CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Ecg 3013 For Libtayo Cemiplimab Rwlc_Final

Defines accepted indications, continuation/ exclusion criteria, and coding for use of Libtayo (cemiplimab-rwlc) for basal cell carcinoma, cutaneous squamous cell carcinoma, and non-small cell lung cancer, including single-agent and combination chemotherapy scenarios. Applies to ordering providers whose medication requests are processed by Evolent for Neighborhood Health Plan of Rhode Island lines of business.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyEcg 3013 For Libtayo Cemiplimab Rwlc_Final

Policy CodePolicy N/A

Change TypeTemplate conversionwording updates

Effective Date

Next Review Date

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

SourceLink

POLICY UPDATE CHANGES

Converted to new Evolent guideline template (February 2025) and replaced prior UM ONC_1089 Libtayo guideline.

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

3Covered Indications

1HCPCS drug code listed

350 mgSingle dose exclusion threshold

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Defines accepted indications for Libtayo (cemiplimab-rwlc) for basal cell carcinoma, cutaneous squamous cell carcinoma (CSCC), and non-small cell lung cancer (NSCLC), and specifies coding and lines of business. Applies to ordering providers whose medication requests are processed by Evolent for Neighborhood Health Plan of Rhode Island lines of business; Evolent processes all medication requests and medications not authorized by Evolent may be deemed not approvable and not reimbursable.

For basal cell carcinoma and CSCC, Libtayo is described for single-agent use in members with locally advanced, recurrent, or metastatic disease who are not candidates for surgery and/or radiation, with CSCC also requiring no prior checkpoint inhibitor therapy. For NSCLC the policy covers both first-line single-agent use when tumor PD-L1 is ≥50% and first-line combination use with platinum-based chemotherapy in specified clinical scenarios (locally advanced not candidate for surgery/definitive chemoradiation, or metastatic disease) and with requirements for absence of actionable ALK/EGFR/ROS1 aberrations where applicable.

The policy includes continuation and exclusion criteria (e.g., prohibition after progression on the same regimen or prior checkpoint inhibitor therapy, and a single dose limit of 350 mg), and identifies the HCPCS code J9119 for cemiplimab-rwlc. It applies across the indicated lines of business identified as Commercial, Exchange/Marketplace, and Medicaid.

Coverage decisions are to be supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidance, or acceptable peer-reviewed literature consistent with CMS Medicare Benefit Policy Manual Chapter 15.

Basal Cell Carcinoma - Medically Necessary

Covered when ALL of the following are met:

ALL of the following

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

Top-level: all of the above criteria must be met

Cutaneous Squamous Cell Carcinoma (CSCC) - Medically Necessary

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 (cemiplimab-rwlc) is being used as a single agent
Member has not received prior therapy with another immune checkpoint inhibitor (e.g., pembrolizumab)

Top-level: all of the above criteria must be met

Non-Small Cell Lung Cancer (NSCLC) - Medically Necessary

Covered when ALL of the following are met (see nested scenarios for first-line single agent or combination):

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 ROS-1 not required for squamous histology)
Member has not experienced disease progression on prior immune checkpoint inhibitor therapy (including pembrolizumab, nivolumab, atezolizumab)
ONE of the following NSCLC treatment scenarios must be met
- First-line single-agent
  - Libtayo (cemiplimab-rwlc) will be used as first line therapy as a single agent

Continuation Therapy & Exceptions

Continuation Therapy Exception

Continuation requests for a not-approvable medication shall be exempt if ALL are met:

ALL of the following

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 authorizationNo lapse >30 days within last year
Additional medication(s) are not being added to the continuation request

Top-level: all of the above must be met for continuation exemption

Definition: Continuation request exemption — A continuation request for a not-approvable medication may be exempt from policy if all of the following are met: the member has not experienced disease progression on the requested medication; the medication was used within the last year without a lapse of more than 30 days of having an active authorization; and no additional medication(s) are being added to the continuation request.

Operational note: When these continuation criteria are met, Evolent may allow continuity of prior authorization (PA) without reapplying the full approval requirements; Evolent processes all medication requests and will honor such continuation exceptions per its PA continuity handling.

Exclusion Criteria / Not Medically Necessary

Not covered when ANY of the following are present:

ANY of the following

Use after disease progression with the same regimen or prior treatment with an immune checkpoint inhibitor (e.g., pembrolizumab, nivolumab, atezolizumab)
Dose limit: Dosing exceeds single dose limit of Libtayo (cemiplimab-rwlc) 350 mgsingle dose limit 350 mg
Investigational/off-label: Investigational use for an off-label indication that lacks sufficient evidence or is not generally accepted by the medical community (not supported by CMS compendia or acceptable peer-reviewed literature)
Sufficient evidence criteria include representativeness of patient/cancer, regimen representation, clinically meaningful outcomes (ASCO definitions), appropriate experimental design; case reports/meeting abstracts generally insufficient

Top-level: any single exclusion triggers not medically necessary

Policy thresholds

Single dose limit350 mg

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

Continuation lapse allowanceNo lapse >30 days within last year

Prior Authorization, Documentation & Billing Rules

Prior Authorization

Medication requests processed by Evolent

All medication requests for Libtayo (cemiplimab-rwlc) must be processed and authorized by Evolent. Medications not authorized by Evolent may be deemed not approvable and not reimbursable.

J9119

Documentation Required

Evidence support requirement

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

Denial Risk

Exclusion for prior checkpoint inhibitor progression

Claims may be denied if Libtayo is used after disease progression on the same regimen or after prior treatment with another immune checkpoint inhibitor.

J9119

Billing Rule

Dose limit enforcement

Dosing requests that exceed a single dose of Libtayo (cemiplimab-rwlc) 350 mg are excluded and may be denied.

350 mg
J9119

Clinical Evidence & Key Trials

3Covered indications (BCC, CSCC, NSCLC)

1HCPCS drug code listed (J9119)

350 mgSingle dose exclusion threshold

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

Key evidence mapped to indications:

- Sezer A et al., Lancet 2021 — phase 3 trial of cemiplimab monotherapy for first-line advanced NSCLC with PD-L1 ≥50%.

- Gogishvili M et al., Nat Med 2022 — randomized phase 3 trial of cemiplimab plus chemotherapy versus chemotherapy alone for NSCLC (combination use).

- Migden MR et al., NEJM 2018 — PD-1 blockade with cemiplimab in advanced CSCC (cutaneous squamous cell carcinoma).

- Libtayo prescribing information, Regeneron 2024 — product label and prescribing information supporting indications and dosing.

OpenPayer

Ecg 3013 For Libtayo Cemiplimab Rwlc_Final

Coverage Summary & Indications

Continuation Therapy & Exceptions

Exclusion Criteria / Not Medically Necessary

Applicable Codes

Prior Authorization, Documentation & Billing Rules

Clinical Evidence & Key Trials

Background & Policy Basis

Revision History