Subject: Wegovy PA with Limit 4774-C UDR 08-2023 v2
| WEIGHT LOSS MANAGEMENT |
|
WEGOVY
(semaglutide injection)
|
| Note: *Drugs that are listed in the target drug box include both brand and generic and all dosage forms and strengths unless otherwise stated. OTC products are not included unless otherwise stated. |
Policy:
FDA-APPROVED INDICATIONS
Wegovy is indicated in combination with a reduced calorie diet and increased physical activity:
• to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal
myocardial infarction, or non-fatal stroke) in adults with established cardiovascular disease and
either obesity or overweight.
• to reduce excess body weight and maintain weight reduction long term in:
° Adults and pediatric patients aged 12 years and older with obesity
° Adults with overweight in the presence of at least one weight-related comorbid condition.
Limitation of Use
• Wegovy contains semaglutide. Coadministration with other semaglutide-containing products or
with any other GLP-1 receptor agonist is not recommended.
COVERAGE CRITERIA
The requested drug will be covered with prior authorization when the following criteria are met:
• The requested drug will be used with a reduced calorie diet and increased physical activity to
reduce excess body weight and maintain weight reduction long term
AND
° The patient is 18 years of age or older
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 baseline body mass index (BMI) greater than or equal to 30
kg/m2. [ACTION REQUIRED: Documentation is required for approval.]
OR
° The patient has a baseline body mass index (BMI) greater than or equal to 27 kg/m2.
[ACTION REQUIRED: Documentation is required for approval.]
AND
• 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.]
OR
° The patient has completed at least 3 months of therapy with the requested drug at a stable
maintenance dose
AND
• 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.]
OR
° The patient is 12 to 17 years of age
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 baseline body mass index (BMI) in the 95th percentile or greater
standardized for age and sex (obesity). [ACTION REQUIRED: Documentation is
required for approval.]
OR
• The request is for continuation of therapy for a patient that has successfully titrated to a
stable maintenance dose
AND
° The patient has had a reduction from their baseline body mass index (BMI) OR the
patient has continued to maintain their reduction in BMI from baseline. [ACTION
REQUIRED: Documentation is required for approval.]
OR
• The requested drug will be used to reduce the risk of major adverse cardiovascular events
(cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in an adult with
established cardiovascular disease and either obesity or overweight
AND
° The requested drug is being used with a reduced calorie diet and increased physical
activity
AND
• The request is NOT for continuation of therapy
AND
° The patient has established cardiovascular disease with a history of ONE of the
following: A) previous myocardial infarction (MI), B) previous stroke, C) symptomatic
peripheral arterial disease (PAD), as evidenced by intermittent claudication with ankle-
brachial index (ABI) less than 0.85 (at rest), peripheral arterial revascularization
procedure, or amputation due to atherosclerotic disease, D) prior history of
revascularization (coronary artery bypass grafting (CABG), percutaneous coronary
intervention (PCI), or angioplasty). [ACTION REQUIRED: Documentation is required for
approval.]
AND
• The patient has a baseline body mass index (BMI) greater than or equal to 27 kg/m2.
[ACTION REQUIRED: Documentation is required for approval.]
AND
• The patient does NOT have type 2 diabetes [NOTE: Ozempic is indicated to reduce
the risk of major cardiovascular events in adults with type 2 diabetes mellitus and
established cardiovascular disease. Patients with type 2 diabetes may be treated for
risk reduction of cardiovascular events with Ozempic.]
AND
• The patient is currently receiving guideline-directed management and therapy (GDMT)
for cardiovascular disease OR the patient has clinical reason not to be treated with
GDMT for cardiovascular disease (e.g., lipid-lowering agent, antiplatelet, beta-
blocker, renin-angiotensin inhibitor, etc.). [ACTION REQUIRED: Documentation is
required for approval.]
OR
° The request is for continuation of therapy
AND
• The patient has established cardiovascular disease with a history of ONE of the following: A)
previous myocardial infarction (MI), B) previous stroke, C) symptomatic peripheral arterial
disease (PAD), as evidenced by intermittent claudication with ankle-brachial index (ABI)
less than 0.85 (at rest), peripheral arterial revascularization procedure, or amputation due to
atherosclerotic disease, D) prior history of revascularization (coronary artery bypass grafting
(CABG), percutaneous coronary intervention (PCI), or angioplasty)
AND
• The patient is being treated with a maintenance dosage the requested drug
Quantity Limits apply.
|
QUANTITY LIMIT
|
|
Drug
|
Dosage
|
1 Month Limit
|
3 Month Limit
|
|
Wegovy (semaglutide)
|
0.25 mg/0.5 mL
|
2 mL (1 package of 4 pens each)
/ 21 days*
|
6 mL (3 packages of 4 pens each)
/ 63 days*
|
|
0.5 mg/0.5 mL
|
|
1 mg/0.5 mL
|
|
1.7 mg/0.75 mL
|
3 mL (1 package of 4 pens each)
/ 21 days*
|
9 mL (3 packages of 4 pens each)
/ 63 days*
|
|
2.4 mg/0.75 mL
|
|
*The duration of 21 days is used for a 28-day fill period and 63 days is used for a 84-day fill period to allow time for refill processing.
|
Duration of Approval (DOA):
• 4774-C: Initial therapy DOA: 7 months; Continuation of therapy DOA: 12 months
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 in combination with a reduced calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in: adults and pediatric patients aged 12 years and older with obesity, adults with overweight in the presence of at least one weight-related comorbid condition. Wegovy contains semaglutide. Coadministration with other semaglutide-containing products or with any other GLP-1 receptor agonist is not recommended.1
The American Heart Association/American College of Cardiology/The Obesity Society (AHA/ACC/TOS) Guideline for the Management of Overweight and Obesity in Adults advises 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 (Grade A recommendation).4 Therefore, Wegovy may be approved when 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.
On the basis of expert opinion, the AHA/ACC/TOS obesity guideline recommends that for individuals with body mass index (BMI) greater than or equal to 30 kg/m2 or BMI greater than or equal to 27 kg/m2 with at least 1 obesity associated comorbid condition who are motivated to lose weight, pharmacotherapy can be considered as an adjunct to comprehensive lifestyle intervention to help achieve targeted weight loss and health goals. Medications should be FDA approved, and clinicians should be knowledgeable about the product label. The provider should weigh the potential risks of the medication being considered against the potential benefits of successful weight loss for the individual patient. Medications work to reinforce lifestyle change and should be prescribed as an adjunct to lifestyle interventions.4 Therefore, coverage may be approved when the requested drug will be used with a reduced calorie diet and increased physical activity.
According to the Endocrine Society Clinical Practice Guideline for Pharmacological Management of Obesity, medications approved for chronic weight management can be useful adjuncts to lifestyle change for patients who have been unsuccessful with diet and exercise alone. These guidelines recommend that diet, exercise, and behavioral modification be included in all obesity management approaches for BMI of at least 25 kg/m2 and that other tools such as pharmacotherapy (BMI of at least 27 kg/m2 with comorbidity or BMI over 30 kg/m2) be used as an adjunct to behavioral modification to reduce food intake and increase physical activity when this is possible.5 Therefore, coverage may be approved when the patient has a BMI greater than or equal to 30 kg/m2 or greater than or equal to 27 kg/m2 along with at least one weight-related comorbid condition.
The Endocrine Society Guideline states that if a patient’s response to a weight loss medication is deemed effective (weight loss greater than or equal to 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 approaches be considered.5
Initial requests for Wegovy will be approved for 7 months to allow for dose escalation to the maintenance dosage (16 weeks) and 12 weeks of maintenance therapy.
For continuation of therapy in adults, the patient must have lost at least 5 percent of baseline body weight or must have continued to maintain their initial 5 percent weight loss. If a patient has not lost at least 5 percent of baseline body weight, Wegovy should be discontinued.5
For continuation of therapy in pediatrics, the patient must have a reduction from baseline BMI or must have continued to maintain their reduction in BMI. If a patient has not experienced any reduction in baseline BMI, Wegovy should be discontinued.1
Wegovy is also indicated in combination with a reduced calorie diet and increased physical activity to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction (MI), or non-fatal stroke) in adults with established cardiovascular disease and either obesity or overweight.1 The Semaglutide Effects on Cardiovascular Outcomes in People with Overweight or Obesity (SELECT) trial was conducted to determine whether semaglutide can reduce cardiovascular risk associated with overweight and obesity in the absence of diabetes. Patients were eligible for enrollment if they were 45 years of age or older, had a BMI of 27 kg/m2 or greater, and had established cardiovascular disease. Established cardiovascular disease was defined as prior MI, prior stroke (ischemic or hemorrhagic), and symptomatic peripheral arterial disease (PAD), as evidenced by intermittent claudication with ankle-brachial index (ABI) less than 0.85 (at rest), peripheral arterial revascularization procedure, or amputation due to atherosclerotic disease. Key exclusion criteria included a previous diagnosis of diabetes or a glycated hemoglobin level of 6.5%.6 Therefore, coverage to reduce the risk of major adverse cardiovascular events in an adult may be approved when the requested drug is being used with a reduced calorie diet and increased physical activity; when the patient has established cardiovascular disease with a history of ONE of the following: A) previous MI, B) previous stroke, C) symptomatic PAD, D) prior history of revascularization; when the patient has a baseline BMI of at least 27 kg/m2; and when the patient does NOT have type 2 diabetes.
According to the 2023 AHA/ACC/ACCP/ASPC/NLA/PCNA Guideline for the Management of Patients with Chronic Coronary Disease (CCD), patients with CCD and overweight or obesity should receive counseling on diet, lifestyle, and goals for weight loss. For patients with CCD and overweight or obesity in whom pharmacologic therapy is warranted for further weight reduction, a glucagon-like peptide-1 (GLP-1) receptor agonist can be beneficial in addition to counseling for diet and physical activity, and it is reasonable to choose semaglutide over liraglutide. Multicomponent interventions including dietary modification, exercise, and behavioral counseling are more effective than interventions targeting single components. Use of a GLP-1 receptor agonist is beneficial when pharmacologic therapy is warranted for further weight reduction.7
In the SELECT trial, the use of guideline-based medical therapies for cardiovascular disease appeared to be well balanced between the groups. Most of the patients were receiving lipid-lowering medications (90.1%) and platelet-aggregation inhibitors (86.2%); 70.2% of the patients were taking beta-blockers, 45.0% were taking angiotensin-converting-enzyme inhibitors, and 29.5% were taking angiotensin-receptor blockers.6 According to the 2023 AHA/ACC/ACCP/ASPC/NLA/PCNA CCD guideline, optimization of guideline-directed management and therapy (GDMT) is recommended to reduce major adverse cardiovascular events in patients with CCD. Comprehensive risk factor control should include lifestyle modifications and GDMT to optimize dyslipidemia, hypertension, weight management, nutrition, physical activity, and hyperglycemia. Recommendations for pharmacologic GDMT include the use of statin and non-statin lipid-lowering therapy, antiplatelet therapy, beta-blockers, and renin-angiotensin-aldosterone inhibitors in select patients with CCD to reduce major adverse cardiovascular events.7 Per the 2021 AHA/ASA Guideline for the Prevention of Stroke in Patients with Stroke and Transient Ischemic Attack, antithrombotic therapy, including antiplatelet or anticoagulant agents, is recommended for nearly all patients without contraindications.8 According to the 2016 AHA/ACC Guideline on the Management of Patients with Lower Extremity PAD, patients with PAD should receive a comprehensive program of GDMT, including structured exercise and lifestyle modification, to reduce cardiovascular ischemic events and improve functional status. A guideline-based program of pharmacotherapy to reduce cardiovascular ischemic events and limb-related events should be prescribed for each patient with PAD and is customized to individual risk factors, such as whether the patient also has diabetes. Pharmacotherapy for the patient with PAD includes antiplatelet and statin agents and is customized to additional risk factors, such as whether the patient also has diabetes or hypertension.9 The beneficial effect of these pharmacotherapies on morbidity and mortality in cardiovascular disease is well documented. Antiplatelet agents and lipid-lowering agents are considered standard of care for patients with established cardiovascular disease. Beta-blockers and angiotensin-aldosterone inhibitors are standard of care for certain patient populations with established cardiovascular disease. Therefore, coverage to reduce the risk of major adverse cardiovascular events in an adult may be approved when the patient is currently receiving GDMT for cardiovascular disease or when the patient has a clinical reason not to be treated with GDMT for cardiovascular disease (e.g., lipid-lowering agent, antiplatelet, beta-blocker, renin-angiotensin inhibitor, etc.).
In adults, initiate Wegovy with a dosage of 0.25 mg injected subcutaneously once-weekly. Then follow the dose escalation schedule below to minimize gastrointestinal adverse reactions.1
|
Recommended Dosage Regimen for Adults1
|
|
Treatment
|
Weeks
|
Once weekly Subcutaneous Dosage
|
|
Initiation
|
1 through 4
|
0.25 mga
|
|
Escalation
|
5 through 8
|
0.5 mga
|
|
9 through 12
|
1 mga
|
|
13 through 16
|
1.7 mg
|
|
Maintenance
|
17 and onward
|
1.7 mg or 2.4 mg
|
aDosage not approved as maintenance for chronic weight management.
If patients do not tolerate a dose during dosing escalation, consider delaying dosage escalation for 4 weeks. The 0.25 mg, 0.5 mg, and 1 mg once-weekly dosages are initiation and escalation dosages and are not approved as maintenance dosages for chronic weight management. The maintenance dosage of Wegovy in adults is either 2.4 mg (recommended) or 1.7 mg once-weekly. Consider treatment response and tolerability when selecting the maintenance dosage.1
In pediatric patients aged 12 years and older, initiate Wegovy according to the dosage escalation schedule below to minimize gastrointestinal adverse reactions.1
|
Recommended Dosage Regimen for Pediatric Patients Aged 12 Years and Older1
|
|
Treatment
|
Weeks
|
Once weekly Subcutaneous Dosage
|
|
Initiation
|
1 through 4
|
0.25 mga
|
|
Escalation
|
5 through 8
|
0.5 mga
|
|
9 through 12
|
1 mga
|
|
13 through 16
|
1.7 mg
|
|
Maintenance
|
17 and onward
|
2.4 mg
|
aDosage not approved as maintenance for chronic weight management.
If patients do not tolerate a dose during dosing escalation, consider delaying dosage escalation for 4 weeks. The 0.25 mg, 0.5 mg, and 1 mg once-weekly dosages are initiation and escalation dosages and are not approved as maintenance dosages for chronic weight management. The maintenance dosage of Wegovy in pediatric patients aged 12 years and older is 2.4 mg once-weekly. If patients do not tolerate the 2.4 mg once-weekly maintenance dosage, the maintenance dosage may be reduced to 1.7 mg once-weekly. Discontinue Wegovy if the patient cannot tolerate the 1.7 mg once-weekly dose.1
The recommended dosage regimen is the same for all indications.
Wegovy is available in cartons containing 4 pre-filled, disposable, single-dose pen-injectors in the following strengths: 0.25 mg/0.5 mL, 0.5 mg/0.5 mL, 1 mg/0.5 mL, 1.7 mg/0.75 mL, 2.4 mg/0.75 mL.1 Based on the recommended dosing of 1 pen per week, patients meeting criteria for approval will be approved for 1 carton of 4 pens per 28 days.
Place of Service:
Outpatient
The above policy is based on the following references:
- Wegovy [package insert]. Plainsboro, NJ: Novo Nordisk Inc.; March 2024.
- Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Waltham, MA: UpToDate, Inc.; 2024. https://online.lexi.com. Accessed March 18, 2024.
- Micromedex® (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com (cited: 03/18/2024).
- 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.
- 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.
- Lincoff AM, Brown-Frandsen K, Colhoun HM, et al. Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes. N Engl J Med. 2023;389:2221-2232.
- Virani SS, Newby LK, Arnold SV, et al. 2023 AHA/ACC/ACCP/ASPC/NLA/PCNA Guideline for the Management of Patients With Chronic Coronary Disease: A Report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines. Circulation. 2023;148:e9-e119.
- Kleindorfer DO, Towfighi A, Chaturvedi S, et al. 2021 Guideline for the Prevention of Stroke in Patients With Stroke and Transient Ischemic Attack: A Guideline From the American Heart Association/American Stroke Association. Stroke. 2021;52(7):e364-e467.
- Gerhard-Herman MD, Gornik HL, Barrett C, et al. 2016 AHA/ACC Guideline on the Management of Patients with Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2017;135(12):e726-e779.
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.
May 01, 2024
