ModifiedColorado Rocky Mountain Health PlansPolicy 2025 1430-3

Augtyro (repotrectinib) prior authorization / coverage criteria

Prior authorization and coverage criteria for Augtyro (repotrectinib) for members, including indications for ROS1-positive NSCLC and NTRK fusion-positive solid tumors, with special auto-approval rules for patients under 19 years. Authorization lengths and reauthorization requirements are specified.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyAugtyro (repotrectinib) prior authorization / coverage criteria

Policy CodePolicy 2025 1430-3

Change TypeCoverage program created and indications updated (1/20248/20248/2025)

Effective DateNov 1, 2025

Next Review Date

Key ActionPrior authorization/notification program applies for Augtyro; members must meet criteria listed for approval and authorizations are issued for 12 months.

SourceLink

POLICY UPDATE CHANGES

New program created (1/2024).

Updated background and coverage criteria to include new indication for solid tumors with NTRK gene fusion per package insert (8/2024).

Updated background and coverage criteria for NSCLC to include recurrent ROS1-positive disease per NCCN (8/2025).

2Covered Indications (ROS1 NSCLC; NTRK fusion solid tumors)

12Authorization duration (months)

≤18Automatic processing age threshold

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Coverage stance: covered_with_criteria. Covered indications: ROS1-positive NSCLC (locally advanced, metastatic, or recurrent) and NTRK gene fusion-positive solid tumors (locally advanced, metastatic, or unresectable). Authorization duration: 12 months for initial approvals and reauthorizations. Automatic processing age threshold: ≤18 (members under age 19 automatically process without a coverage review). Scope summary: Prior authorization and coverage criteria for Augtyro (repotrectinib) for members, including indications for ROS1-positive NSCLC and NTRK fusion-positive solid tumors, with special auto-approval rules for patients under 19 years and specified reauthorization requirements.

Key policy facts

Authorization duration12 months when criteria met (initial and reauthorization)

Covered indications (count)2 (ROS1-positive NSCLC; NTRK gene fusion-positive solid tumors)

Covered indication names1) Locally advanced or metastatic ROS1-positive NSCLC (adults); 2) NTRK fusion-positive locally advanced/metastatic or unresectable solid tumors (adults and pediatric ≥12)

Automatic processing age thresholdPatients <19 years (automatic processing; authorization issued for 12 months)

Effective date / Last reviewEffective: 2025-11-01; Last review: 2025-08

Policy number / Status2025 1430-3 / MODIFIED

Initial Therapy Criteria

Initial Authorization for ROS1-positive NSCLC

Augtyro will be approved based on all of the following criteria:

ALL of the following

Diagnosis of non-small cell lung cancer (NSCLC)
Disease is one of the following
- Advanced
- Metastatic
- Recurrent
Disease is ROS1-positive

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Initial Authorization for NTRK gene fusion-positive solid tumors

Augtyro will be approved based on all of the following criteria:

ALL of the following

Presence of solid tumor(s)
Disease is positive for neurotrophic tyrosine receptor kinase (NTRK) gene fusion (e.g., ETV6-NTRK3, TPM3-NTRK1, LMNA-NTRK1)
Disease is one of the following
- Locally advanced
- Metastatic
- Unresectable

Patients less than 19 years of age

Augtyro will be approved based on the following criterion:

ALL of the following

Patient is less than 19 years of age
Authorization will be issued for 12 months.

Continuation / Reauthorization Criteria

Reauthorization for ROS1-positive NSCLC

Augtyro will be approved based on the following criterion:

ALL of the following

Patient does not show evidence of progressive disease while on Augtyro therapy

Reauthorization for NTRK gene fusion-positive solid tumors

Augtyro will be approved based on the following criterion:

ALL of the following

Patient does not show evidence of progressive disease while on Augtyro therapy

NCCN Recognition

NCCN Recommended Regimens

Recognition by NCCN Drugs and Biologics Compendium

Drug recognized for treatment of the cancer indication by NCCN Compendium with a Category of Evidence and Consensus of 1, 2A, or 2B

Augtyro (repotrectinib) is a kinase inhibitor indicated for adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). It is also indicated for adult and pediatric patients ≥12 years with solid tumors harboring an NTRK gene fusion that are locally advanced, metastatic, or where surgical resection is likely to result in severe morbidity, and that have progressed following treatment or have no satisfactory alternative therapy.

The NTRK solid tumor indication is approved under accelerated approval based on overall response rate and duration of response; continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials. The NCCN also recommends Augtyro for recurrent ROS1-positive NSCLC; the drug is recognized in the NCCN Drugs and Biologics Compendium with an appropriate Category of Evidence and Consensus.

Glossary: ROS1-positive = tumors harboring ROS1 rearrangement. NTRK gene fusion-positive = tumors positive for neurotrophic tyrosine receptor kinase gene fusions (examples include ETV6-NTRK3, TPM3-NTRK1, LMNA-NTRK1).

Provider Actions & Requirements

Prior Authorization

Prior authorization required

Prior authorization/notification program applies for Augtyro; members must meet criteria listed for approval. Authorization will be issued for 12 months when criteria met.

Authorization duration: 12 months

Documentation Required

Clinical evidence for molecular markers

Document tumor molecular testing showing ROS1-positivity for NSCLC or presence of an NTRK gene fusion (examples include ETV6-NTRK3, TPM3-NTRK1, LMNA-NTRK1) to support initial authorization.

Denial Risk

Reauthorization denial risk

Reauthorization requires that the patient does not show evidence of progressive disease while on Augtyro therapy; claims may be denied if documentation or claims indicate disease progression.

Billing Rule

Automatic processing for minors

For members under age 19, the prescription will automatically process without a coverage review; authorization will be issued for 12 months.

Automatic processing age threshold: <19 years
Authorization duration: 12 months

Documentation Required

Potential automated approvals

UnitedHealthcare may approve initial and reauthorization based solely on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic; use of automated approval and re-approval processes varies by program.

Clinical Evidence & Background

References / evidence: P&T approval dates: 1/2024, 8/2024, 8/2025; Package insert: Bristol-Myers Squibb, June 2024; NCCN Compendium access date: Accessed July 2, 2025.

Note on accelerated approval: The NTRK solid tumor indication was granted under accelerated approval based on overall response rate and duration of response; continued/full approval is contingent on verification of clinical benefit from confirmatory trials.

Definitions & P&T

ROS1-positiveTumors harboring ROS1 rearrangement.

NTRK gene fusion-positiveTumors positive for neurotrophic tyrosine receptor kinase gene fusions (examples: ETV6-NTRK3, TPM3-NTRK1, LMNA-NTRK1).

P&T Approval Dates1/2024, 8/2024, 8/2025

Revision History

1/2024program_created

New program created (Prior Authorization/Notification for Augtyro).

8/2024coverage_updated

Updated background and coverage criteria to include new indication for solid tumors with NTRK gene fusion per package insert (accelerated approval; confirmatory trials required).

8/2025coverage_updatedLatest

Updated background and coverage criteria for NSCLC to include recurrent ROS1-positive disease per NCCN recommendations.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyAugtyro (repotrectinib) prior authorization / coverage criteria

Policy CodePolicy 2025 1430-3

Change TypeCoverage program created and indications updated (1/20248/20248/2025)

Effective DateNov 1, 2025

Next Review Date

Key ActionPrior authorization/notification program applies for Augtyro; members must meet criteria listed for approval and authorizations are issued for 12 months.

SourceLink

On This Page

OpenPayer

Augtyro (repotrectinib) prior authorization / coverage criteria

Coverage Summary

Initial Therapy Criteria

Continuation / Reauthorization Criteria

NCCN Recognition

Provider Actions & Requirements

Applicable Codes

Clinical Evidence & Background

Revision History