VOTRIENT, Pazopanib HCl Form

Pazopanib (Votrient®) is a kinase inhibitor. FDA Approved Indication(s) Votrient is indicated for the treatment of adults with: • Advanced renal cell carcinoma (RCC) • Advanced soft tissue sarcoma (STS) in patients who have received prior chemotherapy Limitation(s) of use: The efficacy of Votrient for the treatment of patients with adipocytic STS or gastrointestinal stromal tumors (GIST) has not been demonstrated. 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 Votrient is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Renal Cell Carcinoma (must meet all):

1. Diagnosis of RCC;
   2. Prescribed by or in consultation with an oncologist;
   3. Age ≥ 18 years;
   4. Disease is advanced, relapsed, stage IV, or von Hippel-Lindau (VHL)-associated;
   5. For Votrient requests, member must use pazopanib, if available, unless contraindicated or clinically significant adverse effects are experienced;

2. Request meets one of the following (a or b): a. Dose does not exceed 800 mg (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 Approval duration: Medicaid/HIM – 6 months Commercial – 12 months or duration of request, whichever is less
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   CLINICAL POLICY Pazopanib B. Soft Tissue Sarcoma (must meet all):

3. Diagnosis of STS and meets one of the following (a, b, c, or d): a. STS subtype is solitary fibrous tumor/hemangiopericytoma or alveolar soft part sarcoma; b. Member is ineligible for IV chemotherapy or is not a candidate for anthracycline- based regimens; c. If GIST subtype, failure of one or more of the following agents unless contraindicated or clinically significant adverse effects are experienced: imatinib, Qinlock™, Sutent®, Ayvakit™, Sprycel®, Stivarga®; *Prior authorization is required for imatinib, Sutent, Ayvakit and Stivarga. d. For all other STS subtypes, failure of prior chemotherapy unless contraindicated or clinically significant adverse effects are experienced;
4. Prescribed by or in consultation with an oncologist;
   3. Disease is stage IV, unresectable, advanced, or recurrent with metastases;
   4. Age ≥ 18 years;
   5. For Votrient requests, member must use pazopanib, if available, unless contraindicated or clinically significant adverse effects are experienced;
5. Request meets one of the following (a or b): a. Dose does not exceed 800 mg (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 Approval duration: Medicaid/HIM – 6 months Commercial – 12 months or duration of request, whichever is less
   C. Uterine Sarcoma (off-label) (must meet all):
6. Diagnosis of uterine sarcoma;
   2. Prescribed by or in consultation with an oncologist;
   3. Age ≥ 18 years;
   4. Disease is recurrent or metastatic;
   5. Failure of prior cytotoxic chemotherapy (hormonal therapies such as aromatase inhibitors are not considered cytotoxic);
7. For Votrient requests, member must use pazopanib, if available, unless contraindicated or clinically significant adverse effects are experienced;
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
   D. Thyroid Carcinoma (off-label) (must meet all):

9. Diagnosis of thyroid carcinoma;

   2. Prescribed by or in consultation with an oncologist;
   3. Age ≥ 18 years; Page 2 of 9

   CLINICAL POLICY Pazopanib

10. Disease is unresectable, advanced or metastatic;
    
    5. If papillary, follicular, or Hurthle cell carcinoma, disease is progressive and/or symptomatic iodine-refractory;
11. Histology meets one of the following (a or b): a. If papillary, follicular, or Hurthle cell carcinoma, failure of Lenvima® or Nexavar® unless clinically significant adverse effects are experienced or both are contraindicated;
    b. If medullary carcinoma, failure of Caprelsa® or Cabometyx® unless clinically significant adverse effects are experienced or both are contraindicated; Prior authorization is required for Lenvima, Nexavar, Caprelsa, and Cabometyx.
    7. For Votrient requests, member must use pazopanib, if available, unless contraindicated or clinically significant adverse effects are experienced;
12. 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
    E. Chondrosarcoma (off-label) (must meet all):
13. Diagnosis of metastatic or widespread chondrosarcoma;
    2. Prescribed by or in consultation with an oncologist;
    3. Age ≥ 18 years;
    4. Used as single-agent therapy;
    5. For Votrient requests, member must use pazopanib, if available, unless contraindicated or clinically significant adverse effects are experienced;
14. 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
    F. Other diagnoses/indications (must meet 1 or 2):

15. 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 9

    CLINICAL POLICY Pazopanib

16. 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):
17. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Votrient for a covered indication and has received this medication for at least 30 days;
18. Member is responding positively to therapy;
    3. For Votrient requests, member must use pazopanib, if available, unless contraindicated or clinically significant adverse effects are experienced;
    4. If request is for a dose increase, request meets one of the following (a or b): a. New dose does not exceed 800 mg (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):
19. 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

20. 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:
    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.
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    CLINICAL POLICY Pazopanib IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration
    GIST: gastrointestinal stromal tumor RCC: renal cell carcinoma STS: soft tissue sarcoma 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 STS (not GIST): regimens vary Varies Soft Tissue Sarcoma Chemotherapy agents (examples): doxorubicin, dacarbazine, ifosfamide, mesna, epirubicin, gemcitabine, docetaxel (Taxotere®), vinorelbine, Lartruvo® (olaratumab) imatinib (Gleevec®) Sutent® (sunitinib) Stivarga® (regorafenib) Ayvakit® (avapritinib) Sprycel® (dasatinib) Uterine Sarcoma Cytotoxic chemotherapy agents (examples): doxorubicin, docetaxel, gemcitabine, Lartruvo® (olaratumab) Thyroid Cancer Lenvima® (lenvatinib) GIST: 400 mg PO QD
    GIST: 50 mg PO QD 4 weeks on/2 weeks off GIST: 160 mg PO QD 21 days on/7 days off GIST: 300 mg PO QD, until disease progression GIST: 70 mg PO BID 800 mg/day 87.5 mg/day 160 mg/day 300 mg/day 140 mg/day 150 mg/day Regimens vary Varies Qinlock™ (ripretinib) GIST: 150 mg PO QD Nexavar® (sorafenib) Papillary, follicular, or Hurthle cell carcinoma: 24 mg PO QD Papillary, follicular, or Hurthle cell carcinoma: 400 mg PO BID Caprelsa® (vandetanib) Medullary carcinoma: 300 mg PO QD Cabometyx® (cabozantinib) Medullary carcinoma: 140 mg PO QD 24 mg/day 800 mg/day 300 mg/day 180 mg/day Page 5 of 9

    CLINICAL POLICY Pazopanib 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): none reported • Boxed warning(s): hepatotoxicity V. Dosage and Administration
    Indication Dosing Regimen 800 mg PO QD
    RCC, STS VI. Product Availability
    Tablet: 200 mg Maximum Dose 800 mg/day
    VII.