Subject: Wegovy (Cardiovascular) PA with Limit 6410-C UDR 03-2024

Drug

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 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 of 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):

• 6410-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.

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Wegovy [package insert]. Plainsboro, NJ: Novo Nordisk Inc.; March 2024.
2. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Waltham, MA: UpToDate, Inc.; 2024. https://online.lexi.com. Accessed March 18, 2024.
3. Micromedex® (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 03/18/2024).
4. 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.
5. 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.
6. 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.
7. 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