Cobimetinib (Cotellic) Form

Cobimetinib (Cotellic®) is a kinase inhibitor. FDA Approved Indication(s) Cotellic is indicated: • For the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib. • As a single agent for the treatment of adult patients with histiocytic neoplasms 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 Cotellic is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Melanoma (must meet all):

1. Diagnosis of melanoma with BRAF V600E or V600K mutation;
   2. Disease is for treatment of one of the following (a, b, or c):
      a. Unresectable or metastatic melanoma;
      b. Stage III melanoma as adjuvant therapy;
      c. Limited resectable melanoma;
2. Prescribed by or in consultation with an oncologist;
   4. Age ≥ 18 years;
   5. Prescribed in combination with Zelboraf®;Prior authorization may be required.
3. Member has unacceptable toxicities to Tafinlar®/Mekinist®, or Tafinlar/Mekinist are not appropriate for the member on the basis of agent side-effect profiles;
   
   7. For Cotellic requests, member must use cobimetinib, 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) for the first 21 days of each 28-day cycle: i. 60 mg per day;
   ii. 3 tablets per day;
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   CLINICAL POLICY Cobimetinib 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
   B. Histiocytic Neoplasms (must meet all):

5. Diagnosis of one of the following histiocytic neoplasms (a, b, c, d, or e ): a. Langerhans cell histiocytosis (LCH); b. Rosai-Dorfman disease; c. Erdheim-Chester disease (ECD) d. Xanthogranuloma e. Mixed histiocytosis;
6. Prescribed by or in consultation with an oncologist or hematologist;
   3. Age ≥ 18 years;
   4. Prescribed as a single agent;
   5. Disease is characterized as one of the following (a, b, or c): a. Multi-system; b. Recurrent or refractory;
      c. Single system and unlikely to benefit from conventional therapies;
7. If disease is positive for a BRAF mutation, member has documentation of one of the following (a or b): a. BRAF V600E mutation, and unable to access a BRAF inhibitor or prior treatment with a BRAF inhibitor has been discontinued due to intolerable side effects or toxicity; b. BRAF-mutated ECD or LCH, and disease has progressed on BRAF inhibitor therapy;
8. For Cotellic requests, member must use cobimetinib, if available, unless contraindicated or clinically significant adverse effects are experienced;
9. Request meets one of the following (a or b): a. Dose does not exceed both of the following (i and ii) for the first 21 days of each 28-day cycle: i. 60 mg per day; ii. 3 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. Central Nervous System Cancers (off-label) (must meet all):

10. Diagnosis of one of the following (a, b, c, or d): a. Adult low-grade glioma (World Health Organization [WHO] grade 1); b. Recurrent WHO Grade 2 or 3 adult oligodendroglioma (IDH-mutant, 1p19q codeleted); Page 2 of 7

    CLINICAL POLICY Cobimetinib c. Recurrent adult IDH-mutant astrocytoma (WHO grade 2, 3, or 4);
    d. Glioblastoma;

11. Prescribed by or in consultation with an oncologist;
    3. Age ≥ 18 years;
    4. Disease is positive for the BRAF V600E mutation;
    5. Prescribed in combination with Zelboraf;Prior authorization may be required.
12. For Cotellic requests, member must use cobimetinib, if available, unless contraindicated or clinically significant adverse effects are experienced;
13. Request meets one of the following (a or b): a. Dose does not exceed both of the following (I and ii) for the first 21 days of each 28-day cycle: i. 60 mg per day; ii. 3 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 D. Other diagnoses/indications
14. 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
15. 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):
16. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Cotellic for a covered indication and has received this medication for at least 30 days;

17. Member is responding positively to therapy;

    3. For Cotellic requests, member must use cobimetinib, if available, unless contraindicated or clinically significant adverse effects are experienced;
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    CLINICAL POLICY Cobimetinib

18. Request meets one of the following (a or b): a. Dose does not exceed both of the following (I and ii) for the first 21 days of each 28-day cycle: i. 60 mg per day; ii. 3 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 – 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:
    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;
    B. Treatment of melanoma in patients with wild type BRAF gene.
    IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key BRAF: B-Raf proto-oncogene serine/threonine kinase ECD: Erdheim-Chester disease Appendix B: Therapeutic Alternatives
    Not applicable FDA: Food and Drug Administration LCH: Langerhans cell histiocytosis WHO: World Health Organization Page 4 of 7

    CLINICAL POLICY Cobimetinib Appendix C: Contraindications/Boxed Warnings None reported V. Dosage and Administration
    Indication Melanoma, histiocytic neoplasms Dosing Regimen 60 mg (three tablets) PO QD for 21 days, then off for 7 days (28-day cycle) Maximum Dose 60 mg/day VI. Product Availability
    Tablet: 20 mg VII.