CurrentCignaPolicy N/A

Oncology (Oral - ROS1 Inhibitor) - Ibtrozi Prior Authorization Policy

Cigna prior authorization policy for outpatient prescription coverage of Ibtrozi (taletrectinib) for adults with ROS1‑positive non‑small cell lung cancer.

Policy Summary

PayerCigna

PolicyOncology (Oral - ROS1 Inhibitor) - Ibtrozi Prior Authorization Policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateJun 18, 2025

Key ActionObtain prior authorization and document patient is ≥18 with ROS1‑positive locally advanced or metastatic NSCLC detected by an approved test.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 yrinitial approval duration

≥18minimum age

ROS1+ NSCLCcovered indication

Other uses NMIexclusion

Coverage Criteria for Ibtrozi (taletrectinib)

Initial therapy — FDA‑approved indication

Covered when ALL of the following are met

FDA‑Approved Indication (NSCLC): A) Patient is ≥ 18 years of age; AND B) Patient has locally advanced or metastatic disease; AND C) Patient has ROS1‑positive non‑small cell lung cancer; AND D) The mutation was detected by an approved test.

Approve for 1 year when all criteria met.

Regimen	Indication / NCCN role	Coverage status	Approval duration
Ibtrozi (taletrectinib)	Preferred first-line option for ROS1-positive non‑small cell lung cancer per NCCN (category 2A); preferred choice for patients with brain metastases; also recommended as a subsequent therapy if not previously given.	Covered	Approve for 1 year when FDA‑approved indication criteria are met.

Ibtrozi™ (taletrectinib) is considered not medically necessary for ANY use(s) other than those specifically listed in this policy. This includes any indications, diagnoses, or clinical situations not explicitly approved in the coverage criteria for ROS1‑positive non‑small cell lung cancer.

Any use of Ibtrozi™ (taletrectinib) that is not specified in this policy as an FDA‑approved indication or otherwise supported is considered not medically necessary. The policy criteria will be updated if new published data become available.

Policy Summary

PayerCigna

PolicyOncology (Oral - ROS1 Inhibitor) - Ibtrozi Prior Authorization Policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateJun 18, 2025

Key ActionObtain prior authorization and document patient is ≥18 with ROS1‑positive locally advanced or metastatic NSCLC detected by an approved test.

SourceLink

On This Page

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Provider Actions, Authorization & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required — approvals provided for listed duration when criteria for the FDA‑approved indication are met.

Prior Authorization recommended for Ibtrozi; approvals provided for 1 year when FDA‑approved NSCLC criteria are met.
Coverage limited to FDA‑approved indication(s) or other uses with supportive evidence when criteria are satisfied.

Note

Guideline Context for Sequencing

Guideline context for sequencing — NCCN lists multiple preferred ROS1 inhibitors and sequencing notes that may inform treatment choice and prior authorization decisions.

NCCN (NSCLC v5.2025) designates Ibtrozi, repotrectinib (Augtyro), entrectinib (Rozlytrek), and crizotinib (Xalkori) as preferred first‑line options (category 2A).
For subsequent therapy, recommended options include Ibtrozi (if not previously given), repotrectinib (Augtyro) if not previously given, or lorlatinib (Lorbrena) — all category 2A.
For brain metastases or symptomatic intracranial progression, Ibtrozi, Augtyro, or Lorbrena are preferred; Rozlytrek may be useful if previously treated with crizotinib. Augtyro or Ibtrozi may be options for resistant ROS1 mutations such as G2032R.

Documentation Required

Required Clinical Documentation

Required clinical documentation — documentation must show age, disease stage, ROS1‑positive status, and test details.

Document patient age (≥ 18 years) and that disease is locally advanced or metastatic.
Document ROS1‑positive non‑small cell lung cancer and that the ROS1 mutation was detected by an approved test (include test name and date).
Include clinical notes supporting FDA‑approved indication or supportive evidence for non‑FDA uses, and prior therapy history relevant to sequencing decisions.

Denial Risk

Coding & Claim Denial Risk

Coding noncompliance may trigger denial — claims without covered diagnosis/procedure codes will be denied.

Claims must include covered diagnosis and procedure/drug codes that correspond to the approved indication and the applicable benefit plan; otherwise claims will be denied as not covered.
When billing, providers must use the most appropriate codes as of the service date.

Definitions and Test Requirements

inv-09: ROS1‑positive NSCLC — definition entry

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

Clinical contextLocally advanced or metastatic disease in adults

Age requirementPatient is ≥ 18 years of age

Policy actionCovered when all FDA‑approved indication criteria are met; approve for 1 year

inv-10: Approved ROS1 test — test must be approved per FDA or regulatory guidance

RequirementTest must be an approved test per FDA or other regulatory guidance

PurposeTo confirm ROS1 mutation for eligibility for Ibtrozi (taletrectinib)

Relation to coverageMutation detection by an approved test is required for approval under the FDA‑approved indication

inv-13: ROS1 — Positive (ROS1‑positive NSCLC) detected by an approved test

BiomarkerROS1 — Positive

ContextROS1‑positive NSCLC detected by an approved test

Coverage implicationPresence of a ROS1‑positive result is one of the required criteria for 1‑year approval

VerificationDocumentation must show mutation detected by an approved test

Background

Ibtrozi™ (taletrectinib) is indicated for the treatment of locally advanced or metastatic ROS1‑positive non‑small cell lung cancer (NSCLC) in adults. National Comprehensive Cancer Network (NCCN) guidance (v5.2025) lists Ibtrozi among the preferred first‑line options for ROS1‑positive NSCLC and notes activity against certain ROS1 resistance mutations and in patients with brain metastases.

For coverage, prior authorization is recommended and approval is provided when the member meets the FDA‑approved indication criteria: the patient is ≥18 years of age, has locally advanced or metastatic disease, has documented ROS1‑positive NSCLC, and the ROS1 alteration was detected by an approved test. When all criteria are met, approval is granted for 1 year.

OpenPayer

Oncology (Oral - ROS1 Inhibitor) - Ibtrozi Prior Authorization Policy

Coverage Criteria for Ibtrozi (taletrectinib)

Provider Actions, Authorization & Documentation

Definitions and Test Requirements

Line of Therapy Criteria

Background