BlueCross BlueShield of Tennessee Medical Policy Manual

Cemiplimab-rwlc (Libtayo®)

NDC CODE(S)

61755-0008-XX LIBTAYO 350MG/7ML Solution (REGENERON PHARMACEUTICALS)

DESCRIPTION

Cemiplimab-rwlc is a recombinant human immunoglobulin G4 (IgG4) monoclonal antibody that binds to PD-1 and blocks its interaction with PD-L1 and PD-L2.  This releases the PD-1 pathway mediated inhibition of the immune response, including the anti-tumor immune response through inhibition of active T-cell immune surveillance of tumors.  Binding to and blocking PD-1 activity inhibits T-cell proliferation and cytokine production, resulting in decreased tumor growth.

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL CRITERIA

Universal Criteria

Cutaneous Squamous Cell Carcinoma (CSCC)

Basal Cell Carcinoma (BCC)

Non-Small Cell Lung Cancer (NSCLC)

* If confirmed using an immunotherapy assay-http://www.fda.gov/companiondiagnostics

RENEWAL CRITERIA

DOSAGE/ADMINISTRATION

INDICATION

DOSE

All indications

Administer 350 mg as an intravenous infusion every 3 weeks, until disease progression or unacceptable toxicity.

LENGTH OF AUTHORIZATION

Coverage will be provided for six months and may be renewed.

DOSING LIMITS

Max Units (per dose and over time) [HCPCS Unit]:

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.

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, the express terms of the health plan will govern..

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).

SOURCES

1.     Libtayo [package insert]. Tarrytown, NY; Regeneron Pharmaceuticals; February 2021. Accessed February 2021.

2.     Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) cemiplimab. National Comprehensive Cancer Network, 2021. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed February 2021.

3.     Falchook GS, Leidner R, Stankevich E, et al. Responses of metastatic basal cell and cutaneous squamous cell carcinomas to anti-PD1 monoclonal antibody REGN2810. J Immunother Cancer. 2016 Nov 15;4:70. doi: 10.1186/s40425-016-0176-3. eCollection 2016.

4.     Migden MR, Rischin D, Schmults CD, et al. PD-1 Blockade with Cemiplimab in Advanced Cutaneous Squamous-Cell Carcinoma. N Engl J Med. 2018 Jul 26;379(4):341-351. doi: 10.1056/NEJMoa1805131. Epub 2018 Jun 4.

5.     Migden MR, Khushalani NI, Chang ALS, et al. Cemiplimab in locally advanced cutaneous squamous cell carcinoma: results from an open-label, phase 2, single-arm trial. Lancet Oncol. 2020 Feb;21(2):294-305. doi: 10.1016/S1470-2045(19)30728-4. Epub 2020 Jan 14.

6.     Lewis KD, Fury MG, Stankevich, et al. Phase II study of cemiplimab, a human monoclonal anti-PD-1, in patients with advanced basal cell carcinoma (BCC) who experienced progression of disease on, or were intolerant of prior hedgehog pathway inhibitor (HHI) therapy. Annals of Oncology. 2018 Oct 01; Volume 29, Supplement 8,VII440.

7.     Sezer A, Kilickap S, Gümüş M, et al. Cemiplimab monotherapy for first-line treatment of advanced non-small-cell lung cancer with PD-L1 of at least 50%: a multicentre, open-label, global, phase 3, randomised, controlled trial. Lancet. 2021 Feb 13;397(10274):592-604.

8.     Lexicomp Online. (2021, February). AHFS DI. Cemiplimab-rwlc. Retrieved March 4, 2021 from Lexicomp Online with AHFS.

9.     MICROMEDEX Healthcare Series. Drugdex Evaluations. (2021, February). Cemiplimab-rwlc. Retrieved March 4, 2021 from MICROMEDEX Healthcare Series.

ORIGINAL EFFECTIVE DATE: 3/2/2019

MOST RECENT REVIEW DATE:    6/30/2021

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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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