LORBRENA, Lorlatinib Form

Lorlatinib (Lorbrena®) is a kinase inhibitor. FDA Approved Indication(s) Lorbrena is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive 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 Lorbrena 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 or ROS1 positive;
   5. If disease is ROS1 positive, failure of Rozlytrek™, Xalkori®, or Zykadia®, unless clinically significant adverse effects are experienced or all are contraindicated; *Prior authorization may be required for Rozlytrek, Xalkori and Zykadia.
2. Prescribed as a single agent;
   7. For Lorbrena requests, member must use generic lorlatinib, 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 (i and ii): i. 100 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
   Approval duration:
   Medicaid/HIM – 6 months Commercial – 12 months or duration of request, whichever is less
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   CLINICAL POLICY Lorlatinib B. Additional NCCN Recommended Uses (off-label) (must meet all):

4. Prescribed for one of the following diagnoses (a - d):
   a. Diffuse large B-cell lymphoma and (i): i. Disease is relapsed or refractory; b. Erdheim-Chester disease and (i): i. Disease is symptomatic or relapsed/refractory; c. Inflammatory myofibroblastic tumor (IMT; a soft tissue sarcoma) d. Uterine sarcoma and both (i and ii): i. Presence of IMT; ii. Disease is advanced, recurrent, metastatic, or inoperable;
5. 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 Lorbrena requests, member must use generic lorlatinib, 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 both (i and ii): i. 100 mg per day; ii. 1 tablet 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 Lorlatinib 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 Lorbrena for NSCLC and has received this medication for at least 30 days;
10. Member is responding positively to therapy;
    3. For Lorbrena requests, member must use generic lorlatinib, 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 (i and ii): i. 100 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):
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 Page 3 of 6

    CLINICAL POLICY Lorlatinib IMT: inflammatory myofibroblastic NCCN: National Comprehensive Cancer tumor Network NSCLC: non-small cell lung cancer Appendix B: Therapeutic Alternatives
    This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent and may require prior authorization.
    Drug Name Dosing Regimen Rozlytrek® (entrectinib) Zykadia® (ceritinib) Xalkori® (crizotinib) Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. 600 mg PO QD 450 mg PO QD 250 mg PO BID Dose Limit/ Maximum Dose 600 mg/day 450 mg/day 500 mg/day Appendix C: Contraindications/Boxed Warnings • Contraindication(s): concomitant use with strong CYP3A inducers • Boxed warning(s): none reported V. Dosage and Administration
    Indication ALK-positive NSCLC Dosing Regimen 100 mg PO QD Maximum Dose 100 mg/day VI. Product Availability
    Tablets: 25 mg, 100 mg VII.