Subject: Specialty Quantity Limit Gattex 2245-H P2024
Policy:
I. 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.
II. COVERED QUANTITIES
|
Medication
|
Standard Limit
|
Exception Limit*
|
FDA-recommended dosing
|
|
Gattex (teduglutide) 5 mg (10 mg/mL)
single-dose vial kit
|
One 30-vial kit per 30 days
|
Two 30-vial kits per 30 days
|
0.05 mg/kg/day SC once daily
Renal dose adjustment (eGFR less than
60 mL/min/1.73m2):
• 0.025 mg/kg once daily
|
*Patients over 75 kg qualify for the exception limit.
Place of Service:
Outpatient
The above policy is based on the following references:
- Gattex [package insert]. Lexington, MA: Takeda Pharmaceuticals America, Inc.; October 2022.
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.
June 30, 2024
