LIBTAYO, Cemiplimab-rwlc Form

Cemiplimab-rwlc (Libtayo®) is a programmed death receptor-1 (PD-1) blocking antibody. FDA Approved Indication(s) Libtayo is indicated:
• For the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC)(mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation. • • For the treatment of patients with locally advanced or metastatic basal cell carcinoma (BCC) (laBCC or mBCC) who have been previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate. In combination with platinum-based chemotherapy for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) with no epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) or ROS1 aberrations and is locally advanced where patients are not candidates for surgical resection or definitive chemoradiation or metastatic. • As a single agent for the first-line treatment of adult patients with NSCLC whose tumors have high PD-L1 expression [Tumor Proportion Score (TPS) ≥ 50%] as determined by an FDA-approved test, with no EGFR, ALK or ROS1 aberrations, and is locally advanced where patients are not candidates for surgical resection or definitive chemoradiation or metastatic. 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 Libtayo is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Cutaneous Squamous Cell Carcinoma (must meet all):

1. Diagnosis of CSCC;

   2. Disease is metastatic or locally advanced;
   3. Prescribed by or in consultation with an oncologist;
   4. Age ≥ 18 years;
   5. Member is not a candidate for curative surgery or curative radiation;
   6. Prescribed as a single agent;
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   CLINICAL POLICY Cemiplimab-rwlc

2. Request meets one of the following (a or b): a. Dose does not exceed both of the following (i and ii): i. 350 mg every 3 weeks;
   ii. 1 vial every 3 weeks; 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 – 6 months or to the member’s renewal date, whichever is longer B. Basal Cell Carcinoma (must meet all):
3. Diagnosis of BCC;
   2. Disease is metastatic or locally advanced;
   3. Prescribed by or in consultation with an oncologist;
   4. Age ≥ 18 years;
   5. Previous treatment with a hedgehog pathway inhibitor (e.g., Erivedge®, Odomzo®), unless clinically significant adverse effects are experienced, all are contraindicated, or medical justification indicates that hedgehog pathway inhibitor therapy is not appropriate;
4. Prescribed as a single agent;
   
   7. Request meets one of the following (a or b): a. Dose does not exceed both of the following (i and ii):
      i. 350 mg every 3 weeks;
      ii. 1 vial every 3 weeks; 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 – 6 months or to the member’s renewal date, whichever is longer C. Non-Small Cell Lung Cancer (must meet all):

5. Diagnosis of NSCLC;

   2. Disease is metastatic or locally advanced where members are not candidates for surgical resection or definitive chemoradiation;
   3. Prescribed by or in consultation with an oncologist;
   4. Age ≥ 18 years;
   5. Disease is EGFR negative, ALK negative, and ROS1 negative;
   6. Prescribed in one of the following ways (a, b, or c): a. As a single agent, and one of the following (i or ii): i. Tumor has high PD-L1 expression (TPS ≥ 50%);
      ii. Tumor has PD-L1 expression < 50%, and therapy is prescribed following first-line therapy with Libtayo combination therapy (e.g., cemiplimab-rwlc, [pemetrexed or paclitaxel], and [carboplatin or cisplatin]); b. In combination with platinum-based chemotherapy (e.g., cisplatin carboplatin); Page 2 of 7

   CLINICAL POLICY Cemiplimab-rwlc c. In combination with pemetrexed as continuation maintenance therapy following first-line therapy with Libtayo combination therapy for nonsquamous cell tumors;

6. Request meets one of the following (a or b): a. Dose does not exceed both of the following (i and ii):
   i. 350 mg every 3 weeks;
   ii. 1 vial every 3 weeks;
   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 – 6 months or to the member’s renewal date, whichever is longer D. 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.
   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 Libtayo for a covered indication and has received this medication for at least 30 days;
10. Member is responding positively to therapy;
    3. For BCC or CSCC requests, member has not received more than 24 months of Libtayo therapy;

11. 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. 350 mg every 3 weeks; ii. 1 vial every 3 weeks; 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:
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    CLINICAL POLICY Cemiplimab-rwlc Medicaid/HIM – 12 months (up to a total treatment duration of 24 months for BCC or CSCC) Commercial – 6 months or to the member’s renewal date, whichever is longer (up to a total treatment duration of 24 months for BCC or CSCC) B. Other diagnoses/indications (must meet 1 or 2):

12. 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

13. 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 BCC: basal cell carcinoma
    CSCC: cutaneous squamous cell carcinoma
    EGFR: epidermal growth factor receptor FDA: Food and Drug Administration Appendix B: Therapeutic Alternatives
    Not applicable
    Appendix C: Contraindications/Boxed Warnings None reported
    la: locally advanced m: metastatic NSCLC: non-small cell lung cancer
    PD-1: programmed death receptor-1 TPS: tumor proportion score Page 4 of 7

    CLINICAL POLICY Cemiplimab-rwlc V. Dosage and Administration
    Indication BCC, CSCC NSCLC Dosing Regimen 350 mg IV over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months 350 mg IV over 30 minutes every 3 weeks until disease progression or unacceptable toxicity
    Maximum Dose See dosing regimen See dosing regimen VI. Product Availability
    Single-dose vial for injection: 350 mg/7 mL (50 mg/mL) solution VII.