Prior authorization validity

Prior authorization is required. Initial authorizations are provided for 180 days (6 months) and may be renewed every 180 days thereafter unless an indication-specific limit applies (see neoadjuvant, adjuvant, and indication-specific maximums).

Renewal requirements

Renewals are allowed only when the member continues to meet universal and indication-specific criteria, the original authorization duration has not been exceeded, there is no unacceptable toxicity, and disease response or stabilization is demonstrated.

• Member continues to meet universal and indication-specific criteria (including concomitant therapy requirements and performance status)
• Duration of authorization has not been exceeded (refer to Section I)
• Absence of unacceptable toxicity
• Disease response defined as stabilization or decrease in tumor burden

Diagnosis code required

Submit one of the ICD-10 diagnosis codes listed in Appendix 1 with the request to document an indicated malignancy.

NSCLC regimen positioning

For first-line NSCLC when used in combination with platinum-based chemotherapy, cemiplimab is applied per the regimen described (combination or continuation maintenance branches); no explicit prerequisite therapies are specified in this section for these first-line combination regimens.

• Used in combination with platinum-based chemotherapy as first-line therapy for tumors negative for actionable biomarkers or for select biomarker-positive tumors
• Continuation maintenance allowed after response to first-line cemiplimab-containing regimens

PA consideration per NQTL

Prior authorization is applied following the Non‑Quantitative Treatment Limitations (NQTL) assessment; cost was identified as a factor considered for PA in the NQTL checklist.

• NQTL checklist notes cost of drug as a factor for consideration of prior authorization
• Utilization management/PA is applied comparably across benefit types per the NQTL assessment

Step therapy not specified here

No step therapy (multi‑step prior‑therapy) requirements are specified in the provided sections; refer to other sections of the policy for any clinical step edits.

• The extract does not list prerequisite failure steps for Libtayo
• Check the main policy content for any step therapy edits not shown here

Biomarker testing documentation

For NSCLC and other biomarker‑directed indications, documentation of biomarker testing (actionable biomarkers and PD‑L1 TPS) from an FDA‑approved or CLIA‑compliant test is expected to determine appropriate use.

• PD‑L1 Tumor Proportion Score (TPS) when applicable must be determined by an FDA‑approved or CLIA‑compliant test
• Actionable biomarker testing (per policy-listed biomarkers) via FDA‑approved or CLIA‑compliant assays

Required clinical documentation

Clinical documentation must show single‑agent use when required, biomarker status (e.g., MSI‑H/dMMR or POLE/POLD1 with ultra‑hypermutated/TMB evidence determined by FDA‑approved or CLIA‑compliant testing), disease extent (recurrent, progressive, metastatic or locally unresectable), and prior treatments where relevant.

• Evidence of single‑agent use when the indication requires single‑agent therapy
• Biomarker status documented by FDA‑approved or CLIA‑compliant test (MSI‑H/dMMR or POLE/POLD1 with example TMB > 50 mut/Mb)
• Disease extent (advanced/metastatic, locally unresectable, recurrent/progressive) and relevant prior therapies
• Documentation of response or stability for renewals

Submit covered diagnosis code

When submitting a request, include the applicable ICD‑10 diagnosis code from Appendix 1 that supports medical necessity for Libtayo.

Prior PD‑1/PD‑L1 therapy restriction

Prior authorization may be denied if the member has received previous PD‑1/PD‑L1‑directed therapy unless the policy or indication explicitly allows prior PD‑1/PD‑L1 therapy.

• Universal criteria state member has not received previous PD‑1/PD‑L1 therapy unless otherwise specified

Renewal denial triggers

Renewal may be denied if the authorization duration has been exceeded, unacceptable toxicity is present, or disease response/stabilization is not demonstrated.

• Duration limits per indication (see Section I) must not be exceeded
• Presence of unacceptable toxicity (examples listed in policy) will preclude renewal
• Lack of disease response or stabilization may result in denial

Medicare policy compliance

Comply with applicable Medicare coverage determinations (NCDs/LCDs/LCA) for Part B outpatient drugs where relevant; noncompliance with Medicare rules may affect coverage.

• Medicare coverage guidance in the Medicare Benefit Policy Manual and any applicable NCDs/LCDs must be followed
• Medicare Part B covered diagnosis codes are listed as N/A in this extract—check applicable NCD/LCD

Intravenous administration

Libtayo is administered intravenously as listed in the policy.

Infusion billing and site of care

Bill cemiplimab by HCPCS J9119 (Injection, cemiplimab‑rwlc, 1 mg) and provide infusion administration in an infusion center, hospital outpatient, or office infusion setting per standard oncology practice.

• J9119 — Injection, cemiplimab‑rwlc, 1 mg; 1 billable unit = 1 mg
• Typically provided in infusion centers or hospital outpatient/office infusion settings

Medicare outpatient/Part B administration rules

Medicare-specific rules may apply for outpatient/Part B administration—refer to CMS manuals and any applicable NCDs/LCDs when billing Medicare.

• Consult the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 and search the CMS coverage database for applicable NCDs/LCDs/LCAs