CurrentBlue Cross Blue Shield - IowaPolicy 05.06.02

Emrelis (telisotuzumab vedotin-tl1v) coverage for NSCLC

Defines prior authorization, coverage criteria, dosing/quantity limits, continuation criteria, billing code, and required documentation for Emrelis (telisotuzumab vedotin-tl1v) for locally advanced or metastatic non-squamous NSCLC with high c-Met overexpression.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyEmrelis (telisotuzumab vedotin-tl1v) coverage for NSCLC

Policy CodePolicy 05.06.02

Change TypeNo material change

Effective DateOct 16, 2025

Next Review Date

Key ActionPrior authorization is required and approval may be granted for 12 months when initial criteria are met; submit documentation of c-Met protein expression status (FDA-approved test) and prior systemic therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes.

1Covered Indication (FDA-approved)

12 moAuthorization Duration

8 / 4Quantity Limits (20 mg / 100 mg)

Coverage Summary

Emrelis (telisotuzumab vedotin-tl1v) is FDA-approved for adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression as determined by an FDA-approved test. Coverage stance: covered with criteria. Authorization duration for initial and continued therapy is 12 months. Policy number: 05.06.02; Effective date: 10/16/2025.

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Provider Actions & Billing

Prior Authorization

Prior authorization required

Prior authorization is required for Emrelis (telisotuzumab vedotin-tl1v). Approval may be granted for up to 12 months when the initial criteria are met. Submit documentation of c-Met protein expression status (by an FDA‑approved test) and evidence of prior systemic therapy with the prior authorization request.

C9306

Documentation Required

Required documentation for PA

Submission must include c-Met protein expression status determined by an FDA-approved test defined as greater than or equal to 50% of tumor cells with strong (3+) staining, and evidence of prior systemic therapy.

Billing Rule

Quantity limits apply

Quantity limits apply. Standard vial limits: 20 mg/vial — standard limit 8 vials per 28 days; 100 mg/vial — standard limit 4 vials per 28 days. Dosing per FDA: 1.9 mg/kg IV administered every 2 weeks (infusion over ~30 minutes) until disease progression or unacceptable toxicity; up to a maximum of 190 mg.

C9306
20 mg vial — 8 vials per 28 days
100 mg vial — 4 vials per 28 days

Denial Risk

Not medically necessary if criteria unmet

Claims will be considered not medically necessary and may be denied if the member does not meet the specified initial approval criteria (diagnosis, biomarker status by an FDA‑approved test, and prior systemic therapy).

C9306

Definitions & Background

Definition: High c-Met protein overexpression = greater than or equal to 50% of tumor cells with strong (3+) staining as determined by an FDA-approved test. Background: Emrelis is FDA-approved for adults with locally advanced or metastatic non-squamous NSCLC with high c-Met protein overexpression who have received prior systemic therapy.

Thresholds

c-Met protein overexpression>= 50% of tumor cells with strong (3+) staining

FDA recommended dosing maximumUp to a maximum of 190 mg for patients >= 100 kg

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyEmrelis (telisotuzumab vedotin-tl1v) coverage for NSCLC

Policy CodePolicy 05.06.02

Change TypeNo material change

Effective DateOct 16, 2025

Next Review Date

SourceLink

On This Page

OpenPayer

Emrelis (telisotuzumab vedotin-tl1v) coverage for NSCLC

Coverage Summary

Initial Therapy Criteria

Continuation of Therapy Criteria

Not Medically Necessary / Exclusions

Applicable Codes

Provider Actions & Billing

Clinical Evidence & References

Definitions & Background

Revision History