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Libtayo® (cemiplimab-rwlc)

Policy Number: VP-0398

Intravenous

 

Last Review Date: 12/07/2023

Date of Origin: 10/30/2018

Dates Reviewed: 11/2018, 03/2019, 06/2019, 09/2019, 12/2019, 03/2020, 6/2020, 12/2020, 03/2021, 06/2021, 09/2021, 12/2021, 03/2022, 06/2022, 09/2022, 12/2022, 03/2023, 06/2023, 09/2023, 12/2023

FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill.

  1. Length of Authorization Δ 1,12,14

Coverage will be provided for 6 months and may be renewed, unless otherwise specified.

  • Neoadjuvant therapy in Cutaneous Squamous Cell Carcinoma (cSCC) can be authorized up to a maximum of 4 doses and cannot be renewed.
  • Treatment for metastatic, locally advanced, or recurrent cSCC, Vulvar Cancer and Basal Cell Carcinoma (BCC) can be renewed up to a maximum of twenty-four (24) months of therapy (35 doses).
  • Treatment for recurrent or metastatic Cervical Cancer can be authorized up to a maximum of ninety-six (96) weeks of therapy (32 doses).
  1. Dosing Limits
  1. Quantity Limit (max daily dose) [NDC Unit]:
  • Libtayo 350 mg/7 mL single-dose vial: 1 vial per 21 days
  1. Max Units (per dose and over time) [HCPCS Unit]:

All Indications –

    • 350 billable units (350 mg) every 21 days
  1. Initial Approval Criteria 1

Coverage is provided for the following conditions:

  • Patient is at least 18 years of age; AND

Universal Criteria 1

  • Patient has not received previous therapy with a programmed death (PD-1/PD-L1)-directed therapy (e.g., avelumab, pembrolizumab, atezolizumab, durvalumab, nivolumab, dostarlimab, nivolumab/relatlimab-rmbw, retifanlimab etc.), unless otherwise specified Δ;

Cutaneous Squamous Cell Carcinoma (cSCC) 1-5,8,12

  • Used as a single agent; AND
    • Patient has metastatic, locally advanced, or recurrent disease Δ; AND
      • Patient is not a candidate for curative surgery or curative radiation therapy; OR
    • Used as neoadjuvant therapy; AND
      • Patient has borderline resectable disease, unresectable disease, or surgery may carry a high morbidity

Cervical Cancer ‡ 2,14

  • Used as a single agent as subsequent therapy; AND
  • Patient has recurrent or metastatic disease Δ

Basal Cell Carcinoma (BCC) 1,2,6,9,13

  • Used as a single agent; AND
    • Patient has locally advanced or metastatic disease Δ; OR
    • Patient has nodal disease and surgery is not feasible Δ

Non-Small Cell Lung Cancer (NSCLC) 1,2,7,10,15,16

  • Patient has recurrent, advanced, or metastatic disease (excluding locoregional recurrence or symptomatic local disease with no evidence of disseminated disease) or mediastinal lymph node recurrence with prior radiation therapy; AND
    • Used in combination with platinumbased chemotherapy (e.g., paclitaxel and either carboplatin or cisplatin OR pemetrexed and either carboplatin or cisplatin); AND
        • Used as first-line therapy for one of the following:
        • Patients with a performance status (PS) 0-1 who have tumors that are negative for actionable molecular biomarkers* and PD-L1 expression <1%
        • Patients with a PS 0-1 who are positive for one of the following molecular biomarkers: EGFR exon 20, KRAS G12C, BRAF V600E, NTRK1/2/3 gene fusion, MET exon 14 skipping, RET rearrangement, or ERBB2 (HER2)
        • PD-L1 expression-positive (PD-L1 ≥1%) tumors that are negative for actionable molecular biomarkers*; OR
        • Used as subsequent therapy for one of the following:
        • Patients with a PS 0-1 who are positive for one of the following molecular biomarkers and have received prior targeted therapy§: EGFR exon 19 deletion or exon 21 L858R tumors, EGFR S768I, L861Q, and/or G719X, ALK rearrangement, or ROS1 rearrangement
        • Patients with a PS 0-1 who are positive for one of the following molecular biomarkers: BRAF V600E, NTRK1/2/3 gene fusion, MET exon 14 skipping, or RET rearrangement; OR
    • Used in combination with pemetrexed; AND
      • Used as continuation maintenance therapy in patients who have achieved a tumor response or stable disease after first-line therapy with cemiplimab, pemetrexed, and either carboplatin or cisplatin for non-squamous cell histology; OR
    • Used as a single agent; AND
      • Patient has tumors that are negative for actionable molecular biomarkers* and high PD-L1 expression (Tumor Proportion Score [TPS] ≥ 50%) as determined by an FDA-approved or CLIA compliant testv; AND
        • Used as first-line therapy ; OR
        • Used as continuation maintenance therapy in patients who achieved a tumor response or stable disease after first-line therapy with cemiplimab as monotherapy or as part of combination therapy; OR
      • Patient has tumors with PD-L1 expression <1% or ≥1%-49%; AND
        • Used as continuation maintenance therapy in patients who have achieved a tumor response or stable disease following initial therapy with cemiplimab combination therapy

Vulvar Cancer ‡ 2,4

  • Used as a single agent as subsequent therapy; AND
  • Patient has advanced or recurrent/metastatic disease Δ

* Note: Actionable molecular genomic biomarkers include EGFR, KRAS, ALK, ROS1, BRAF, NTRK1/2/3, MET exon 14 skipping mutation, RET rearrangement and ERBB2 (HER2). If there is insufficient tissue to allow testing for all of EGFR, KRAS, ALK, ROS1, BRAF, NTRK1/2/3, MET, RET, and ERBB2 (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 patients are treated as though they do not have driver oncogenes.

v If confirmed using an FDA approved assay – http://www.fda.gov/companiondiagnostics

FDA Approved Indication(s); Compendia Recommended Indication(s); Ф Orphan Drug

§ Genomic Aberration/Mutational Driver Targeted Therapies

(Note: not all inclusive, refer to guidelines for appropriate use)

Sensitizing EGFR mutation-positive tumors

ALK rearrangement-positive tumors

ROS1 rearrangement-positive tumors

BRAF V600E-mutation positive tumors

NTRK1/2/3 gene fusion positive tumors

  • Afatinib
  • Erlotinib
  • Dacomitinib
  • Gefitinib
  • Osimertinib
  • Amivantamab

(exon-20 insertion)

  • Alectinib
  • Brigatinib
  • Ceritinib
  • Crizotinib
  • Lorlatinib
  • Ceritinib
  • Crizotinib 
  • Entrectinib
  • Lorlatinib
  • Dabrafenib ± trametinib
  • Encorafenib + binimetinib
  • Vemurafenib
  • Larotrectinib
  • Entrectinib

PD-L1 tumor expression ≥ 1%

MET exon-14 skipping mutations

RET rearrangement-positive tumors

KRAS G12C mutation positive tumors

ERBB2 (HER2) mutation positive tumors

  • Pembrolizumab
  • Atezolizumab
  • Nivolumab + ipilimumab
  • Cemiplimab
  • Tremelimumab + durvalumab
  • Capmatinib
  • Crizotinib
  • Tepotinib
  • Selpercatinib
  • Cabozantinib
  • Pralsetinib
  • Sotorasib
  • Adagrasib
  • Fam-trastuzumab deruxtecan-nxki
  • Ado-trastuzumab emtansine
  1. Renewal Criteria Δ 1,12

Coverage may be renewed based on the following criteria:

  • Patient continues to meet the universal and other indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in section III; AND
  • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: severe infusion-related reactions, severe and fatal immune-mediated adverse reactions (e.g., pneumonitis, colitis, hepatitis, endocrinopathies, nephritis with renal dysfunction, dermatologic adverse reactions, etc.), complications of allogeneic hematopoietic stem cell transplantation (HSCT), etc.; AND
  • Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread; AND

Non-Small Cell Lung Cancer (continuation maintenance therapy):

  • Refer to Section III for criteria

Cutaneous Squamous Cell Carcinoma (cSCC) (neoadjuvant therapy):

  • Coverage may not be renewed

Cutaneous Squamous Cell Carcinoma (cSCC) (metastatic, locally advanced, or recurrent disease)

  • Patient has not exceeded a maximum of twenty-four (24) months of therapy

Cervical Cancer

  • Patient has not exceeded a maximum of ninety-six (96) weeks of therapy

Basal Cell Carcinoma

  • Patient has not exceeded a maximum of twenty-four (24) months of therapy

Vulvar Cancer

  • Patient has not exceeded a maximum of twenty-four (24) months of therapy

 

Δ Notes:

  • Patients responding to therapy who relapse ≥ 6 months after discontinuation due to duration are eligible to re-initiate PD-directed therapy.
  • Patients previously presenting with aggressive disease who are exhibiting stable disease on treatment as their best response (or if therapy improved performance status) may be eligible for continued therapy without interruption or discontinuation.
  • Patients who complete adjuvant therapy and progress ≥ 6 months after discontinuation are eligible to re-initiate PD-directed therapy for metastatic disease.
  • Patients whose tumors, upon re-biopsy, demonstrate a change in actionable mutation (e.g., MSS initial biopsy; MSI-H subsequent biopsy) may be eligible to re-initiate PD-directed therapy and will be evaluated on a case-by-case basis.

  1. Dosage/Administration Δ 1,12

Indication

Dose

cSCC

Metastatic, locally advanced, or recurrent disease:

Administer 350 mg intravenously every 3 weeks for up to a maximum of 24 months in patients without disease progression or unacceptable toxicity

Neoadjuvant therapy:

Administer 350 mg intravenously every 3 weeks for up to 4 doses in patients without disease progression or unacceptable toxicity

Cervical Cancer

Administer 350 mg intravenously every 3 weeks up to a maximum of 96 weeks in patients without disease progression or unacceptable toxicity

BCC

Administer 350 mg intravenously every 3 weeks up to a maximum of 24 months in patients without disease progression or unacceptable toxicity

NSCLC

Administer 350 mg intravenously every 3 weeks until disease progression or unacceptable toxicity

Vulvar Cancer

Administer 350 mg intravenously every 3 weeks for up to a maximum of 24 months in patients without disease progression or unacceptable toxicity

  1.  Billing Code/Availability Information

HCPCS Code:

  • J9119 − Injection, cemiplimab-rwlc, 1 mg; 1 billable units = 1 mg

NDC:

  • Libtayo 350 mg/7 mL single-dose vial: 61755-0008-xx
  1. References
  1. Libtayo [package insert]. Tarrytown, NY; Regeneron Pharmaceuticals; April 2023. Accessed October 2023.
  2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) cemiplimab-rwlc. National Comprehensive Cancer Network, 2023.  The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed October 2023.
  3. 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 Nov 15;4:70. doi: 10.1186/s40425-016-0176-3. eCollection 2016.
  4. Migden MR, Rischin D, Schmults CD, et al. PD-1 Blockade with Cemiplimab in Advanced Cutaneous Squamous-Cell Carcinoma. N Engl J Med. 2018 Jul 26;379(4):341-351. doi: 10.1056/NEJMoa1805131. Epub 2018 Jun 4.
  5. Migden MR, Khushalani NI, Chang ALS, et al. Cemiplimab in locally advanced cutaneous squamous cell carcinoma: results from an open-label, phase 2, single-arm trial. Lancet Oncol. 2020 Feb;21(2):294-305. doi: 10.1016/S1470-2045(19)30728-4. Epub 2020 Jan 14.
  6. Lewis KD, Fury MG, Stankevich, et al. Phase II study of cemiplimab, a human monoclonal anti-PD-1, in patients with advanced basal cell carcinoma (BCC) who experienced progression of disease on, or were intolerant of prior hedgehog pathway inhibitor (HHI) therapy. Annals of Oncology. 2018 Oct 01; Volume 29, Supplement 8,VII440.
  7. Sezer A, Kilickap S, Gümüş 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, randomised, controlled trial. Lancet. 2021 Feb 13;397(10274):592-604.
  8. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Squamous Cell Skin Cancer. Version 3.2023. National Comprehensive Cancer Network, 2023. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed October 2023.
  9. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Basal Cell Skin Cancer. Version 2.2024. National Comprehensive Cancer Network, 2023. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed October 2023.
  10. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Non-Small Cell Lung Cancer. Version 5.2023. National Comprehensive Cancer Network, 2023. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed November 2023.
  11. Gogishvili M, Melkadze T, Makharadze T, et al. LBA51 EMPOWER-Lung 3: Cemiplimab in combination with platinum doublet chemotherapy for first-line (1L) treatment of advanced non-small cell lung cancer (NSCLC). Annals of Oncology, ISSN: 0923-7534, Vol: 32, SUPPLEMENT 5, S1328, SEPTEMBER 01, 2021. DOI10.1016/j.annonc.2021.08.2130.
  12. Gross N, Miller D, Khushalani N, et al. Neoadjuvant Cemiplimab for Stage II to IV Cutaneous Squamous-Cell Carcinoma N Engl J Med 2022; 387:1557-1568. doi: 10.1056/NEJMoa2209813
  13. Stratigos AJ, Sekulic A, Peris K, et al. Cemiplimab in locally advanced basal cell carcinoma after hedgehog inhibitor therapy: an open-label, multicentre, single-arm, phase 2 trial. Lancet Oncol 2021;22:848-857.
  14. Tewari KS, Monk BJ, Vergote I, et al. Survival with Cemiplimab in Recurrent Cervical Cancer. N Engl J Med 2022;386:544-555.
  15. Gogishvili M, Melkadze T, Makharadze T, et al. Cemiplimab plus chemotherapy versus chemotherapy alone in non-small cell lung cancer: a randomized, controlled, double-blind phase 3 trial. Nat Med. 2022 Nov;28(11):2374-2380. doi: 10.1038/s41591-022-01977-y. Epub 2022 Aug 25. PMID: 36008722; PMCID: PMC9671806.
  16. Özgüroğlu M, Kilickap S, Sezer A, et al. First-line cemiplimab monotherapy and continued cemiplimab beyond progression plus chemotherapy for advanced non-small-cell lung cancer with PD-L1 50% or more (EMPOWER-Lung 1): 35-month follow-up from a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol 2023; 24: 989–1001.

Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

C33

Malignant neoplasm of trachea

C34.00

Malignant neoplasm of unspecified main bronchus

C34.01

Malignant neoplasm of right main bronchus

C34.02

Malignant neoplasm of left main bronchus

C34.10

Malignant neoplasm of upper lobe, unspecified bronchus or lung

C34.11

Malignant neoplasm of upper lobe, right bronchus or lung

C34.12

Malignant neoplasm of upper lobe, left bronchus or lung

C34.2

Malignant neoplasm of middle lobe, bronchus or lung

C34.30

Malignant neoplasm of lower lobe, unspecified bronchus or lung

C34.31

Malignant neoplasm of lower lobe, right bronchus or lung

C34.32

Malignant neoplasm of lower lobe, left bronchus or lung

C34.80

Malignant neoplasm of overlapping sites of unspecified bronchus and lung

C34.81

Malignant neoplasm of overlapping sites of right bronchus and lung

C34.82

Malignant neoplasm of overlapping sites of left bronchus and lung

C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

C44.01

Basal cell carcinoma of skin of lip

C44.02

Squamous cell carcinoma of skin of lip

C44.111

Basal cell carcinoma of skin of unspecified eyelid, including canthus

C44.1121

Basal cell carcinoma of skin of right upper eyelid, including canthus

C44.1122

Basal cell carcinoma of skin of right lower eyelid, including canthus

C44.1191

Basal cell carcinoma of skin of left upper eyelid, including canthus

C44.1192

Basal cell carcinoma of skin of left lower eyelid, including canthus

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

C44.211

Basal cell carcinoma of skin of unspecified ear and external auricular canal

C44.212

Basal cell carcinoma of skin of right ear and external auricular canal

C44.219

Basal cell carcinoma of skin of left ear and external auricular canal

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

C44.310

Basal cell carcinoma of skin of unspecified parts of face

C44.311           

Basal cell carcinoma of skin of nose

C44.319

Basal cell carcinoma of skin of other parts of face

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

C44.41

Basal cell carcinoma of skin of scalp and neck

C44.42

Squamous cell carcinoma of skin of scalp and neck

C44.510

Basal cell carcinoma of anal skin

C44.511

Basal cell carcinoma of skin of breast

C44.519

Basal cell carcinoma of skin of other part of trunk

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

C44.611

Basal cell carcinoma of skin of unspecified upper limb, including shoulder

C44.612

Basal cell carcinoma of skin of right upper limb, including shoulder

C44.619

Basal cell carcinoma of skin of left upper limb, including shoulder

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

C44.711

Basal cell carcinoma of skin of unspecified lower limb, including hip

C44.712

Basal cell carcinoma of skin of right lower limb, including hip

C44.719

Basal cell carcinoma of skin of left lower limb, including hip

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

C44.81

Basal cell carcinoma of overlapping sites of skin

C44.82

Squamous cell carcinoma of overlapping sites of skin

C44.91

Basal cell carcinoma of skin, unspecified

C44.92

Squamous cell carcinoma of skin, unspecified

C51.0

Malignant neoplasm of labium majus

C51.1

Malignant neoplasm of labium minus

C51.2

Malignant neoplasm of clitoris

C51.8

Malignant neoplasm of overlapping sites of vulva

C51.9

Malignant neoplasm of vulva, unspecified

C53.0

Malignant neoplasm of endocervix

C53.1

Malignant neoplasm of exocervix

C53.8

Malignant neoplasm of overlapping sites of cervix uteri

C53.9

Malignant neoplasm of cervix uteri, unspecified

Z85.118

Personal history of other malignant neoplasm of bronchus and lung

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications may be covered at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A

Medicare Part B Administrative Contractor (MAC) Jurisdictions

Jurisdiction

Applicable State/US Territory

Contractor

E (1)

CA, HI, NV, AS, GU, CNMI

Noridian Healthcare Solutions, LLC

F (2 & 3)

AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ

Noridian Healthcare Solutions, LLC

5

KS, NE, IA, MO

Wisconsin Physicians Service Insurance Corp (WPS)

6

MN, WI, IL

National Government Services, Inc. (NGS)

H (4 & 7)

LA, AR, MS, TX, OK, CO, NM

Novitas Solutions, Inc.

8

MI, IN

Wisconsin Physicians Service Insurance Corp (WPS)

N (9)

FL, PR, VI

First Coast Service Options, Inc.

J (10)

TN, GA, AL

Palmetto GBA, LLC

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA, LLC

L (12)

DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA)

Novitas Solutions, Inc.

K (13 & 14)

NY, CT, MA, RI, VT, ME, NH

National Government Services, Inc. (NGS)

15

KY, OH

CGS Administrators, LLC

 

 

 

 

LIBTAYO® (cemiplimab-rwlc) Prior Auth Criteria
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