Brigatinib (Alunbrig) Form

Brigatinib (Alunbrig®) is a kinase inhibitor. FDA Approved Indication(s) Alunbrig is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)- positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
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 Alunbrig is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Non-Small Cell Lung Cancer (must meet all):

1. Diagnosis of recurrent, advanced or metastatic NSCLC;
   2. Prescribed by or in consultation with an oncologist;
   3. Age ≥ 18 years;
   4. Disease is ALK positive;
   5. Prescribed as a single agent;
   6. For Alunbrig requests, member must use generic brigatinib, 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 180 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 Commercial – 12 months or duration of request, whichever is less
   B. Additional NCCN Recommended Uses (off-label) (must meet all):

3. Prescribed for one of the following diagnoses (a - c):
   a. Erdheim-Chester disease and (i): i. Disease is symptomatic or relapsed/refractory; b. Inflammatory myofibroblastic tumor (IMT; a soft tissue sarcoma) Page 1 of 6

   CLINICAL POLICY Brigatinib c. Uterine sarcoma and both (i and ii): i. Presence of IMT; ii. Disease is advanced, recurrent, metastatic, or inoperable;

4. Prescribed by or in consultation with an oncologist or hematologist;
   
   3. Age ≥ 18 years;
   4. Disease is ALK positive;
   5. Prescribed as a single agent;
   6. For Alunbrig requests, member must use generic brigatinib, 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 180 mg per day; b. Requested 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):
6. 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
7. 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):
8. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Alunbrig for NSCLC or IMT and has received this medication for at least 30 days;

9. Member is responding positively to therapy;

   3. For Alunbrig requests, member must use generic brigatinib, if available, unless contraindicated or clinically significant adverse effects are experienced;
      Page 2 of 6

   CLINICAL POLICY Brigatinib

10. If request is for a dose increase, request meets one of the following (a or b): a. New dose does not exceed 180 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):
11. 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

12. 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 policy – 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 ALK: anaplastic lymphoma kinase FDA: Food and Drug Administration IMT: inflammatory myofibroblastic tumor
    Appendix B: Therapeutic Alternatives
    Not applicable NCCN: National Comprehensive Cancer Network NSCLC: non-small cell lung cancer Appendix C: Contraindications/Boxed Warnings None reported Page 3 of 6

    CLINICAL POLICY Brigatinib V. Dosage and Administration
    Indication ALK-positive NSCLC Dosing Regimen 90 mg PO QD for the first 7 days; then increase to 180 mg PO QD Maximum Dose 180 mg/day VI. Product Availability
    Tablets: 30 mg, 90 mg, 180 mg VII.