziy

2. Failure of all of the following (a, b, and c): a. Two or more prior regimens (see Appendix B); b. At least one of the prior regimens administered for metastatic disease (see Appendix B); c. If HR-positive disease, an endocrine based therapy (see Appendix B);
3. Prescribed as a single agent;
   7. Request meets one of the following (a or b): a. Dose does not exceed 10 mg/kg on days 1 and 8 of each 21-day cycle; 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:
      HIM/Medicaid – 6 months
      Commercial – 6 months or to the member’s renewal date, whichever is longer B. Urothelial Cancer (must meet all):
4. Diagnosis of locally advanced, recurrent, or metastatic urothelial cancer;
   2. Prescribed by or in consultation with an oncologist;
   3. Age ≥ 18 years;
   4. Failure of both of the following (a and b): a. Platinum-containing chemotherapy (see Appendix B); b. Programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor (see Appendix B);
5. Prescribed as a single agent;
   6. Request meets one of the following (a or b): a. Dose does not exceed 10 mg/kg on days 1 and 8 of each 21-day cycle; 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:
      HIM/Medicaid – 6 months
      Commercial – 6 months or to the member’s renewal date, whichever is longer C. 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: 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

7. 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 Page 2 of 7

   CLINICAL POLICY Sacituzumab Govitecan-hziy 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. All Indications in Section I (must meet all):

8. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Trodelvy for a covered indication and has received this medication for at least 30 days;
9. Member is responding positively to therapy;
   3. If request is for a dose increase, request meets one of the following (a or b): a. New dose does not exceed 10 mg/kg on days 1 and 8 of each 21-day cycle; 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:
      HIM/Medicaid – 12 months Commercial – 6 months or to the member’s renewal date, whichever is longer 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 FDA: Food and Drug Administration Page 3 of 7

    CLINICAL POLICY Sacituzumab Govitecan-hziy HER2: human epidermal growth factor receptor 2 HR: hormone receptor
    PD-1: programmed death receptor-1 PD-L1: programmed death-ligand mTNBC: metastatic triple-negative breast cancer mUC: metastatic urothelial cancer 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.
    Drug Name Dosing Regimen Dose Limit/ Maximum Dose Varies Varies Examples of systemic therapies for recurrent unresectable or metastatic breast cancer paclitaxel Abraxane® (albumin- bound paclitaxel) docetaxel (Taxotere®) doxorubicin Liposomal doxorubicin (Doxil®) capecitabine (Xeloda®) Varies Varies 50 mg/m2 IV day 1, cycled every 28 days Varies Varies Varies Varies Varies Varies gemcitabine (Gemzar®) vinorelbine Halaven® (eribulin) carboplatin cisplatin cyclophosphamide epirubicin (Ellence®) Varies 1,000-1,250 mg/m2 PO BID on days 1-14, cycled every 21 days 800-1,200 mg/m2 IV on days 1,8 and 15, cycled every 28 days Varies 1.4 mg/m2 IV on days 1 and 8, cycled every 21 days AUC 6 IV on day 1, cycled every 21-28 days Varies 75 mg/m2 IV on day 1, cycled every 21 days Varies Varies 50 mg PO QD on days 1-21, cycled every 28 days 60-90 mg/m2 IV on day 1, cycled every 21 days 40 mg/m2 IV on day 1, cycled every 21 days Varies Varies Varies 40 mg/m2 Ixempra® (ixabepilone) Examples of platinum-containing regimens for urothelial cancer Varies
    DDMVAC (dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin)
    gemcitabine with either cisplatin or carboplatin
    Examples of PD-1 and PD-L1 inhibitors for urothelial cancer Keytruda® Varies
    (pembrolizumab) Tecentriq® (atezolizumab) Varies
    Opdivo® (nivolumab) Varies
    Bavencio® (avelumab) 800 mg IV infusion once every 2 weeks Varies
    Varies
    Varies
    Varies
    Varies
    Varies
    Varies Page 4 of 7

    CLINICAL POLICY Sacituzumab Govitecan-hziy Drug Name Dosing Regimen Dose Limit/ Maximum Dose Varies
    Examples of endocrine based therapy for breast cancer Tamoxifen; aromatase inhibitors: anastrozole (Arimidex®), letrozole (Femara®), exemestane (Aromasin®) 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. Varies
    Appendix C: Contraindications/Boxed Warnings
    • Contraindication(s): severe hypersensitivity reaction to Trodelvy • Boxed warning(s): neutropenia and diarrhea V. Dosage and Administration
    Indication breast cancer, urothelial cancer Dosing Regimen 10 mg/kg IV on days 1 and 8 of each 21-day cycle Maximum Dose 10 mg/kg VI. Product Availability
    Single-dose vial: 180 mg lyophilized powder for reconstitution VII.