CurrentAnthemPolicy CC-0284

Emrelis (telisotuzumab vedotin-tllv) — Medical Benefit Prior Authorization and Coverage Criteria

Medical benefit prior authorization and coverage criteria for Emrelis (telisotuzumab vedotin-tllv) for treatment of adults with locally advanced or metastatic non-squamous non-small cell lung cancer with high c-Met expression who have received prior systemic therapy.

Policy Summary

PayerAnthem

PolicyEmrelis (telisotuzumab vedotin-tllv) — Coverage Criteria

Policy CodePolicy CC-0284

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit prior authorization with documentation of diagnosis, prior systemic therapy, c-Met IHC showing ≥50% tumor cells with 3+ staining, ECOG 0-2, and hepatic function to confirm absence of moderate/severe impairment.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥50%c-Met expression threshold

1.9 mg/kg q2wDosage

0-2ECOG for approval

J9326HCPCS

Coverage Criteria for Emrelis (telisotuzumab vedotin-tllv)

Policy Summary

PayerAnthem

PolicyEmrelis (telisotuzumab vedotin-tllv) — Coverage Criteria

Policy CodePolicy CC-0284

Change TypeNo material change

Effective Date

Next Review Date

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Emrelis approval criteria: Individual has a diagnosis of non-small cell lung cancer (NSCLC).N/A

Per FDA indication and label.

Emrelis approval criteria: Individual has advanced or metastatic non-squamous (EGFR wild-type) NSCLC.N/A

Matches covered population.

Emrelis approval criteria: High c‑Met/MET protein expression demonstrated by IHC: ≥ 50% of tumor cells with strong (IHC 3+) staining.≥ 50% with IHC 3+

Required tumor biomarker result for coverage.

Emrelis approval criteria: Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.ECOG 0-2

Performance status required for approval.

Emrelis approval criteria: Individual has received prior systemic therapy (prior therapies in trials included chemotherapy, tyrosine kinase inhibitors, or immune checkpoint inhibitors).N/A

Line-of-therapy requirement: post‑prior systemic therapy.

inv-02: Exclusions / Not approved

Requests for Emrelis will not be approved when ANY of the following apply:

Exclusion criteria: Individual has moderate or severe hepatic impairment (total bilirubin > 1.5 x ULN and any AST).total bilirubin > 1.5 x ULN and any AST

Avoid use due to increased exposure to MMAE and increased risk of adverse reactions.

Exclusion criteria: The required approval criteria (diagnosis, non‑squamous histology, high c‑Met IHC ≥50% with 3+ staining, ECOG 0‑2, prior systemic therapy) are not met.see approval nodes

Requests not meeting the listed criteria are not approved.

Exclusion criteria: Request is for an indication other than locally advanced or metastatic non‑squamous NSCLC with high c‑Met expression after prior systemic therapy.N/A

Use outside the covered indication is not approved.

Billing and Diagnosis Codes

HCPCSHCPCSCovered

J9326

Injection, telisotuzumab vedotin- tllv, 1 mg [Emrelis]

ICD-10 DiagnosisICD-10

C33	Malignant neoplasm of trachea
C34.00	Malignant neoplasm of bronchus and lung - unspecified laterality
C34.01	Malignant neoplasm of bronchus and lung - right main bronchus
C34.02	Malignant neoplasm of bronchus and lung - left main bronchus
C34.10	Malignant neoplasm of upper lobe, bronchus or lung, unspecified laterality
C34.11	Malignant neoplasm of upper lobe, bronchus or lung, right
C34.12	Malignant neoplasm of upper lobe, bronchus or lung, left
C34.90	Malignant neoplasm of bronchus and lung, unspecified
C34.91	Malignant neoplasm of bronchus and lung, right
C34.92	Malignant neoplasm of bronchus and lung, left

c-Met/MET IHC expression — coverage threshold

Threshold≥ 50% of tumor cells with strong (IHC 3+) staining

Test methodImmunohistochemistry (IHC) for c‑Met/MET protein expression

Scoring requirementTumor sample must demonstrate 3+ (strong) staining intensity in ≥50% of tumor cells

ContextMatches FDA indication population and trial inclusion characteristics for Emrelis use

What Providers Must Do

Prior Authorization

Prior Authorization Required

Prior authorization is required for Emrelis (telisotuzumab vedotin-tllv). Approval will be granted only when the medical necessity criteria in the policy are met (diagnosis, disease stage, c-Met IHC result, ECOG status, and prior systemic therapy).

Prior auth required before dispensing/administering Emrelis
Approval when ALL clinical criteria in the policy are met

Step Therapy

Line of Therapy Requirement

Emrelis is indicated only for patients who have received prior systemic therapy. Prior systemic therapy may include chemotherapy, tyrosine kinase inhibitors (TKIs), or immune checkpoint inhibitors (ICIs). Documentation must show prior therapy regimen(s) and dates.

Prior systemic therapy required (e.g., chemo, TKIs, or ICIs)
List prior regimens and treatment dates in request documentation

Documentation Required

Required Clinical Documentation

Include documentation to support the diagnosis of non-squamous NSCLC, ECOG performance status (0–2), evidence of high c-Met/MET protein expression by IHC (≥50% tumor cells with strong [3+] staining), and records of prior systemic therapy. Also include weight for dosing calculation and any hepatic function tests.

Pathology report confirming non-squamous NSCLC and EGFR wild-type when available
c-Met/MET IHC report showing ≥50% tumor cells with strong (3+) staining
Records showing ECOG 0–2
Documentation of prior systemic therapy (regimens and dates)
Recent hepatic function tests (total bilirubin, AST) and patient weight for dosing

Denial Risk

Denial Conditions / High-Risk Situations

Do not approve requests for patients with moderate or severe hepatic impairment. Emrelis has not been studied in moderate/severe hepatic impairment and such patients are at increased risk for toxicity due to higher MMAE exposure. Also deny when the policy approval criteria are not met or for other non‑listed indications.

Moderate or severe hepatic impairment (total bilirubin >1.5 x ULN and any AST) — not eligible
Requests not meeting ALL policy criteria (diagnosis, disease type/stage, c-Met IHC, ECOG, prior therapy) — not eligible
All other indications outside the specified FDA/NCCN context — not eligible

Background

Emrelis (telisotuzumab vedotin-tllv) is an antibody‑drug conjugate indicated for adults with locally advanced or metastatic non‑squamous non‑small cell lung cancer (NSCLC) with high c‑Met/MET protein expression. The policy requires documentation of c‑Met IHC ≥ 50% of tumor cells with strong (IHC 3+) staining, an ECOG performance status of 0–2, and prior systemic therapy. Recommended dosing per the clinical background is 1.9 mg/kg IV every 2 weeks (maximum 190 mg per dose), administered until disease progression or unacceptable toxicity; avoid use in patients with moderate or severe hepatic impairment (total bilirubin > 1.5 x ULN and any AST).

Definitions and Clinical Terms

ECOG Performance Status (definition)

Scale range0–5 (ECOG Performance Status)

0Fully active, able to carry on all pre-disease performance without restriction

1Restricted in physically strenuous activity but ambulatory and able to carry out light work

2Ambulatory and capable of all self-care but unable to work; up and about >50% of waking hours

3–53 = limited self-care, confined >50% of waking hours; 4 = completely disabled; 5 = dead

Line of Therapy — definitions

First-line therapyThe first or primary treatment for the diagnosis (may include surgery, chemotherapy, radiation, or combination)

Second-line therapyTreatment given when initial (first-line) therapy is not effective or disease progresses

Third-line therapyTreatment given when both first- and second-line therapies are not effective or disease progresses

Related termsPrimary treatment = first-line therapy; Maintenance therapy = designed to maintain condition to prevent relapse

Initial Therapy

inv-15: Initial Therapy

Initial coverage for Emrelis may be approved when ALL of the following initial therapy criteria are satisfied:

Initial therapy nodes: Diagnosed non‑small cell lung cancer (NSCLC); advanced or metastatic non‑squamous (EGFR wild‑type) NSCLC; high c‑Met/MET protein expression by IHC (≥50% tumor cells with strong 3+ staining); ECOG performance status 0–2; prior systemic therapy received; no moderate or severe hepatic impairment (total bilirubin ≤1.5 x ULN when applicable).see individual node texts

Matches FDA indication and trial population; avoid use in moderate/severe hepatic impairment.

OpenPayer

Emrelis (telisotuzumab vedotin-tllv) — Medical Benefit Prior Authorization and Coverage Criteria

Coverage Criteria for Emrelis (telisotuzumab vedotin-tllv)

Billing and Diagnosis Codes

What Providers Must Do

Background

Definitions and Clinical Terms

Initial Therapy

Continuation Therapy

Step Therapy / Prior Treatments

Dosage and Quantity Limits

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