ModifiedmhnPolicy CP.PHAR.667

Repotrectinib (Augtyro) coverage

Medical necessity and prior authorization criteria for repotrectinib (Augtyro) for ROS1-positive NSCLC and NTRK‑fusion–positive cancers, including initial and continued therapy requirements and dosing limits; applies to members under the payer's commercial, HIM, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyRepotrectinib (Augtyro) coverage

Policy CodePolicy CP.PHAR.667

Change TypeAdded NTRK cancer indicationclarified NSCLC recurrent diseasedosing/capsule strength update

Effective DateMar 1, 2024

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of diagnosis, biomarker positivity, prescriber specialty, age, and dosing within policy limits.

SourceLink

POLICY UPDATE CHANGES

Added a new solid tumor (NTRK fusion-positive cancer) indication with specific criteria and dosing using the 160 mg capsule strength.

For NSCLC, recurrent disease was added per NCCN compendium recommendation.

NTRK fusion-positive 'solid tumor' section was revised to 'NTRK fusion-positive cancer' to include certain off-label non-solid tumor indications (e.g., histiocytic neoplasms).

320 mg/dayMaximum daily dose

6 monthsInitial approval

12 monthsContinued approval

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Coverage Criteria

Initial Therapy — ROS1-positive NSCLC

Covered when ALL of the following are met for ROS1-positive NSCLC:

NSCLC initial criteria: 1. Diagnosis of recurrent, locally advanced, or metastatic non-small cell lung cancer (NSCLC); 2. Prescribed by or in consultation with an oncologist; 3. Age ≥ 18 years; 4. Disease is ROS1 positive; 5. Member must use repotrectinib (Augtyro) when available unless contraindicated or clinically significant adverse effects are experienced; 6. Request meets one of the following: (a) Dose does not exceed both (i) 320 mg per day and (ii) 2 capsules per day; OR (b) Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use with prescriber-submitted supporting evidence. Prescribed regimen must be FDA-approved or recommended by NCCN.

Approval duration: 6 months

Initial Therapy — NTRK fusion-positive cancer

Covered when ALL of the following are met for NTRK fusion-positive cancer:

NTRK initial criteria: 1. Diagnosis of one of the following: (a) solid tumor (see Appendix D for examples); OR (b) histiocytic neoplasm (e.g., Erdheim-Chester disease, Langerhans cell histiocytosis, Rosai-Dorfman disease) (off-label); 2. Prescribed by or in consultation with: (a) an oncologist; OR (b) for histiocytic neoplasm, a hematologist; 3. Age ≥ 12 years; 4. Disease is positive for an NTRK gene fusion (e.g., ETV6-NTRK3, IL1RL2-NTRK2, TPM3-NTRK1); 5. Disease meets one of the following: (a) recurrent, advanced, or metastatic; (b) surgical resection is likely to result in severe morbidity; OR (c) is a histiocytic neoplasm; 6. One of the following applies: (a) disease has progressed following treatment; (b) there is no satisfactory alternative therapy; OR (c) disease is one of the NCCN compendium recommended indications (examples include biliary tract cancer, GIST, salivary gland tumors, hepatocellular carcinoma, histiocytic neoplasms, NSCLC, pancreatic adenocarcinoma, soft tissue sarcoma, anaplastic thyroid carcinoma); 7. Member must use repotrectinib (Augtyro) when available unless contraindicated or clinically significant adverse effects are experienced; 8. Request meets one of the following: (a) Dose does not exceed both (i) 320 mg per day and (ii) 2 capsules per day; OR (b) Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use with prescriber-submitted supporting evidence. Prescribed regimen must be FDA-approved or recommended by NCCN.

Approval duration: 6 months

Continuation Therapy

Covered when ALL of the following are met for continuation:

Continued therapy criteria: 1. Member is currently receiving Augtyro via the Centene benefit, or documentation supports current use for a covered indication and member has received Augtyro for at least 30 days; 2. Member is responding positively to therapy; 3. Member must use repotrectinib (Augtyro) when available unless contraindicated or clinically significant adverse effects are experienced; 4. If request is for a dose increase, request meets one of the following: (a) new dose does not exceed both (i) 320 mg per day and (ii) 2 capsules per day; OR (b) new dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use with prescriber-submitted supporting evidence. Prescribed regimen must be FDA-approved or recommended by NCCN.

Approval duration: 12 months

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with the payer's applicable off‑label use policies (for example, CP.CPA.09 for commercial, HIM.PA.154 for Health Insurance Marketplace, or CP.PMN.53 for Medicaid) or per the member's evidence of coverage documents.

Coverage and administration of benefits described in this policy are subject to all terms, conditions, exclusions, and limitations of the member's coverage documents (for example, evidence of coverage, certificate of coverage, policy, or contract of insurance), as well as applicable state and federal requirements and Health Plan administrative policies and procedures. This policy is intended as a guide to medical necessity and does not guarantee coverage or payment.

Indication	Regimen / Dosing	Capsule strengths	Maximum daily dose
ROS1‑positive non‑small cell lung cancer (NSCLC)	Start 160 mg PO once daily for 14 days, then 160 mg PO twice daily until disease progression or unacceptable toxicity.	40 mg, 160 mg	320 mg/day
NTRK fusion‑positive cancers (advanced/metastatic solid tumors and histiocytic neoplasms)	Start 160 mg PO once daily for 14 days, then 160 mg PO twice daily until disease progression or unacceptable toxicity.	40 mg, 160 mg	320 mg/day

Coding

Codes referencedmixed

N/A	No specific CPT/HCPCS/ICD-10/NDC codes listed in this document portion.

inv-07: Maximum daily dose

Maximum daily dose320 mg/day

Capsule strengths available40 mg and 160 mg capsules

Usual maintenance regimen160 mg PO BID after 14-day lead-in (160 mg PO QD) until progression or unacceptable toxicity

Provider Actions & Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must submit documentation (such as office chart notes, lab results, pathology reports, biomarker testing results, and other clinical information) that supports the diagnosis, biomarker positivity (e.g., ROS1 or NTRK fusion), prescriber specialty, age criteria, dosing, and other approval criteria in this policy.

Affected drugs: Augtyro (repotrectinib)
Prescriber: oncologist (or hematologist for histiocytic neoplasms) as specified in criteria
Age requirements: ≥18 for NSCLC; ≥12 for NTRK fusion–positive cancers
Documentation: office notes, labs, pathology, biomarker reports

Denial Risk

Potential Denial for Non‑Listed or Non‑FDA Indications

Requests for indications that are not listed in this policy or are non‑FDA approved may be denied unless the prescriber provides sufficient supporting documentation of efficacy and safety consistent with the applicable off‑label use policies and evidence of coverage documents.

Definitions

inv-17: Definition — ROS1-positive disease (NSCLC)

DefinitionROS1-positive disease (NSCLC) confirmed by testing demonstrating ROS proto-oncogene 1 positivity.

FDA indication contextAugtyro indicated for adult patients with locally advanced or metastatic ROS1-positive NSCLC.

Coverage requirement noteCovered when disease is ROS1 positive per policy initial approval criteria (NSCLC).

inv-18: Definition — Presence of NTRK gene fusion (examples included)

DefinitionPresence of an NTRK gene fusion (examples include ETV6-NTRK3, IL1RL2-NTRK2, TPM3-NTRK1).

FDA indication contextAugtyro indicated for patients ≥12 years with solid tumors that have an NTRK gene fusion and are locally advanced/metastatic or where surgery likely causes severe morbidity.

Line of Therapy

Second-line | Salvage

Second-line / salvage use: Policy allows use in recurrent, locally advanced, or metastatic disease and, for NTRK indications, when disease has progressed following treatment or there is no satisfactory alternative therapy or the tumor type is listed in the NCCN compendium (see criteria I.B).

Biomarker Requirements

inv-21: ROS1 biomarker requirement

Required biomarker testDocumented ROS1 positivity is required for the NSCLC indication (testing demonstrating ROS proto-oncogene 1 positivity).

Prescriber requirementRequest must be prescribed by or in consultation with an oncologist for NSCLC indication.

Prior authorization evidencePrior authorization requires documentation of diagnosis and biomarker positivity per policy prior authorization requirements.

inv-22: NTRK gene fusion requirement

Required biomarker testDocumented presence of an NTRK gene fusion (e.g., ETV6-NTRK3, IL1RL2-NTRK2, TPM3-NTRK1) is required for the NTRK indication.

Age and clinical contextIndication applies to patients ≥12 years for solid tumors that are locally advanced/metastatic or where surgery would cause severe morbidity, and for histiocytic neoplasms as specified.

Background

Repotrectinib (Augtyro) is a small‑molecule kinase inhibitor with regulatory indications for ROS1‑positive and NTRK fusion‑positive disease. The agent is indicated for adult patients with locally advanced or metastatic ROS1‑positive non‑small cell lung cancer, and for patients aged ≥12 years with NTRK fusion‑positive solid tumors that are advanced or metastatic or where surgical resection is likely to result in severe morbidity under the accelerated approval context. Dosing per the product information begins with 160 mg orally once daily for 14 days, then 160 mg orally twice daily until disease progression or unacceptable toxicity, with a maximum daily dose of 320 mg/day. Repotrectinib is supplied as capsules, including 40 mg and 160 mg strengths.