CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Libtayo (cemiplimab‑rwlc) — Coverage Criteria

Defines accepted indications, coverage conditions, exclusions, and coding for Libtayo (cemiplimab‑rwlc) for members of the payer lines of business; applies to prior authorization and utilization management of medication requests processed by Evolent.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLibtayo (cemiplimab‑rwlc) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionPrior authorization is required and Evolent processes medication requests; continuation requests may be exempt if member has not progressed, prior authorization lapsed ≤30 days, and no additional medications are added.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3tumor types with explicit coverage criteria (BCC, CSCC, NSCLC)

J9119single HCPCS code listed for billing

350 mgsingle dose maximum cited in exclusions

Commercial, Medicaid, Exchangeapplicable lines of business

Coverage Criteria for Libtayo (cemiplimab-rwlc)

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Basal Cell Carcinoma

Covered when ALL of the following are met for Basal Cell Carcinoma:

BCC coverage: Member has locally advanced, recurrent, or metastatic basal cell carcinoma and is not a candidate for surgery and/or radiation therapy; Libtayo (cemiplimab-rwlc) is being used as a single agent.

Cutaneous Squamous Cell Carcinoma

Covered when ALL of the following are met for Cutaneous Squamous Cell Carcinoma (CSCC):

CSCC coverage: Member has unresectable locally advanced or metastatic cutaneous squamous cell carcinoma and is not a candidate for curative surgery and/or curative radiation; Libtayo (cemiplimab-rwlc) 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

Covered when ALL of the following are met for Non-Small Cell Lung Cancer (NSCLC):

NSCLC baseline requirements: Member has locally advanced, recurrent, or metastatic NSCLC and is negative for actionable molecular markers ALK, EGFR, and ROS1 (testing not required for squamous histology); member has not experienced disease progression on prior immune checkpoint inhibitor therapy (e.g., pembrolizumab, nivolumab, atezolizumab).

NSCLC first-line options: Libtayo (cemiplimab-rwlc) will be used as first-line single-agent therapy when tumor PD-L1 expression is greater than or equal to 50%.PD-L1 ≥ 50%

NSCLC chemo combination: Libtayo may be used in combination with platinum-based chemotherapy for first-line treatment of adult members with NSCLC without EGFR/ALK/ROS1 genomic aberrations in either: (a) locally advanced disease not a candidate for surgical resection and not a candidate for definitive chemoradiation, or (b) metastatic NSCLC.

Requests for Libtayo (cemiplimab-rwlc) should be denied or considered not medically necessary when any of the exclusion conditions apply. Specifically, coverage is not supported if the medication is being used after disease progression on the same regimen or after prior treatment with an immune checkpoint inhibitor (for example, pembrolizumab, nivolumab, or atezolizumab). Additionally, dosing that exceeds a single dose of 350 mg is outside the covered parameters and may trigger denial. Providers should confirm prior therapy history and ensure dosing does not surpass the 350 mg single-dose limit before submitting an authorization request.

Off-label or investigational uses of Libtayo (cemiplimab-rwlc) that lack sufficient supporting evidence are excluded from coverage. Sufficient evidence is defined in the policy by accepted sources and study quality: coverage requires support from CMS-recognized compendia or acceptable peer-reviewed literature. The policy highlights that evidence assessment should consider whether the patient and regimen are represented in the published data, whether outcomes are clinically meaningful (ASCO-recommended thresholds such as hazard ratio < 0.80 or survival benefits of at least 3 months for OS/PFS), and whether study design and size are appropriate. Case reports, meeting abstracts without full peer-reviewed publication, or inadequately powered uncontrolled data generally do not meet the threshold for coverage.

Permitted Regimens and Line of Therapy

first-line

First-line NSCLC: Single-agent cemiplimab for PD-L1 ≥50% OR cemiplimab plus platinum-based chemotherapy for first-line treatment in specified NSCLC scenarios.

Regimen	Indication / Criteria	Coverage
Cemiplimab monotherapy	First-line treatment of locally advanced, recurrent, or metastatic non-small cell lung cancer (NSCLC) when tumor PD-L1 ≥ 50%; member is negative for actionable molecular markers ALK, EGFR, and ROS1 (not required for squamous histology) and has not experienced disease progression on prior immune checkpoint inhibitor therapy.	Covered

Regimen	Indication / Criteria	Coverage
Cemiplimab in combination with platinum-based chemotherapy	First-line treatment of adult members with locally advanced (not candidate for resection/definitive chemoradiation) or metastatic NSCLC who are negative for EGFR, ALK, and ROS1 genomic aberrations (ALK, EGFR, and ROS-1 not required for squamous histology) and have not experienced disease progression on prior immune checkpoint inhibitor therapy.	Covered

Regimen	Indication / Criteria	Coverage
Cemiplimab monotherapy	Locally advanced, recurrent, or metastatic basal cell carcinoma in members who are not candidates for surgery and/or radiation; or unresectable locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC) in members who are not candidates for curative surgery and/or curative radiation and who have not received prior therapy with another immune checkpoint inhibitor (e.g., pembrolizumab).	Covered

Biomarker and Molecular Testing Requirements

ALK — negative status

RequirementALK must be negative for NSCLC (not required for squamous histology).

ContextApplies to members with locally advanced, recurrent, or metastatic NSCLC being considered for Libtayo.

Source guidanceNegative ALK status is one of the actionable molecular marker requirements for NSCLC.

EGFR — negative status

RequirementEGFR must be negative for NSCLC (not required for squamous histology).

ContextRequired as part of molecular testing before using Libtayo for NSCLC in the specified indications.

Source guidanceNegative EGFR status is one of the actionable molecular marker requirements for NSCLC.

ROS1 — negative status

RequirementROS1 (ROS-1) must be negative for NSCLC (not required for squamous histology).

ContextPart of the actionable molecular marker panel required before Libtayo use in NSCLC per policy.

Source guidanceNegative ROS-1 status is listed with ALK and EGFR as required molecular exclusions for NSCLC.

PD-L1 — threshold requirement

ThresholdPD-L1 expression must be ≥ 50% for single-agent first-line Libtayo in NSCLC.

ContextThis threshold enables use of Libtayo as first-line monotherapy for PD-L1 high tumors.

SpecificationApplies to first-line therapy decision when considering cemiplimab as a single agent.

Actionable molecular markers and squamous histology exception

Actionable markersPolicy requires negative ALK, EGFR, and ROS-1 for NSCLC; these markers are not required for squamous histology.

Squamous histology exceptionALK, EGFR, and ROS-1 testing is not required when NSCLC is of squamous histology.

Clinical implicationNegative results for these markers support using Libtayo as monotherapy or in combination per the coverage criteria.

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Evolent processes all medication requests from network ordering providers; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

Evolent is responsible for processing all medication requests from network ordering providers.
Medications not authorized by Evolent may be deemed not approvable and therefore not reimbursable.

Prior Authorization

Continuation Request Rules

Continuation requests for a not-approvable medication may be exempt when the continuation criteria are met. Requests for continuation must show no disease progression on the requested medication, use within the last year without a lapse >30 days of active authorization, and that no additional medications are being added to the request.

Member has not experienced disease progression on the requested medication.
Requested medication was used within the last year without a lapse of more than 30 days of having an active authorization.
No additional medication(s) are being added to the continuation request.

Documentation Required

Supportive Documentation Required

Use must be supported by FDA labeling, CMS-recognized compendia, or authoritative oncology guidelines/peer-reviewed literature. Requests lacking adequate supportive documentation risk denial.

Supportive evidence: FDA approved product labeling, CMS-approved compendia, NCCN or ASCO clinical guidelines, or peer-reviewed literature that meets CMS evidence standards.
Insufficient evidence includes case reports alone, abstracts without full peer‑reviewed articles, or literature that does not adequately represent the patient population, regimen, or clinically meaningful outcomes.

Documentation Required

Prior ICI and Biomarker Considerations

Prior immune checkpoint inhibitor (ICI) exposure and biomarker status directly affect eligibility. Libtayo is not approved when the member has received prior ICI therapy for the same indication and progressed on that therapy; NSCLC use requires negative actionable biomarkers where specified and PD‑L1 threshold for single‑agent first‑line use.

CSCC: Member must not have received prior therapy with another immune checkpoint inhibitor (e.g., pembrolizumab).
NSCLC: Member must be negative for actionable molecular markers ALK, EGFR, and ROS1 (not required for squamous histology) when specified, and must not have experienced disease progression on prior ICI therapy (e.g., pembrolizumab, nivolumab, atezolizumab).
NSCLC: Single‑agent first‑line use requires PD‑L1 ≥ 50%; combination with platinum‑based chemotherapy allowed for specified scenarios.

Denial Risk

Exclusion-based Denial Risks

Denial risks include use after progression on the same regimen or prior ICI therapy, dosing above the single‑dose limit, and investigational/off‑label uses without sufficient evidence as defined by CMS compendia or acceptable peer‑reviewed literature.

Use after disease progression with the same regimen or after prior ICI therapy (e.g., pembrolizumab, nivolumab, atezolizumab).
Dosing that exceeds the single dose limit of 350 mg per administration.
Investigational or off‑label indications lacking sufficient supporting evidence (insufficient representation of patient/tumor characteristics, inadequate regimen representation, lack of clinically meaningful outcomes, reliance on case reports or abstracts only).

Background

Cemiplimab (Libtayo) is a programmed death-1 (PD-1) immune checkpoint inhibitor used as a single agent for certain cutaneous and non-cutaneous malignancies. The policy supports Libtayo monotherapy for locally advanced, recurrent, or metastatic basal cell carcinoma and for unresectable or metastatic cutaneous squamous cell carcinoma when the patient is not a candidate for curative surgery or radiation. For non-small cell lung cancer (NSCLC), cemiplimab is covered in selected first-line settings: as single-agent therapy when PD-L1 ≥ 50%, or in combination with platinum-based chemotherapy for first-line treatment of NSCLC without EGFR/ALK/ROS1 aberrations. Coverage is contingent on meeting the policy’s biomarker and prior-therapy requirements and on adherence to dosing and exclusion rules.

OpenPayer