Subject: Specialty Quantity Limit Entyvio 2269-H P2026

Drug

ENTYVIO  (vedolizumab)

Policy:

Program Description

The standard limit is designed to allow a quantity sufficient for the most common uses of the medication. If 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
Entyvio (vedolizumab) 300 mg single-dose vial	1 vial per 56 days	3 vials per 42 days
Entyvio (vedolizumab) 108 mg/0.68 mL single-dose prefilled syringe/pen	2 syringes/pens per 28 days	N/A

FDA-recommended Dosing

Crohn’s Disease (CD), Ulcerative Colitis (UC)

Loading doses, intravenous

300 mg at weeks 0, 2, and 6

Maintenance dose, intravenous

300 mg every 8 weeks thereafter

After initial intravenous doses at week 0 and 2, may switch to subcutaneous 108 mg every 2 weeks starting at week 6.

Place of Service:

Outpatient

The above policy is based on the following references:

1.      Entyvio [package insert]. Cambridge, MA: Takeda Pharmaceuticals U.S.A., Inc.; May 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.

August 16, 2026