Commercial

Cemiplimab-rwlc (LIBTAYO®)
08.01.66


Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract. The Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition.

MEDICALLY NECESSARY

Cemiplimab-rwlc (LIBTAYO®) is considered medically necessary and, therefore, covered as a (NCCN-preferred) single-agent therapy for the treatment of adult individuals (18 years or older) with cutaneous squamous cell carcinoma (CSCC) and Eastern Cooperative Oncology Group (ECOG) performance status ≤1, when one of the following indications are met:
  • The individual has locally advanced (i.e., a cancer that has spread from the first site to nearby tissue), high risk CSCC in which curative surgery and curative radiation therapy are not feasible and any of the following scenarios:
    • As primary treatment for non-surgical candidates
    • After surgery with positive margins
    • When residual disease is present and further surgery is not feasible
  • The individual has regional disease (i.e., a cancer that has spread to nearby tissue but not to distant sites) that is inoperable or incompletely resected and curative radiation therapy is not feasible
  • The individual has regional recurrence or distant metastases in which curative surgery and curative radiation therapy are not feasible

EXPERIMENTAL/INVESTIGATIONAL

All other uses for cemiplimab-rwlc (LIBTAYO®) are considered experimental/investigational and, therefore, not covered unless the indication is supported as an accepted off-label use, as defined in the Company medical policy on off-label coverage for prescription drugs and biologics.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the drug.

Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, cemiplimab-rwlc (LIBTAYO®) is covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.

THE EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG) PERFORMANCE STATUS

The Eastern Cooperative Oncology Group (ECOG), established in 1955, was one of the first groups to coordinate multicenter cancer clinical trials. The National Cancer Institute (NCI) is the primary funding source, and ECOG has evolved from a small consortium of institutions in the eastern United States to one of the largest clinical cancer research organizations in the country. As part of their work in the treatment of cancer, ECOG has developed the ECOG Performance Status (EPS), originally published in 1982 in the American Journal of Clinical Oncology. The use of the scales and the criteria in the EPS allows clinicians and researchers to determine an individual’s disease progression in terms of how the activities of daily living (ADL) are affected.
ECOG Performance Status
Grade
ECOG
0
Fully active, able to carry on all pre-disease performance without restriction
1
Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (e.g., light house work, office work)
2
Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50 percent of waking hours
3
Capable of only limited self care, confined to bed or chair more than 50 percent of waking hours
4
Completely disabled. Cannot carry on any self care: Totally confined to bed or chair
5
Dead
Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol.1982;5(6):649-655.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

Cemiplimab-rwlc (LIBTAYO®) was approved by the FDA on September 28, 2018 for the treatment of individuals with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.

PEDIATRIC USE

The safety and effectiveness of cemiplimab-rwlc (LIBTAYO®) has not been established in pediatric individuals.

Description

Cutaneous squamous cell carcinoma (CSCC) is a type of skin cancer arising from the uncontrolled growth of cells in the upper layers of the skin, often characterized by a presence of persistent scaly patches, open sores, warts and elevated growths with a central depression, which may crust and bleed. The most common causes of CSCC are long-term exposure to ultraviolet (UV) radiation from sunlight and the use of indoor tanning. However, it can also be caused by skin injuries such as scars, long-standing sores, burns, ulcers, chronic infections, skin inflammation and X-ray exposure.

Cemiplimab-rwlc (LIBTAYO®) is a monoclonal antibody that belongs to a class of drugs that binds to the programmed death receptor-1 (PD-1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response with the potential for breaking of peripheral tolerance and induction of immune-mediated adverse reactions.

The efficacy of cemiplimab-rwlc (LIBTAYO®) in individuals with metastatic (nodal or distant) cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who were not candidates for curative surgery or curative radiation was evaluated in two open-label, multi-center, non-randomized, multicohort studies: Study 1423 (NCT02383212) and 1540 (NCT02760498). Both studies excluded individuals with autoimmune disease that required systemic therapy with immunosuppressant agents within five years; history of solid organ transplant; prior treatment with anti–PD-1/PD-L1 blocking antibodies or other immune checkpoint inhibitor therapy; infection with HIV, hepatitis B or hepatitis C; or ECOG performance score (PS) of 2 or greater.

Individuals received cemiplimab-rwlc (LIBTAYO®) 3 mg/kg intravenously every two weeks for up to 48 weeks in Study 1423 or up to 96 weeks in Study 1540. Treatment continued until progression of disease, unacceptable toxicity, or completion of planned treatment. Tumor response assessments were performed every eight weeks. The major efficacy outcome measures were confirmed objective response rate (ORR), as assessed by independent central review (ICR) and ICR-assessed duration of response. For individuals with metastatic CSCC without externally visible target lesions, ORR was determined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1). For individuals with externally visible target lesions (locally advanced and metastatic CSCC), ORR was determined by a composite endpoint that integrated ICR assessments of radiologic data (RECIST 1.1) and digital medical photography (WHO criteria). The efficacy analysis was conducted when all individuals had the opportunity for at least six months of follow-up.

A total of 26 individuals with CSCC were enrolled in Study 1423 and 82 individuals were enrolled in Study 1540. Of these 108 individuals, 75 had metastatic CSCC and 33 had locally advanced CSCC. The median age was 71 years (38 to 96 years); 43 percent had ECOG PS 0 and 57 percent had ECOG PS 1; 50 percent received at least one prior anti-cancer systemic therapy; 96 percent received prior cancer-related surgery; and 79 percent received prior radiotherapy. Among individuals with metastatic CSCC, 69 percent had distant metastases and 31 percent had only nodal metastases.

At a median follow-up of 8.9 months, the objective response rate was 47.2 percent; complete responses were achieved in 3.7 percent of individuals. In the cohort of individuals with metastatic cutaneous squamous cell carcinoma at a median follow-up of 8.1 months, the objective response rate was 46.7 percent; complete responses were achieved in 5.3 percent of individuals. In the cohort of individuals with locally advanced cutaneous squamous cell carcinoma at a median follow-up 10.2 months, the objective response rate was 48.5 percent; there were no complete responses. At the time of analysis, the overall median duration of response had not been reached; however, 60 or 63 percent of individuals with metastatic or locally advanced cutaneous squamous cell carcinoma, respectively, had durable responses of six months or more.


References

American Hospital Formulary Service (AHFS). cemiplimab-rwlc (LIBTAYO®). AHFS Drug Information 2020. [Lexicomp Web site]. 03/04/2020. Available at: http://online.lexi.com/lco/action/doc/retrieve/docid/complete_ashp/6726027?cesid=aUlOAHlUktZ&searchUrl=%2Flco%2Faction%2Fsearch%3Fq%3Dcemiplimab%2520rwlc%26t%3Dname%26va%3Dcemiplimab%2520rwlc [via subscription only]. Accessed June 01, 2020.

Elsevier's Clinical Pharmacology Compendium. cemiplimab-rwlc (LIBTAYO®) [ Clinical Key Web site]. 10/08/2018. Available at: https://www.clinicalkey.com/#!/content/drug_monograph/6-s2.0-5103?scrollTo=%23Indications [via subscription only]. Accessed June 01, 2020.

LIBTAYO® (cemiplimab-rwlc) injection full U.S. prescribing information. Regeneron Pharmaceuticals, Inc., and sanofi-aventis U.S. LLC. [Libtayo Web site]. February 2020. Available at:
https://www.libtayohcp.com/accessinglibtayo/productsupport . Accessed June 01, 2020.

Micromedex® Healthcare Series. cemiplimab-rwlc (LIBTAYO®). [Micromedex® Web site]. 12/06/2019. Available at: http://www.micromedex.com [via subscription only]. Accessed June 01, 2020.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology. Squamous cell skin cancer. Version 1.2020. [NCCN web site]. 10/02/2019. Available at:
https://www.nccn.org/professionals/physician_gls/pdf/squamous.pdf. Accessed June 01, 2020.

National Comprehensive Cancer Network (NCCN). NCCN Drugs & Biologics Compendium.cemiplimab-rwlc (LIBTAYO®). [NCCN Web site]. 1.2020. Available at: https://www.nccn.org/professionals/drug_compendium/content/ [via subscription only]. Accessed June 01, 2020.

National Comprehensive Cancer Network (NCCN). Patient and caregiver resources. Dictionary. [NCCN Web site]. 2020. Available at: https://www.nccn.org/patients/resources/dictionary/default.aspx. Accessed June 01, 2020.

National Institutes of Health. Clinical trials: A first-in-human study of repeat dosing with REGN2810, a monoclonal, fully human antibody to programmed death - 1 (PD-1), as single therapy and in combination with other anti-cancer therapies in patients with advanced malignancies (NCT02383212). [ClinicalTrials Web site]. last updated 01/27/2020. Available at:
https://clinicaltrials.gov/ct2/show/NCT02383212. Accessed June 01, 2020.

National Institutes of Health. Clinical trials: A Phase 2 Study of REGN2810, a Fully Human Monoclonal Antibody to Programmed Death-1 (PD-1), in Patients With Advanced Cutaneous Squamous Cell Carcinoma (NCT02760498). [ClinicalTrials Web site]. last updated 05/20/2020. Available at:
https://clinicaltrials.gov/ct2/show/record/NCT02760498. Accessed June 01, 2020.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Drugs @FDA. Prescribing information. cemiplimab-rwlc (LIBTAYO®). [FDA Web site]. 03/20/2019. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761097s001lbl.pdf. Accessed June 01, 2020.


Coding

CPT Procedure Code Number(s)

ICD - 10 Procedure Code Number(s)
N/A

ICD - 10 Diagnosis Code Number(s)

C44.02 Squamous cell carcinoma of skin of lip
C44.121 Squamous cell carcinoma of skin of unspecified eyelid, including canthus
C44.1221 Squamous cell carcinoma of skin of right upper eyelid, including canthus
C44.1222 Squamous cell carcinoma of skin of right lower eyelid, including canthus
C44.1291 Squamous cell carcinoma of skin of left upper eyelid, including canthus
C44.1292 Squamous cell carcinoma of skin of left lower eyelid, including canthus
C44.221 Squamous cell carcinoma of skin of unspecified ear and external auricular canal
C44.222 Squamous cell carcinoma of skin of right ear and external auricular canal
C44.229 Squamous cell carcinoma of skin of left ear and external auricular canal
C44.320 Squamous cell carcinoma of skin of unspecified parts of face
C44.321 Squamous cell carcinoma of skin of nose
C44.329 Squamous cell carcinoma of skin of other parts of face
C44.42 Squamous cell carcinoma of skin of scalp and neck
C44.520 Squamous cell carcinoma of anal skin
C44.521 Squamous cell carcinoma of skin of breast
C44.529 Squamous cell carcinoma of skin of other part of trunk
C44.621 Squamous cell carcinoma of skin of unspecified upper limb, including shoulder
C44.622 Squamous cell carcinoma of skin of right upper limb, including shoulder
C44.629 Squamous cell carcinoma of skin of left upper limb, including shoulder
C44.721 Squamous cell carcinoma of skin of unspecified lower limb, including hip
C44.722 Squamous cell carcinoma of skin of right lower limb, including hip
C44.729 Squamous cell carcinoma of skin of left lower limb, including hip
C44.82 Squamous cell carcinoma of overlapping sites of skin
C44.92 Squamous cell carcinoma of skin, unspecified

HCPCS Level II Code Number(s)
J9119 Injection, cemiplimab-rwlc, 1 mg

Revenue Code Number(s)



Coding and Billing Requirements


Policy History

7/20/2020
7/20/2020
 
08.01.66
Medical Policy Bulletin
Commercial
No