Subject: Zepbound Exception (ACCF, ACF, ACFC, SCCF, SF, SFC, VF, VFC) 6981-A P04-2025

Drug

ZEPBOUND  (tirzepatide)

Note:             Exception Criteria Zepbound             This document informs prescribers of preferred products when the target drug is requested.         Products Referenced by this Document             Drugs that are listed in the following table include both brand and generic and all dosage forms and strengths except 2.5 mg/0.5 mL, 5 mg/0.5 mL, 7.5 mg/0.5             mL, and 10 mg/0.5 mL vials that are covered under the LillyDirect manufacturer program. Over-the-counter (OTC) products are not included unless otherwise             stated.

Policy:

Indications

FDA-approved Indications

Zepbound is indicated in combination with a reduced-calorie diet and increased physical activity:

• To reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition.
• To treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity.

Limitations of Use

• Zepbound contains tirzepatide. Coadministration with other tirzepatide-containing products or with any glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended.

Plan Design Summary

Primary Formulary Alternative	Secondary Alternative	Non-Formulary Agent
Wegovy (semaglutide)	Mounjaro (tirzepatide)	Zepbound (tirzepatide)

This document informs prescribers of the availability of the primary formulary alternative (Wegovy) and secondary alternative (tirzepatide [Brand Mounjaro]).

Medications considered formulary or preferred on your plan may still require a clinical prior authorization review.

Primary Formulary Alternative

Authorization may be granted for the primary formulary alternative (Wegovy) when the following criteria is met:

• The patient can be treated with Wegovy.

Secondary Alternative

Authorization may be granted for the secondary alternative (tirzepatide [Brand Mounjaro]) when ALL of the following criteria are met:

• The patient cannot be treated with the primary formulary alternative (Primary Formulary Alternative: Wegovy).
• The patient has experienced an inadequate treatment response, intolerance, or has a contraindication to Wegovy. [ACTION REQUIRED: Documentation is required for approval.]
• The patient can be treated with tirzepatide (Brand Mounjaro).

Place of Service:

Outpatient

The above policy is based on the following references:

1. Zepbound [package insert]. Indianapolis, IN: Lilly USA, LLC; December 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.

July 01, 2025