CurrentBlue Cross Blue Shield - IowaPolicy 05.05.98

Ibtrozi_Medical_Policy

Defines coverage and prior authorization criteria for Ibtrozi (taletrectinib) for treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer, including continuation criteria, dosing limits, quantity limits, and required documentation.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyIbtrozi_Medical_Policy

Policy CodePolicy 05.05.98

Change TypeClarified

Effective DateSep 25, 2025

Next Review Date

Key ActionPrior authorization review requires submission of ROS1 status and verification of member benefits; authorization of 12 months may be granted for initial and continued therapy.

SourceLink

POLICY UPDATE CHANGES

Policy aligns coverage with FDA-approved indication and compendial uses for ROS1-positive NSCLC; requires ROS1 status submission for prior authorization.

1Covered Indications (FDA-approved)

12Authorization Period (months)

90/30dStandard Quantity Limit

Coverage Summary

Covered with criteria: Ibtrozi (taletrectinib) is covered for treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) in accordance with FDA-approved indication and policy criteria. Authorization may be granted for up to 12 months for initial or continued therapy when all coverage criteria are met, including submission of required documentation and adherence to dosing/quantity limits.

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Initial Therapy Criteria

Initial Therapy - FDA-Approved Indication

Covered when ALL of the following are met:

Age: Patient is an adult.
Diagnosis of locally advanced or metastatic non-small cell lung cancer (NSCLC).
ROS1 status: Tumor is ROS1-positive (ROS1 rearrangement-positive).
Presence of ROS1 rearrangement in tumor; ROS1 status must be submitted for prior authorization.
Indication and setting: Ibtrozi (taletrectinib) is prescribed as a single agent for treatment of recurrent, advanced, or metastatic disease.
Authorization of 12 months may be granted for treatment as a single agent.
Benefit verification: No contract exclusions to the prescribed therapy exist and benefit for this therapy is verified.
Benefits are determined based on applicable contract language and individual member benefits must be verified.

Continuation Therapy Criteria

Continuation (Reauthorization)

Authorization for continued therapy may be granted when ALL of the following are met:

Prior authorization or current use: Member has prior authorization or is currently receiving Ibtrozi for ROS1-positive NSCLC.
Toxicity: There is no evidence of unacceptable toxicity while on the current regimen.
Dosing within labeling: Prescribed dosing remains within FDA-recommended dosing and any approved dose reductions per labeling.
FDA recommended dosing = 600 mg orally once daily (three 200 mg capsules); first reduction to 400 mg once daily; second reduction to 200 mg once daily; permanently discontinue if unable to tolerate 200 mg once daily.

Provider Actions & Billing Rules

Prior Authorization

Prior authorization required

Prior authorization is required. Submit ROS1 status and verify member benefits as part of the PA review. Authorization of 12 months may be granted for initial and continued therapy.

Documentation Required

Required documentation for PA

Required documentation for prior authorization: submit ROS1 status (where applicable) to initiate the PA review.

Billing Rule

Quantity limits enforcement

Quantity limit: 90 capsules per 30 days for Ibtrozi (taletrectinib) 200 mg capsules. Approvals and dosing follow FDA labeling, accepted compendia, and evidence‑based practice guidelines.

Operational notes: Prior to prescribing or billing, verify member benefits and ensure no contract exclusions apply. Submit ROS1 status as required for prior authorization. Confirm authorization and any applicable quantity or dosing limits before dispensing.

Background & Definitions

Background and intent: Ibtrozi (taletrectinib) is indicated for treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC. Compendial uses include recurrent, advanced, or metastatic ROS1 rearrangement-positive tumors. The policy is intended to align coverage with product labeling, FDA guidance, and accepted compendia and requires submission of ROS1 status for prior authorization.

Definitions

ROS1-positivePresence of ROS1 rearrangement in tumor; ROS1 status must be submitted for prior authorization.