CurrentColorado Rocky Mountain Health PlansPolicy N/A

Ibtrozi (taletrectinib) — Step Therapy Coverage Criteria

Defines coverage and step therapy requirements for Ibtrozi (taletrectinib) for members, including required trials of alternative ROS1 inhibitors and special processing for patients under 19 and current users.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyIbtrozi (taletrectinib) — Step Therapy Coverage Criteria

Policy CodePolicy N/A

Change TypeNew step therapy program

Effective DateFeb 1, 2026

Next Review DateN/A

Key ActionObtain documentation of trial or documented contraindication/intolerance to repotrectinib or entrectinib before requesting coverage for Ibtrozi.

SourceLink

POLICY UPDATE CHANGES

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

12 monthsstandard authorization duration

2required prior agents

under 19members <19 auto-process

11/2025P&T approval

Coverage Criteria

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Coverage criteria

Pediatric (patients <19): Authorization is approved when the patient is less than 19 years of age.age < 19

Authorization will be issued for 12 months.

ROS1-positive NSCLC

Prior therapy or contraindication: Patient has a contraindication or history of intolerance to Augtyro (repotrectinib) OR Rozlytrek (entrectinib).
Continuation rules: Continuation of therapy AND patient has not received a manufacturer-supplied sample or any manufacturer assistance (including sample cards or 30-day free trials) used to establish current user status.

Other indications: Ibtrozi may be approved for other indications per state mandates or member-specific benefit plan coverage.

Authorization will be issued for 12 months.

State mandates, federal regulatory requirements, and the member-specific benefit plan may supersede or modify the coverage rules described in this policy. Some states mandate benefit coverage for off-label use of medications or require use of specific compendia; when such mandates apply they take precedence over the policy language. Providers should confirm applicable state requirements and the member’s benefit plan provisions when seeking coverage for indications not explicitly listed in this policy.

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for members new to Ibtrozi (taletrectinib). Members currently on Ibtrozi per claims history may continue without new prior authorization. Members under 19 years old may auto-process without coverage review.

Authorization duration: 12 months

Step Therapy

Step Therapy Requirement

A trial of Augtyro (repotrectinib) or Rozlytrek (entrectinib) is required prior to approval of Ibtrozi unless the patient has a documented contraindication or intolerance to one of these agents, or meets continuation therapy criteria.

Step agents: Augtyro (repotrectinib); Rozlytrek (entrectinib)

Documentation Required

Required Documentation

Documentation must support a ROS1‑positive NSCLC diagnosis and either: (1) documented contraindication or history of intolerance to Augtyro or Rozlytrek, or (2) justification for continuation of therapy. Documentation may include prior medication/claim history, provider notes, diagnostic testing confirming ROS1 positivity, and records showing prior manufacturer assistance or sample receipt when relevant.

Required: evidence of ROS1‑positive NSCLC (pathology/genetic testing)
If claiming contraindication/intolerance: clinical notes detailing adverse reaction or reason for contraindication
If continuation: prior claim/medication history showing Ibtrozi use; note if patient received manufacturer sample or assistance

Denial Risk

Step Therapy Noncompliance

Failure to document required step‑therapy trial or a valid contraindication/intolerance, or failure to meet continuation requirements (including evidence of prior use or exclusion for manufacturer sample assistance), may result in denial of authorization. Automated approvals may occur only when prior claim/medication history or diagnosis codes substantiate therapy; absence of such evidence risks noncoverage.

Denial risk if no documentation of trial, contraindication/intolerance, or prior Ibtrozi use
Automated approval possible when claims/ICD-10 history alone support use — do not assume approval without documentation

Step	Requirement	Coverage status
1
Trial of Augtyro (repotrectinib) or Rozlytrek (entrectinib) prior to initiation of Ibtrozi (taletrectinib); trial may be bypassed if patient has a documented contraindication or history of intolerance to one of these agents.
Coverage of Ibtrozi allowed after required trial or documented contraindication/intolerance

Definitions

ROS1-positive NSCLC definition key/value

TermROS1-positive non-small cell lung cancer (ROS1-positive NSCLC)

Clinical definitionNon‑small cell lung cancer with a ROS1 gene rearrangement (ROS1‑positive)

Policy implicationDiagnosis of ROS1‑positive NSCLC is required for coverage of Ibtrozi (taletrectinib).

Related therapiesStep therapy requires trial of Augtyro (repotrectinib) or Rozlytrek (entrectinib) prior to Ibtrozi unless contraindicated or not tolerated.

Authorization durationAuthorization will be issued for 12 months when criteria met.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyIbtrozi (taletrectinib) — Step Therapy Coverage Criteria

Policy CodePolicy N/A

Change TypeNew step therapy program

Effective DateFeb 1, 2026

Next Review DateN/A

Key ActionObtain documentation of trial or documented contraindication/intolerance to repotrectinib or entrectinib before requesting coverage for Ibtrozi.

SourceLink

On This Page

OpenPayer

Ibtrozi (taletrectinib) — Step Therapy Coverage Criteria

Coverage Criteria

Provider Actions & Requirements

Initial Therapy

Continuation Therapy

Step Therapy Requirements

Definitions

Background