CurrentColorado Rocky Mountain Health PlansPolicy N/A

Augtyro (repotrectinib) prior authorization

Defines prior authorization and reauthorization criteria for Augtyro (repotrectinib) for Colorado Rocky Mountain Health Plans members, including indications for ROS1-positive NSCLC and NTRK fusion-positive solid tumors; applies to pharmacy prior authorization/notification programs.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyAugtyro (repotrectinib) prior authorization

Policy CodePolicy N/A

Change TypeAdded NTRK indicationclarified ROS1 recurrent disease

Effective DateNov 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization for Augtyro when diagnostic and disease-state criteria for ROS1-positive NSCLC or NTRK fusion-positive solid tumors are met.

SourceLink

POLICY UPDATE CHANGES

Coverage criteria were updated to include the accelerated-approval NTRK fusion-positive solid tumor indication per the package insert.

Background and coverage criteria for NSCLC were updated to include recurrent ROS1-positive disease per NCCN recommendations.

12 monthsauthorization duration

age <19pediatric auto-process

ROS1-positiveROS1-covered

NTRK fusion

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage and Authorization Criteria

Pediatric (<19) Initial Authorization

Patients under 19 years of age

Pediatric automatic approval: Patient is less than 19 years of age

Authorization issued for 12 months

Initial Authorization — ROS1-positive NSCLC

Covered when ALL of the following are met

ROS1 NSCLC initial: (1) Diagnosis of non-small cell lung cancer (NSCLC) AND (2) Disease is advanced, metastatic, or recurrent AND (3) Disease is ROS1-positive

Authorization issued for 12 months

Reauthorization — ROS1-positive NSCLC

Reauthorization criteria

ROS1 NSCLC reauth: Patient does not show evidence of progressive disease while on Augtyro therapy

Authorization issued for 12 months

Initial Authorization — NTRK Fusion-Positive Solid Tumors

Covered when ALL of the following are met

NTRK solid tumor initial: (1) Presence of solid tumor(s) AND (2) Disease is positive for NTRK gene fusion (e.g., ETV6-NTRK3, TPM3-NTRK1, LMNA-NTRK1) AND (3) Disease is locally advanced, metastatic, or unresectable

Authorization issued for 12 months; indication approved under accelerated approval for patients ≥12 years

Reauthorization — NTRK Fusion-Positive Solid Tumors

Reauthorization criteria

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

Authorization issued for 12 months

NCCN Recommended Regimens

NCCN recognized: The drug is recognized by the NCCN Drugs and Biologics Compendium with Category 1, 2A, or 2B recommendations

May support coverage per NCCN recommendation

Coverage decisions in this document are subject to member-specific benefit plan terms and applicable state mandates. State laws or mandated benefit provisions that require coverage for certain uses or reference alternative compendia take precedence and supersede the criteria described here where they apply.

Providers should verify the member’s plan benefits and any state-specific mandates prior to submission; if a state mandate or the member’s benefit plan provides different coverage requirements, those requirements will govern the authorization decision.

Initial Therapy — Initial authorization criteria per indication (grouping/placeholder for indication-specific initial therapy blocks)

Initial authorization criteria per indication

initial_ros1: NSCLC diagnosis AND disease advanced/metastatic/recurrent AND ROS1-positive

12-month authorization

initial_ntrk: Presence of solid tumor(s) AND NTRK gene fusion positive AND disease locally advanced/metastatic/unresectable

12-month authorization; accelerated approval for ≥12 years

Provider Requirements and Authorization Process

Note

State/Benefit Limitations

Coverage may be superseded by state mandates or member benefit plan limitations. Some states mandate benefit coverage for off‑label medication use or require different compendium references; where applicable those mandates take precedence over the criteria in this policy. For members under age 19, the prescription will automatically process without a coverage review.

Prior Authorization

Authorization Sources

Approval may be based on prior claim or medication history, diagnosis codes (ICD‑10), and/or claim logic. Automated approval and re‑approval processes may be used depending on program and therapeutic class.

Step Therapy

Supply / Utilization Limits

Supply limits and utilization management programs may apply. Providers should anticipate quantity or duration limits and that prior authorization requirements may be enforced at the point of dispensing.

Initial Therapy Authorization Details

inv-15: Initial Therapy — Initial authorization criteria per indication (detailed criteria tree for initiating therapy)

Initial authorization criteria per indication

initial_ros1: Diagnosis of non-small cell lung cancer (NSCLC) AND disease is advanced, metastatic, or recurrent AND disease is ROS1-positive

Authorization issued for 12 months

initial_ntrk: Presence of solid tumor(s) AND disease is positive for NTRK gene fusion (e.g., ETV6-NTRK3, TPM3-NTRK1, LMNA-NTRK1) AND disease is locally advanced, metastatic, or unresectable

Authorization issued for 12 months; indication under accelerated approval for patients ≥12 years

Reauthorization / Continuation Criteria

Continuation/Reauthorization — Reauthorization for continued therapy

Reauthorization for continued therapy

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

Authorization periods of 12 months

Clinical Background and Indications

Repotrectinib (Augtyro) is a small-molecule kinase inhibitor indicated for treatment of adults with locally advanced or metastatic ROS1-positive non–small cell lung cancer (NSCLC). It is also indicated under accelerated approval for adults and pediatric patients aged ≥12 years with NTRK gene fusion–positive solid tumors that are locally advanced, metastatic, or unresectable and have progressed or for whom there are no satisfactory alternative treatments.

The NTRK fusion–positive indication is an accelerated approval based on tumor response rate and duration of response; continued approval for this indication may depend on verification in confirmatory trials. Clinical guidance (including NCCN recommendations) recognizes repotrectinib for ROS1-rearranged NSCLC, and authorization criteria in this policy reflect those indications with initial and reauthorization approvals issued for 12 months where applicable.

Key Definitions

inv-13: NTRK gene fusion — definition and examples of fusion events

DefinitionPresence of an NTRK (neurotrophic tyrosine receptor kinase) gene fusion detected in tumor tissue.

Common fusion examplesETV6-NTRK3, TPM3-NTRK1, LMNA-NTRK1 (examples listed in policy).

Indication contextRepotrectinib (Augtyro) is indicated for adults and pediatric patients ≥12 years with NTRK fusion–positive solid tumors that are locally advanced, metastatic, or unresectable.

inv-14: ROS1-positive — definition: tumor testing demonstrating ROS1 rearrangement

DefinitionTumor testing demonstrating ROS1 rearrangement (ROS1‑positive) in non–small cell lung cancer (NSCLC).

Indication contextAugtyro is indicated for adult patients with locally advanced or metastatic ROS1‑positive NSCLC; NCCN also recommends use for recurrent ROS1‑rearranged NSCLC.

Supply and Quantity Information

inv-17: Augtyro (repotrectinib) — may be supply limits; quantity/dispense notes

Quantity/dispense policySupply limits may be in place for Augtyro; utilization management programs and program-specific limits may apply.

Authorization basisNotwithstanding coverage criteria, approvals may be granted based solely on previous claim/medication history, diagnosis codes, and/or claim logic (automated processes may be used).

Unit timingQuantity limits are managed on a per‑month basis as applicable under program rules.

Site-of-Care Restrictions

Note

No site‑of‑care restrictions specified

No site‑of‑care restrictions are specified for Augtyro in this document.