|61755-0008-XX Libtayo 350 MG/7ML SOLN (REGENERON PHARMACEUTICALS)|
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.
Cemiplimab-rwlc for the treatment of cutaneous squamous cell carcinoma (CSCC) is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Cemiplimab-rwlc for the treatment of other conditions/diseases is considered investigational.
Cemiplimab-rwlc is considered medically appropriate if ALL of the following:
Individual is 18 years of age or older
Individual has NOT received ANY ONE of the following therapies:
A programmed death (PD-1/PD-L1)-directed therapy (e.g., avelumab, pembrolizumab, atezolizumab, durvalumab, nivolumab, etc.) unless otherwise specified
A BRAF-inhibitor (e.g., vemurafenib, dabrafenib, encorafenib, etc.)
A small-molecule inhibitor (phosphatidylinositol-3 kinase inhibitor [PI3-K]) therapy (e.g., idelalisib, duvelisib, etc.)
A cytotoxic T-lymphocyte antigen 4 (CTLA-4) targeting agent (e.g., ipilimumab, etc.) within the immediate 4 weeks prior to therapy
Diagnosis of Cutaneous Squamous Cell Carcinoma (CSCC) if ALL of the following:
Used as a single-agent therapy
Is not a candidate for curative surgery or radiation therapy
Individual has ANY ONE of the following:
Locally advanced disease
Nodal or distant metastatic disease
Cemiplimab-rwlc is considered medically appropriate for renewal if ALL of the following criteria are met:
Individual continues to meet approval criteria
Absence of unacceptable toxicity from the drug, e.g., severe infusion reactions, severe immune-mediated adverse reactions such as pneumonitis, colitis, hepatitis, endocrinopathies, nephritis/renal dysfunction, rash, encephalitis, etc.
Tumor response with stabilization of disease or decrease in size of tumor or tumor spread
|INDICATION(S)||DOSAGE & ADMINISTRATION|
|Cutaneous Squamous Cell Carcinoma (CSCC)||
The recommended dosage is 350 mg administered 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
Refer to DOSAGE LIMITS below
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.
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..
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).
Lexicomp Online. (2019, February). AHFS DI. Cemiplimab-rwlc. Retrieved April 26, 2019 from Lexicomp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Evaluations. (2018, October). Cemiplimab-rwlc. Retrieved April 26, 2019 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2018). NCCN Drugs & Biologics Compendium®. Cemiplimab-rwlc. Retrieved November 6, 2018 from the National Comprehensive Cancer Network.
U. S. Food and Drug Administration. (2018, September). Center for Drug Evaluation and Research. Libtayo® (cemiplimab-rwlc) injection, for intravenous use. Retrieved April 26, 2019 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761097s000lbl.pdf.
ORIGINAL EFFECTIVE DATE: 3/2/2019
MOST RECENT REVIEW DATE: 6/11/2019
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.
This document has been classified as public information.
Maximum billable units per dose and over time by indication as a Medical Benefit; 1 billable unit = 1 mg