ModifiedNeighborhood Health Plan of Rhode IslandPolicy 3013

Libtayo (cemiplimab-rwlc) usage for cancer indications

Defines accepted indications, continuation criteria, exclusions, and coding for Libtayo (cemiplimab-rwlc) for Evolent-managed lines of business; includes FDA-approved and evidence-supported off-label uses and billing code J9119.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLibtayo (cemiplimab-rwlc) usage for cancer indications

Policy CodePolicy 3013

Change TypeMODIFIED

Effective Date

Next Review Date

Key ActionAll medication requests must be processed by Evolent; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

SourceLink

POLICY UPDATE CHANGES

Updated verbiage in single-agent use and in combination with platinum-based chemotherapy under NSCLC indication section (February 2024).

Converted to new Evolent guideline template (February 2025), replacing UM ONC_1089 Libtayo policy.

3Primary Covered Indications (BCC, CSCC, NSCLC)

1HCPCS drug code listed

350Single dose limit (mg)

Coverage Summary

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Coverage stance: covered_with_criteria for cemiplimab-rwlc (Libtayo). Primary covered indications include: Basal Cell Carcinoma (locally advanced, recurrent, or metastatic BCC), Cutaneous Squamous Cell Carcinoma (unresectable locally advanced or metastatic CSCC), and Non‑Small Cell Lung Cancer (locally advanced, recurrent, or metastatic NSCLC). Coverage requires adherence to the specific criteria listed for each indication (e.g., candidate status for surgery/radiation, PD‑L1 threshold and molecular testing for NSCLC, prior immune checkpoint inhibitor exclusions) and observance of continuation and exclusion rules (including the 350 mg single dose limit and continuation lapse rules). All medication requests for Libtayo must be processed and authorized by Evolent; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

Key thresholds and quick facts

PD-L1 threshold (first-line single agent NSCLC)>= 50%

Single dose limit (exclusion)350 mg

Continuation lapse window (eligibility)No lapse > 30 days within the last year

Policy number3013

Policy statusMODIFIED

Initial Therapy Criteria

Basal Cell Carcinoma - coverage criteria

Libtayo (cemiplimab-rwlc) may be used when ALL of the following are met:

ALL of the following

Member has locally advanced, recurrent, or metastatic basal cell carcinoma
Member is not a candidate for surgery and/or radiation therapy
Libtayo is used as a single agent

Cutaneous Squamous Cell Carcinoma (CSCC) - coverage criteria

Covered when ALL of the following are met:

ALL of the following

Member has unresectable locally advanced or metastatic cutaneous squamous cell carcinoma
Member is not a candidate for curative surgery and/or curative radiation
Libtayo is being used as a single agent
Member has not received prior therapy with another immune checkpoint inhibitor (e.g., pembrolizumab)

Non-Small Cell Lung Cancer (NSCLC) - coverage criteria

Covered when ALL of the following general criteria are met, then see scenario-specific rules:

ALL of the following

Member has locally advanced, recurrent, or metastatic NSCLC
Tumor is negative for actionable molecular markers ALK, EGFR, and ROS1 (ALK, EGFR, and ROS1 testing not required for squamous histology)
Member has not experienced disease progression on prior immune checkpoint inhibitor therapy (including pembrolizumab, nivolumab, atezolizumab)

First-line single agent when PD-L1 >=50%: Libtayo will be used as first-line single agent if PD-L1 is greater than or equal to 50%PD-L1 >= 50%

First-line combination with platinum-based chemotherapy

Continuation Therapy Criteria

Continuation requests for ongoing therapy

Continuation requests for a not-approvable medication shall be exempt provided ALL of the following are met:

ALL of the following

The member has not experienced disease progression on the requested medication
The requested medication was used within the last year without a lapse of more than 30 days of having an active authorizationno lapse > 30 days
Additional medication(s) are not being added to the continuation request

Exclusions and Not Covered Scenarios

Exclusions and denial-risk conditions

Exclusion - prior progression or prior ICI: Requests for Libtayo after disease progression on the same regimen or after treatment with prior immune checkpoint inhibitors (e.g., pembrolizumab, nivolumab, atezolizumab) are excluded and at risk for denial.

Exclusion - single dose limit: Dosing that exceeds single dose limit of Libtayo is an exclusion and may be denied.350 mg

Exclusion - additional meds on continuation: Additional medication(s) added to a continuation request will render the continuation exemption inapplicable.

Off-label uses of Libtayo must be supported by one of the accepted evidence sources per CMS requirements: FDA approved product labeling, CMS-recognized compendia, NCCN/ASCO clinical guidelines, or peer-reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 standards. Requests relying on insufficient or non‑generally accepted evidence (e.g., lone case reports or unpublished abstracts) are at risk for denial.

Provider Actions & Authorization Requirements

Prior Authorization

Medication request processing and authorization

All medication requests must be processed by Evolent; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

J9119

Documentation Required

Support for off-label use

Off-label use must be supported by FDA approved product labeling, CMS-recognized compendia, NCCN/ASCO clinical guidelines, or peer-reviewed literature that meets the requirements of the CMS Medicare Benefit Policy Manual Chapter 15.

Documentation Required

Molecular testing for NSCLC

For non-squamous NSCLC, documentation that the tumor is negative for actionable molecular markers ALK, EGFR, and ROS1 is required; ALK, EGFR, and ROS1 testing is not required for squamous histology.

Actionable markers: ALK, EGFR, ROS1

Denial Risk

Prior immune checkpoint inhibitor therapy exclusion

Requests for Libtayo after disease progression on the same regimen or after prior treatment with immune checkpoint inhibitors (e.g., pembrolizumab, nivolumab, atezolizumab) are excluded and at risk for denial.

Denial Risk

Dose limit enforcement

Dosing that exceeds the single dose limit of 350 mg is an exclusion and may be denied.

J9119 — threshold: 350 mg

Clinical Evidence & References

Key evidence entries for cemiplimab-rwlc (Libtayo):

• Gogishvili M et al., Nat Med. 2022 — randomized phase 3 trial of cemiplimab plus chemotherapy versus chemotherapy alone (maps to cemiplimab + platinum-based chemotherapy for first‑line NSCLC).

• Sezer A et al., phase 3 — cemiplimab monotherapy for first‑line treatment of advanced NSCLC with PD‑L1 ≥ 50% (maps to first‑line single‑agent NSCLC scenario).

• Migden MR et al., N Engl J Med. 2018 — PD‑1 blockade with cemiplimab in advanced CSCC (supports CSCC indication).

• Libtayo prescribing information, Regeneron 2024 — product labeling and dosing information (including single‑dose 350 mg limit) and FDA‑approved indications.

Background

This policy defines accepted indications for Libtayo (cemiplimab-rwlc), covering FDA‑approved uses and evidence‑supported off‑label uses, and describes continuation, exclusion, and documentation criteria. Evolent is responsible for processing all medication requests from network ordering providers and authorizing Libtayo; medications not authorized by Evolent may be deemed not approvable and not reimbursable. Accepted evidence sources include FDA approved product labeling, CMS‑recognized compendia, NCCN and ASCO clinical guidelines, or peer‑reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 requirements. The policy scope includes primary indications for basal cell carcinoma, cutaneous squamous cell carcinoma, and non‑small cell lung cancer, as well as continuation rules (no disease progression, use within the last year without a lapse > 30 days, and no added medications), exclusions (including prior immune checkpoint inhibitor therapy and dosing exceeding 350 mg per single dose), and the HCPCS drug code J9119 for billing.

Definitions (operational)

Continuation request exemptionExempt if member has no disease progression, prior use within last year without >30 day lapse of active authorization, and no additional medications added.

Actionable molecular markersALK, EGFR, and ROS1 genomic aberrations relevant to NSCLC therapy selection; testing not required for squamous histology.

Revision History

February 2025administrative

Converted to new Evolent guideline template; replaced prior policy UM ONC_1089 Libtayo (cemiplimab-rwlc).

February 2024clinical (material)

Material wording clarification: updated verbiage for single‑agent use and for use in combination with platinum‑based chemotherapy under the NSCLC indication section.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLibtayo (cemiplimab-rwlc) usage for cancer indications

Policy CodePolicy 3013

Change TypeMODIFIED

Effective Date

Next Review Date

Key ActionAll medication requests must be processed by Evolent; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

SourceLink

On This Page

OpenPayer

Libtayo (cemiplimab-rwlc) usage for cancer indications

Coverage Summary

Initial Therapy Criteria

Continuation Therapy Criteria

Exclusions and Not Covered Scenarios

Applicable Codes

Provider Actions & Authorization Requirements

Clinical Evidence & References

Background

Revision History