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

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.)