CurrentUnitedHealthcarePolicy N/A

Step therapy for Ibtrozi (taletrectinib)

Defines step therapy requirements for coverage of Ibtrozi (taletrectinib) for patients with ROS1-positive non-small cell lung cancer and other indications; applies to UnitedHealthcare pharmacy benefits and affected members and prescribers.

Policy Summary

PayerUnitedHealthcare

PolicyStep therapy for Ibtrozi (taletrectinib)

Policy CodePolicy N/A

Change TypeNew program — step therapy added

Effective DateFeb 1, 2026

Next Review DateN/A

Key ActionRequire trial of repotrectinib (Augtyro) or entrectinib (Rozlytrek) or documented contraindication/intolerance before approving Ibtrozi for ROS1-positive NSCLC.

SourceLink

POLICY UPDATE CHANGES

New step therapy program requiring trial of repotrectinib (Augtyro) or entrectinib (Rozlytrek) before coverage of Ibtrozi (taletrectinib).

12 monthsAuthorization duration for approved requests

Step TherapyProgram type

Repotrectinib, EntrectinibRequired trial alternatives

Auto-approveMembers <19

Coverage Criteria for Ibtrozi (taletrectinib)

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Coverage criteria

Coverage for Ibtrozi (taletrectinib) is determined as follows:

Patients <19 years: Ibtrozi will be approved if the patient is less than 19 years of age.

Authorization issued for 12 months.

ROS1-positive NSCLC - Initial or continuation: Diagnosis of ROS1-positive non-small cell lung cancer AND either (1) patient has a contraindication or history of intolerance to Augtyro (repotrectinib) or Rozlytrek (entrectinib) OR (2) continuation of therapy (with verification that the patient has not been established solely via manufacturer samples or assistance).

Patients established on Ibtrozi via manufacturer samples or assistance are treated as new to therapy and must meet initial authorization criteria; members currently on Ibtrozi as documented in claims history may continue. Authorization issued for 12 months.

Other indications

Other indications: Ibtrozi will be approved for other indications consistent with state mandates and member benefit plan coverage; federal regulations and other policies may affect coverage.

Authorization issued for 12 months.

Patients who were established on therapy solely through receipt of manufacturer-supplied samples or manufacturer-sponsored assistance programs (including sample cards redeemable at a pharmacy or a 30-day free trial from a pharmacy) are treated as new to therapy for authorization purposes. Such patients must meet the initial authorization criteria for Ibtrozi (taletrectinib) rather than continuation criteria. Authorization for these requests will be issued for 12 months.

Initial Authorization Criteria

Initial therapy

Initial authorization criteria for ROS1-positive NSCLC

Initial therapy for ROS1-positive NSCLC: Diagnosis of ROS1-positive non-small cell lung cancer AND one of the following: (1) patient has a contraindication or history of intolerance to Augtyro (repotrectinib) or Rozlytrek (entrectinib); OR (2) continuation of therapy as described in continuation criteria.

Patients established only via manufacturer samples or manufacturer assistance must meet initial criteria as if new to therapy. Authorization issued for 12 months.

Provider Actions and Prior Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Ibtrozi (taletrectinib). Requests for Ibtrozi may be denied if documentation does not demonstrate that the patient trialed and failed, or has a documented contraindication or intolerance to, the required alternatives repotrectinib (Augtyro) or entrectinib (Rozlytrek). Members currently documented in claims history as receiving Ibtrozi may continue therapy; new-to-therapy members must meet the criteria below.

Prior authorization required for Ibtrozi
Denial risk if no trial or documented contraindication/intolerance to Augtyro or Rozlytrek
Continuation allowed for members with claims-documented current Ibtrozi use

Step Therapy

Step Therapy Requirement

Step therapy requirement: initial requests for Ibtrozi must include evidence that the patient trialed and failed, or has a documented contraindication or intolerance to, repotrectinib (Augtyro) or entrectinib (Rozlytrek). Alternatively, approval may be granted for continuation of therapy for members already receiving Ibtrozi as shown in claims.

Required alternatives: repotrectinib (Augtyro) or entrectinib (Rozlytrek)
Continuation allowed for established users per claims history

Documentation Required

Documentation Requirements

Documentation must support the diagnosis of ROS1-positive non-small cell lung cancer and must include clinical evidence of ROS1 positivity. Additionally, documentation must include records demonstrating a trial and failure of, or documented contraindication/intolerance to, repotrectinib (Augtyro) or entrectinib (Rozlytrek). If the member was established on therapy via a manufacturer-provided free sample or assistance program, the request must meet initial authorization criteria as if new to therapy.

Must document ROS1-positive NSCLC diagnosis (e.g., pathology/genetic testing results)
Must document trial and failure, or contraindication/intolerance, to Augtyro or Rozlytrek
Patients initiated on therapy via manufacturer samples/assistance are treated as new-to-therapy for authorization purposes

Denial Risk

Denial Conditions

Denial conditions: requests may be denied if there is no documentation of a trial and failure of, or a documented contraindication/intolerance to, the required alternatives (repotrectinib or entrectinib), or if required diagnostic evidence of ROS1-positive NSCLC is not provided. Also, requests for initial authorization may be denied if the member received a manufacturer-supplied sample or assistance but documentation to meet initial criteria is not supplied.

Possible denial if no documented trial/failure of Augtyro or Rozlytrek
Possible denial if ROS1-positive NSCLC is not documented
Initial authorizations treated strictly for patients established via manufacturer assistance — may be denied without required documentation

Step Therapy Requirements

Step	Requirement	Coverage implication
1	Patient must have trial and failure of, or documented contraindication or intolerance to, Augtyro (repotrectinib) or Rozlytrek (entrectinib).	Covered with criteria — Ibtrozi will be approved only after the required trial or documented contraindication/intolerance is met for members new to therapy.
Exception	Members currently on Ibtrozi as documented in claims history may continue therapy without meeting the step requirement.	Continuation allowed — coverage for existing users is permitted without completing the prior step.
Pediatric processing	Members under 19 years of age process automatically for approval.	Covered — members <19 years may be approved without meeting step requirements.

Key Definitions

inv-09: ROS1-positive NSCLC definition

DefinitionROS1-positive non-small cell lung cancer (NSCLC): NSCLC with a ROS1 gene rearrangement (diagnosis required for Ibtrozi coverage).

Required documentationDiagnosis of ROS1-positive NSCLC must be documented to support coverage requests for Ibtrozi.

Step therapy requirementFor new-to-therapy patients, approval requires either a contraindication or history of intolerance to Augtyro (repotrectinib) or Rozlytrek (entrectinib), or meeting continuation criteria.

Continuation allowanceMembers currently on Ibtrozi as documented in claims history may continue therapy without meeting the step requirement, subject to verification they were not established solely via manufacturer samples or assistance.

Authorization durationWhen approved, authorization is issued for 12 months.

Background

Ibtrozi (taletrectinib) is a kinase inhibitor indicated for adult patients with advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). Within this policy, Ibtrozi is included in a new step therapy program that requires trial of preferred alternatives—Augtyro (repotrectinib) or Rozlytrek (entrectinib)—before coverage for Ibtrozi will be approved for members new to therapy, unless the patient meets a documented contraindication or intolerance to those agents. Members currently documented in claims history as receiving Ibtrozi may qualify for continuation of therapy, subject to verification that they were not established on treatment solely via manufacturer samples or assistance. Authorization for approved requests is issued for 12 months.

OpenPayer