Subject: Specialty Quantity Limit Rozlytrek 3167-H P2025

Drug

ROZLYTREK  (entrectinib)

Policy:

Program Description

The standard limit is designed to allow a quantity sufficient for the most common uses of the medication. The recommended dosing parameters for all FDA-approved indications fall within the standard limits. Coverage of an additional quantity may be reviewed on a case-by-case basis upon request.

Covered Quantities

Medication	Standard Limit
Rozlytrek (entrectinib) 100 mg capsules	30 capsules per 30 days
Rozlytrek (entrectinib) 200 mg capsules	90 capsules per 30 days
Rozlytrek (entrectinib) pellets 50 mg per packet (42 count carton)	8 cartons (336 packets) per 28 days

FDA-recommended Dosing

Adult

600 mg once daily

Pediatric

Patients > 1 month to ≤ 6 months

• 250 mg/m² once daily

Patients > 6 months

• BSA ≥51 m²: 600 mg once daily
• BSA 1.11 to 1.50 m²: 400 mg once daily
• BSA 0.81 to 1.10 m²: 300 mg once daily
• BSA 0.51 to 0.80 m²: 200 mg once daily
• BSA ≤50 m²: 300 mg/m² once daily

Dosage modifications for adverse reactions and drug interactions may be required.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Rozlytrek [package insert]. South San Francisco, CA: Genentech USA, Inc. January 2024.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

January 01, 2026