CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Rozlytrek (entrectinib) coverage

Defines accepted indications, dosing limits, exclusions, and prior authorization expectations for Rozlytrek (entrectinib) for Neighborhood Health Plan of Rhode Island members processed by Evolent.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyRozlytrek (entrectinib) coverage

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization from Evolent; continuation requests may be exempt only if no progression, prior use within last year without >30-day lapse, and no additional medications are added.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

ROS1 & NTRKmolecular indications

600 mgmax adult daily dose

J8999HCPCS

Commercial/Exchange/Medicaidlines of business

BSA/weight tablespediatric guidance

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Coverage Criteria for Rozlytrek (entrectinib)

NSCLC (ROS1)

Covered when ALL of the following are met for ROS1 NSCLC

ROS1 NSCLC coverage: Member has recurrent, advanced, or metastatic non-small cell lung cancer (NSCLC) with ROS1 rearrangement

Rozlytrek (entrectinib) may be used as a single agent in adults as first-line or subsequent therapy

NTRK-Fusion Positive Metastatic Solid Tumors

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

NTRK fusion coverage: Adult or pediatric member (older than 1 month) has a recurrent, metastatic, or unresectable solid tumor with a positive NTRK gene fusion confirmed in tumor tissue

Rozlytrek (entrectinib) may be used as a single agent as initial or subsequent therapy

Dosing - Adults and Pediatrics

Covered dosing conditions

Adult dosing: Adults and pediatric patients with body surface area (BSA) > 1.51 m^2: 600 mg orally once daily until disease progression or unacceptable toxicity600 mg daily

Single-dose limit of 600 mg for NSCLC; maximum monthly dispensing limits apply (see pediatric table and limits)

Pediatric dosing specified by BSA/weight tables: see Table 1 and Table 2 for recommended dosages by BSA/age (examples include 250 mg/m2 for patients 1 month to <6 months, and BSA-based fixed mg doses for older infants and children) with duration until disease progression or unacceptable toxicityvaries by BSA/weight

Refer to Table 1 and Table 2 for exact mg or mg/m^2 dosing; treatment and dispensing are subject to monthly capsule/pellet maximums (90 of 100 mg and 200 mg capsules; 84 of 50 mg oral pellets)

Coverage excludes concurrent use with other anti-cancer therapies and use of Rozlytrek (entrectinib) after disease progression on the same regimen or after progression on another NTRK-targeted therapy (for example, larotrectinib), except in the specific ROS1-rearranged NSCLC scenario described by the policy where continuation may be allowed for asymptomatic members or when disease is limited to CNS progression. Do not authorize Rozlytrek when dosing would exceed the single-dose limit of 600 mg for Non‑Small Cell Lung Cancer, or when projected treatment would exceed the stated monthly dispensing limits.

Investigational use and off‑label indications are not covered when sufficient supporting evidence is lacking — specifically when not supported by CMS‑recognized compendia or acceptable peer‑reviewed literature. The policy defines insufficient evidence to include situations where the patient/cancer characteristics or the administered regimen are not adequately represented in published studies, reported outcomes are not clinically meaningful (per ASCO standards), study design is inappropriate to answer the clinical question, evidence is limited to uncontrolled case reports, or only abstracts without full peer‑reviewed articles are available.

Maximum monthly dispensing limits — capsules and pellets

100 mg capsulesMaximum 90 capsules per 30 days

200 mg capsulesMaximum 90 capsules per 30 days

50 mg oral pelletsMaximum 84 pellets per 30 days

Coding and Billing

Drug HCPCSHCPCS

J8999

entrectinib

Maximum monthly dispensing limits (billing visibility)

100 mg capsules (monthly)90 capsules per month

200 mg capsules (monthly)90 capsules per month

50 mg oral pellets (monthly)84 oral pellets per month

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization required — Evolent processes medication requests; medications not authorized by Evolent may be deemed not approvable and not reimbursable. Continuation requests for a not-approvable medication shall be exempt from this Evolent policy provided all of the following are met: the 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 additional medication(s) are not being added to the continuation request.

Evolent is responsible for processing all medication requests from network ordering providers.
Medications not authorized by Evolent may be deemed not approvable and therefore not reimbursable.
Continuation exemption conditions: no disease progression on requested medication; used within last year with ≤30-day lapse; no additional medications added to continuation request.

Step Therapy

Sequencing Restriction

Sequencing restriction — Rozlytrek (entrectinib) is excluded when used after disease progression on the same regimen or after other NTRK-targeted therapy (e.g., Vitrakvi/larotrectinib). Exception: continuation may be allowed if the member progressed on first-line Rozlytrek for ROS1-rearranged NSCLC and is asymptomatic or has disease limited to lung with CNS progression as the exception.

Not approvable after progression on the same regimen or other NTRK-targeted therapy (unless exception applies).
Exception for ROS1-rearranged NSCLC progressed on first-line Rozlytrek: may continue if asymptomatic or limited lung disease with CNS progression.

Documentation Required

Documentation Standards

Documentation standards — Use of Rozlytrek must be supported by one of the following: FDA-approved product labeling, CMS-approved compendia, National Comprehensive Cancer Network (NCCN) guidelines, American Society of Clinical Oncology (ASCO) clinical guidelines, or peer-reviewed literature that meets the requirements of the CMS Medicare Benefit Policy Manual Chapter 15.

Supportive evidence sources: FDA labeling; CMS-recognized compendia; NCCN; ASCO; acceptable peer-reviewed literature per CMS Medicare Benefit Policy Manual Ch. 15.

Denial Risk

Approval Gating

Approval gating — requests for medications not authorized by Evolent may be deemed not approvable and not reimbursable. Continuation requests that meet the exemption conditions (no progression, recent use within last year with ≤30-day lapse, no additional meds) may be processed despite a prior not-approvable determination.

Requests not authorized by Evolent may be considered not approvable and not reimbursable.
Continuation request exemptions allow processing when all continuation conditions are satisfied.

Line of Therapy

first-line | second-line

line of therapy: May be used as initial (first-line) or subsequent (second-line) therapy

Applies to ROS1-rearranged NSCLC and NTRK-fusion positive solid tumors as described

Biomarker Requirements

ROS1 — biomarker requirement

Required biomarkerROS1 rearrangement in tumor (ROS-1) for NSCLC

Test confirmationMolecular confirmation of ROS1 rearrangement in tumor tissue is required

Indication linkROS1 rearrangement-positive NSCLC covered as single-agent therapy in adults

NTRK (TRK) fusion — biomarker requirement

Required biomarkerNTRK (TRK) gene fusion detected in tumor tissue

Age rangeApplies to adult and pediatric members older than 1 month

Test confirmationPositive NTRK fusion must be confirmed in tumor tissue (testing required)

Definitions

NTRK fusion-positive definition

DefinitionNTRK fusion-positive solid tumor: recurrent, metastatic, or unresectable solid tumor with a positive NTRK gene fusion in tumor tissue

Age applicabilityApplies to adult and pediatric patients (>1 month) as specified

Therapy useRozlytrek may be used as a single agent as initial or subsequent therapy

ROS1 rearrangement-positive NSCLC definition

DefinitionROS1 rearrangement-positive NSCLC: non-small cell lung cancer that harbors ROS1 gene rearrangement

Therapy useRozlytrek (entrectinib) may be used as a single agent in adult members as first-line or subsequent therapy

Disease stateApplies to recurrent, advanced, or metastatic NSCLC with ROS1 rearrangement

Background

Entrectinib (Rozlytrek) is a targeted oral therapy indicated for adults and pediatric patients with ROS1‑rearranged Non‑Small Cell Lung Cancer and for NTRK fusion‑positive metastatic or unresectable solid tumors. It is administered until disease progression or unacceptable toxicity and pediatric dosing is specified by body surface area/weight tables in the policy.