Subject: Specialty Quantity Limit Gavreto 4208-H P2025

Drug

GAVRETO  (pralsetinib)

Policy:

Program Description

The standard limit is designed to allow a quantity sufficient for the most common uses of the medication. If the member’s plan allows a quantity limit exception review for the requested medication, coverage of an additional quantity may be provided up to the exception limit with prior authorization.

Covered Quantities

Coverage up to the exception limits may be provided with prior authorization via the Specialty Post Limit Quantity Exception Criteria for approval.

Medication	Standard Limit	Exception Limit
Gavreto (pralsetinib) 100 mg capsule	120 per 30 days	240 per 30 days

FDA-Recommended Dosing

400 mg orally once daily.

Dose reductions, to as low as 100 mg orally once daily, may be needed based on adverse reactions or when used with known strong or moderate CYP3A inhibitors and/or P-glycoprotein (P-gp) inhibitors.

When used with strong or moderate CYP3A inducers, increase the starting dose of Gavreto starting on day 7 of coadministration, up to 800 mg orally once daily.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Gavreto [package insert]. South San Francisco, CA: Rigel Pharmaceuticals, Inc.; June 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