INLYTA, Axitinib Form

Axitinib (Inlyta®) is a kinase inhibitor. FDA Approved Indication(s) Inlyta is indicated: • In combination with avelumab, for the first-line treatment of patients with advanced renal cell carcinoma (RCC). In combination with pembrolizumab, for the first-line treatment of patients with advanced RCC. • • As a single agent, for the treatment of advanced RCC after failure of one prior systemic therapy. Policy/Criteria Provider must submit documentation (including 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 Inlyta is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Renal Cell Carcinoma (must meet all):

1. Diagnosis of relapsed, metastatic, or stage IV RCC;
   2. Prescribed by or in consultation with an oncologist;
   3. Age ≥ 18 years;
   4. For Inlyta requests, member must use axitinib, if available, unless contraindicated or clinically significant adverse effects are experienced;
2. Prescribed in one of the following ways (a or b): a. As single-agent therapy;
   b. For clear cell histology, in combination with Keytruda® or Bavencio®;Prior authorization may be required

3. Request meets one of the following (a or b): a. Both of the following (i and ii): i. Dose does not exceed 20 mg per day; ii. Dose does not exceed 4 tablets per day; 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
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   CLINICAL POLICY Axitinib Approval duration: Medicaid/HIM – 6 months Commercial – 12 months or duration of request, whichever is less
   B. Thyroid Carcinoma (off-label) (must meet all):

4. Diagnosis of differentiated thyroid carcinoma (DTC; i.e., follicular, oncocytic (formerly known as Hurthle cell) or papillary thyroid carcinoma);
5. Prescribed by or in consultation with an oncologist;
   3. Age ≥ 18 years;
   4. For Inlyta requests, member must use axitinib, if available, unless contraindicated or clinically significant adverse effects are experienced;
6. Disease is both of the following (a and b): a. Unresectable locoregional recurrent, persistent, or metastatic; b. Progressive and/or symptomatic;
7. Disease is not amenable to radioactive iodine therapy;
   7. Clinical trials or other systemic therapies are not available or appropriate (see Appendix B);Prior authorization may be required
8. Dose is within FDA maximum limit for any FDA-approved indication or 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
   C. Soft Tissue Sarcoma (off-label) (must meet all):
   1. Diagnosis of alveolar soft part sarcoma;
   2. Prescribed by or in consultation with an oncologist;
   3. Age ≥ 18 years;
   4. For Inlyta requests, member must use axitinib, if available, unless contraindicated or clinically significant adverse effects are experienced;
9. Prescribed in combination with Keytruda®;Prior authorization may be required
10. Dose is within FDA maximum limit for any FDA-approved indication or 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
    D. Other diagnoses/indications (must meet 1 or 2):

11. 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): Page 2 of 7

    CLINICAL POLICY Axitinib 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

12. 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. All Indications in Section I (must meet all):
13. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Inlyta for a covered indication and has received this medication for at least 30 days;
14. Member is responding positively to therapy;
    3. For Inlyta requests, member must use axitinib, if available, unless contraindicated or clinically significant adverse effects are experienced;
15. If request is for a dose increase, request meets one of the following (a or b): a. Both of the following (i and ii): i. New dose does not exceed 20 mg per day; ii. New dose does not exceed 4 tablets per day 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:
    Medicaid/HIM – 12 months Commercial – 12 months or duration of request, whichever is less
    B. Other diagnoses/indications (must meet 1 or 2):

16. 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 Page 3 of 7

    CLINICAL POLICY Axitinib

17. 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 DTC: differentiated thyroid carcinoma FDA: Food and Drug Association NCCN: National Comprehensive Cancer Network RCC: renal cell carcinoma 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 and may require prior authorization.
    Drug Name Dosing Regimen Dose Limit/ Maximum Dose DTC Lenvima® (lenvatinib) Nexavar® (sorafenib) Cometriq® (cabozantinib) Vitravki® (larotrectinib) Rozlytrek™ (entrectinib) Retevmo™ (selpercatinib) Gavreto™ (pralsetinib) 24 mg PO QD 400 mg PO QD 140 mg PO QD (NTRK fusion-positive):
    Adult and pediatric patients with body surface area ≥ 1.0 m2: 100 mg PO BID (NTRK fusion-positive):
    Adults: 600 mg PO QD
    Pediatrics (≥ 12 years of age) dosed by body surface area (BSA) (RET-mutant or fusion positive): Weight < 50 kg: 120 mg PO BID
    Weight ≥ 50 kg: 160 mg PO BID (RET-mutant or fusion positive):
    400 mg PO QD Keytruda® (pembrolizumab) (Tumor mutational burden-high, MSI-H or dMMR tumors):
    24 mg/day 400 mg/day 140 mg/day 200 mg/day 600 mg/day See dosing regimen 800 mg/day with coadministration of strong CYP3A inducers See dosing regimen Page 4 of 7

    CLINICAL POLICY Axitinib Drug Name Dosing Regimen Dose Limit/ Maximum Dose 200 mg IV every 3 weeks OR 400 mg every 6 weeks up to 24 months 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 None reported V. Dosage and Administration
    Indication Dosing Regimen RCC Single-agent therapy • 5 mg PO BID Maximum Dose 20 mg/day Combination therapy: • 5 mg PO BID with avelumab 800 mg every 2 weeks. • 5 mg PO BID with pembrolizumab 200 mg every 3 weeks or 400 mg every 6 weeks. VI. Product Availability
    Tablets: 1 mg, 5 mg VII.