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Cemiplimab-rwlc (Libtayo®)
MA08.124c

Policy

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

BASAL CELL CARCINOMA (BCC)
Cemiplimab-rwlc (Libtayo) is considered medically necessary and, therefore, covered as a single-agent therapy for the treatment of adult individuals (18 years or older) with basal cell carcinoma (BCC) when one of the following indications are met:
  • The treatment of individuals with locally advanced BCC (laBCC) previously treated with a hedgehog pathway inhibitor (HHI) (e.g., vismodegib, sonidegib) or for whom an HHI is not appropriate 
  • The treatment of individuals with metastatic BCC (mBCC) previously treated with an HHI or for whom an HHI is not appropriate
  • The treatment of complicated cases of laBCC or for local recurrence if previously treated with an HHI or for whom an HHI is not appropriate if curative surgery and curative radiation therapy (RT) is not feasible for either of the following: 
    • As primary treatment 
    • Postoperative treatment if residual disease is present 
  • The treatment of individuals previously treated with an HHI or for whom an HHI is not appropriate for either of the following: 
    • Nodal or regional disease, especially if surgery and RT are not feasible 
    • Distant metastatic disease, especially if surgery and RT are not feasible
CUTANEOUS SQUAMOUS CELL CARCINOMA (CSCC)
Cemiplimab-rwlc (L​ibtayo) is considered medically necessary and, therefore, covered as a National Comprehensive Cancer Network (NCCN)-preferred single-agent therapy for the treatment of adult individuals (18 years or older) with cutaneous squamous cell carcinoma (CSCC) when one of the following indications are met:
  • The individual has complicated locally advanced CSCC (laCSCC) (i.e., a cancer that has spread from the first site to nearby tissue) or for local recurrence in which curative surgery and curative RT are not feasible for either of the following: 
    • As primary systemic treatment 
    • As postoperative systemic therapy when residual disease is present
  • The individual has unresectable, inoperable or incompletely resected regional disease, or new regional disease if curative RT is not feasible 
  • The individual has regional recurrence or distant metastases in which curative surgery or curative RT are not feasible 
  • As neoadjuvant treatment for disease that is borderline resectable, unresectable, or if surgery may carry a high morbidity​
​NON-SMALL CELL LUNG CANCER (NSCLC)
Cemiplimab-rwlc (Libtayo) is considered medically necessary and, therefore, covered for the treatment of adult individuals (18 years or older) with non-small cell lung cancer (NSCLC), with no contraindications* to Programmed Death Receptor-1 (PD-1) or PD-L1 inhibitors, and with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2 when one of the following indications are met:

  • The tumor is Programmed Death-Ligand 1 (PD-L1) expression–positive (Tumor Proportion Score [TPS] 50 percent or higher) as determined by a US Food and Drug Administration (FDA)-approved test and negative for actionable molecular biomarkers** and one of the following:
    • As a single agent as first-line treatment in an individual with both of the following: 
      • The tumor is locally advanced
      • The individual is not a candidate for surgical resection or definitive chemoradiation
    • As a single agent as first-line treatment in an individual whose tumor is metastatic 
    • As a single agent as first-line therapy (NCCN preferred) for individuals whose tumor is recurrent (including mediastinal lymph node recurrence with prior RT), advanced, or metastatic disease but excluding locoregional recurrence or symptomatic local disease
    • As a single agent as continuation maintenance therapy for individuals with both of the following:
      •  The tumor is recurrent (including mediastinal lymph node recurrence with prior RT), advanced, or metastatic disease but excluding locoregional recurrence or symptomatic local disease
      • The tumor achieved a response or stable disease following first-line therapy with cemiplimab-rwlc as monotherapy, or as part of combination therapy 
  • The tumor is PD-L1 expression–positive (TPS 1 percent or higher) as determined by a FDA-approved test and negative for actionable molecular biomarkers** and one of the following:
    • As first-line treatment for individuals whose tumor is recurrent (including mediastinal lymph node recurrence with prior RT), advanced, or metastatic disease but excluding locoregional recurrence or symptomatic local disease in one of the following regimens: 
      • In combination with paclitaxel and either carboplatin or cisplatin
      • In combination with pemetrexed and either carboplatin or cisplatin for nonsquamous cell histology
    • As continuation maintenance therapy in combination with pemetrexed for individuals with both of the following:
      • The tumor is recurrent (including mediastinal lymph node recurrence with prior RT), advanced, or metastatic disease but excluding locoregional recurrence or symptomatic local disease
      • The tumor achieved a response or stable disease following first-line therapy with cemiplimab-rwlc/pemetrexed/carboplatin or cisplatin for nonsquamous cell histology 
  • The tumor is PD-L1 expression–positive (TPS 1 to 49 percent) as determined by a FDA-approved test and negative for actionable molecular biomarkers** and both of the following: 
    • As a single agent as continuation maintenance therapy for individuals whose tumor is recurrent (including mediastinal lymph node recurrence with prior RT), advanced, or metastatic disease, but excluding locoregional recurrence or symptomatic local disease
    • The tumor achieved a response or stable disease following first-line therapy with cemiplimab-rwlc combination therapy
  • The tumor is PD-L1 expression–positive (TPS less than 1 percent) as determined by a FDA-approved test and negative for actionable molecular biomarkers** and one of the following:
    • As a single agent (if previously received first-line cemiplimab-rwlc combination therapy) as continuation maintenance therapy for individuals with both of the following: 
      • The tumor is recurrent (including mediastinal lymph node recurrence with prior RT), advanced, or metastatic disease but excluding locoregional recurrence or symptomatic local disease
      • The tumor achieved a response or stable disease following initial systemic therapy
    • In combination with pemetrexed (if previously received first-line cemiplimab-rwlc/pemetrexed/carboplatin or cisplatin) as continuation maintenance therapy for nonsquamous cell histology and both of the following: 
      • The tumor is recurrent (including mediastinal lymph node recurrence with prior RT), advanced, or metastatic disease, but excluding locoregional recurrence or symptomatic local disease
      • The tumor achieved a response or stable disease following initial systemic therapy
  • The tumor PD-L1 expression is not specified and one of the following:
    • In combination with platinum-based chemotherapy as first-line treatment in an individual with all of the following: 
      • The tumor is locally advanced
      • The individual is not a candidate for surgical resection or definitive chemoradiation
      • The tumor is negative for actionable molecular biomarkers** 
    • In combination with platinum-based chemotherapy as first-line treatment in an individual with all of the following: 
      • The tumor is metastatic
      • ​The tumor is negative for actionable molecular biomarkers**
​Cemiplimab-rwlc (Libtayo) is considered medically necessary and, therefore, covered for the initial systemic treatment of adult individuals (18 years or older) with NSCLC, with no contraindications* to PD-1 or PD-L1 inhibitors, with a PS of 0 to 1, a tumor with PD-L1 <1 percent and negative for any actionable biomarkers**, and both of the following: 
  • The tumor is recurrent (including mediastinal lymph node recurrence with prior RT), advanced, or metastatic disease, but excluding locoregional recurrence or symptomatic local disease
  • In combination with one of the following regimens:
    • Paclitaxel and either carboplatin or cisplatin
    • Pemetrexed and either carboplatin or cisplatin for nonsquamous cell histology
Cemiplimab-rwlc (Libtayo) is considered medically necessary and, therefore, covered for the treatment of adult individuals (18 years or older) with NSCLC, with no contraindications* to PD-1 or PD-L1 inhibitors, with a PS of 0 to 1, and all of the following: 
  • The tumor is recurrent (including mediastinal lymph node recurrence with prior RT), advanced, or metastatic disease, but excluding locoregional recurrence or symptomatic local disease
  • In combination with one of the following regimens:
    • Paclitaxel and either carboplatin or cisplatin
    • Pemetrexed and either carboplatin or cisplatin for nonsquamous cell histology
  • The above regimens are used for one of the following:
    • First-line therapy for EGFR exon 20 mutation–​positive tumors
    • First-line therapy for KRAS G12C mutation–positive tumors
    • First-line or subsequent therapy for BRAF V600E mutation–positive tumors
    • First-line or subsequent therapy for NTRK 1/2/3 gene fusion–positive tumors
    • First-line or subsequent therapy for MET exon 14 skipping mutation–positive tumors
    • First-line or subsequent therapy for RET rearrangement–positive tumors
    • First-line therapy for ERBB2 (HER2) mutation–positive tumors
    • Subsequent therapy for EGFR exon 19 deletion or exon 21 L858R tumors and prior erlotinib ± (ramucirumab or bevacizumab), afatinib, gefitinib, osimertinib, or dacomitinib therapy
    • Subsequent therapy for EGFR S768I, L861Q, and/or G719X mutation–positive tumors and prior afatinib, osimertinib, erlotinib, gefitinib, or dacomitinib therapy
    • Subsequent therapy for ALK rearrangement–positive tumors and prior crizotinib, ceritinib, alectinib, brigatinib, or lorlatinib therapy
    • Subsequent therapy for ROS1 rearrangement–positive tumors and prior crizotinib, entrectinib, or ceritinib therapy​ 

 * Contraindications for treatment with PD-1/PD-L1 inhibitors may include active or previously documented autoimmune disease and/or current use of immunosuppressive agents, and some oncogenic drivers (i.e., epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R ALK rearrangements) have been shown to be associated with less benefit from PD-1/PD-L1 inhibitors​.


** If there is insufficient tissue to allow testing for all of EGFR, Kirsten rat sarcoma (KRAS), anaplastic lymphoma kinase (ALK), c-ros oncogene 1 (ROS1), B-Raf Proto-Oncogene (BRAF), neurotrophic tyrosine kinase receptor (NTRK) 1/2/3, mesenchymal-epithelial transition (MET), rearranged during transfection (RET), and erythroblastic oncogene B (ERBB2) human epidermal growth factor receptor 2 (HER2), repeat biopsy and/or plasma testing should be done. If these are not feasible, treatment is guided by available results and, if unknown, these individuals​ are treated as though they do not have driver oncogenes​.

EXPERIMENTAL/INVESTIGATIONAL

All other uses for cemiplimab-rwlc (L​ibtayo) 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 P​rescription 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 Evidence of Coverage, cemiplimab-rwlc (L​ibtayo) is covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in this medical policy are met. However, services that are identified as noncovered are not eligible for coverage reimbursement by the Company.

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 (eg, light housework, 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 (L​​ibtayo) was approved by the FDA on September 28, 2018, for the treatment of individuals with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation. Supplemental approvals for cemiplimab-rwlc (Libtayo) have since been issued by the FDA. 

Refer to the cemiplimab-rwlc (Libtayo)  prescribing information for further information on FDA-approved tests for determining Programmed Death receptor-1 (PD-1), Programmed Death-Ligand 1 (PD-L1), epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), c-ros oncogene 1 (ROS1), proto-oncogene B-Raf (BRAF), neurotrophic tyrosine kinase receptor (NTRK) 1/2/3, mesenchymal-epithelial transition (MET) exon 14–​skipping mutation, and rearranged during transfection (RET) expression.​

PEDIATRIC USE

The safety and effectiveness of cemiplimab-rwlc (L​ibtayo) has not been established in pediatric individuals.

Description

In a normal immune response, the body can recognize the presence of tumors and mount a response to eradicate them. The process of eradicating a tumor begins with antigen-presenting cells that gather and process the antigens released by tumors. This activates the T cells, which proliferate and attack the tumor.

Tumors have learned to evade the normal immune response by exploiting the immune checkpoint pathway. The Programmed Death Receptor-1 (PD-1) is a checkpoint protein expressed on the membrane of activated T cells. The Programmed Death-Ligand 1 (PD-L1) and the Programmed Death-Ligand 2 (PD-L2) are checkpoint proteins expressed on tumor cells and tumor-infiltrating immune cells. When PD-L1 and PD-L2 attach to PD-1 receptors on the T cells, the T cells become inhibited and will not attack the tumor; thus, the tumor can continue to proliferate. Cemiplimab-rwlc (L​ibtayo) is a PD-L1 blocker. The drug acts by stopping the ligands from attaching to the PD-1 receptor and thus allowing the T cells to recognize the tumor and attack it.

BASAL CELL CARCINOMA (BCC)

Basal cell carcinoma (BCC) is a type of skin cancer that often develops on sun-exposed skin. BCC has a high risk for mutation. Tumors that have high mutational burdens are more likely to express immunogenic tumor neoantigens that attract effector T cells. The T cells can be more effective when PD-1 immune checkpoint inhibitors are used as part of the therapeutic regimen. The US Food and Drug Administration (FDA) approved cemiplimab-rwlc (Libtayo) for use in locally advanced BCC (laBCC) previously treated with a hedgehog pathway inhibitor (HHI) or for whom an HHI is not appropriate as well as for the treatment of individuals with metastatic BCC (mBCC) previously treated with an HHI or for whom an HHI is not appropriate under an accelerated approval based on tumor response rate and durability of response on February 9, 2021. Continued approval for mBCC may be contingent on verification and description of clinical benefit.

The efficacy of cemiplimab-rwlc (Libtayo) in 112 individuals with advanced BCC (unresectable laBCC or metastatic [nodal or distant] mBCC) who had progressed on HHI therapy, had not had an objective response after 9 months on HHI therapy, or were intolerant of prior HHI therapy was evaluated in NCT03132636, an open-label, multicenter, nonrandomized study. The study excluded individuals with autoimmune disease that required systemic therapy with immunosuppressant agents within 5 years; history of solid organ transplant; prior treatment with anti–PD-1/PD-L1 therapy or other immune checkpoint inhibitor therapy; infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C; or Eastern Cooperative Oncology Group (ECOG) performance score (PS) of 2 or greater.

Individuals received cemiplimab-rwlc (Libtayo) 350 mg every 3 weeks for up to 93 weeks until disease progression, unacceptable toxicity, or completion of planned treatment. Tumor assessments were performed every 9 weeks for the first 45 weeks of treatment and every 12 weeks thereafter. The major efficacy outcome measures were confirmed objective response rate (ORR) and duration of response (DOR) as assessed by independent central review (ICR). For individuals with mBCC 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 (laBCC and mBCC), ORR was determined by a composite endpoint that integrated ICR assessments of radiologic data (RECIST 1.1) and digital medical photography (World Health Organization [WHO] criteria).

A total of 112 individuals with advanced BCC were included in the efficacy analysis. Of these, 25 percent had mBCC and 75 percent had laBCC. In individuals with laBCC, the median age was 70 years (42 to 89 years); 67 percent were male; 68 percent were White; 61 percent had a PS 0 and 39 percent had a PS 1; 83 percent had received at least one prior cancer-related surgery; and 50 percent had received prior radiotherapy. In individuals with mBCC, the median age was 65.5 years (38 to 90 years); 82 percent were male; 79 percent were White; 57 percent had a PS 0 and 43 percent had a PS 1; 82 percent had received at least one prior cancer-related surgery; and 61 percent had received prior radiotherapy. Among individuals with mBCC, 32 percent had distant metastases only, 14 percent had nodal disease only, and 54 percent had both distant and nodal disease.

For the responding individuals, the median time to response was 3.2 months (range, 2.1 to 10.5 months) for the mBCC group and 4.2 months (range, 2.1 to 13.4 months) for the laBCC group. The ORR for the mBCC group was 21 percent and for the laBCC group was 29 percent. There were no complete responses in the mBCC group, but there were 6 percent in the laBCC group. There was a 21 percent partial response in the mBCC group and 23 percent in the laBCC group. The median DOR had not been reached.

CUTANEOUS SQUAMOUS CELL CARCINOMA (CSCC)

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.

The efficacy of cemiplimab-rwlc (L​ibtayo) in individuals with metastatic (nodal or distant) ​(mCSCC​) or locally advanced CSCC (laCSCC) who were not candidates for curative surgery or curative radiation was evaluated in two open-label, multicenter, nonrandomized, multicohort studies: Study NCT02383212 and NCT02760498. Both studies excluded individuals with autoimmune disease that required systemic therapy with immunosuppressant agents within 5 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 PS of 2 or greater.

Individuals received cemiplimab-rwlc (L​ibtayo) 3 mg/kg intravenously (IV) every 2 weeks for up to 48 weeks in Study NCT02383212 or up to 96 weeks in Study NCT02760498. Treatment continued until progression of disease, unacceptable toxicity, or completion of planned treatment. Tumor response assessments were performed every 8 weeks. The major efficacy outcome measures were confirmed ORR, as assessed by ICR and ICR-assessed DOR. For individuals with mCSCC without externally visible target lesions, ORR was determined by 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 (World Health Organization [​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 NCT02383212 and 82 individuals were enrolled in Study NCT02760498. Of these 108 individuals, 75 had mCSCC and 33 had laCSCC. The median age was 71 years (38 to 96 years); 43 percent had a PS 0 and 57 percent had a 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 mCSCC, 69 percent had distant metastases and 31 percent had only nodal metastases.

At a median follow-up of 8.9 months, the ORR was 47.2 percent; complete responses (CRs) were achieved in 3.7 percent of individuals. In the cohort of individuals with mCSCC at a median follow-up of 8.1 months, the ORR was 46.7 percent; CRs were achieved in 5.3 percent of individuals. In the cohort of individuals with laCSCC at a median follow-up 10.2 months, the ORR was 48.5 percent; there were no CRs. At the time of analysis, the overall median DOR had not been reached; however, 60 or 63 percent of individuals with metastatic or locally advanced CSCC, respectively, had durable responses of six months or more.

NON-SMALL CELL LUNG CANCER (NSCLC)

Non-small cell lung cancer can occur when cancer cells form in the tissue of the lung. The types of cancer cell that make up the category of NSCLC can be squamous cell carcinoma, large cell carcinoma, adenocarcinoma, adenosquamous carcinoma, sarcomatoid carcinoma, salivary gland carcinoma, carcinoid tumor, and unclassified carcinoma. Treatment for these cancers must be individualized based on the histology. The FDA approved cemiplimab-rwlc (Libtayo) for the first-line treatment of individuals with NSCLC whose tumors have high PD-L1 expression (Tumor Proportion Score [TPS] 50 percent or higher) as determined by an FDA-approved test, with no epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), c-ros oncogene 1 (ROS1) aberrations and is either metastatic disease or locally advanced where the individuals are not candidates for surgical resection or definitive chemoradiation on February 22, 2021.

The efficacy of cemiplimab-rwlc (Libtayo) was evaluated in NCT03088540, a randomized, multi-center, open-label, active-controlled trial in 710 individuals with locally advanced NSCLC who were not candidates for surgical resection or definitive chemoradiation, or with metastatic NSCLC.

Only individuals whose tumors had high PD-L1 expression (Tumor Proportion Score [TPS] 50 percent or greater) as determined by an immunohistochemistry assay using the PD-L1 IHC 22C3 pharmDx kit and who had not received prior systemic treatment for metastatic NSCLC were eligible. Individuals with EGFR, ALK or ROS1 genomic tumor aberrations; a medical condition that required systemic immunosuppression; autoimmune disease that required systemic therapy within two years of treatment; or who had never smoked were ineligible. Individuals with a history of brain metastases were eligible if they had been adequately treated and had neurologically returned to baseline for at least two weeks prior to randomization.

Randomization was stratified by histology (non-squamous vs squamous) and geographic region (Europe versus Asia versus Rest of world). Individuals were randomized (1:1) to receive cemiplimab-rwlc (Libtayo) 350 mg IV every three weeks for up to 108 weeks or a platinum-doublet chemotherapy regimen for four to six cycles followed by optional pemetrexed maintenance for individuals with non-squamous histology who received a pemetrexed containing regimen.

Treatment with cemiplimab-rwlc (Libtayo) continued until RECIST 1.1-defined progressive disease, unacceptable toxicity, or up to 108 weeks. Individuals who experienced ICR-assessed RECIST 1.1-defined progressive disease on cemiplimab-rwlc (Libtayo) therapy were permitted to continue treatment with cemiplimab-rwlc (Libtayo) (up to an additional 108 weeks) with the addition of four cycles of histology-specific chemotherapy until further progression was observed. Of the 203 individuals randomized to receive chemotherapy who had ICR-assessed RECIST 1.1- defined disease progression, 150 (74 percent) individuals crossed over to treatment with cemiplimab-rwlc (Libtayo). Assessment of tumor status was performed every nine weeks. The major efficacy outcome measures were overall survival (OS) and progression-free survival (PFS). An additional efficacy outcome measure was ORR.

The study population characteristics were median age of 63 years (range, 31 to 84 years), 45 percent age 65 or older; 85 percent male; 86 percent White, 11 percent Asian; and 0.6 percent Black. Nine percent were Hispanic or Latino. Twenty-seven percent had a PS 0 and 73 percent had a PS 1; 84 percent had metastatic disease and 16 percent had stage IIIB or IIIC disease and were not candidates for surgical resection or definitive chemoradiation per investigator assessment; 56 percent had nonsquamous and 44 percent had squamous histology; and 12 percent had history of treated brain metastases at baseline. The trial demonstrated a statistically significant improvement in OS and PFS for individuals randomly assigned to cemiplimab-rwlc (Libtayo) as compared with chemotherapy.​

Treatment for NSCLC with cemiplimab-rwlc (Libtayo) in combination with platinum-based chemotherapy was evaluated in a randomized, multicenter, double-blind, active-controlled trial in 466 individuals with locally advanced or metastatic NSCLC who received either cemiplimab-rwlc (Libtayo) or placebo every 3 weeks for 108 weeks. The primary endpoint was OS. Secondary endpoints included PFS and ORR.

The overall survival rate was 21.9 months in the cemiplimab-rwlc (Libtayo) cohort versus 13.0 months in the placebo cohort (P=0.0140). PFS was 8.2 months in the cemiplimab-rwlc (Libtayo) cohort versus 5.0 months in the placebo cohort (P<0.0001). ORR was 43 (2.6 complete responses, 41 partial responses) in the cemiplimab-rwlc (Libtayo) cohort versus 23 (no complete responses, 23 partial responses) in the placebo cohort (​P<0.0001). The median DOR was 15.6 months in the cemiplimab-rwlc (Libtayo) cohort versus 7.3 months in the placebo cohort.​

References

American Hospital Formulary Service (AHFS). Cemiplimab-rwlc (Libtayo®). AHFS Drug Information 2023. [LexiComp Web site]. 04/21/2023. Available at: https://online.lexi.com/lco/action/home# [via subscription only]. Accessed June 21, 2023.

Clinical trials.gov. PD-1 patients with advanced basal cell carcinoma who experienced progression of disease on hedgehog pathway inhibitor therapy, or were intolerant of prior hedgehog pathway inhibitor therapy. ClinicalTrials.gov identifier: NCT03132636. First Posted: April 28, 2017. Last Update Posted: June18, 2023. Available at: https://clinicaltrials.gov/. Accessed June 21, 2023.

Clinical trials.gov. Study of REGN 2810 compared to platinum-based chemotherapies in participants with metastatic non-small cell lung cancer (NSCLC). ClinicalTrials.gov identifier: NCT03088540. First Posted: March 23, 2017. Last Update Posted: September 21, 2022. Available at: https://clinicaltrials.gov/. Accessed June 21, 2023.

Clinical trials.gov. Study of REGN2810 (Anti-PD-1) in patients with advanced malignancies. ClinicalTrials.gov identifier: NCT02383212. First Posted: March 9, 2015. Last Update Posted: January 27, 2020. Available at: https://clinicaltrials.gov/. Accessed June 21, 2023.

Clinical trials.gov. Study of REGN2810 in patients with advanced cutaneous squamous cell carcinoma. ClinicalTrials.gov identifier: NCT02760498. First Posted: May 3, 2016. Last Update Posted January 5, 2023. Available at: https://clinicaltrials.gov/. Accessed June 21, 2023.

Elsevier's Clinical Pharmacology Compendium. Cemiplimab-rwlc (Libtayo®). [Clinical Key Web site]. 05/11/2023. Available at: https://www.clinicalkey.com/#!/ [via subscription only]. Accessed June 21, 2023.

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;4:70.

IBM Micromedex® DRUGDEX® (electronic version). Cemiplimab-rwlc (Libtayo®). [Micromedex Web site]. IBM Watson Health, Greenwood Village, Colorado, USA. 06/14/2023. Available at: https://www.micromedexsolutions.com/micromedex2/librarian [via subscription only]. Accessed June 21, 2023.

Lexi-Drugs Compendium. Cemiplimab-rwlc (Libtayo®). [LexiComp Web site]. 06/13/2023. Available at: https://online.lexi.com/lco/action/home  [via subscription only]. Accessed June 21, 2023.

Libtayo® (cemiplimab-rwlc). [prescribing information]. Regeneron Pharmaceuticals, Inc. (Tarrytown, NY), and Sanofi-Aventis. U.S. LLC (Bridgewater, NJ). [Libtayo®  Web site]. 04/2023. Available at: https://www.libtayohcp.com/. Accessed June 21, 2023.

Migden MR, Rischin D, Schmults CD, et al. PD-1 blockade with Cemiplimab in advanced cutaneous squamous-cell carcinoma. N Engl J Med. 2018;379(4):341-351.

National Cancer Institute (NCI). Non-small cell lung cancer treatment. [Cancer.gov Web site]. 02/17/2023. Available at: https://www.cancer.gov/types/lung/hp/non-small-cell-lung-treatment-pdq. Accessed June 21, 2023.

National Cancer Institute (NCI). Skin cancer treatment. [Cancer.gov Web site]. 03/02/2023. Available at: https://www.cancer.gov/types/skin/hp/skin-treatment-pdq#_177_toc. Accessed June 21, 2023.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology® - Basal cell skin cancer V1.2023. [NCCN web site]. 03/10/2023. Available at: https://www.nccn.org/professionals/physician_gls/pdf/nmsc.pdf. [via subscription only] Accessed June 21, 2023.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology® - Non-small cell lung cancer V3.2023. [NCCN Web site]. 04/13/2023. Available at: https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. [via subscription only]. Accessed June 21, 2023.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology® - Squamous cell skin cancer V1.2023. [NCCN web site]. 03/10/2023. Available at: https://www.nccn.org/professionals/physician_gls/pdf/squamous.pdf [via subscription only]. Accessed June 21, 2023.

National Comprehensive Cancer Network (NCCN). NCCN Drugs & Biologics Compendium®. [NCCN Web site]. Cemiplimab-rwlc (Libtayo®). Available at: https://www.nccn.org/professionals/drug_compendium/content/ [via subscription only]. Accessed June 21, 2023.

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.

Sezer A, Kilickap S, Gumas 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, randomized, controlled trial. Lancet. 2021;397(10274):592-604.

Stratigos AJ, Sekulic A, Peris K, et al. Cemiplimab in locally advanced basal cell carcinoma after hedgehog inhibitor therapy: an open-label, multi-centre, single-arm, phase 2 trial. Lancet Oncol. 2021;22(6):848-857.

US Food and Drug Administration (FDA).​ Center for Drug Evaluation and Research. Cemiplimab-rwlc (Libtayo®) Prescribing information. [FDA Web site]. 04/28/2023. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm. Accessed June 21, 2023.​

US Food and Drug Administration (FDA). In Vitro Diagnostics. List of cleared or approved companion diagnostic devices (in vitro and imaging tools). [FDA Web site]. 05/23/2023. Available at: ​https://www.fda.gov/medical-devices/vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-vitro-and-imaging-tools. Accessed June 21, 2023.​

Coding

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


C33Malignant neoplasm of trachea
C34.01Malignant neoplasm of right main bronchus
C34.02Malignant neoplasm of left main bronchus
C34.11Malignant neoplasm of upper lobe, right bronchus or lung
C34.12Malignant neoplasm of upper lobe, left bronchus or lung
C34.2Malignant neoplasm of middle lobe, bronchus or lung
C34.31Malignant neoplasm of lower lobe, right bronchus or lung
C34.32Malignant neoplasm of lower lobe, left bronchus or lung
C34.81Malignant neoplasm of overlapping sites of right bronchus and lung
C34.82Malignant neoplasm of overlapping sites of left bronchus and lung
C34.91Malignant neoplasm of unspecified part of right bronchus or lung
C34.92Malignant neoplasm of unspecified part of left bronchus or lung
C44.01Basal cell carcinoma of skin of lip
C44.02Squamous cell carcinoma of skin of lip
C44.1121Basal cell carcinoma of skin of right upper eyelid, including canthus
C44.1122Basal cell carcinoma of skin of right lower eyelid, including canthus
C44.1191Basal cell carcinoma of skin of left upper eyelid, including canthus
C44.1192Basal cell carcinoma of skin of left lower eyelid, including canthus
C44.1221Squamous cell carcinoma of skin of right upper eyelid, including canthus
C44.1222Squamous cell carcinoma of skin of right lower eyelid, including canthus
C44.1291Squamous cell carcinoma of skin of left upper eyelid, including canthus
C44.1292Squamous cell carcinoma of skin of left lower eyelid, including canthus
C44.212Basal cell carcinoma of skin of right ear and external auricular canal
C44.219Basal cell carcinoma of skin of left ear and external auricular canal
C44.222Squamous cell carcinoma of skin of right ear and external auricular canal
C44.229Squamous cell carcinoma of skin of left ear and external auricular canal
C44.310Basal cell carcinoma of skin of unspecified parts of face
C44.311Basal cell carcinoma of skin of nose
C44.319Basal cell carcinoma of skin of other parts of face
C44.320Squamous cell carcinoma of skin of unspecified parts of face
C44.321Squamous cell carcinoma of skin of nose
C44.329Squamous cell carcinoma of skin of other parts of face
C44.41Basal cell carcinoma of skin of scalp and neck
C44.42Squamous cell carcinoma of skin of scalp and neck
C44.510Basal cell carcinoma of anal skin
C44.511Basal cell carcinoma of skin of breast
C44.519Basal cell carcinoma of skin of other part of trunk
C44.520Squamous cell carcinoma of anal skin
C44.521Squamous cell carcinoma of skin of breast
C44.529Squamous cell carcinoma of skin of other part of trunk
C44.612Basal cell carcinoma of skin of right upper limb, including shoulder
C44.619Basal cell carcinoma of skin of left upper limb, including shoulder
C44.622Squamous cell carcinoma of skin of right upper limb, including shoulder
C44.629Squamous cell carcinoma of skin of left upper limb, including shoulder
C44.712Basal cell carcinoma of skin of right lower limb, including hip
C44.719Basal cell carcinoma of skin of left lower limb, including hip
C44.722Squamous cell carcinoma of skin of right lower limb, including hip
C44.729​Squamous cell carcinoma of skin of left lower limb, including hip
C44.81Basal cell carcinoma of ​overlapping sites of skin
C44.82Squamous cell carcinoma of overlapping sites of skin
C44.91Basal cell carcinoma of skin, unspecified
C44.92Squamous cell carcinoma of skin, unspecified

HCPCS Level II Code Number(s)

J9119 Injection, cemiplimab-rwlc, 1 mg​

Revenue Code Number(s)
N/A



Coding and Billing Requirements

Policy History

Revisions From MA08.124c:
08/14/2023
This version of the policy will become effective 08/14/2023.

The following policy criteria have been revised in accordance with National Comprehensive Cancer Network (NCCN) compendium (accessed October 16, 2022) and guidelines:

Non-small cell lung cancer (V3.2023; 04/13/2023)
Squamous cell skin cancer (V1.2023; 03/10/2023)​

Revisions From ​MA08.124b:
12/19/2022
This version of the policy will become effective 12/19/2022.

The following policy criteria have been revised in accordance with National Comprehensive Cancer Network (NCCN) compendium (accessed October 16, 2022) and guidelines:
Basal cell skin cancer (V2.2022; 03/24/2022)
Non-small cell lung cancer (V5.2022; 09/26/2022)
Squamous cell skin cancer (V2.2022; 05/02/2022)

The following policy criterion has been added ​in accordance with US Food and Drug Administration (FDA) labeling (11/08/2022):
​Use in combination with platinum-based chemotherapy for non-small cell lung cancer​

The following ICD-10 codes have been removed:
C34.00, C34.10, C34.30, C34.80, C34.90, C44.111, C44.121, C44.211, C44.221, C44.611, C44.621, C44.711, C44.721, C87.89​

Revisions From MA08.124a:
01/03/2022
This version of the policy will become effective 01/03/2022.

The following criteria have been added to this policy in accordance with US Food and Drug Administration (FDA) labeling (02/22/2021) and National Comprehensive Cancer Network (NCCN) compendium (accessed 09/15/2021) and guidelines:
Basal cell skin cancer (V2.2021; 02/25/2021)
Non-small cell lung cancer (V5.2021; 06/15/2021)

The following policy criteria have been revised in accordance with FDA and NCCN compendium and guideline criteria:
Cutaneous squamous cell carcinoma (V2.2021; 08/16/2021)

The following ICD-10 codes have been ​added to this policy:​

C33, C34.00, C34.01, C34.02, C34.10, C34.11, C34.12, C34.2, C34.30, C34.31, C34.32, C34.80, C34.81, C34.82, C34.90, C34.91, C34.92, C44.01, C44.111, C44.1121, C44.1122, C44.1191, C44.1192, C44.211, C44.212, C44.219, C44.310, C44.311, C44.319, C44.41, C44.510, C44.511, C44.519, C44.611, C44.612, C44.619, C44.711, C44.712, C44.719, C44.81, C44.91, Q87.89​


Revisions From MA08.124:
07/20/2020This version of the policy will become effective 07/20/2020.

The following new policy has been developed to communicate the Company’s coverage criteria for cemiplimab-rwlc (LIBTAYO®).
8/14/2023
8/14/2023
MA08.124
Medical Policy Bulletin
Medicare Advantage
No
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