CurrentCentenePolicy CP.PMN.295

Clinical Policy: Semaglutide (Wegovy)

Defines medical necessity criteria, exclusions, dosing limits, and renewal requirements for Wegovy (semaglutide) injection and tablets for cardiovascular event prevention and metabolic dysfunction-associated steatohepatitis (MASH); explicitly excludes coverage for weight management indication.

Policy Summary

PayerCentene

PolicyClinical Policy: Semaglutide (Wegovy)

Policy CodePolicy CP.PMN.295

Change TypeRT4 additions; multiple added/revised criteria

Effective DateJun 1, 2024

Next Review Date

Key ActionProvider must submit chart notes, lab results, prescriber attestations, baseline and current body weight in kg, and weight program enrollment documentation to support that member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

Added Wegovy tablets formulation and Wegovy HD injection 7.2 mg; updated criteria to include tablets and tablet dosing escalation/maintenance.

MASH criteria updated per FDA labeling: biopsy lookback revised from 6 months to 3 years; imaging examples updated to VCTE; non-invasive test examples moved to Appendix E.

For cardiovascular event prevention, Rybelsus added as an option for members with concurrent T2DM.

Added step therapy bypass for Illinois HIM per IL HB 5395 effective 2026-01-01.

Modified preferred liraglutide product language to 'liraglutide (generic Victoza)'.

2Covered Indications (CV prevention, MASH)

1Excluded Indication (Weight management)

2.4 mg/weekInjection max

Coverage Summary

Scope: Defines medical necessity criteria, exclusions, dosing limits, and renewal requirements for Wegovy (semaglutide) injection and tablets for cardiovascular event prevention and metabolic dysfunction-associated steatohepatitis (MASH). Coverage stance: mixed (covered for specified indications with detailed criteria; excluded for weight management). Covered indications: CV event risk reduction in adults with established CVD and obesity/overweight, and MASH (F2–F3 fibrosis) in adults (injection only) when criteria are met. Excluded indication: use of Wegovy for weight management is a benefit exclusion and will not be authorized. Effective date: 06.01.24. Last review date: 05.26.

Thresholds and Policy Metadata

policy_numberCP.PMN.295

subjectSemaglutide (Wegovy) coverage for CV event prevention and MASH

statusCURRENT

Age≥ 18 years (CV prevention and MASH)

BMI≥ 27 kg/m2 (CV prevention)

Weight loss responseFirst renewal: ≥ 5% of baseline body weight; second/subsequent: lost weight and/or maintained weight loss

Diabetes therapy trial duration≥ 3 consecutive months each of specified agents (Ozempic or Rybelsus, Trulicity, liraglutide) unless adverse effects/contraindications

MASH biopsy lookbackLiver biopsy within the last 3 years

MASH noninvasive assessments lookbackBoth serum-based and imaging-based assessments within the last 6 months

I. Initial Approval Criteria — A. Cardiovascular Event Prevention

I. Initial Approval Criteria - A. Cardiovascular Event Prevention

Covered when ALL of the following are met:

A. Cardiovascular Event Prevention

Member has at least one established CVD: history of myocardial infarction, history of stroke, or symptomatic peripheral arterial disease (PAD)
Age ≥ 18 years
Body mass index (BMI) ≥ 27 kg/m2
Prescriber attestation that member is currently receiving cardiovascular standard of care management
For members with concurrent T2DM

I. Initial Approval Criteria — B. Weight Management (Excluded)

I. Initial Approval Criteria - B. Weight Management

B. Weight Management: Use of Wegovy for the treatment of weight management is a benefit exclusion and will not be authorized

Approval duration: Not applicable

I. Initial Approval Criteria — C. Metabolic Dysfunction-Associated Steatohepatitis (MASH)

I. Initial Approval Criteria - C. Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Covered when ALL of the following are met:

C. Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Diagnosis of MASH (formerly known as NASH)
Request is for Wegovy injection
Prescribed by or in consultation with a hepatologist or gastroenterologist
Age ≥ 18 years
Fibrosis confirmation

II. Continued Therapy (Renewal) — A. Cardiovascular Event Prevention

II. Continued Therapy (Renewal) - A. Cardiovascular Event Prevention

Renewal authorized when ALL of the following are met:

A. Cardiovascular Event Prevention - Continued Therapy (Renewal)

Continuity of care: Member currently receiving medication via Centene benefit or previously met initial approval criteria, OR member currently receiving medication and enrolled in a state/product with continuity of care regulations
Positive response evidence: If first renewal: member has lost ≥ 5% of baseline body weight; If second or subsequent renewal: member has lost weight and/or maintained weight loss on therapy
Documentation of member's current body weight in kg

II. Continued Therapy (Renewal) — C. MASH

II. Continued Therapy (Renewal) - C. MASH

Renewal authorized when ALL of the following are met after at least 12 months of therapy:

C. MASH - Continued Therapy (Renewal)

Continuity of care: Member currently receiving medication via Centene benefit or previously met initial approval criteria, OR member currently receiving medication and enrolled in a state/product with continuity of care regulations
Evidence of positive response after ≥ 12 months: Improvement in fibrosis ≥ 1-stage from baseline with no worsening of MASH; OR resolution of MASH with no worsening of fibrosis; OR no increase in fibrosis stage and no worsening of MASH from baseline
Prescriber attestation that member is currently receiving standard of care management for concomitant related conditions

III. Diagnoses/Indications Not Authorized

III. Diagnoses/Indications Not Authorized: Non-FDA approved indications not addressed in this policy are not authorized unless there is sufficient documentation of efficacy and safety per off-label use policies (HIM.PA.154 for health insurance marketplace/ICHRA or CP.PMN.53 for Medicaid) or per evidence of coverage documents

Coding

HCPCS / Informational codes referencedHCPCS

C9399	Unclassified drugs or biologicals
J3490	Unclassified drugs

Provider Actions

Documentation Required

Provide supporting documentation

Provider must submit chart notes, lab results, baseline and current body weight (kg), prescriber attestations of standard of care management, and documentation of enrollment in a physician-directed weight loss program to support that the member meets all approval criteria.

Office chart notes
Lab results
Baseline and current body weight in kg
Prescriber attestation of standard of care management
Documentation of enrollment in physician-directed weight loss program

Prior Authorization

Prior authorization required

Background & Evidence

Background: Wegovy (semaglutide) is a GLP‑1 receptor agonist. FDA indications include: (1) in combination with diet and increased physical activity to reduce the risk of major adverse cardiovascular events in adults with established CVD and obesity/overweight; (2) for MASH (formerly NASH) with stage F2–F3 fibrosis in adults (Wegovy injection). The labeling notes that concomitant use with other semaglutide-containing products or any other GLP‑1 receptor agonist is not recommended.

Key Trials

Definitions

Revision History

2026-03-24addedLatest

Added Wegovy tablets formulation and Wegovy HD injection 7.2 mg; updated criteria to include tablets and tablet dosing escalation/maintenance.

2025-11-18added

For cardiovascular event prevention, Rybelsus added as an option for members with concurrent T2DM to reflect Rybelsus's new FDA CV indication.

2025-09-09revised

MASH criteria updated per FDA labeling: biopsy lookback revised from 6 months to 3 years; imaging examples updated to VCTE; non-invasive test examples moved to Appendix E; added trial requirements of Rybelsus, Trulicity and Victoza for concurrent T2DM; clarified continuation requirements and tolerance to maintenance dose ≥1.7 mg after dosage escalation.

Policy Summary

PayerCentene

PolicyClinical Policy: Semaglutide (Wegovy)

Policy CodePolicy CP.PMN.295

Change TypeRT4 additions; multiple added/revised criteria

Effective DateJun 1, 2024

Next Review Date

SourceLink

On This Page

Member has received optimal diabetic standard of therapy as evidenced by a trial of ≥ 3 consecutive months each of Ozempic or Rybelsus, Trulicity, and liraglutide (Victoza), unless clinically significant adverse effects or contraindications

If member is currently receiving a GLP-1 receptor agonist and requesting to switch to Wegovy, medical justification supports necessity for Wegovy (intolerance to common class adverse effects like GI symptoms is NOT acceptable justification)

Wegovy is not prescribed concurrently with other semaglutide-containing products or any other GLP-1 receptor agonist(s)

Weight program participation

Member has been actively enrolled in a physician-directed weight loss program involving reduced calorie diet, increased physical activity, and behavioral modification for at least 6 months
Member will continue to be enrolled in such a program while prescribed Wegovy

Documentation of member's baseline body weight in kg

Dose limits / request type

Wegovy-naïve injection requests: Dose does not exceed specified escalation schedule for injectionsWeek1-4 0.25 mg once weekly; Week5-8 0.5 mg once weekly; Week9-12 1 mg once weekly; Week13-16 1.7 mg once weekly; Week17 and onward 2.4 mg once weekly
Wegovy-naïve tablet requests: Dose does not exceed 1 tablet per day and follows tablet escalation scheduleDays1-30 1.5 mg/day; Days31-60 4 mg/day; Days61-90 9 mg/day; Days91+ 25 mg/day
Switching between injection and tablet
- Switch to injection: For injection requests when switching: member is prescribed or unable to tolerate Wegovy 25 mg tablets; member is able to tolerate a maintenance dose of ≥ 1.7 mg once weekly; dose does not exceed 2.4 mg once weekly
- Switch to tablet: For tablet requests when switching: member is prescribed or unable to tolerate Wegovy 2.4 mg injection; member is able to tolerate a maintenance dose of 25 mg per day; dose does not exceed 25 mg per day; dose does not exceed 1 tablet per day

Liver biopsy within the last 3 years confirming stage F2 or F3 fibrosis

Both assessments within last 6 months: Both a serum-based assessment and an imaging-based assessment performed within the last 6 months (examples: serum-based FIB-4, NFS, ELF; imaging-based VCTE, MRE, MRI-PDFF)

For members with concurrent T2DM: Member has received optimal diabetic standard of care therapy as evidenced by a trial of ≥ 3 consecutive months each of Ozempic or Rybelsus, Trulicity, and liraglutide (Victoza), unless clinically significant adverse effects or contraindications

Weight program participation: Member has been actively enrolled in a physician-directed weight loss program for at least 6 months and will continue enrollment while prescribed Wegovy

Prescriber attestation that member is currently receiving standard of care management for concomitant related conditions (including T2DM, dyslipidemia, hypertension)

Wegovy is not prescribed concurrently with Rezdiffra

Wegovy is not prescribed concurrently with other semaglutide-containing products or any other GLP-1 receptor agonist(s)

Dose escalation and limits: Dose escalation schedule and limits for injection: Week1-4 0.25 mg; Week5-8 0.5 mg; Week9-12 1 mg; Week13-16 1.7 mg; Week17+ 2.4 mg once weekly (dose does not exceed 2.4 mg once weekly)

Prescriber attestation that member is currently receiving cardiovascular standard of care management

Wegovy is not prescribed concurrently with other semaglutide-containing products or any other GLP-1 receptor agonist(s)

Documentation that member is actively enrolled in a physician-directed program (reduced calorie diet, increased physical activity, behavioral modification)

Renewal-specific tolerance and dose limits

Injection renewal criteria: After initial dose escalation, member is able to tolerate a maintenance dose of ≥ 1.7 mg once weekly; dose does not exceed 2.4 mg once weekly
Tablet renewal criteria: After initial dose escalation, member is able to tolerate a maintenance dose of 25 mg per day; dose does not exceed 25 mg per day; dose does not exceed 1 tablet per day

Documentation that member is actively enrolled in a physician-directed program (reduced calorie diet, increased physical activity, behavioral modification)

Wegovy is not prescribed concurrently with Rezdiffra; Wegovy is not prescribed concurrently with other semaglutide-containing products or any other GLP-1 receptor agonist(s)

Maintenance dose tolerance: After initial dose escalation, member is able to tolerate a maintenance dose of ≥ 1.7 mg once weekly; dose does not exceed 2.4 mg once weekly

Requests require prior authorization and must meet the policy's applicable initial or renewal criteria. Prior authorization may also be required for documentation of the cited diabetic therapy trials.

Billing Rule

Dose limits enforcement

Claims should conform to the policy dosing escalation and maximum maintenance dose limits. Affected HCPCS/informational codes: C9399 and J3490. Injection maximum maintenance dose is 2.4 mg once weekly. Tablet maximum maintenance dose is 25 mg per day and tablets are limited to 1 tablet per day.

Affected codes: C9399, J3490
Injection max: 2.4 mg once weekly
Tablet max: 25 mg per day
Tablet limit: 1 tablet per day

Denial Risk

Denial risk for excluded indication

Requests for Wegovy for the treatment of weight management are a benefit exclusion and will be denied.

Documentation Required

MASH diagnostic evidence

For the MASH indication, provide either a liver biopsy within the last 3 years confirming stage F2–F3 fibrosis or both a serum-based assessment and an imaging-based assessment obtained within the last 6 months. Examples of serum-based assessments include FIB-4, NAFLD fibrosis score (NFS), and ELF; imaging-based examples include VCTE, MRE, and MRI-PDFF.

Liver biopsy within the last 3 years (F2–F3 fibrosis)
Or both within last 6 months: serum-based assessment (e.g., FIB-4, NFS, ELF) and imaging-based assessment (e.g., VCTE, MRE, MRI-PDFF)

Step Therapy

Step therapy for concurrent T2DM

For members with concurrent T2DM, document trials of at least 3 consecutive months each of Ozempic or Rybelsus, Trulicity, and liraglutide (Victoza) unless clinically significant adverse effects or all agents are contraindicated. Note: Illinois HIM requests are exempt from these step therapy requirements per IL HB 5395 effective 2026-01-01.

Trial ≥ 3 months: Ozempic or Rybelsus
Trial ≥ 3 months: Trulicity
Trial ≥ 3 months: liraglutide (Victoza)
Illinois HIM bypass per IL HB 5395 effective 2026-01-01

2025-06-27added

Added step therapy bypass for Illinois HIM per IL HB 5395 effective 2026-01-01.

2026-05-26revised

Administrative update: modified preferred liraglutide product language to 'liraglutide (generic Victoza)'.