Subject: Specialty Quantity Limit Gattex 2245-H P2023

Drug

GATTEX  (teduglutide)

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:

1. 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 11, 2023