CurrentEmblemHealthPolicy MG.MM.PH.438

Emrelis (telisotuzumab vedotin) Intravenous

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

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

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

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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

Regimen	Dose / Schedule	Maximum dose	Indication / Notes	Coverage status
Telisotuzumab vedotin (Emrelis) as single-agent therapy	1.9 mg/kg IV every 2 weeks	Maximum 190 mg per dose	Adult 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 toxicity	Covered 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 summary	Dose / Schedule	Maximum dose	Duration	Coverage status
Telisotuzumab vedotin (single-agent)	1.9 mg/kg IV every 2 weeks	Maximum 190 mg per dose	Until disease progression or unacceptable toxicity	Covered with criteria

Coding — Procedure, NDC, and Diagnosis Codes

Applicable Procedure CodesHCPCS

J9399	Unclassified drugs or biologicals
J9999	Not otherwise classified, antineoplastic drugs

Applicable NDCsNDC

00074-1044-01	Emrelis 20mg
00074-1055-01	Emrelis 100mg

ICD-10 DiagnosesICD-10

C33	Malignant Neoplasm Of Trachea
C34.00	Malignant Neoplasm Of Unspecified Main Bronchus
C34.01	Malignant Neoplasm Of Right Main Bronchus
C34.02	Malignant Neoplasm Of Left Main Bronchus
C34.10	Malignant Neoplasm Of Upper Lobe, Unspecified Bronchus Or Lung
C34.11	Malignant Neoplasm Of Upper Lobe, Right Bronchus Or Lung
C34.12	Malignant Neoplasm Of Upper Lobe, Left Bronchus Or Lung
C34.2	Malignant Neoplasm Of Middle Lobe, Bronchus Or Lung
C34.30	Malignant Neoplasm Of Lower Lobe, Unspecified Bronchus Or Lung
C34.31	Malignant Neoplasm Of Lower Lobe, Right Bronchus Or Lung

1–10 of 17

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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).