Subject: Xenical PA with Limit 250-C P08-2025

Drug

Weight Loss Management

XENICAL  (orlistat)

Policy:

Indications

FDA-approved Indications

Xenical is indicated for obesity management including weight loss and weight maintenance when used in conjunction with a reduced-calorie diet. Xenical is also indicated to reduce the risk for weight regain after prior weight loss. Xenical is indicated for obese patients with an initial body mass index (BMI) greater than or equal to 30 kg/m² or greater than or equal to 27 kg/m² in the presence of other risk factors (e.g., hypertension, diabetes, dyslipidemia).

Coverage Criteria

Obesity Management

Authorization may be granted when the requested drug will be used with a reduced-calorie diet AND increased physical activity for obesity management 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

Obesity Management

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

• The patient has completed at least 6 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

90 capsules per 25 days or 270 capsules 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)

• 250-C: DOA: 12 months

Place of Service:

Outpatient

The above policy is based on the following references:

1. Xenical [package insert]. Montgomery, AL: H2-Pharma, LLC; July 2024.
2. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Waltham, MA: UpToDate, Inc.; 2025. https://online.lexi.com. Accessed June 11, 2025.
3. Micromedex® (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 06/11/2025).
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.
6. Torgerson JS, Hauptman J, Boldrin MN, et al. Xenical in the Prevention of Diabetes in Obese Subjects (XENDOS) Study: A randomized study of orlistat as an adjunct to lifestyle changes for the prevention of type 2 diabetes in obese patients. Diabetes Care. 2004;27:155-161.

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