Subject: Saxenda PA with Limit 1227-C P08-2024_R

Drug

SAXENDA  (liraglutide)

Policy:

Indications

FDA-approved Indications

Saxenda is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in:

• Adult patients 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)

• Pediatric patients aged 12 years and older with:

• body weight above 60 kg and

• an initial BMI corresponding to 30 kg/m² or greater for adults (obese) by international cut-offs (Cole Criteria)

Limitations of Use

• Saxenda contains liraglutide and should not be coadministered with other liraglutide-containing products or with any other GLP-1 receptor agonist.

• The safety and effectiveness of Saxenda in pediatric patients with type 2 diabetes have not been established.

• The safety and effectiveness of Saxenda 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 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

• If the patient is 18 years of age or older, then 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.]

• If the patient is 12 to 17 years of age, then ALL of the following criteria are met:

• The patient has a baseline body weight above 60 kg [ACTION REQUIRED: Documentation is required for approval.] [NOTE: If the patient is transitioning from another drug therapy for weight loss, please consider their baseline body weight at the start of any drug therapy.]

• The patient has a baseline BMI corresponding to 30 kg/m² or greater for adults by international cut-off points based on the Cole Criteria [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.]

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 when ONE of the following criteria is met:

• The patient is 18 years of age or older and ALL of the following criteria are met:

• The patient has completed at least 16 weeks of therapy with the requested drug

• The patient has lost at least 4 percent of baseline body weight OR the patient has continued to maintain their initial 4 percent weight loss [ACTION REQUIRED: Documentation is required for approval.]

• The patient is 12 to 17 years of age and ALL of the following criteria are met:

• The patient has completed at least 12 weeks of therapy on the maintenance dose of the requested drug

• The patient has had at least 1 percent reduction in body mass index (BMI) from baseline OR the patient has continued to maintain their initial 1 percent BMI reduction [ACTION REQUIRED: Documentation is required for approval.]

Quantity Limits Apply

15 mL (1 package of five 3 mL pens) per 25 days or 45 mL (3 packages of five 3 mL pens each) 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)

• 1227-C:

• Adults: Initial therapy DOA: 4 months; Continuation of therapy DOA: 12 months

• Pediatrics: Initial therapy DOA: 5 months; Continuation of therapy DOA: 12 months

Place of Service:

Outpatient

The above policy is based on the following references:

1. Saxenda [package insert]. Plainsboro, NJ: Novo Nordisk Inc.; April 2023.
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.
6. US Preventive Services Task Force. Interventions for High Body Mass Index in Children and Adolescents US Preventive Services Task Force Recommendation Statement. JAMA. 2024;Online ahead of print. doi: 10.1001/jama.2024.11146.

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