Subject: Zepbound PA with Limit 6192-C P08-2024_R

Drug

Weight Loss Management

ZEPBOUND  (tirzepatide)

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.

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.

Coverage Criteria

Reduction in Excess Body Weight, Maintenance of Weight Reduction Long Term

Authorization may be granted when the requested drug will be used with a reduced-calorie diet AND increased physical activity to reduce excess body weight or maintain weight reduction long term in an adult when ALL of the following criteria are met:

• The patient has participated in a comprehensive weight management program that encourages behavioral modification, reduced-calorie diet, AND increased physical activity with continuing follow-up for at least 6 months prior to using drug therapy
• The patient meets ONE of the following:
  • The patient has a baseline body mass index (BMI) greater than or equal to 30 kg/m² [ACTION REQUIRED: Documentation is required for approval.] [NOTE: If the patient is transitioning from another drug therapy for weight loss, please consider their baseline BMI at the start of any drug therapy.]
  • The patient has a baseline BMI greater than or equal to 27 kg/m² [ACTION REQUIRED: Documentation is required for approval.] [NOTE: If the patient is transitioning from another drug therapy for weight loss, please consider their baseline BMI at the start of any drug therapy.] In addition, the following criteria is met:
    • The patient has at least ONE weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, dyslipidemia) [ACTION REQUIRED: Documentation is required for approval.] [NOTE: If the patient is transitioning from another drug therapy for weight loss, please consider their weight-related comorbid condition(s) at the start of any drug therapy.]

Continuation of Therapy

Reduction in Excess Body Weight, Maintenance of Weight Reduction Long Term

Authorization may be granted when the requested drug will be used with a reduced-calorie diet AND increased physical activity to reduce excess body weight or maintain weight reduction long term in an adult when ALL of the following criteria are met:

• The patient has completed at least 3 months of therapy with the requested drug at a stable maintenance dose
• The patient has lost at least 5 percent of baseline body weight OR the patient has continued to maintain their initial 5 percent weight loss [ACTION REQUIRED: Documentation is required for approval.]

Quantity Limits Apply

Quantity Limit

The duration of 21 days is used for a 28-day fill period and 63 days is used for an 84-day fill period to allow time for refill processing.

Drug	Dosage	1 Month Limit	3 Months Limit
Zepbound (tirzepatide)	2.5 mg / 0.5 mL	2 mL (1 package of 4 pens each or   4 single-dose vials) / 21 days	6 mL (3 packages of 4 pens each or   12 single-dose vials) / 63 days
Zepbound (tirzepatide)	5 mg / 0.5 mL	2 mL (1 package of 4 pens each or   4 single-dose vials) / 21 days	6 mL (3 packages of 4 pens each or   12 single-dose vials) / 63 days
Zepbound (tirzepatide)	7.5 mg / 0.5 mL	2 mL (1 package of 4 pens each or   4 single-dose vials) / 21 days	6 mL (3 packages of 4 pens each or   12 single-dose vials) / 63 days
Zepbound (tirzepatide)	10 mg / 0.5 mL	2 mL (1 package of 4 pens each or   4 single-dose vials) / 21 days	6 mL (3 packages of 4 pens each or   12 single-dose vials) / 63 days
Zepbound (tirzepatide)	12.5 mg / 0.5 mL	2 mL (1 package of 4 pens each or   4 single-dose vials) / 21 days	6 mL (3 packages of 4 pens each or   12 single-dose vials) / 63 days
Zepbound (tirzepatide)	15 mg / 0.5 mL	2 mL (1 package of 4 pens each or   4 single-dose vials) / 21 days	6 mL (3 packages of 4 pens each or   12 single-dose vials) / 63 days

Duration of Approval (DOA)

• 6192-C: Initial therapy DOA: 8 months; Continuation of therapy DOA: 12 months

Place of Service:

Outpatient

The above policy is based on the following references:

1. Zepbound [package insert]. Indianapolis, IN: Lilly USA, LLC; October 2024.
2. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Waltham, MA: UpToDate, Inc.; 2024. https://online.lexi.com. Accessed June 28, 2024.
3. Micromedex® (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 06/28/2024).
4. Jensen MD, Ryan DH, Apovian DM, et al. 2013 AHA/ACC/TOS Guideline for the Management of Overweight and Obesity in Adults A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Obesity Society. Circulation. 2014;129(suppl 2):S102-S138.
5. Apovian CM, Aronne LJ, Bessesen DH, et al. Pharmacological Management of Obesity: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2015;100(2):342–362.

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.

December 19, 2024