Subject: Specialty Quantity Limit sunitinib-Sutent 2216-H P2023
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SUTENT
(sunitinib malate)
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sunitinib
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Policy:
I. 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.
II. COVERED QUANTITIES
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Medication
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Standard Limit
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FDA-recommended dosing
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Sutent (sunitinib malate) capsule 12.5 mg
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30 per 30 days
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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
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
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Sutent (sunitinib malate) capsule 25 mg
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30 per 30 days
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Sutent (sunitinib malate) capsule 37.5 mg
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30 per 30 days
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Sutent (sunitinib malate) capsule 50 mg
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30 per 30 days
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*The limits may apply to the generic equivalent medication.
Place of Service:
Outpatient
The above policy is based on the following references:
- Sutent [package insert]. New York, NY: Pfizer Labs.; August 2021.
- Suntinib [package insert]. Parsippany, NJ: Teva Pharmaceuticals USA, Inc.; September 2021.
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 22, 2023