CurrentNeighborhood Health Plan of Rhode IslandPolicy UM ONC_1490

Drug Policy: Augtyro (repotrectinib)

Defines accepted indications, inclusion and exclusion criteria, and authorization/approval processes for Augtyro (repotrectinib) for Neighborhood Health Plan of Rhode Island members; applies to requests processed by Evolent/UM. Affects prescribers seeking coverage for Augtyro.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDrug Policy: Augtyro (repotrectinib)

Policy CodePolicy UM ONC_1490

Change TypeNo material change

Effective DateAug 30, 2024

Next Review Date

Key ActionSubmit prior authorization requests to Evolent/Utilization Management with supporting evidence from FDA labeling, CMS compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 yrsminimum age for NTRK indication

160 mgsingle dose maximum

ROS1+NSCLC biomarker requirement

30 dayscontinuation lapse allowed

Coverage Criteria for Augtyro (repotrectinib)

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Non-Small Cell Lung Cancer (ROS1+)

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

ROS1 NSCLC coverage: Member has locally advanced or metastatic non–small cell lung cancer that is positive for a ROS1 rearrangement.

Augtyro may be used as initial or subsequent line therapy.

Solid Tumors (NTRK fusion-positive)

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

NTRK solid tumor coverage: Member is age ≥ 12 years; tumor harbors a neurotrophic tyrosine receptor kinase (NTRK) gene fusion; disease is locally advanced or metastatic or surgical resection is likely to result in severe morbidity; and disease has progressed following treatment or there is no satisfactory alternative therapy.age >= 12 years

Continuation Therapy Exemption

Continuation requests exempt from full policy if ALL the following are met:

Continuation exemption: Member has not experienced disease progression on the requested medication; the requested medication was used within the last year without a lapse of more than 30 days of having an active authorization; and no additional medication(s) are being added to the continuation request.lapse <= 30 days

Applies only to continuation requests for medications that would otherwise be not-approvable under this policy.

Coverage is denied when any of the policy exclusion criteria are met. Specifically, requests will be excluded for members who have experienced disease progression while taking Augtyro (repotrectinib), for requests that propose concurrent use with other anticancer therapies, or if the requested dosing would exceed the policy quantity limit of a single dose greater than 160 mg.

Continuation requests that seek to circumvent these exclusions will not be approved if the member has progressed on the drug or if additional anticancer agents are being added. The single-dose maximum of 160 mg must be observed for all approvals; requests that exceed this threshold should be denied or returned for dose correction.

Off-label uses of Augtyro that are not supported by sufficient evidence are considered investigational and are excluded from coverage. The policy defines insufficient evidence as situations where the published literature does not adequately represent the patient or tumor clinical characteristics, the regimen under study, or clinically meaningful outcomes.

Examples of evidence shortcomings that render an off-label indication non-coverable include reliance on case reports or meeting abstracts without a peer‑reviewed full article, studies with inappropriate experimental design for the question at hand, or reports that do not demonstrate clinically meaningful benefit (for example, survival improvements that do not meet commonly accepted thresholds such as the ASCO-recommended benchmarks). Uses lacking support from CMS‑recognized compendia or acceptable peer‑reviewed literature meeting these standards should be considered investigational and not approvable.

Initial Therapy — Indications and Requirements

ROS1 NSCLC

Initial or subsequent line therapy for ROS1-positive NSCLC:

Initial/subsequent ROS1 NSCLC: Member has locally advanced or metastatic non–small cell lung cancer positive for a ROS1 rearrangement.

Augtyro may be used as initial or subsequent line therapy.

NTRK Fusion Solid Tumors

Use for NTRK fusion–positive solid tumors after progression or when no satisfactory alternative exists:

NTRK solid tumor initial use: Member is an adult or pediatric patient aged ≥ 12 years with a solid tumor that harbors an NTRK gene fusion, the disease is locally advanced or metastatic or surgical resection is likely to cause severe morbidity, and the disease has progressed following treatment or there is no satisfactory alternative therapy.age >= 12 years

Provider Actions and Authorization Process

Prior Authorization

Prior Authorization Required

Prior authorization is required and routed to Utilization Management for review and final approval. Evolent (on behalf of the payer) processes all medication requests from network ordering providers; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

All prior authorization requests are reviewed by the Utilization Management Department and final approval is by the Utilization Management Committee
Requests not authorized by Evolent may be denied and result in non-reimbursement

Note

Continuation Exemption — Operational Conditions

Continuation (renewal) requests for medications that would otherwise be not-approvable are exempt from this policy only when all operational conditions are met: the member has not experienced disease progression on the requested medication; the medication was used within the last year without a lapse of more than 30 days of having an active authorization; and no additional medications are being added to the continuation request.

Member has not experienced disease progression on the requested medication
Requested medication was used within the last year without >30 day lapse of active authorization
No additional medications are being added to the continuation request

Documentation Required

Supporting Evidence Requirement

Use of Augtyro (repotrectinib) must be supported by one of the following sources: FDA-approved product labeling; CMS-recognized compendia; National Comprehensive Cancer Network (NCCN); American Society of Clinical Oncology (ASCO) clinical guidelines; or peer-reviewed literature that meets CMS evidence standards. Requests lacking adequate supporting evidence will be subject to denial.

Acceptable evidence sources: FDA product labeling; CMS-recognized compendia; NCCN or ASCO clinical guidelines; peer-reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 requirements
Peer-reviewed literature must adequately represent the patient population, regimen, and clinically meaningful outcomes as described in policy
Case reports and abstracts without full peer-reviewed articles generally do not provide adequate supporting evidence

Denial Risk

Denial / Exclusion Triggers

Requests will be excluded or denied under the following conditions related to member status and therapy: disease progression while taking Augtyro, concurrent use with other anticancer therapies, dosing exceeding single dose limit, investigational use without sufficient evidence, or when continuation exemption conditions are not met.

Denial triggers: documented disease progression on Augtyro (repotrectinib)
Denial triggers: concurrent use with other anticancer therapies
Denial triggers: dosing above the single dose limit of 160 mg
Denial triggers: investigational or off-label indications not supported by CMS compendia or acceptable peer-reviewed evidence
Denial triggers: continuation requests that fail to meet the exemption operational conditions (e.g., >30 day lapse, addition of other medications, or prior disease progression)

Definitions and Key Terms

ROS1-positive NSCLC definition

Disease scopeLocally advanced or metastatic Non–Small Cell Lung Cancer (NSCLC)

Biomarker requirementTumor must be positive for a ROS1 rearrangement (ROS1-positive)

Line of therapyMay be used as initial or subsequent line therapy for ROS1-rearranged NSCLC

NTRK fusion–positive solid tumor definition

Disease scopeLocally advanced or metastatic solid tumors (adult and pediatric members ≥12 years)

Biomarker requirementTumor must harbor an NTRK gene fusion (NTRK fusion-positive)

Clinical contextIndicated when surgical resection is likely to cause severe morbidity and disease has progressed following treatment or no satisfactory alternative exists

Minimum ageEligible in members 12 years of age and older

Background on Augtyro (repotrectinib)

Repotrectinib (Augtyro) is an antineoplastic targeted therapy indicated for patients with ROS1‑rearranged locally advanced or metastatic non–small cell lung cancer (NSCLC) and for NTRK fusion–positive locally advanced or metastatic solid tumors when surgery would likely cause severe morbidity or when disease has progressed and no satisfactory alternative therapy exists. The policy references FDA labeling and recognized oncology compendia and guidelines as the evidence basis for these uses.

For the NTRK fusion–positive solid tumor indication, eligibility includes adult and pediatric members aged 12 years and older. For ROS1‑positive NSCLC, repotrectinib may be used as an initial or subsequent line of therapy for locally advanced or metastatic disease. Prior authorization requests for Augtyro are processed by the Utilization Management department and final approval is granted by the Utilization Management Committee.

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