Subject:
Cemiplimab-rwlc (Libtayo)
Description:
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IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
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LIBTAYO is a programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.
The efficacy of LIBTAYO was evaluated in two open-label, multi-center, non-randomized, multi-cohort studies: Study 1423 (NCT02383212) and 1540 (NCT02760498). Both studies excluded patients 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 ECOG performance score (PS) ≥ 2. Patients received LIBTAYO 3 mg/kg intravenously every 2 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 8 weeks. The major efficacy outcome measure was confirmed objective response rate (ORR), as assessed by independent central review (ICR) and ICR-assessed duration of response. For patients with metastatic CSCC without externally visible target lesions, ORR was determined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1). For patients 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 patients had the opportunity for at least 6 months of follow-up.
A total of 26 patients with CSCC were enrolled in Study 1423 and 82 patients were enrolled in Study 1540. Of these 108 patients, 75 had metastatic CSCC and 33 had locally advanced CSCC. The median age was 71 years (38 to 96 years); 85% were male; 97% were White; 43% had ECOG PS 0 and 57% had ECOG PS 1; 50% received at least one prior anti-cancer systemic therapy; 96% received prior cancer-related surgery; and 79% received prior radiotherapy. Among patients with metastatic CSCC, 69% had distant metastases and 31% had only nodal metastases
In the combined CSCC population, the objective response rate was 47.2% (95 CI 37.5 – 57.1). Partial response rate was 43.5% while complete response rate was only 3.7%. The duration of response ranges between 1 to 15.2 months, with 61% of the studied population showed a sustained duration of response of at least 6 months.
Policy:
1. Cemiplimab-rwlc (Libtayo) is medically necessary for the following FDA approved indication(s) when ALL of the following criteria are met:
a. Treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation
i. Member must be 18 years of age or older
ii. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
iii. Negative pregnancy test prior to therapy initiation. Females of reproductive potential should use effective contraception during treatment and for at least 4 months after the last dose.
iv. Member does not have any of the following:
1. Significant autoimmune disease that requires systemic immunosuppressive treatment in the past 5 years
2. Prior treatment with an agent that blocks the programmed death-1/ programmed death-ligand 1 (PD-1/PD-L1 pathway) such as nivolumab (Opdivo), pembrolizumab (Keytruda), atezolizumab (Tecentriq), avelumab (Bavencio), or durvalumab (Imfinzi)
3. Prior treatment with BRAF inhibitor such as dabrafenib (Tafinlar), encorafenib (Braftovi), or vemurafenib (Zelboraf)
4. Prior treatment with idelalisib
5. Prior treatment with other immune modulating agents within fewer than 4 weeks prior to therapy initiation (i.e. CTLA-4, ipilimumab (Yervoy)
6. Active CNS metastases that require management with systemic corticosteroids for within 4 weeks of therapy initiation. Members with stable CNS metastases (defined by no evidence of progression by imaging for at least 6 weeks prior to therapy initiation) may be eligible
7. Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to therapy initiation
8. Infection with HIV and/or chronic/active infection with hepatitis B or hepatitis C virus
9. History of solid organ transplant
v. The prescriber is a specialist in the area of the patient’s diagnosis (e.g. oncologist ) or has consulted with a specialist in the area of the patient’s diagnosis
2. When cemiplimab-rwlc (Libtayo) is medically necessary, initial therapy will be approved for 6 months at the FDA recommended dosage of:
- Metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC
- 350 mg as an intravenous infusion over 30 minutes every 3 weeks
[INFORMATIONAL NOTE:
Withhold or discontinue Libtayo to manage adverse reactions as described in Table 1. No dose reduction of Libtayo is recommended.
Table 1: Recommended Dosage Modifications for Adverse Reactions
3. Cemiplimab-rwlc (Libtayo) is medically necessary for annual approval if the patient meets the following criteria:
- Tumor response with stabilization of disease or decrease in tumor spread; AND
- Absence of unacceptable toxicity, including but not limited to immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, and other immune-mediated reactions.
4. Cemiplimab-rwlc (Libtayo) is considered medically necessary for off-label indications that have in effect a rating of ‘Category 1’ or ‘Category 2A’ in the current recommendations in the National Comprehensive Cancer Network (NCCN) compendium. Refer to National Comprehensive Cancer Network: Drugs and Biologics Compendium - Cemiplimab-rwlc. Available at: https://www.nccn.org/professionals/drug_compendium/content/
5. Other uses of cemiplimab-rwlc (Libtayo) are considered investigational.
Medicaid Coverage:
For Horizon NJ Health members, please follow this link for the corresponding HNJH drug policy https://services3.horizon-bcbsnj.com/ddn/NJhealthWeb.nsf
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Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
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Index:
Cemiplimab-rwlc (Libtayo)
Libtayo (Cemiplimab-rwlc)
References:
1. Libtayo (cemiplimab-rwlc) Prescribing Information. Regeneron. Tarrytown, New York. March 2019.
2. Clinicaltrials.gov. Study of REGN2810 in patients with advanced cutaneous squamous cell carcinoma. Available at https://clinicaltrials.gov/ct2/show/NCT02760498
3. ClinicalTrials.gov. Study of REGN 2810 (anti-PD-1) in Patients with Advanced Malignancies. Available at https://clinicaltrials.gov/ct2/show/NCT02383212
4. National Comprehensive Cancer Network: Drugs and Biologics Compendium. Carfilzomib-rwlc. 2020. Available at http://www.nccn.org/professionals/drug_compendium/MatrixGenerator/Matrix.aspx?AID=385. [Accessed May 31, 2020].
5. MICROMEDEX® 2.0 (Healthcare Series). DRUGDEX® Evaluations. Cemiplimab-rwlc. Available at: http://www.thomsonhc.com. November 4, 2018.
6. ClinicalTrials.gov. Libtayo Available at https://clinicaltrials.gov/ct2/results?cond=&term=libtayo&cntry=&state=&city=&dist=
Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)
CPT*
HCPCS
J9119
* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association
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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.
The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
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