CurrentViva Health PlanPolicy IC-0799

Emrelis (telisotuzumab vedotin-tllv) Intravenous Therapy for c-Met-Overexpressing Non-Small Cell Lung Cancer

Customize your policy alerts

Sign up for vivahealthplan Policy IC-0799 alerts

Get alerted when Policy IC-0799 changes without checking for updates manually.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Prior authorization, dosing, billing, and medical-necessity criteria for intravenous Emrelis in adult commercial members with specified recurrent, advanced, or metastatic non-squamous non-small cell lung cancer.

Policy Summary

PayerViva Health Plan

PolicyEmrelis (telisotuzumab vedotin-tllv) intravenous therapy

Policy CodePolicy IC-0799

Change TypeNo material change

Effective DateN/A

Last ReviewOct 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of qualifying NSCLC, high c-Met overexpression, EGFR wild-type status, and single-agent subsequent therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsInitial authorization

6 monthsRenewal interval

200/14 daysMaximum units

1.9 mg/kgRecommended dose

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.

CurrentViva Health PlanPolicy IC-0799

Emrelis (telisotuzumab vedotin-tllv) Intravenous Therapy for c-Met-Overexpressing Non-Small Cell Lung Cancer

Customize your policy alerts

Sign up for vivahealthplan Policy IC-0799 alerts

Get alerted when Policy IC-0799 changes without checking for updates manually.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Policy Summary

PayerViva Health Plan

PolicyEmrelis (telisotuzumab vedotin-tllv) intravenous therapy

Policy CodePolicy IC-0799

Change TypeNo material change

Effective DateN/A

Last ReviewOct 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of qualifying NSCLC, high c-Met overexpression, EGFR wild-type status, and single-agent subsequent therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsInitial authorization

6 monthsRenewal interval

200/14 daysMaximum units

1.9 mg/kgRecommended dose

≥50%High c-Met threshold

Coverage Criteria

Initial Therapy

Covered for initial therapy when ALL of the following are met.

Initial approval

Universal criteria
- Member is at least 18 years of age.
- Member will be monitored for ocular surface disorders during treatment and will receive an ophthalmic examination and treatment, if required, for Grade 2 or higher ocular toxicity.
- Member will be monitored for interstitial lung disease and/or pneumonitis.
- Member will be monitored for new or worsening peripheral neuropathy.
- Member will be monitored for severe infusion-related reactions.
- Emrelis is used as single-agent therapy.
NSCLC criteria
- Member has recurrent, advanced, or metastatic disease, excluding locoregional recurrence or symptomatic local disease without evidence of disseminated disease, or has mediastinal lymph node recurrence with prior radiation therapy.
- Emrelis is used as subsequent therapy.
- Member has high c-Met protein overexpression, defined as at least 50% of tumor cells with strong (3+) staining, as determined by an FDA-approved or CLIA-compliant test, unless otherwise specified.≥50% of tumor cells with strong (3+) staining
- Member is epidermal growth factor receptor (EGFR) mutation-negative (wild-type).
- Member's disease has non-squamous cell histology.

Renewal Therapy

Covered for renewal when ALL of the following are met.

Renewal criteria

Member continues to meet the universal and other relevant indication-specific criteria identified for initial approval, including applicable concomitant therapy requirements and performance status criteria.
Disease response is demonstrated by stabilization of disease or a decrease in the size of the tumor or tumor spread.
There is no unacceptable toxicity from Emrelis, including peripheral neuropathy, severe interstitial lung disease and/or pneumonitis, severe ocular surface disorders, or severe infusion-related reactions.

Locoregional recurrence or symptomatic local disease without evidence of disseminated disease is excluded from coverage. An exception applies for mediastinal lymph node recurrence with prior radiation therapy.

Coverage does not apply to squamous cell NSCLC. The member must have EGFR mutation-negative (wild-type) disease; EGFR mutation-positive disease does not meet the covered indication criteria.

Emrelis must be administered as single-agent therapy. Combination therapy is excluded under this policy.

Continuation is not medically necessary when treatment does not produce disease stabilization or a decrease in tumor size or tumor spread, or when the member experiences unacceptable drug toxicity, including peripheral neuropathy, severe interstitial lung disease or pneumonitis, severe ocular surface disorders, or severe infusion-related reactions.

Coding and Utilization Parameters

HCPCS Code(s)HCPCSCovered

J9326

Injection, telisotuzumab vedotin-tllv, 1 mg; 1 billable unit = 1 mg

NDC(s)NDCCovered

00074-1044-xx	Emrelis 20 mg as a lyophilized powder in a single-dose vial
000741055-xx	Emrelis 100 mg as a lyophilized powder in a single-dose vial

Covered Diagnosis CodesICD-10Covered

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 18

1/2

High c-Met Protein Overexpression

Expression thresholdAt least 50% of tumor cells

Staining intensityStrong (3+) staining

Testing methodFDA-approved or CLIA-compliant test

Dosing Limit

Maximum quantity200 billable units

Time periodEvery 14 days

Unit type

Authorization and Documentation Requirements

Prior Authorization

Prior Authorization and Authorization Period

Obtain prior authorization before treatment. Initial authorization is valid for 6 months (180 days), and renewal authorization may be granted for additional 6-month (180-day) periods.

Initial authorization: 6 months (180 days)
Renewal authorization: every 6 months (180 days)

Documentation Required

Document Disease and Histology

Submit documentation confirming recurrent, advanced, or metastatic NSCLC, subject to the policy’s permitted disease characteristics and exclusions.

Disease may include mediastinal lymph node recurrence with prior radiation therapy
Exclude locoregional recurrence or symptomatic local disease without evidence of disseminated disease

Policy Background

Emrelis (telisotuzumab vedotin-tllv) is administered intravenously as a single agent for selected adults with recurrent, advanced, or metastatic non-squamous non-small cell lung cancer. Coverage is limited to subsequent therapy for tumors with high c-Met protein overexpression and EGFR mutation-negative (wild-type) status. Treatment is given every 2 weeks until disease progression or unacceptable toxicity, with monitoring for ocular, pulmonary, neurologic, and infusion-related toxicities.

Key Definitions

High c-Met Protein Overexpression

Required expression levelAt least 50% of tumor cells

Staining resultStrong (3+) staining

Acceptable testFDA-approved or CLIA-compliant test

Eligible NSCLC Molecular and Histologic Profile

HistologyNon-squamous NSCLC

EGFR statusMutation-negative (wild-type)

Treatment settingUsed as subsequent therapy

Initial Approval Criteria

Initial authorization requires ALL applicable criteria.

Adult single-agent NSCLC treatment

Member is at least 18 years of age.
Emrelis is used as single-agent subsequent therapy.
Member has recurrent, advanced, or metastatic non-squamous non-small cell lung cancer, excluding locoregional recurrence or symptomatic local disease without evidence of disseminated disease, or has mediastinal lymph node recurrence with prior radiation therapy.
High c-Met protein overexpression is documented as at least 50% of tumor cells with strong (3+) staining on an FDA-approved or CLIA-compliant test, unless otherwise specified.≥50% of tumor cells with strong (3+) staining

Renewal Criteria

Renewal is permitted when ALL of the following are met.

Continuation therapy

Member continues to meet the applicable universal and indication-specific criteria identified for initial approval.
Disease response is shown by stabilization of disease or a decrease in the size of the tumor or tumor spread.
Unacceptable toxicity from Emrelis is absent, including peripheral neuropathy, severe interstitial lung disease and/or pneumonitis, severe ocular surface disorders, or severe infusion-related reactions.

Quantity Limits

ProductEmrelis (telisotuzumab vedotin-tllv)

Quantity limit200 billable units

Limit periodEvery 14 days

Policy Summary

PayerViva Health Plan

PolicyEmrelis (telisotuzumab vedotin-tllv) intravenous therapy

Policy CodePolicy IC-0799

Change TypeNo material change

Effective DateN/A

Last ReviewOct 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of qualifying NSCLC, high c-Met overexpression, EGFR wild-type status, and single-agent subsequent therapy.

SourceLink

On This Page

HCPCS billable units

Recommended Dose

Recommended dose1.9 mg/kg

Route and frequencyAdministered intravenously every 2 weeks

Maximum dose190 mg for members at least 100 kg

Documentation Required

Document c-Met Test Result

Submit an FDA-approved or Clinical Laboratory Improvement Amendments (CLIA)-compliant test documenting high c-Met protein overexpression.

At least 50% of tumor cells must demonstrate strong (3+) c-Met staining
If confirmed using an immunotherapy assay, use the applicable FDA companion-diagnostic requirements

Documentation Required

Document Molecular and Treatment History

Document that the member has EGFR mutation-negative (wild-type) disease, is receiving Emrelis as subsequent therapy, and will receive it as single-agent therapy.

EGFR mutation-negative (wild-type) status is required
Subsequent therapy is required
Single-agent use is required

Documentation Required

Safety Monitoring Plan

Establish and document a safety monitoring plan throughout treatment, including monitoring for ocular, pulmonary, neurologic, and infusion-related toxicities.

Monitor for ocular surface disorders and provide an ophthalmic examination and treatment, if required, for Grade ≥2 ocular toxicity
Monitor for interstitial lung disease and/or pneumonitis
Monitor for new or worsening peripheral neuropathy, including hypoesthesia, hyperesthesia, paresthesia, burning sensation, neuropathic pain, or muscle weakness
Monitor for severe infusion-related reactions

Documentation Required

Renewal Clinical Documentation

For renewal, submit documentation showing that the member continues to meet the universal and indication-specific criteria, has disease response or stabilization, and is tolerating treatment without unacceptable toxicity.

Document continued eligibility, including relevant concomitant therapy requirements and other criteria from initial approval
Document stabilization of disease or a decrease in tumor size or tumor spread
Document absence of unacceptable toxicity, including peripheral neuropathy, severe interstitial lung disease and/or pneumonitis, severe ocular surface disorders, or severe infusion-related reactions

Denial Risk

Member Must Be at Least 18

Authorization may be denied when the member is younger than 18 years of age.

Member must be at least 18 years of age

Denial Risk

Universal Criteria Must Be Met

Authorization may be denied if Emrelis is not used as single-agent therapy or if the required toxicity monitoring plan is absent.

Single-agent therapy is required
Required ocular, pulmonary, neurologic, and infusion-reaction monitoring must be documented

Denial Risk

NSCLC Indication Criteria Must Be Met

Authorization may be denied when the NSCLC disease, treatment-line, molecular, c-Met, or histology requirements are not met or adequately documented.

Required recurrent, advanced, or metastatic disease characteristics must be present
Use must be as subsequent therapy
High c-Met protein overexpression must be documented by an FDA-approved or CLIA-compliant test
Disease must be EGFR mutation-negative (wild-type) and have non-squamous cell histology

Denial Risk

Renewal Criteria Must Be Met

Renewal may be denied when the member no longer meets applicable eligibility criteria, lacks disease response or stabilization, or develops unacceptable toxicity.

Continued universal and indication-specific criteria are required
Disease must be stabilized or show a decrease in tumor size or spread
Unacceptable toxicity must be absent

Billing Rule

Do Not Exceed Dosing Limit

Doses exceeding the policy’s quantity limit or the recommended dose and maximum may be denied.

Maximum: 200 billable units every 14 days
Recommended dose: 1.9 mg/kg intravenously every 2 weeks
For members weighing ≥100 kg, the maximum dose is 190 mg

EGFR status is mutation-negative (wild-type).

The member will be monitored for ocular surface disorders, interstitial lung disease and/or pneumonitis, new or worsening peripheral neuropathy, and severe infusion-related reactions, including ophthalmic examination and treatment if Grade 2 or higher ocular toxicity occurs.