CurrentUnitedHealthcarePolicy N/A

Prior authorization and coverage criteria for Ibtrozi (taletrectinib) for ROS1-positive NSCLC

Prior authorization and coverage criteria for Ibtrozi (taletrectinib) for treatment of ROS1-positive non-small cell lung cancer; applies to UnitedHealthcare members (pediatric prescriptions under age 19 auto-process).

Policy Summary

PayerUnitedHealthcare

PolicyPrior authorization and coverage criteria for Ibtrozi (taletrectinib) for ROS1-positive NSCLC

Policy CodePolicy N/A

Change TypeNew prior authorization program

Effective DateNov 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization for Ibtrozi with documentation confirming ROS1-positive advanced or metastatic NSCLC.

SourceLink

POLICY UPDATE CHANGES

New prior authorization program created for Ibtrozi (taletrectinib).

Coverage criteria specify approval for adult patients with ROS1-positive metastatic or advanced NSCLC and reauthorization contingent on no evidence of progressive disease.

Prescriptions for members under age 19 will automatically process without coverage review and will be authorized for 12 months.

12 monthsauthorization period

ROS1+ NSCLCindication covered

P&T 8/2025program approval

11/1/2025policy effective

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Coverage Criteria for Ibtrozi (taletrectinib)

Initial Authorization

Covered when ALL of the following are met

Initial Authorization for adults: (1) Diagnosis of non-small cell lung cancer (NSCLC) AND (2) disease is metastatic or advanced AND (3) tumor is ROS1 positive.

Authorization will be issued for 12 months if criteria met.

Reauthorization

Covered when ALL of the following are met

Reauthorization: Patient does not show evidence of progressive disease while on Ibtrozi therapy.

Authorization will be issued for 12 months when criterion met; state mandates and benefit plan terms may affect coverage.

Patients less than 19 years of age

Covered when criterion is met

Members under 19: Patient is less than 19 years of age; prescription will automatically process without coverage review.

Authorization will be issued for 12 months.

State law and certain compendia requirements can change coverage applicability for off-label medication use. Where a state mandate or a specified compendium applies, that requirement supersedes the language in this policy and may alter whether Ibtrozi (taletrectinib) is covered for a given diagnosis or circumstance.

Use of Ibtrozi is limited to the indications and continuation conditions specified in this policy. Treatment of non-small cell lung cancer that is not ROS1-positive is not supported by these coverage criteria. Likewise, continuation or reauthorization is not supported when there is evidence of progressive disease while on Ibtrozi therapy.

Initial Therapy

Initial therapy: Diagnosis of NSCLC that is advanced or metastatic and tumor is ROS1 positive.

Authorization will be issued for 12 months if criteria met.

Continuation Therapy / Reauthorization

Reauthorization requirement

Continuation: Reauthorization requires no evidence of progressive disease while on Ibtrozi therapy.

Authorization period is 12 months; state mandates and member benefit plan terms may impact coverage.

Provider Actions and Documentation Requirements

Prior Authorization

Prior authorization required for Ibtrozi

Prior authorization is required for Ibtrozi (taletrectinib). Approval for initial requests requires documentation that the patient has non-small cell lung cancer (NSCLC) that is metastatic or advanced and that the tumor is ROS1 positive.

Step Therapy

NCCN recognition (no step-therapy specified)

Ibtrozi is recognized in the NCCN Drugs and Biologics Compendium with a Category of Evidence and Consensus of 1, 2A, or 2B; the policy does not specify any required step-therapy sequencing tied to that recognition.

Documentation Required

Acceptable supporting documentation

Quantity Limits for Ibtrozi (taletrectinib)

Ibtrozi (taletrectinib) — Supply / Quantity Limits

Quantity limitSupply limit may be in place (per month)

Authorization periodAuthorization issued for 12 months when criteria met

Automatic pediatric processingMembers under 19: prescriptions automatically process without coverage review and authorized for 12 months

Approval basisUnitedHealthcare may use previous claim/medication history, diagnosis codes (ICD-10), and/or claim logic for approvals

Definitions

ROS1‑positive NSCLC — Definition and Eligibility for ROS1‑Targeted Therapy

DefinitionROS1-positive non-small cell lung cancer (NSCLC): non-small cell lung cancer in which the tumor harbors a ROS1 gene rearrangement, making it eligible for ROS1-targeted kinase inhibitor therapy such as taletrectinib.

Covered indicationIbtrozi is covered for adult patients with advanced or metastatic ROS1-positive NSCLC when all coverage criteria are met (diagnosis of NSCLC, disease is metastatic or advanced, and tumor is ROS1 positive).

Prior authorization requirementPrior authorization is required for Ibtrozi; approval requires confirmed ROS1-positive tumor and advanced/metastatic NSCLC.

Reauthorization criterionReauthorization is approved when the patient does not show evidence of progressive disease while on Ibtrozi therapy (authorization issued for 12 months).

NCCN recognitionRegimen recognized by NCCN Drugs and Biologics Compendium with Category 1, 2A, or 2B evidence/consensus.

Background

Ibtrozi (taletrectinib) is a kinase inhibitor indicated for the treatment of adult patients with advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). Prior authorization is required for Ibtrozi; approval for initial therapy requires documentation of a diagnosis of NSCLC that is advanced or metastatic and a tumor confirmed ROS1 positive. Reauthorization is contingent on the absence of evidence of progressive disease, and approvals are issued for a 12-month period when criteria are met.

Revision History

8/2025P&T approval

Program established with Pharmacy & Therapeutics (P&T) committee approval for a new prior authorization program for Ibtrozi (taletrectinib).

2025-11-01Policy effectiveLatest

Prior authorization policy for Ibtrozi (taletrectinib) became effective for UnitedHealthcare members.