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    v1.0.28
    OpenPayerPolicy UpdatesHematology/OncologyEmblemHealth Emrelis Coverage Prior Auth Update | …
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    CurrentEmblemHealthPolicy MG.MM.PH.438

    Emrelis (telisotuzumab vedotin) Intravenous

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    Defines EmblemHealth prior authorization, dosing limits, and medical necessity criteria for Emrelis (telisotuzumab vedotin) for adult patients with locally advanced or metastatic non-squamous NSCLC with high c-Met overexpression who have received prior systemic therapy.

    Policy Summary
    PayerEmblemHealth
    PolicyEmrelis (telisotuzumab vedotin) Intravenous
    Policy CodePolicy MG.MM.PH.438
    Change TypeNew policy
    Effective DateAugust 1, 2025
    Last ReviewAug 1, 2025
    Next Review Date
    Key ActionSubmit clinical evidence that the member meets the treatment criteria when requesting prior authorization.
    SourceLink
    POLICY UPDATE CHANGES

    New policy created for Emrelis (telisotuzumab vedotin) with clinical criteria and dosing limits.

    6 monthsinitial prior authorization duration

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    1.9 mg/kg q14 daysrecommended dosing (max 190 mg)
    ≥50% (3+)cMet overexpression threshold for coverage
    ≥18minimum patient age
    J9399, J9999applicable HCPCS procedure codes

    Coverage Criteria for Emrelis (telisotuzumab vedotin)

    Initial Therapy

    Covered when ALL of the following are met

    Age: Patient is at least 18 years of age
    Indication: Diagnosis of locally advanced or metastatic non‑squamous non‑small cell lung cancer (NSCLC)
    Line of therapy: Used as subsequent therapy (following prior systemic therapy) and as single‑agent therapy
    Biomarker: High cMet protein overexpression as determined by an FDA‑approved or CLIA‑compliant test>=50% of tumor cells with strong (3+) staining
    EGFR status: Epidermal growth factor receptor (EGFR) mutation negative (wild‑type)
    Histology: Non‑squamous cell histology
    Monitoring and toxicity management: Patient will be monitored for ocular surface disorders (with ophthalmic exam and treatment for Grade ≥2 ocular toxicity), interstitial lung disease/pneumonitis, new or worsening peripheral neuropathy, and severe infusion‑related reactions

    Per universal monitoring requirements; lack of monitoring or unacceptable toxicity may preclude renewal

    RegimenDose / ScheduleMaximum doseIndication / NotesCoverage status
    Telisotuzumab vedotin (Emrelis) as single-agent therapy1.9 mg/kg IV every 2 weeksMaximum 190 mg per doseAdult patients with locally advanced or metastatic non-squamous NSCLC with high cMet protein overexpression (≥50% of tumor cells with strong 3+ staining) who have received prior systemic therapy; continue until disease progression or unacceptable toxicityCovered with criteria

    Emrelis (telisotuzumab vedotin) is not indicated for patients who do not have high cMet protein overexpression as defined by the label (≥50% of tumor cells with strong [3+] staining by an FDA‑approved test), and the indication is limited to non‑squamous histology. The approved indication specifically covers adult patients with locally advanced or metastatic, non‑squamous non‑small cell lung cancer who have received prior systemic therapy; it does not apply to squamous NSCLC or to patients lacking the specified biomarker overexpression.

    Use of Emrelis in combination with other anticancer agents is not supported by the policy; Emrelis is specified as single‑agent therapy. Additionally, continuation or renewal of prior authorization requires ongoing adherence to the policy’s monitoring and toxicity management requirements (for example, surveillance for ocular surface disorders, interstitial lung disease/pneumonitis, peripheral neuropathy, and severe infusion‑related reactions). Use in patients who do not meet those monitoring/toxicity management requirements, or who experience unacceptable toxicity or lack of disease response, is not supported for renewal.

    Biomarker / Diagnostic Requirements

    cMet (MET) protein overexpression
    DefinitioncMet (MET) protein overexpression ≥50% of tumor cells with strong (3+) staining
    Test methodDetermined by an FDA‑approved or CLIA‑compliant test
    Context of useRequired for coverage in locally advanced or metastatic non‑squamous NSCLC after prior systemic therapy
    High cMet overexpression
    ThresholdHigh cMet overexpression defined as ≥50% of tumor cells with strong (3+) staining
    DeterminationAs determined by an FDA‑approved test
    Regulatory note

    Line of Therapy

    Subsequent Therapy

    Subsequent therapy requirement: Used as subsequent therapy after prior systemic therapy (administered as single‑agent therapy)

    Covered Regimens and Dosing

    Regimen summaryDose / ScheduleMaximum doseDurationCoverage status
    Telisotuzumab vedotin (single-agent)1.9 mg/kg IV every 2 weeksMaximum 190 mg per doseUntil disease progression or unacceptable toxicityCovered with criteria

    Coding — Procedure, NDC, and Diagnosis Codes

    Applicable Procedure CodesHCPCS
    J9399Unclassified drugs or biologicals
    J9999Not otherwise classified, antineoplastic drugs
    Applicable NDCsNDC
    00074-1044-01Emrelis 20mg
    00074-1055-01Emrelis 100mg
    ICD-10 DiagnosesICD-10
    C33Malignant Neoplasm Of Trachea
    C34.00Malignant Neoplasm Of Unspecified Main Bronchus
    C34.01Malignant Neoplasm Of Right Main Bronchus
    C34.02Malignant Neoplasm Of Left Main Bronchus
    C34.10Malignant Neoplasm Of Upper Lobe, Unspecified Bronchus Or Lung
    C34.11Malignant Neoplasm Of Upper Lobe, Right Bronchus Or Lung
    C34.12Malignant Neoplasm Of Upper Lobe, Left Bronchus Or Lung
    C34.2Malignant Neoplasm Of Middle Lobe, Bronchus Or Lung
    C34.30Malignant Neoplasm Of Lower Lobe, Unspecified Bronchus Or Lung
    C34.31Malignant Neoplasm Of Lower Lobe, Right Bronchus Or Lung
    1–10 of 17
    1/2
    Maximum dose and HCPCS unit
    Dose1.9 mg/kg IV every 14 days (maximum 190 mg)
    Treatment frequencyOnce every 2 weeks (q14 days)
    HCPCS unit200 mg every 14 days
    DurationContinue until disease progression or unacceptable toxicity

    Provider Actions and Documentation Requirements

    Prior Authorization

    Prior Authorization Required

    Prior authorization is required. Initial authorization will be provided for 6 months. Renewals may be requested and will be considered every 6 months thereafter.

    • Initial authorization: 6 months
    • Renewal authorization: may be renewed every 6 months
    Step Therapy

    Subsequent Therapy Requirement

    This therapy is covered only as subsequent systemic therapy following prior systemic therapy; it is intended for use as single‑agent subsequent treatment in the specified indication.

    • Indication: Non‑Small Cell Lung Cancer (locally advanced or metastatic)
    • Use: Subsequent single‑agent systemic therapy following prior systemic therapy

    Background

    Emrelis (telisotuzumab vedotin) received accelerated approval for the treatment of adult patients with locally advanced or metastatic, non‑squamous non‑small cell lung cancer who have high cMet protein overexpression (defined as ≥50% of tumor cells with strong [3+] staining by an FDA‑approved test) and who have received prior systemic therapy. Continued approval of this indication may be contingent on verification of clinical benefit in confirmatory trials; the approval was based on overall response rate and duration of response.

    Revision History

    2025-08-01Policy created

    New policy created for Emrelis (telisotuzumab vedotin); origin date listed as August 1, 2025.

    2025-08-01Last reviewLatest

    Policy last reviewed on August 1, 2025 (status: New Policy).

    Policy Summary
    PayerEmblemHealth
    PolicyEmrelis (telisotuzumab vedotin) Intravenous
    Policy CodePolicy MG.MM.PH.438
    Change TypeNew policy
    Effective DateAugust 1, 2025
    Last ReviewAug 1, 2025
    Next Review Date
    Key ActionSubmit clinical evidence that the member meets the treatment criteria when requesting prior authorization.
    SourceLink
    On This Page
    Coverage Criteria for Emrelis (telisotuzumab vedotin)Biomarker / Diagnostic RequirementsLine of TherapyCovered Regimens and DosingCoding — Procedure, NDC, and Diagnosis CodesProvider Actions and Documentation RequirementsBackgroundRevision History
    Threshold used in the indication for Emrelis (telisotuzumab vedotin)
    Documentation Required

    Clinical Evidence Submission

    The treating provider must submit clinical evidence demonstrating the member meets all treatment criteria listed in the guideline (diagnosis, age, biomarker status, histology, prior therapy). Without submitted clinical documentation, EmblemHealth cannot properly review the prior authorization request or perform post-payment review.

    • Submit documentation of diagnosis and disease stage (e.g., locally advanced or metastatic NSCLC)
    • Submit age verification (patient ≥ 18 years)
    • Submit prior systemic therapy history
    • Submit biomarker testing results (e.g., cMet protein overexpression ≥50% with 3+ staining, EGFR mutation negative), from an FDA‑approved or CLIA‑compliant test
    • Submit tumor histology confirming non‑squamous cell type
    Denial Risk

    Documentation Requirement / Denial Risk

    Failure to provide the requested clinical documentation will prevent proper review and may result in denial of the request.

    • Lack of submitted clinical documentation prevents proper prior authorization review
    • Incomplete or missing biomarker test reports, prior therapy documentation, or histology may lead to denial