ERIVEDGE, Vismodegib Form

Vismodegib (Erivedge®) is a hedgehog pathway inhibitor. FDA Approved Indication(s) Erivedge is indicated for the treatment of adults with metastatic basal cell carcinoma (BCC), or with locally advanced BCC that has recurred following surgery or who are not candidates for surgery and who are not candidates for radiation. 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 Erivedge is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Basal Cell Carcinoma (must meet all):

1. Diagnosis of one of the following (a or b): a. Advanced, recurrent, or metastatic BCC that meets one of the following (i, ii, or iii): i. Member has disease that recurred following surgery; ii. Member had disease that recurred following radiation; iii. Member is not a candidate for surgery or radiation; b. Diffuse BCC formation (e.g., Gorlin syndrome or other genetic forms of multiple BCC);
2. Prescribed by or in consultation with an oncologist;
   3. Age ≥ 18 years;
   4. Erivedge is prescribed as a single agent;
   5. For Erivedge requests, member must use generic vismodegib, if available, unless contraindicated or clinically significant adverse effects are experienced;

3. Request meets one of the following (a or b): a. Dose does not exceed both of the following (i and ii):
   i. 150 mg per day; ii. 1 capsule 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 Vismodegib Approval duration:
   Medicaid/HIM – 6 months Commercial – 12 months or duration of request, whichever is less B. Medulloblastoma (off-label) (must meet all):

   1. Diagnosis of recurrent medulloblastoma;
   2. Prescribed by or in consultation with an oncologist;
   3. Age ≥ 18 years;
   4. Member has received prior chemotherapy;
   5. Tumor is positive for a sonic hedgehog mutation;
   6. Erivedge is prescribed as a single agent;
   7. For Erivedge requests, member must use generic vismodegib, 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 both of the following (i and ii):
   i. 150 mg per day; ii. 1 capsule 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. 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.
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   CLINICAL POLICY Vismodegib II. Continued Therapy A. All Indications in Section I (must meet all):

7. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Erivedge for a covered indication and has received this medication for at least 30 days;
8. Member has responded positively to therapy;
   3. For Erivedge requests, member must use generic vismodegib, 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 both of the following (i and ii): i. 150 mg day; ii. 1 capsule 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 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 BCC: basal cell carcinoma Page 3 of 6

    CLINICAL POLICY Vismodegib FDA: Food and Drug Administration NCCN: National Comprehensive Cancer Network Appendix B: Therapeutic Alternatives
    Not applicable. Appendix C: Contraindications/Boxed Warnings • Contraindication(s): none reported • Boxed warning(s): embryo-fetal toxicity
    V. Dosage and Administration
    Indication BCC Dosing Regimen 150 mg PO QD Maximum Dose 150 mg/day VI. Product Availability
    Capsule: 150 mg
    VII.