BlueCross BlueShield of Tennessee Medical Policy Manual
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
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.
FDA-Approved Indications
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.
Basal Cell Carcinoma (BCC)
Libtayo is indicated for the treatment of patients with locally advanced or metastatic BCC who have been previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate.
Non-Small Cell Lung Cancer (NSCLC)
Compendial Uses
All other indications are considered experimental/investigational and not medically necessary.
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.
Submission of the following information is necessary to initiate the prior authorization review:
COVERAGE CRITERIA
Cutaneous Squamous Cell Carcinoma (CSCC)
Authorization of 6 months may be granted as single-agent neoadjuvant treatment of very high risk, locally advanced, unresectable, or regional cutaneous squamous cell carcinoma.
Authorization of 6 months may be granted for treatment of cutaneous squamous cell carcinoma when all of the following criteria are met:
Basal Cell Carcinoma (BCC)
Authorization of 6 months may be granted for single-agent treatment of 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 and when any of the following criteria are met:
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:
Vulvar Cancer
Authorization of 6 months may be granted as subsequent therapy for advanced or recurrent/metastatic vulvar cancer when the requested medication will be used as a single agent.
Cervical Cancer
Authorization of 6 months may be granted as subsequent therapy for recurrent or metastatic cervical cancer when the requested medication will be used as a single agent.
Vaginal Cancer
Authorization of 6 months may be granted as subsequent therapy for recurrent or metastatic vaginal cancer when the requested medication will be used as a single agent.
Anal Carcinoma
Authorization of 6 months may be granted as subsequent therapy for metastatic anal carcinoma when the requested medication will be used as a single agent.
Small Bowel Adenocarcinoma
Authorization of 6 months may be granted as a single agent for treatment of either of the following:
CONTINUATION OF THERAPY
Basal Cell Carcinoma or Cutaneous Squamous Cell Carcinoma
Authorization of 6 months may be granted (up to 24 months total) for continued treatment in members requesting reauthorization for treatment of basal cell carcinoma or cutaneous squamous cell carcinoma who have not experienced disease progression or an unacceptable toxicity.
All Other Indications
Authorization of 6 months may be granted for continued treatment in members requesting reauthorization for an indication listed in the coverage criteria section 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
ORIGINAL EFFECTIVE DATE: 3/2/2019
MOST RECENT REVIEW DATE: 7/31/2025
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.
This document has been classified as public information.