Subject: Specialty Quantity Limit sunitinib-Sutent 2216-H P2025

Drug

SUTENT  (sunitinib malate)

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

The limits may apply to the generic equivalent medication.

Medication	Standard Limit
Sutent (sunitinib malate) capsule 12.5 mg	30 per 30 days
Sutent (sunitinib malate) capsule 25 mg	30 per 30 days
Sutent (sunitinib malate) capsule 37.5 mg	30 per 30 days
Sutent (sunitinib malate) capsule 50 mg	30 per 30 days

FDA-recommended Dosing

Gastrointestinal stromal tumor (GIST) and renal cell carcinoma (RCC)

50 mg once daily, 4 weeks on treatment followed by 2 weeks off.

Pancreatic neuroendocrine tumors (pNET)

37.5 mg once daily.

CYP3A4 Drug Interactions and Inducers

Dose modifications may be needed for adverse reactions and CYP3A4 drug interactions.

If co-administered with a CYP3A4 inducer, maximum recommended dose

GIST and RCC

87.5 mg once daily.

pNET

62.5 mg once daily.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Sutent [package insert]. New York, NY: Pfizer Labs.; August 2021.
2. Sunitinib [package insert]. Parsippany, NJ: Teva Pharmaceuticals USA, Inc.; January 2025.

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.

October 12, 2025