Alectinib (Alecensa) Form

Alectinib (Alecensa®) is a tyrosine kinase inhibitor that targets the activity of anaplastic lymphoma kinase. FDA Approved Indication(s) Alecensa is indicated for the treatment of 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 Alecensa 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 Alecensa requests, member must use generic alectinib, 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 1,200 mg (8 capsules) 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
   B. Additional NCCN Recommended Uses (off-label) (must meet all):

3. Prescribed for one of the following diagnoses (a - d):
   a. Anaplastic large cell lymphoma; b. Diffuse large B-cell lymphoma and (i): Page 1 of 6

   CLINICAL POLICY Alectinib i. Disease is relapsed or refractory; c. Erdheim-Chester disease and (i): i. Disease is symptomatic or relapsed/refractory; d. Uterine sarcoma and both (i and ii): i. Presence of inflammatory myofibroblastic tumor; 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 anaplastic large cell lymphoma: Member meets one of the following (a or b): a. Treatment is palliative; b. Treatment is subsequent therapy for relapsed or refractory disease;
5. For Alecensa requests, member must use generic alectinib, if available, unless contraindicated or clinically significant adverse effects are experienced;
6. Request meets one of the following (a or b): a. Dose does not exceed 1,200 mg (8 capsules) 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):
7. 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

8. 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 Alectinib II. Continued Therapy A. All Indications in Section I (must meet all):

9. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Alecensa for NSCLC and has received this medication for at least 30 days;
10. Member is responding positively to therapy;
    3. For Alecensa requests, member must use generic alectinib, 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 1,200 mg (8 capsules) 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 – 6 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 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 ALK: anaplastic lymphoma kinase FDA: Food and Drug Administration NSCLC: non-small cell lung cancer Page 3 of 6

    Appendix B: Therapeutic Alternatives Not applicable Appendix C: Contraindications/Boxed Warnings None reported V. Dosage and Administration Indication ALK-positive NSCLC Dosing Regimen 600 mg PO BID Maximum Dose 1,200 mg/day VI. Product Availability Capsule: 150 mg
    VII.