Subject: Zepbound PA with Limit FE Compatible 6947-C P04-2025

Drug

Zepbound FE Compatible Weight Loss Management

MOUNJARO  (tirzepatide)

ZEPBOUND  (tirzepatide)

Note: 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

Tirzepatide (Brand Zepbound and Brand Mounjaro)

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.

Mounjaro is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Limitations of Use

• Mounjaro has not been studied in patients with a history of pancreatitis.
• Mounjaro is not indicated for use in patients with type 1 diabetes mellitus.

Coverage Criteria

Approval for all indications will be for tirzepatide.

Obstructive Sleep Apnea

Authorization may be granted when the requested drug will be used with a reduced-calorie diet AND increased physical activity to treat moderate to severe obstructive sleep apnea (OSA) in an adult with obesity when ALL of the following criteria are met:

• The patient has an established diagnosis of moderate to severe OSA with an apnea-hypopnea index (AHI) of at least 15 events per hour on polysomnography (PSG) or home sleep apnea test (HSAT) with a technically adequate device. [ACTION REQUIRED: Documentation is required for approval.]
• The patient has a current body mass index (BMI) greater than or equal to 30 kg/m². [ACTION REQUIRED: Documentation is required for approval.]

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

Approval for all indications will be for tirzepatide.

Obstructive Sleep Apnea

Authorization may be granted when the requested drug will be used with a reduced-calorie diet AND increased physical activity to treat moderate to severe obstructive sleep apnea (OSA) in an adult with obesity when ALL of the following criteria are met:

• The patient has an established diagnosis of moderate to severe OSA with an apnea-hypopnea index (AHI) of at least 15 events per hour on polysomnography (PSG) or home sleep apnea test (HSAT) with a technically adequate device. [ACTION REQUIRED: Documentation is required for approval.]
• The patient has achieved or maintained a positive response to treatment from baseline, evidenced by a decrease in OSA symptoms.
• The patient is being treated with a maintenance dosage of the requested drug which is based on individual treatment response and tolerability.

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

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 Month Limit
Tirzepatide (Brand Mounjaro)	2.5 mg / 0.5 mL	2 mL (1 package of 4 pens each / 21 days	6 mL (3 packages of 4 pens each) / 63 days
Tirzepatide (Brand Mounjaro)	5 mg / 0.5 mL	2 mL (1 package of 4 pens each) / 21 days	6 mL (3 packages of 4 pens each) / 63 days
Tirzepatide (Brand Mounjaro)	7.5 mg / 0.5 mL	2 mL (1 package of 4 pens each) / 21 days	6 mL (3 packages of 4 pens each) / 63 days
Tirzepatide (Brand Mounjaro)	10 mg / 0.5 mL	2 mL (1 package of 4 pens each) / 21 days	6 mL (3 packages of 4 pens each) / 63 days
Tirzepatide (Brand Mounjaro)	12.5 mg / 0.5 mL	2 mL (1 package of 4 pens each) / 21 days	6 mL (3 packages of 4 pens each) / 63 days
Tirzepatide (Brand Mounjaro)	15 mg / 0.5 mL	2 mL (1 package of 4 pens each) / 21 days	6 mL (3 packages of 4 pens each) / 63 days

Duration of Approval (DOA)

• 6947-C:
  • Obstructive Sleep Apnea (OSA): Initial therapy DOA: 6 months; Continuation of therapy DOA: 12 months
  • Reduction in excess body weight, maintenance of weight reduction long term: 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; December 2024.
2. Mounjaro [package insert]. Indianapolis, IN: Lilly USA, LLC; November 2024.
3. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Waltham, MA: UpToDate, Inc.; 2025. https://online.lexi.com. Accessed April 15, 2025.
4. Micromedex® (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 04/15/2025).
5. 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.
6. 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.
7. Malhorta A, Grunstein RR, Fietze I, et al. Tirzepatide for the Treatment of Obstructive Sleep Apnea and Obesity. New Engl J Med. 2024;391:1193-1205.
8. Kapur VK, Auckley DH, Chowdhuri S, et al. Clinical Practice Guideline for Diagnostic Testing for Adult Obstructive Sleep Apnea: An American Academy of Sleep Medicine Clinical Practice Guideline. J Clin Sleep Med. 2017;13(3):479-504.

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