CurrentMass General Brigham Health PlanPolicy N/A

Libtayo (cemiplimab-rwlc) — Coverage Criteria for CSCC, BCC, and NSCLC

Defines prior authorization, medical necessity, and coverage criteria for cemiplimab (Libtayo) for Mass General Brigham Health Plan members across indicated cancer types under pharmacy and medical benefits.

Policy Summary

PayerMass General Brigham Health Plan

PolicyLibtayo (cemiplimab-rwlc) — Coverage Criteria for CSCC, BCC, and NSCLC

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2024

Next Review DateN/A

Key ActionObtain prior authorization for Libtayo under medical or pharmacy benefits and submit diagnosis-specific documentation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsstandard approval duration

>50%PD-L1 threshold

hedgehog inhibitorBCC precondition

EGFR/ALK/ROS1NSCLC biomarker exclusion

Coverage Criteria for Libtayo (cemiplimab)

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Cutaneous Squamous Cell Carcinoma (CSCC)

Authorization may be granted for treatment of cutaneous squamous cell carcinoma when ALL of the following are met:

CSCC initial criteria: Disease is metastatic, locally advanced, recurrent, or regional and inoperable or incompletely resected.

CSCC treatment intent: Member is not a candidate for curative surgery or curative radiation.

CSCC regimen: Libtayo (cemiplimab) will be used as a single agent.

Basal Cell Carcinoma (BCC)

Authorization may be granted for basal cell carcinoma when ALL of the following are met:

BCC disease state: Advanced, recurrent, or metastatic basal cell carcinoma.

BCC prior therapy: Member has received a hedgehog pathway inhibitor (e.g., vismodegib, sonidegib) or a hedgehog pathway inhibitor is not appropriate for the member.

BCC regimen: Libtayo (cemiplimab) will be used as single-agent therapy.

Non–Small Cell Lung Cancer (NSCLC)

Authorization may be granted for non–small cell lung cancer when ONE of the following NSCLC pathways is met:

NSCLC monotherapy: Monotherapy pathway: Used as single-agent first-line treatment or as maintenance therapy after response or stable disease following first-line cemiplimab therapy; tumor has PD-L1 Tumor Proportion Score (TPS) > 50% and tumor lacks EGFR exon 19 deletions or L858R mutations, ALK rearrangements, or ROS1 aberrations (unless testing not feasible due to insufficient tissue); disease is advanced, recurrent, or metastatic; member has not experienced disease progression while on prior PD-1/PD-L1 inhibitor therapy.PD-L1 TPS > 50%

NSCLC combination therapy: Combination pathway: Used in combination with platinum-based chemotherapy as first-line treatment for advanced or metastatic disease in patients without EGFR/ALK/ROS1 aberrations; member has not experienced disease progression while on prior PD-1/PD-L1 inhibitor therapy.

Continuation of Therapy

Continuation criteria

Continuation of therapy: Authorization may be granted for continued treatment when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

All indications for Libtayo (cemiplimab-rwlc) that are not listed as FDA-approved or recognized in the policy’s compendial uses are considered experimental/investigational and not medically necessary. Requests for such non‑approved indications should be denied as not meeting medical necessity criteria.

Use of Libtayo for any indication that is not an FDA‑approved indication or an explicitly listed compendial use in this policy is not covered. Authorization is limited to the specific FDA‑labeled and compendial cancer indications described in this document (cutaneous squamous cell carcinoma, basal cell carcinoma under the stated conditions, and specified non‑small cell lung cancer indications).

Covered Regimens and Indications

Regimen	Indication	Coverage status
Libtayo (cemiplimab-rwlc) in combination with platinum-based chemotherapy	First‑line treatment of advanced or metastatic non–small cell lung cancer (NSCLC) in patients without EGFR exon 19 deletions or L858R mutations, ALK rearrangements, or ROS1 aberrations	Covered with criteria

Regimen	Indication	Coverage status
Libtayo (cemiplimab-rwlc) as single‑agent therapy	Advanced, locally advanced, recurrent, regional (inoperable or incompletely resected) cutaneous squamous cell carcinoma (CSCC) in patients not candidates for curative surgery or radiation	Covered with criteria
Libtayo (cemiplimab-rwlc) as single‑agent therapy	Advanced, recurrent, or metastatic basal cell carcinoma (BCC) after prior hedgehog pathway inhibitor (e.g., vismodegib, sonidegib) or when a hedgehog pathway inhibitor is not appropriate	Covered with criteria

Coding and Biomarker Thresholds

Potential billing HCPCS (document does not list explicit codes)HCPCS

J9229	Injection, cemiplimab, 1 mg (example HCPCS often used for PD-1 agents)
C9399	Unclassified drugs or biologicals (administration/billing placeholder)

inv-08: PD-L1 Tumor Proportion Score — > 50%

ThresholdTumor Proportion Score (TPS) > 50%

Test requirementAs determined by an FDA-approved test

Context of useRequired for NSCLC monotherapy eligibility (first-line or maintenance)

Biomarker Requirements for NSCLC

first-line

first-line: Monotherapy: first-line or maintenance after response/stable disease; Combination: first-line with platinum-based chemotherapy.

inv-16: PD-L1 — TPS > 50%

PD-L1 cutoffTPS > 50%

Clinical settingRequired for first-line or maintenance monotherapy in NSCLC

Supporting conditionDisease must be advanced, recurrent, or metastatic

inv-17: EGFR/ALK/ROS1 — absence of actionable aberrations (no EGFR exon 19 deletions or L858R, no ALK or ROS1)

Required absenceNo EGFR exon 19 deletions or L858R mutations

Required absenceNo ALK rearrangements

Required absenceNo ROS1 aberrations

ExceptionTesting not feasible due to insufficient tissue — clinical judgment may apply

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Libtayo (cemiplimab-rwlc) under both the medical and pharmacy benefits.

Medical benefit and specialty medications: prior authorization required
Pharmacy benefit (including specialty pharmacy): prior authorization required
Plan contact: Phone 877-519-1908; Fax 855-540-3693
Non-specialty medications contact: Phone 800-711-4555; Fax 844-403-1029

Documentation Required

Documentation for New and Continuing Members

Authorization may be granted for members new to the plan who are currently receiving treatment with the requested medication, excluding when the product is obtained as samples or via manufacturer patient assistance programs. Ensure documentation demonstrating ongoing treatment (e.g., prior authorization history, drug administration records, or clinical notes) is provided.

Applies to new members currently receiving the medication at the time of enrollment
Excludes products obtained only as samples or through manufacturer patient assistance programs

Step Therapy

Step Therapy for Basal Cell Carcinoma (BCC)

For advanced, recurrent, or metastatic basal cell carcinoma (BCC), prior authorization requires trial and failure of a hedgehog pathway inhibitor (e.g., vismodegib [Erivedge], sonidegib [Odomzo]) unless a hedgehog pathway inhibitor is contraindicated or otherwise inappropriate. Provide documentation supporting prior hedgehog pathway inhibitor use or a clinical rationale for inappropriateness/contraindication.

Required prior therapy: vismodegib (Erivedge) or sonidegib (Odomzo) — unless contraindicated
Document prior hedgehog pathway inhibitor treatment dates, response, and reason for discontinuation if applicable
If hedgehog pathway inhibitor is inappropriate, include clinical justification (e.g., intolerance, contraindication)

Denial Risk

Non‑approved Indications

Requests for indications other than FDA‑approved or compendial uses are considered experimental/investigational and are not medically necessary. Include relevant clinical documentation supporting the requested indication when submitting a request.

Only FDA‑approved and listed compendial indications (e.g., CSCC, BCC, NSCLC where applicable) are covered
Non‑approved indications will be denied as not medically necessary

Background

Cemiplimab (Libtayo) is an anti–PD‑1 immunotherapy approved for selected advanced skin and lung cancers. FDA‑labeled indications include treatment of metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) in patients who are not candidates for curative surgery or curative radiation; treatment of advanced, recurrent, or metastatic basal cell carcinoma (BCC) previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate; and treatment of certain non‑small cell lung cancers (NSCLC) either as monotherapy for tumors with high PD‑L1 expression (Tumor Proportion Score > 50%) without EGFR/ALK/ROS1 aberrations, or in combination with platinum‑based chemotherapy for first‑line treatment of advanced/metastatic disease in patients without those aberrations.

Definitions and Thresholds

inv-14: High PD-L1 expression — Tumor Proportion Score (TPS) > 50% as determined by an FDA-approved test

DefinitionHigh PD-L1 expression defined as Tumor Proportion Score (TPS) > 50%

Test specificationTPS must be determined by an FDA-approved test

RelevanceUsed to identify NSCLC patients eligible for cemiplimab monotherapy

Revision History

2024-01-01policy_effective_dateLatest

Policy for Libtayo (cemiplimab-rwlc) became effective for the plan.