ODOMZO, Sonidegib Phosphate Form

Sonidegib (Odomzo®) is a hedgehog pathway inhibitor. FDA Approved Indication(s) Odomzo is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy. 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 Odomzo 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. Locally advanced or locally recurrent BCC that meets one of the following (i, ii, or iii): i. Member has disease that recurred following surgery; ii. Member has 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. Odomzo is prescribed as a single agent;
   5. For Odomzo requests, member must use generic sonidegib, 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. 200 mg per day; ii. 1 tablet 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 Sonidegib Approval duration:
   Medicaid/HIM – 6 months Commercial – 12 months or duration of request, whichever is less
   B. Other diagnoses/indications (must meet 1 or 2):

4. 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
5. 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. Basal Cell Carcinoma (must meet all):
6. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Odomzo for BCC and has received this medication for at least 30 days;
7. Member is responding positively to therapy;
   3. For Odomzo requests, member must use generic sonidegib, 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. 200 mg per day; ii. 1 tablet 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):

8. 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 5

   CLINICAL POLICY Sonidegib 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

9. 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 FDA: Food and Drug Administration NCCN: National Comprehensive Care Network Appendix B: Therapeutic Alternatives
   Not applicable Appendix C: Contraindication/Boxed Warnings • Contraindication(s): none reported • Boxed warning(s): embryo-fetal toxicity V. Dosage and Administration
   Indication BCC Dosing Regimen 200 mg PO QD Maximum Dose 200 mg/day VI. Product Availability
   Capsule: 200 mg VII.