CurrentBlue Cross Blue Shield - IowaPolicy 05.05.30

Augtyro (repotrectinib) Medical Policy

Defines coverage, prior authorization criteria, continuation criteria, dosing/quantity limits, and billing guidance for Augtyro (repotrectinib) for members of Blue Cross Blue Shield - Iowa consistent with FDA labeling and compendia.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyAugtyro (repotrectinib) Medical Policy

Policy CodePolicy 05.05.30

Change TypeRevision (Jan 2026)

Effective DateJan 1, 2026

Next Review Date

Key ActionSubmit prior authorization with documentation of NTRK gene fusion status or ROS1 status (where applicable) to initiate review; approvals are for 12 months.

SourceLink

POLICY UPDATE CHANGES

Policy reviewed and revised in January 2026 with current effective date January 1, 2026.

3Covered Indications (FDA/Compendial categories listed)

12Authorization Duration (months)

240Std qty limit 40 mg capsules

Coverage Summary

Policy stance: Augtyro (repotrectinib) is covered with criteria when member benefits permit, aligned with FDA-approved indications and compendial uses. FDA-approved indications include treatment of ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) and treatment of adult and pediatric patients aged ≥12 years with solid tumors harboring an NTRK gene fusion that are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity. Compendial uses include NTRK1/2/3 gene fusion–positive or ROS1 rearrangement–positive NSCLC and NTRK gene fusion–positive histiocytic neoplasms (Erdheim-Chester Disease, Langerhans Cell Histiocytosis, Rosai–Dorfman Disease).

Coverage is provided through prior authorization with required documentation (e.g., laboratory evidence of NTRK gene fusion or ROS1 status) and approvals may be granted for an authorization duration of 12 months for initial and continued therapy when criteria are met. The policy effective date is January 1, 2026 and the document was reviewed and revised in January 2026.

Initial Therapy Criteria (Prior Authorization)

Criteria for Initial Approval

Authorization of 12 months may be granted when criteria below are met:

ONE of the following covered indications

Recurrent, advanced, or metastatic ROS1-positive non-small cell lung cancer (NSCLC); treatment as a single agent
Authorization duration = 12 months
Solid tumors in members ≥12 years with an NTRK gene fusion that are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy; treatment as a single agent>= 12 years
Authorization duration = 12 months; NTRK demonstrated by laboratory testing (e.g., NGS or FISH)
Histiocytic neoplasms with NTRK gene fusion: symptomatic or relapsed/refractory Erdheim-Chester Disease (ECD); Langerhans Cell Histiocytosis (LCH); symptomatic or relapsed/refractory Rosai-Dorfman Disease; treatment as a single agent
Authorization duration = 12 months

Required Documentation

Submission of the following information is necessary to initiate the prior authorization review:

NTRK gene fusion status or ROS1 status (where applicable)

Continuation of Therapy Criteria

Continuation of Therapy

Authorization of 12 months may be granted for continued treatment when criteria below are met:

ANY of the following

Continued treatment for ROS1-positive NSCLC when there is no evidence of unacceptable toxicity while on the current regimen
Authorization duration = 12 months
Continued treatment for NTRK gene-fusion positive solid tumors when there is no evidence of unacceptable toxicity or disease progression while on the current regimen
Authorization duration = 12 months

Provider Actions and Billing Guidance

Prior Authorization

Prior authorization required

Submit prior authorization with documentation of NTRK gene fusion status or ROS1 status (where applicable) to initiate review; approvals are for 12 months.

Documentation Required

Laboratory evidence required

Provide laboratory testing demonstrating NTRK gene fusion (e.g., NGS or FISH) or ROS1 status as applicable.

Documentation Required

Reauthorization requirements

For continuation, document absence of unacceptable toxicity (all indications) and absence of disease progression (all other indications except explicit ROS1 continuation criterion which requires no unacceptable toxicity).

Billing Rule

Quantity limits

Adhere to quantity limits: Augtyro 40 mg capsules standard limit = 240 per 30 days; 160 mg capsules (1) = 60 per 30 days. Dosing per FDA recommended schedule and dose reductions apply.

40 mg capsules, Standard Limit = 240 per 30 days
160 mg capsules (1) = 60 per 30 days
FDA recommended dosing and dose reduction guidance apply

Background and Definitions

Background: The policy aligns coverage with FDA-approved labeling and compendial uses for repotrectinib (Augtyro). It specifies coverage for ROS1-positive NSCLC and for solid tumors with an NTRK gene fusion in patients aged ≥12 years, as well as compendial coverage for NTRK fusion–positive histiocytic neoplasms including Erdheim-Chester Disease, Langerhans Cell Histiocytosis, and Rosai–Dorfman Disease. Coverage is provided only when the member’s benefits permit and prior authorization criteria (including documentation of NTRK or ROS1 status) are satisfied.

Term	Definition
NTRK	Neurotrophic tyrosine receptor kinase gene fusion
ROS1	ROS1 rearrangement positive