Cemiplimab-rwlc (Libtayo®)
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the medical policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
POLICY
I. INDICATIONS
The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.
A. FDA-Approved Indications
1. Cutaneous Squamous Cell Carcinoma (CSCC)
Libtayo is indicated for the treatment of patients with metastatic CSCC or locally advanced CSCC who are not candidates for curative surgery or curative radiation.
2. Basal Cell Carcinoma (BCC)
a. Libtayo is indicated for the treatment of patients with locally advanced BCC previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate.
b. Libtayo is indicated for the treatment of patients with metastatic BCC previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate.
3. Non-Small Cell Lung Cancer (NSCLC)
a. Libtayo, as a single agent, is indicated for the first-line treatment of adult patients with non-small cell lung cancer (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:
i. locally advanced where patients are not candidates for surgical resection or definitive chemoradiation or
ii. metastatic
b. Libtayo, in combination with platinum-based chemotherapy, is indicated for the first-line treatment of adult patients with NSCLC with no EGFR, ALK, or ROS1 aberrations and is:
i. locally advanced where patients are not candidates for surgical resection or definitive chemoradiation or
ii. metastatic
B. Compendial Uses
1. Squamous cell skin cancer
2. Basal cell skin cancer
3. Non-small cell lung cancer
All other indications are considered experimental/investigational and not medically necessary.
II. EXCLUSIONS
Coverage will not be provided for members who have experienced disease progression while on programmed death receptor-1 (PD-1) or programmed death ligand 1 (PD-L1) inhibitor therapy.
III. DOCUMENTATION
Submission of the following information is necessary to initiate the prior authorization review:
A. Documentation of programmed death ligand 1 (PD-L1) tumor expression, where applicable.
B. Documentation of molecular testing for EGFR, ALK, ROS1, BRAF, NTRK, MET, or RET genomic tumor aberrations, where applicable.
IV. CRITERIA FOR INITIAL APPROVAL
A. Cutaneous Squamous Cell Carcinoma (CSCC)
Authorization of 6 months may be granted for treatment of cutaneous squamous cell carcinoma when all of the following criteria are met:
1. The disease is one of the following:
a. Metastatic
b. Locally advanced
c. Recurrent
d. Regional and inoperable or incompletely resected
2. The member is not a candidate for curative surgery or curative radiation
3. The requested medication will be used as a single agent
B. Basal Cell Carcinoma (BCC)
Authorization of 6 months may be granted for single-agent treatment of advanced, recurrent, or metastatic basal cell carcinoma in members who have received a hedgehog pathway inhibitor (e.g., vismodegib [Erivedge], sonidegib [Odomzo]) or for whom a hedgehog pathway inhibitor is not appropriate.
C. Non-Small Cell Lung Cancer (NSCLC)
Authorization of 6 months may be granted for treatment of recurrent, advanced, or metastatic non-small cell lung cancer (NSCLC) when any of the following criteria are met:
1. The requested medication will be used as first-line therapy and the tumor does not have EGFR exon 19 deletions or L858R mutations, ALK rearrangements, or ROS1 aberrations (unless testing is not feasible due to insufficient tissue) as either:
a. A single agent for tumors with a high PD-L1 expression [Tumor Proportion Score (TPS) > 50%], or
b. In combination with platinum-based chemotherapy
2. The requested medication will be used as maintenance therapy following first-line cemiplimab-rwlc therapy and the tumor does not have EGFR exon 19 deletions or L858R mutations, ALK rearrangements, or ROS1 aberrations (unless testing is not feasible due to insufficient tissue) as either:
a. A single agent, or
b. In combination with pemetrexed
3. The requested medication will be used as subsequent therapy in combination with platinum-based chemotherapy for any of the following biomarkers:
a. BRAF V600E mutation, NTRK 1/2/3 gene fusion, MET exon 14 skipping mutation, or RET rearrangement
b. A sensitizing EGFR mutation (e.g., exon 19 deletion, exon 21 L858R, S768I, L861Q, G719X mutation) and the member has received prior therapy with an EGFR inhibitor (e.g., erlotinib, afatinib, gefitinib, osimertinib, dacomitinib)
c. An ALK rearrangement and the member has received prior therapy with an ALK inhibitor (e.g., crizotinib, ceritinib, alectinib, brigatinib, lorlatinib)
d. The member has a ROS1 rearrangement and has received prior therapy with crizotinib, entrecitinib, or ceritinib
V. CONTINUATION OF THERAPY
Authorization of 6 months may be granted for continued treatment in members requesting reauthorization for an indication listed in Section IV when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
ADDITIONAL INFORMATION
For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).
REFERENCES
1. Libtayo [package insert]. Tarrytown, NY: Regeneron Pharmaceuticals, Inc.; November 2022.
2. The NCCN Drugs & Biologics Compendium® © 2023 National Comprehensive Cancer Network, Inc. Available at: https://www.nccn.org. Accessed April 5, 2023.
ORIGINAL EFFECTIVE DATE: 3/2/2019
MOST RECENT REVIEW DATE: 1/1/2024
ID_CHS
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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