Specialty Pharmacy Clinical Policy Bulletins
Aetna Non-Medicare Prescription Drug Plan
Subject: Wegovy PA 4774-A 08-2022
| Drug | ||||||
| WEIGHT LOSS MANAGEMENT | ||||||
| WEGOVY (semaglutide injection) | ||||||
Policy:
FDA-approved
Wegovy 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 (obesity), 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
• Wegovy contains semaglutide and should not be coadministered
with other semaglutide-containing products or with any other GLP-
1 receptor agonist.
• The safety and effectiveness of Wegovy in combination with other
products intended for weight loss, including prescription drugs,
over-the-counter drugs, and herbal preparations, have not been
established.
• Wegovy has not been studied in patients with a history of
pancreatitis
COVERAGE CRITERIA
The requested drug will be covered with prior authorization when the following criteria are met:
• The patient has completed at least 3 months of therapy with
the requested drug at a stable maintenance dose
AND
º The patient lost at least 5 percent of baseline body
weight OR the patient has continued to maintain their
initial 5 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)
RATIONALE
The intent of the criteria is to provide coverage consistent with product labeling, FDA guidance, standards of medical practice, evidence-based drug information, and/or published guidelines. Wegovy 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).1-3 The safety and efficacy of coadministration of Wegovy with other products intended for weight loss including prescription drugs, over-the-counter drugs, and herbal preparations have not been established.1-3
The guidelines state that the purpose of weight loss and weight maintenance is to reduce health risk. Weight loss programs should begin with a basic weight loss regimen consisting of a reduced-calorie diet and increased physical activity. The major role of medications is to help with patient compliance to a weight loss plan. Therefore, drugs should be used as part of a comprehensive weight loss program and should never be used without concomitant lifestyle modification. Drugs may be used as an adjunct to diet and physical activity for patients with a BMI that is greater than or equal to 30 kg/m2 or greater than or equal to 27 kg/m2 if other risk factors are present (e.g., hypertension, diabetes, dyslipidemia, sleep apnea, cardiovascular disease).4-6
The Endocrine Society Clinical Practice Guideline states that if a patient’s response to a weight loss medication is deemed effective (weight loss at least 5% of body weight at 3 months) and safe, it is recommended that the medication be continued. If deemed ineffective (weight loss less than 5% at 3 months) or if there are safety or tolerability issues at any time, it is recommended that the medication be discontinued and alternative medications or referral for alternative treatment.5 The American Heart Association Guideline for the Management of Overweight and Obesity in Adults recommends that overweight and obese individuals who would benefit from weight loss participate for at least 6 months in a comprehensive lifestyle program that assists participants in adhering to a lower-calorie diet and in increasing physical activity through the use of behavioral strategies.6
Wegovy will be approved initially for 7 months to allow for dose escalation (16 weeks) to the maintenance dosage and 12 weeks of maintenance therapy if 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. For renewal after 7 months of Wegovy therapy, the patient must have lost at least 5% of baseline body weight or has continued to maintain their initial 5% weight loss. If a patient has not lost at least 5% of baseline body weight, Wegovy should be discontinued as it is recommended that the medication be discontinued and alternative medications or referral for alternative treatment be initiated.
Wegovy is to be initiated at a dose of 0.25mg once weekly and increased as outlined in the dose escalation schedule table below. The maintenance dose of Wegovy is 2.4mg once weekly. If patients are unable to tolerate the maintenance 2.4mg once weekly dose, the dose can be temporarily decreased to 1.7mg once weekly for a maximum of 4 weeks. After 4 weeks, increase to the maintenance 2.4mg once weekly dose and discontinue Wegovy if the patient cannot tolerate the 2.4mg dose.1
The optimal duration of treatment is unclear. Considering that drug discontinuation invariably leads to weight regain, if clinically significant weight loss is achieved, longer courses of treatment are reasonable to consider after the benefits and risks of treatment are re-reviewed with the patient and lack of long-term data is acknowledged.4-6
Place of Service:
Outpatient
The above policy is based on the following references:
- Wegovy [package insert]. Plainsboro, NJ: Novo Nordisk, Inc.; June 2021.
- Lexicomp Online, AHFS DI (Adult and Pediatric) Online, Hudson, Ohio: UpToDate, Inc.; 2022; Accessed May 25, 2022.
- Micromedex (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www.micromedexsolutions.com/. Accessed May 25, 2022.
- 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.
- 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.
- 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
Additional Information
Clinical Policy Bulletin Notes
