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This policy governs Apple Health coverage and prior authorization for Wegovy semaglutide injection and tablet formulations for adults with established cardiovascular disease and overweight or obesity or with moderate-to-severe noncirrhotic MASH. It establishes medical-necessity criteria, reauthorization requirements, dosage limits, and an exclusion for weight-loss use.
Wegovy tablet formulations were added to the policy.
Lifestyle requirements were removed from the policy.
The policy added a definition of symptomatic peripheral arterial disease.
The waist-circumference requirement was removed.
Titration requirements were removed from the clinical criteria.
Additional anticoagulant or secondary-prevention medication options were added.
The policy added a cross-reference to the Zepbound anti-obesity policy.
Reauthorization criteria were revised to require continued satisfaction of the applicable criteria, with an exception for BMI.
The clinical criteria were reworded to match the labeled indication.
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6 monthsInitial cardiovascular authorization
12 monthsReauthorization period
≥27Minimum cardiovascular BMI
F2–F3Eligible MASH fibrosis stages
Not coveredWeight-loss-only use
Medical Necessity and Coverage Criteria
Initial therapy: established cardiovascular disease with overweight or obesity
Covered for adults with established cardiovascular disease and overweight or obesity when ALL criteria are met.
Initial cardiovascular indication
Patient characteristics: Patient has a BMI of at least 27 kg/m², is at least 18 years of age, and does not have diabetes or an HbA1c greater than 6.5%.BMI ≥ 27 kg/m²; age ≥ 18 years; HbA1c ≤ 6.5%
Patients with type 2 diabetes or HbA1c greater than 6.5% should request a GLP-1 agent indicated for type 2 diabetes under policy 27.17.00.
Established cardiovascular disease
Symptomatic carotid artery disease: Moderate-to-severe carotid artery stenosis, internal carotid artery revascularization, or one or more transient ischemic attacks with focal neurological dysfunction or transient monocular blindness is present.Carotid occlusion > 50%
Symptomatic coronary artery disease: Coronary stenosis, symptomatic angina pectoris, or prior coronary revascularization is present.Coronary stenosis ≥ 50%
Symptomatic peripheral arterial disease: Intermittent claudication with a qualifying ankle-brachial index, peripheral arterial revascularization, or amputation due to atherosclerotic disease is present.Ankle-brachial index < 0.85 at rest
Prior major cardiovascular event: Patient has a prior ischemic or hemorrhagic stroke or prior myocardial infarction.
Secondary cardiovascular prevention therapy: Treatment plan includes concurrent antiplatelet, antihypertensive, or lipid-lowering therapy for secondary prevention of adverse cardiovascular events, unless contraindicated or not tolerated.
Examples include aspirin, clopidogrel, ticagrelor, prasugrel, or cangrelor; an ACE or ARB inhibitor, beta blocker, or calcium channel blocker; or a statin, fibrate, or PCSK-9 inhibitor.
Combination-therapy restriction: Semaglutide is not used in combination with another GLP-1 receptor agonist or a DPP-4 inhibitor.
Continuation therapy: cardiovascular indication
Covered for reauthorization when ALL criteria are met.
Cardiovascular reauthorization: Member has received previous authorization approval or has been established on therapy from another health plan, excluding therapy established through samples, patient assistance programs, or coupons, and the patient continues to meet criteria 2 through 6 of the initial cardiovascular criteria.
If all criteria are met, authorization is for 12 months.
Initial therapy: moderate-to-severe MASH
Covered for moderate-to-severe noncirrhotic MASH in adults when ALL criteria are met.
MASH initial therapy
Adult without diabetes: Patient is at least 18 years of age and does not have diabetes or an HbA1c greater than 6.5%.Age ≥ 18 years; HbA1c ≤ 6.5%
Patients with type 2 diabetes or HbA1c greater than 6.5% should request a GLP-1 agent indicated for type 2 diabetes under policy 27.17.00.
Moderate-to-severe MASH confirmation: Patient has moderate-to-severe MASH with fibrosis stage F2 or F3 confirmed by biopsy, Fib-4, Fibroscan, APRI, Fibrotest, or elastography.Fib-4: 1.3–3.48; Fibroscan: 8.5–13.5 kPa; APRI: 1.0–1.9; Fibrotest: 0.49–0.74; elastography: 1.38–2.33 m/s
The policy describes this indication as noncirrhotic moderate-to-severe MASH.
Continuation therapy: MASH
Covered for MASH reauthorization when ALL criteria are met.
MASH reauthorization: Member has received previous authorization approval or has been established on therapy from another health plan, excluding therapy established through samples, patient assistance programs, or coupons; the patient continues to meet criteria 1 through 4; and the patient does not have cirrhosis or a fibrosis score greater than F3.Fibrosis not greater than F3
If all criteria are met, authorization is for 12 months.
Wegovy (semaglutide) injection or tablet is not covered by Apple Health when requested for weight loss.
Patients with type 2 diabetes or HbA1c greater than 6.5% should be directed to a GLP-1 agent indicated for type 2 diabetes under policy 27.17.00, rather than this policy.
Use of Wegovy solely for weight loss is excluded from Apple Health coverage.
Apple Health statutory/regulatory authority cited for exclusion of Wegovy for weight loss
42 U.S.C. 1396r-8(d)(2)(A)
Federal statutory authority cited for exclusion of Wegovy for weight loss
Minimum BMI for cardiovascular indication
ThresholdBMI ≥ 27 kg/m²
Applies toAdults with established cardiovascular disease and overweight or obesity
IndicationCardiovascular disease with risk for major adverse cardiovascular events
Adult age requirement
Minimum age≥ 18 years
Cardiovascular indicationPatient must be at least 18 years old
MASH indication
Authorization, Documentation, and Denial Risks
Prior Authorization
Prior Authorization and Preferred-Drug-List Requirements
New-to-market drugs added to the Apple Health Preferred Drug List (AHPDL) class are non-preferred and require prior authorization. Non-preferred agents must meet the preferred-agent trial requirements before coverage can be authorized.
Consult the current Apple Health Preferred Drug List for preferred agents.
If there are at least two preferred agents, document inadequate response or intolerance to at least two.
If there is only one preferred agent, document inadequate response or intolerance to that one agent.
Prior Authorization
Initial Cardiovascular Indication Authorization
Initial cardiovascular-risk authorization for Wegovy® semaglutide injection or tablet is available for adults with obesity or overweight and established cardiovascular disease who are at risk for major adverse cardiovascular events. All listed clinical criteria must be met; approval is for 6 months.
BMI ≥27 kg/m².
Clinical Background
Overweight is defined as a body mass index (BMI) of 25 to 29.9 kg/m², and obesity as a BMI of at least 30 kg/m². Obesity is associated with cardiovascular disease, type 2 diabetes, hypertension, dyslipidemia, and coronary heart disease. This policy addresses selected adults with overweight or obesity and established cardiovascular disease without diabetes, as well as adults with moderate-to-severe noncirrhotic MASH.
Assessment requirementMASH must be confirmed by a qualifying fibrosis assessment
Fib-4 score
Qualifying range1.3 to 3.48
AssessmentFib-4 score
UseQualifying confirmation of moderate-to-severe F2 or F3 MASH
Fibroscan score
Qualifying range8.5 to 13.5 kPA
AssessmentFibroscan score
UseQualifying confirmation of moderate-to-severe F2 or F3 MASH
APRI
Qualifying range1.0 to 1.9
AssessmentAPRI
UseQualifying confirmation of moderate-to-severe F2 or F3 MASH
Fibrotest
Qualifying range0.49 to 0.74
AssessmentFibrotest
UseQualifying confirmation of moderate-to-severe F2 or F3 MASH
Elastography
Qualifying range1.38 to 2.33 m/s
AssessmentElastography (ARFI/PSWE)
UseQualifying confirmation of moderate-to-severe F2 or F3 MASH
Age ≥18 years.
No diabetes and HbA1c ≤6.5%; patients with type 2 diabetes or HbA1c >6.5% should request a GLP-1 indicated for type 2 diabetes under Policy 27.17.00.
Established cardiovascular disease: prior stroke, prior myocardial infarction, qualifying symptomatic carotid artery disease, qualifying symptomatic coronary artery disease, or qualifying symptomatic peripheral arterial disease.
Qualifying carotid disease includes >50% stenosis, internal carotid revascularization, or transient ischemic attack with focal neurologic dysfunction or transient monocular blindness.
Qualifying coronary disease includes ≥50% coronary stenosis, symptomatic angina pectoris, or prior coronary revascularization.
Qualifying peripheral arterial disease includes intermittent claudication with resting ankle-brachial index <0.85, peripheral arterial revascularization, or amputation due to atherosclerotic disease.
Prior Authorization
Cardiovascular Reauthorization
For cardiovascular reauthorization, the member must have a previous authorization or be established on therapy through another health plan, and must continue to meet the applicable initial criteria. Therapy established through samples, patient assistance programs, or coupons does not qualify.
Continuation criteria include age ≥18, BMI ≥27 kg/m², no diabetes or HbA1c >6.5%, qualifying established cardiovascular disease, and the required secondary-prevention treatment plan.
If all criteria are met, reauthorization is for 12 months.
Prior Authorization
Initial MASH Authorization
Initial MASH authorization is available for Wegovy® semaglutide injection in adults with moderate to severe noncirrhotic MASH, formerly called NASH. All criteria must be documented; approval is for 6 months.
Age ≥18 years.
No diabetes and HbA1c ≤6.5%; patients with type 2 diabetes or HbA1c >6.5% should request a GLP-1 indicated for type 2 diabetes under Policy 27.17.00.
Moderate to severe MASH with fibrosis stage F2 or F3, confirmed by biopsy, Fib-4 1.3–3.48, FibroScan 8.5–13.5 kPa, APRI 1.0–1.9, FibroTest 0.49–0.74, or elastography (ARFI/PSWE) 1.38–2.33 m/s.
At least one cardiovascular risk factor, such as chronic kidney disease, dyslipidemia, hypertension, obesity with BMI ≥30 kg/m², or prediabetes.
Prior Authorization
MASH Reauthorization
MASH reauthorization requires a previous authorization or established therapy from another health plan and continued satisfaction of the initial MASH criteria. Therapy established through samples, patient assistance programs, or coupons does not qualify.
The member must continue to meet the age, diabetes/HbA1c, F2–F3 MASH evidence, and cardiovascular-risk-factor criteria.
The patient must not have cirrhosis or fibrosis greater than F3.
If all criteria are met, reauthorization is for 12 months.
Step Therapy
Preferred-Agent Trial Requirement
Before requesting a non-preferred agent, document an inadequate response or intolerance to the required preferred agents. Intolerance must be due to a severe adverse reaction or a contraindication.
Document inadequate response or documented intolerance to at least two preferred agents when at least two preferred agents are available.
When only one preferred agent is available, document inadequate response or documented intolerance to that one agent.
Documentation Required
Cardiovascular Indication Documentation
The cardiovascular request must include documentation supporting each clinical criterion for the requested Wegovy® formulation.
Document BMI ≥27 kg/m² and age ≥18 years.
Document absence of diabetes and HbA1c ≤6.5%, or explain why a diabetes-indicated GLP-1 is not being requested.
Identify the qualifying established cardiovascular disease and provide supporting evidence: stroke, myocardial infarction, carotid disease, coronary disease, or peripheral arterial disease.
For qualifying symptomatic disease, document the applicable stenosis, revascularization, transient ischemic attack, angina, ankle-brachial index, or amputation findings.
Documentation Required
Secondary Cardiovascular Prevention Plan
The cardiovascular request must document a secondary cardiovascular-prevention treatment plan. Concurrent therapy is required unless the medication is contraindicated or not tolerated.
Document concurrent antiplatelet therapy, such as aspirin, clopidogrel, ticagrelor, prasugrel, or cangrelor; or
Document concurrent antihypertensive therapy, such as an ACE or ARB inhibitor, beta blocker, or calcium channel blocker; or
Document concurrent lipid-lowering therapy, such as a statin, fibrate, or PCSK-9 inhibitor.
If the applicable therapy is contraindicated or not tolerated, document the contraindication or intolerance.
Documentation Required
Continuation Documentation
For continuation requests, document the prior authorization approval or qualifying established therapy and confirm that the member continues to satisfy all applicable criteria.
Do not use samples, patient assistance programs, or coupons as evidence of established therapy.
For cardiovascular reauthorization, document continued satisfaction of criteria 2–6.
For MASH reauthorization, document continued satisfaction of criteria 1–4 and absence of cirrhosis or fibrosis greater than F3.
Documentation Required
MASH Documentation
MASH requests must include documentation of the clinical and diagnostic findings supporting moderate to severe noncirrhotic MASH.
Document age ≥18 years and absence of diabetes or HbA1c >6.5%.
Document fibrosis stage F2 or F3 and the qualifying biopsy, Fib-4, FibroScan, APRI, FibroTest, or elastography result.
Document at least one qualifying cardiovascular risk factor.
For reauthorization, document continued satisfaction of the initial criteria and absence of cirrhosis or fibrosis greater than F3.
Documentation Required
MASH Reauthorization Documentation
Continuation requests must show that the member remains eligible under the applicable indication criteria. Failure to document continued eligibility, or documentation of an exclusion, creates a denial risk.
Document prior authorization or qualifying established therapy and continued cardiovascular or MASH criteria.
For MASH, document that the patient does not have cirrhosis or fibrosis greater than F3.
Samples, patient assistance programs, and coupons do not establish qualifying prior therapy.
Denial Risk
Failure to Meet Cardiovascular Indication Criteria
An initial cardiovascular request will be denied when the member does not meet all required criteria for BMI, age, diabetes/HbA1c status, established cardiovascular disease, and the secondary-prevention treatment plan.
No qualifying established cardiovascular disease or insufficient supporting evidence.
BMI below 27 kg/m² or age younger than 18 years.
Diabetes or HbA1c >6.5%; these patients should request a GLP-1 indicated for type 2 diabetes under Policy 27.17.00.
No qualifying concurrent secondary-prevention therapy and no documented contraindication or intolerance.
Denial Risk
Prohibited Combination Therapy
Semaglutide must not be used in combination with another GLP-1 receptor agonist or a dipeptidyl peptidase-4 (DPP-4) inhibitor.
Document that the requested semaglutide therapy will not be combined with another GLP-1 receptor agonist.
Document that the requested semaglutide therapy will not be combined with a DPP-4 inhibitor.
Denial Risk
Failure to Meet Reauthorization Criteria
Continuation authorization may be denied when the member lacks qualifying prior authorization or established therapy, fails to continue meeting the applicable criteria, or has an MASH exclusion.
Denial risk applies when required continuation documentation is absent.
For MASH, cirrhosis or fibrosis greater than F3 disqualifies reauthorization.
Establishment of therapy through samples, patient assistance programs, or coupons does not satisfy the prior-therapy requirement.
Denial Risk
Weight-Loss-Only Use Excluded
Wegovy® semaglutide injection or tablet is not covered by Apple Health when requested for weight loss.
Weight-loss-only use is excluded under WAC 182-530-2100(1)(b)(i) and section 1927 of the Social Security Act [42 U.S.C. 1396r-8(d)(2)(A)].
Denial Risk
Preferred-Drug-List Failure
A non-preferred agent is at risk for denial when the required preferred-drug-list trial or intolerance documentation is missing.
Document inadequate response or documented intolerance due to severe adverse reaction or contraindication to at least two preferred agents when two or more preferred agents are available.
If only one preferred agent is available, document inadequate response or documented intolerance to that agent.
New-to-market drugs included in the class are non-preferred and subject to these prior authorization requirements.
MASH
Full termMetabolic dysfunction-associated steatohepatitis
SeverityModerate-to-severe
Fibrosis stageF2 or F3
MACE
AbbreviationMACE
Full termMajor adverse cardiovascular events
Policy contextPatients with established cardiovascular disease may be at risk for MACE