Subject: Saxenda PA Policy 1227-A 08-2022

Drug

WEIGHT LOSS MANAGEMENT

SAXENDA  (liraglutide injection)

Note: •  ••

Policy:

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
The requested drug will be covered with prior authorization when the following criteria are met:
     •   The patient is 18 years of age or older
          AND
          •   The patient has completed at least 16 weeks of therapy with the requested drug
               AND
               o   The patient lost at least 4 percent of baseline body weight OR the patient has continued to maintain their initial 4 percent weight loss.
                    [Documentation is required for approval.]
          OR
          •   The requested drug will be used with a reduced calorie diet and increased physical activity for chronic weight management in an adult
               AND
          •   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
                AND
                o   The patient has a body mass index (BMI) greater than or equal to 30 kilogram per square meter
                      OR
                o   The patient has a body mass index (BMI) greater than or equal to 27 kilogram per square meter AND has at least one weight related
                     comorbid condition (e.g., hypertension, type 2 diabetes mellitus or dyslipidemia)
          OR
          •   The patient is 12 to 17 years of age
               AND
               •   The patient has completed at least 12 weeks of therapy on the maintenance dose of therapy with the requested drug
               AND
               •   The patient has at least 1 percent reduction in body mass index (BMI) from baseline OR the patient has continued to maintain their
                    initial 1 percent reduction in BMI from baseline. [Documentation is required for approval.]
          OR
          •   The requested drug will be used with a reduced calorie diet and increased physical activity for chronic weight management
               AND
          •   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
               AND
          •   The patient has a body weight above 60 kilograms
               AND
          •   The patient has an initial body mass index (BMI) corresponding to 30 kilogram per square meter or greater for adults by international
               cut-off points based on the Cole Criteria

Place of Service:

Outpatient

The above policy is based on the following references:

1. Saxenda [package insert]. Plainsboro, NJ: Novo Nordisk Inc; June 2022.
2. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Hudson, Ohio: UpToDate, Inc.; 2022; Accessed May 18, 2022.
3. Micromedex (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www.micromedexsolutions.com/. Accessed May 18, 2022.
4. Expert Panel on Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents. National Heart, Lung, and Blood Institute. NIH Publication No. 12-7486. October 2012. http://www.nhlbi.nih.gov/guidelines/cvd_ped/peds_guidelines_full.pdf. 141-159. Accessed May 17, 2022.
5. Pharmacological Management of Obesity: An Endocrine Society Clinical Practice Guideline. The Journal of Clinical Endocrinology & Metabolism, Volume 100, Issue 2, 1 February 2015, Pages 342–362. https://academic.oup.com/jcem/article/100/2/342/2813109. Accessed May 17, 2022.
6. Jensen MD, 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. 2013; 129:S102–S138.

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 10, 2022