CurrentBlue Cross Blue Shield - IowaPolicy 05.06.02

BENEFIT APPLICATION

Defines prior authorization, coverage criteria, dosing/quantity limits, and billing codes for Emrelis (telisotuzumab vedotin-tllv) for treatment of adult patients with locally advanced or metastatic non-squamous NSCLC with high c-Met overexpression, and denial for other uses.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyBENEFIT APPLICATION

Policy CodePolicy 05.06.02

Change TypeRevised billing codes

Effective DateOct 16, 2025

Next Review Date

Key ActionPrior authorization required with submission of c-Met protein expression status to initiate review; authorization may be granted for 12 months when criteria met.

SourceLink

POLICY UPDATE CHANGES

J9326 effective 1/1/26 added as HCPCS code for telisotuzumab vedotin-tllv; C9306 cancelled 12/31/25.

12 monthsInitial Authorization Duration

12 monthsReauthorization Duration

>=50%c-Met Overexpression Threshold

190 mgMaximum Dose

Coverage Summary & Scope

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.

Policy subject: Emrelis (telisotuzumab vedotin-tllv) for adult patients with locally advanced or metastatic non-squamous NSCLC with high c-Met overexpression per FDA labeling.

Coverage stance: Covered with criteria. Scope: Defines prior authorization, coverage criteria, dosing/quantity limits, and billing codes for Emrelis (telisotuzumab vedotin-tllv) for treatment of adult patients with locally advanced or metastatic non-squamous NSCLC with high c-Met overexpression, and denial for other uses.

Key Policy Attributes

Policy Number05.06.02

Effective Date2025-10-16

Last Review2025-08-01

StatusCURRENT

Coverage Stancecovered_with_criteria

Authorization DurationInitial: 12 months; Reauthorization: 12 months

c-Met threshold>=50%

Maximum Dose190 mg

Initial Therapy Criteria

Initial Authorization - Non-Small Cell Lung Cancer (NSCLC)

Authorization of 12 months may be granted when ALL of the following are met:

ALL of the following

Diagnosis of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC)
High c-Met protein overexpression defined as>=50% of tumor cells with strong (3+) staining
c-Met test: c-Met protein overexpression determined by an FDA-approved test
Prior therapy: Member has received a prior systemic therapy

Continuation / Reauthorization Criteria

Continuation of Therapy - NSCLC

Authorization of 12 months for reauthorization may be granted when ALL of the following are met:

ALL of the following

Prior authorization: Current treatment was previously authorized for an indication listed in Initial Authorization section
Tolerability: There is no evidence of unacceptable toxicity while on the current regimen
Efficacy: There is no evidence of disease progression while on the current regimen

Not Medically Necessary / Exclusions

Not Medically Necessary

Emrelis is not medically necessary when the following applies:

ANY of the following

Not meet initial criteria: Member does not meet the criteria outlined in the Initial Authorization section

Prior Authorization, Documentation & Billing Rules

Prior Authorization

Prior authorization required

Prior authorization required with submission of c-Met protein expression status to initiate review; authorization may be granted for 12 months when criteria met.

J9326
Authorization duration: 12 months

Documentation Required

Required documentation for PA

Submit documentation of c-Met protein expression status, including result from an FDA-approved test showing >=50% tumor cells with strong (3+) staining.

See definition: High c-Met protein overexpression = greater than or equal to 50% of tumor cells with strong (3+) staining

Billing Rule

Quantity limits

Standard vial sizes and limits: 20 mg/vial — standard limit 8 vials per 28 days; 100 mg/vial — standard limit 4 vials per 28 days. Dosing guidance: FDA-recommended dosing is 1.9 mg/kg IV infusion every 2 weeks (over ~30 minutes) until disease progression or unacceptable toxicity, up to a maximum of 190 mg for patients ≥100 kg.

J9326

Definitions & Background

Background: Policy aligns coverage with FDA labeling and evidence-based guidance.

Indication: Emrelis is indicated for adult patients with locally advanced or metastatic, non-squamous NSCLC with high c-Met protein overexpression (defined as >=50% of tumor cells with strong (3+) staining) as determined by an FDA-approved test, for patients who have received prior systemic therapy.

Definitions

High c-Met protein overexpressionGreater than or equal to 50% of tumor cells with strong (3+) staining as determined by an FDA-approved test.

Policy Revision History

2025-10-16effective

Policy effective date: 2025-10-16 (policy aligns coverage with FDA labeling and criteria for Emrelis).

2025-08-01reviewed

Policy last reviewed: 2025-08-01.

2025-12-31revised

C9306 cancelled 12/31/25.

2026-01-01revisedLatest

J9326 effective 1/1/26 added as HCPCS code for telisotuzumab vedotin-tllv; C9306 cancelled 12/31/25. (Billing codes updated to reflect upcoming HCPCS J-code implementation and cancellation of prior C-code.)