CurrentAetnaPolicy N/A

Libtayo (cemiplimab-rwlc) Medication Precertification Request — Coverage Criteria

Precertification form and requirements for provider submission to request initiation or continuation of Libtayo (cemiplimab-rwlc) under Aetna; collects patient, insurance, prescriber, administration, product, diagnosis and clinical information to support coverage decisions.

Policy Summary

PayerAetna

PolicyLibtayo (cemiplimab-rwlc) Medication Precertification Request — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionRequest precertification by phone or fax using Aetna's Libtayo precertification form with all fields completed and legible.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3 pagesform length

requiredclinical documentation

1-866-752-7021phone

1-888-267-3277fax

ICD codesdiagnosis capture

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Information required to assess medical necessity

Coverage evaluation requires completion of indication‑specific items and prior therapy information; examples below are fields the payer requires to determine appropriateness.

General requirements: All requests must include completed patient, insurance, prescriber, product, diagnosis, and required clinical information; answer whether patient experienced disease progression on prior PD-1/PD-L1 inhibitor therapy.

Form mandates these fields for any request.

Basal Cell Carcinoma specifics: Indicate single-agent use, clinical setting (metastatic or locally advanced), whether nodal disease and surgery is not feasible, prior hedgehog pathway inhibitor use (e.g., vismodegib, sonidegib), and whether a hedgehog inhibitor is appropriate.

Used to determine place in therapy.

Cutaneous Squamous Cell Carcinoma specifics: Indicate single-agent use, whether neoadjuvant treatment is planned, clinical setting (very high risk, locally advanced, unresectable, regional), candidacy for curative surgery/radiation, and whether disease is metastatic, locally advanced, recurrent, or other.

Used to determine appropriateness for neoadjuvant or advanced disease use.

Non-Small Cell Lung Cancer specifics: Document clinical setting (metastatic, advanced, recurrent), tumor genomic status for EGFR/ALK/ROS1 (including whether testing is not feasible), PD-L1 Tumor Proportion Score (TPS > 50% or other), requested regimen (single agent, combination with platinum chemotherapy or pemetrexed), maintenance vs first-line, and line of therapy.

Form differentiates EGFR/ALK/ROS1-negative tumors and PD-L1 high tumors.

Cervical and Vulvar cancer specifics: Indicate place in therapy (first-line or subsequent), clinical setting (recurrent, metastatic, advanced, other), and whether the drug will be used as a single agent.

Used to establish place in therapy for these indications.

Continuation requests: Provide start date of medication, evidence of disease progression or unacceptable toxicity on the current regimen, current regimen details (including whether maintenance combination chemotherapy is continued), presence of severe toxicity requiring continuous monitoring or adverse events not responsive to conventional interventions, reason for outpatient hospital setting if applicable, and months of continuous treatment (including whether within initial 6 months).

Required to continue authorization.

The precertification form specifically asks whether a hedgehog pathway inhibitor (for example, vismodegib or sonidegib) has been received and whether a hedgehog pathway inhibitor is appropriate for the patient when the requested indication is basal cell carcinoma (BCC). These fields are used to document prior hedgehog-inhibitor exposure and appropriateness and to determine the drug’s place in therapy for BCC (single‑agent use, metastatic vs locally advanced disease).

For continuation requests, the form requires documentation of the medication start date and explicit documentation of evidence of disease progression or unacceptable toxicity while on the current regimen. If these continuation-specific fields (start date and evidence of progression or toxicity) are not provided, the information required to support ongoing authorization is missing and may lead to discontinuation or non‑approval of continued therapy.

Providers must complete the continuation items that describe severe toxicities, adverse events not responsive to interventions, and other clinical factors used to justify ongoing treatment; these items are requested on all continuation requests and are part of the clinical documentation required for adjudication.

Submission, documentation, and provider responsibilities

Prior Authorization

Precertification submission

Precertification submission — All precertification requests for Libtayo (cemiplimab-rwlc) must be requested via phone or fax using the Aetna Libtayo precertification form. All fields on the form must be completed and legible. For Medicare Advantage Part B members, use the Medicare request form. Aetna Precertification Notification Phone: 1-866-752-7021 (TTY: 711). Fax: 1-888-267-3277.

Use the Aetna Libtayo precertification form (all fields completed and legible).
For Medicare Advantage Part B — submit using the Medicare request form.
Precertification phone: 1-866-752-7021 (TTY: 711); Fax: 1-888-267-3277.

Documentation Required

Prior therapy documentation

Prior therapy documentation — The precertification request must document prior relevant therapies and the place in therapy for the requested indication. Capture prior PD-1/PD-L1 inhibitor exposure (e.g., avelumab, durvalumab, pembrolizumab, nivolumab, atezolizumab) and prior hedgehog pathway inhibitor use when applicable (e.g., vismodegib, sonidegib). Indicate whether the hedgehog pathway inhibitor was appropriate and list prior lines of therapy or whether the requested use is first-line or subsequent therapy as applicable.

Document prior PD-1/PD-L1 inhibitor therapy (yes/no; list agents).
Document prior hedgehog pathway inhibitor use (e.g., vismodegib, sonidegib) and appropriateness.
Specify place in therapy (first-line vs subsequent) and prior lines of treatment.

Documentation Required

Required clinical documentation

Required clinical documentation — Providers must include supporting clinical information for all requests and for continuation requests provide additional continuation-specific details such as medication start date, date of last treatment, evidence of disease progression or unacceptable toxicity on current regimen, and details on infusion setting or severe toxicity if applicable. Indicate clinical setting (e.g., metastatic, locally advanced, recurrent), whether the agent will be used as a single agent or in combination, and any relevant tumor testing results (e.g., EGFR/ALK/ROS1 status, PD-L1 TPS).

For all requests: complete required clinical information fields (disease setting, single agent vs combination, prior PD-1/PD-L1 exposure).
For initiation: indicate clinical setting (metastatic, locally advanced, nodal disease not feasible for surgery, etc.) and place in therapy.
For continuation: provide medication start date and date of last treatment; document disease progression or unacceptable toxicity (yes/no) and details if yes.
Include tumor testing results when relevant (EGFR/ALK/ROS1, PD-L1 TPS) and requested regimen (e.g., with platinum-based chemotherapy).

Denial Risk

Fraud and additional information

Fraud and additional information — Any person who knowingly submits false information or conceals material information in a precertification request may be committing a fraudulent insurance act and is subject to criminal and civil penalties. The plan may request additional information or clarification as needed to evaluate requests.

Do not knowingly provide materially false information or conceal material facts; such actions may lead to criminal and civil penalties.
Aetna may request additional information or clarification to evaluate precertification requests.

Policy context and use

This precertification form is used to determine medical necessity for cemiplimab-rwlc (Libtayo) across multiple oncologic indications, including basal cell carcinoma, cervical cancer, cutaneous squamous cell carcinoma, non‑small cell lung cancer, and vulvar cancer. It collects patient, insurance, prescriber, administration, product and diagnosis data along with indication‑specific clinical details such as prior therapies (including prior PD‑1/PD‑L1 and hedgehog inhibitors), disease setting (metastatic, locally advanced, recurrent), tumor biomarker status where relevant, and response to prior PD‑(L)1 therapy.

The form requires completion of indication‑specific fields for both initiation and continuation requests and instructs that required clinical information must be completed in its entirety for all precertification reviews.

Requirements for initiation of therapy

Initiation therapy requirements

Initiation requests require indication‑specific place‑in‑therapy and documentation of prior therapies where applicable.

Initiation - Basal Cell Carcinoma: State whether requested drug will be used as a single agent, specify clinical setting (metastatic or locally advanced; indicate if nodal disease and surgery is not feasible), and document prior hedgehog pathway inhibitor use and whether a hedgehog inhibitor is appropriate.

Initiation - Cutaneous Squamous Cell Carcinoma (CSCC): State whether requested drug will be used as a single agent, whether it will be used neoadjuvantly, indicate clinical setting (very high risk, locally advanced, unresectable, regional), and whether the patient is a candidate for curative surgery or curative radiation.

Initiation - Non-Small Cell Lung Cancer (NSCLC): Document tumor genomic status (EGFR, ALK, ROS1 positive or negative, or testing not feasible), PD-L1 TPS, requested regimen (single agent, combination with platinum-based chemotherapy, or combination with pemetrexed), and place/line of therapy (first-line vs subsequent).

Initiation - Cervical and Vulvar Cancer: Indicate place in therapy (first-line or subsequent), clinical setting (recurrent, metastatic, advanced, other), and whether the drug will be used as a single agent.

Requirements for ongoing therapy

Continuation therapy requirements

For continuation requests, the form requires details to support ongoing coverage.

Continuation documentation: Provide medication start date, state whether there is evidence of disease progression or unacceptable toxicity on the current regimen, supply current regimen details (including whether on maintenance combination chemotherapy), report severe toxicities requiring continuous monitoring (examples listed: Grade 2-4 bullous dermatitis, transaminitis, pneumonitis, Stevens-Johnson syndrome, etc.), describe any adverse events not responsive to conventional interventions or severe infusion reactions, indicate if severe venous access or behavioral/medical instability necessitates outpatient hospital setting, confirm whether patient is within initial 6 months of therapy, and report number of continuous months of treatment (specifically for BCC and CSCC when applicable).

This information is required on continuation requests.

Primary ICD Code	Primary diagnosis ICD-10 code
Secondary ICD Code	Secondary diagnosis ICD-10 code
Other ICD Code	Other diagnosis ICD-10 code

Prior therapy / question	Response options / documentation required	Notes
For initiation/placement in therapy (disease-specific prior therapy capture) — NSCLC: prior systemic therapy and biomarker testing
Document tumor genomic status (EGFR/ALK/ROS1 negative or testing infeasible), PD-L1 TPS (>50% status), and requested regimen (single agent or combination with platinum chemo).
Information required to determine appropriate line/regimen; PD-L1 TPS >50% captured on form; testing infeasibility can be indicated if insufficient tissue.

OpenPayer

Libtayo (cemiplimab-rwlc) Medication Precertification Request — Coverage Criteria

Coverage evaluation and required information

Diagnosis and billing codes

Submission, documentation, and provider responsibilities

Policy context and use

Key definitions and thresholds

Requirements for initiation of therapy

Requirements for ongoing therapy

Prior therapy and step requirements

Place of administration capture