CAPRELSA, Vandetanib Form

Vandetanib (Caprelsa®) is a kinase inhibitor. FDA Approved Indication(s) Caprelsa is indicated for the treatment of symptomatic or progressive medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease.
Use Caprelsa in patients with indolent, asymptomatic or slowly progressing disease only after careful consideration of the treatment related risks of Caprelsa. 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 Caprelsa is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Thyroid Cancer (must meet all):

1. Diagnosis of one of the following (a or b): a. Recurrent, persistent, unresectable, or metastatic MTC; b. Recurrent, persistent, unresectable or metastatic differentiated thyroid carcinoma (DTC; i.e., follicular, oncocytic carcinoma [Hurthle cell], or papillary thyroid carcinoma) that is not amenable to radioactive iodine therapy (off-label);
2. Prescribed by or in consultation with an oncologist;
   3. Age ≥ 18 years;
   4. If DTC, failure of Lenvima® or Nexavar® unless clinically significant adverse effects are experienced or both are contraindicated; *Prior authorization may be required for Lenvima or Nexavar
3. For Caprelsa requests, member must use generic vandetanib, if available, unless contraindicated or clinically significant adverse effects are experienced;

4. Request meets one of the following (a or b): a. Dose does not exceed 300 mg 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 Page 1 of 6

   CLINICAL POLICY Vandetanib Commercial: 12 months or duration of request, whichever is less B. Other diagnoses/indications (must meet 1 or 2):

5. 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
6. 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. Thyroid Cancer (must meet all):
7. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Caprelsa for a covered indication and has received this medication for at least 30 days;
8. Member is responding positively to therapy;
   3. For Caprelsa requests, member must use generic vandetanib, 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 300 mg 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):

9. 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 Page 2 of 6

   CLINICAL POLICY Vandetanib 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

10. 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 Administration MTC: medullary thyroid carcinoma NCCN: National Comprehensive Cancer Network 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 Lenvima (lenvatinib) Nexavar (sorafenib) 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. DTC: 24 mg PO QD DTC: 400 mg PO QD Dose Limit/ Maximum Dose 24 mg/day 400 mg/day Appendix C: Contraindications/Boxed Warnings • Contraindication(s): Congenital long QT syndrome • Boxed warning(s): QT prolongation, Torsades de pointes, sudden death V. Dosage and Administration
    Indication MTC Dosing Regimen 300 mg PO QD
    Maximum Dose 300 mg/day VI. Product Availability
    Tablets: 100 mg, 300 mg Page 3 of 6

    CLINICAL POLICY Vandetanib VII.