Subject: Contrave PA with Limit 1190-C P08-2025

Drug

Weight Loss Management

CONTRAVE  (naltrexone hydrochloride and bupropion hydrochloride extended-release)

Policy:

Indications

FDA-approved Indications

Contrave is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of:

• 30 kg/m² or greater (obese) or
• 27 kg/m² or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia).

Limitations of Use

• The effect of Contrave on cardiovascular morbidity and mortality has not been established.
• The safety and effectiveness of Contrave in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established.

Coverage Criteria

Chronic Weight Management

Authorization may be granted when the requested drug will be used with a reduced-calorie diet AND increased physical activity for chronic weight management 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.[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.] [ACTION REQUIRED: Documentation is required for approval.]
  • The patient has a baseline BMI greater than or equal to 27 kg/m². [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.] [ACTION REQUIRED: Documentation is required for approval.] 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). [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.] [ACTION REQUIRED: Documentation is required for approval.]

Continuation of Therapy

Chronic Weight Management

Authorization may be granted when the requested drug will be used with a reduced-calorie diet AND increased physical activity for chronic weight management in an adult when ALL of the following criteria are met:

• The patient has completed at least 4 months of therapy with the requested drug.
• 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

120 tablets per 25 days or 360 tablets per 75 days.

The duration of 25 days is used for a 30-day fill period and 75 days is used for a 90-day fill period to allow time for refill processing.

Duration of Approval (DOA)

• 1190-A: Initial therapy DOA: 4 months; Continuation of therapy DOA: 12 months

Place of Service:

Outpatient

The above policy is based on the following references:

1. Contrave Extended-Release [package insert]. Brentwood, TN: Currax Pharmaceuticals LLC; May 2024.
2. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Waltham, MA: UpToDate, Inc.; 2025. https://online.lexi.com. Accessed June 10, 2025.
3. Micromedex® (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 06/10/2025).
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 12, 2025