ModifiedCentenePolicy CP PMN.295

Clinical Policy: Semaglutide (Wegovy)

Defines Centene coverage criteria for Wegovy (semaglutide) for cardiovascular event prevention and other indications, including documentation, dosing, exclusions, and prior authorization requirements for affected members and providers.

Policy Summary

PayerCentene

PolicySemaglutide (Wegovy) clinical coverage criteria

Policy CodePolicy CP PMN.295

Change TypeStep therapy bypass added for Illinois HIM

Effective DateJun 1, 2024

Next Review Date

Key ActionSubmit prior authorization with chart notes, labs, baseline/current body weight, and prescriber attestation that cardiovascular standard-of-care management is being provided.

SourceLink

POLICY UPDATE CHANGES

Added step therapy bypass for Illinois HIM per IL HB 5395.

6 monthsInitial approval duration

12 monthsContinued therapy duration

≥27BMI threshold

2.4 mgMax dose

IL HB 5395IL step therapy bypass

Coverage Criteria for Semaglutide (Wegovy)

Initial Therapy

Covered when ALL of the following are met for cardiovascular event prevention:

Initial Approval - CV Event Prevention: Member has established cardiovascular disease evidenced by at least one of: history of myocardial infarction OR history of stroke OR symptomatic peripheral arterial disease (PAD)

Initial Approval - Body Mass Index: Body mass index (BMI) ≥ 27 kg/m²BMI ≥ 27 kg/m²

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

Type 2 Diabetes Concurrence: For members with concurrent type 2 diabetes mellitus, additional requirements apply as specified in policy (both subcriteria must be met)

Prior Therapy / Step Therapy: Failure of ≥3 consecutive months of the specified GLP-1 receptor agonists (e.g., Ozempic, Trulicity, Victoza) is required unless all are contraindicated or clinically significant adverse effects are experienced; intolerance to common class adverse effects is not acceptable justification to bypass step therapy>= 3 months

For Illinois HIM requests, step therapy requirements do not apply as of 1/1/2026 per IL HB 5395

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

Weight Loss Program Participation: Documentation supports member's participation in a physician-directed weight loss program: actively enrolled for at least 6 months and will continue enrollment while on Wegovyenrolled ≥ 6 months

Baseline Weight Documentation: Documentation of member's baseline body weight in kilograms

Dosing follows the specified escalation schedule (0.25 mg wk1–4; 0.5 mg wk5–8; 1 mg wk9–12; 1.7 mg wk13–16; 2.4 mg week17 onward) and maintenance dose does not exceed 2.4 mg once weeklymaintenance ≤ 2.4 mg once weekly

Documentation Submission: Provider must submit chart notes, lab results, or other clinical information supporting that the member has met all approval criteria

Prior authorization may be required

Continuation Therapy

Continued therapy covered when ALL of the following are met:

Eligibility for Continued Therapy: Member is currently receiving medication via the Centene benefit or has previously met initial approval criteria

Response to Therapy: Member is responding positively to therapy: if first renewal, ≥ 5% loss of baseline body weight; if second or subsequent renewal, member has lost weight and/or maintained weight loss on therapyFirst renewal ≥5% weight loss

Current Weight Documentation: Documentation of member's current body weight in kilograms

Prescriber Attestation: Prescriber attestation of ongoing cardiovascular standard of care management

Continued Weight Loss Program Enrollment: Documentation that member remains actively enrolled in a physician-directed weight loss program involving reduced calorie diet, increased physical activity, and behavioral modification

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

Dose Requirements for Continuation: After initial dose escalation, maintenance dose is ≥ 1.7 mg once weekly and does not exceed 2.4 mg once weeklymaintenance ≥1.7 mg; ≤2.4 mg

Documentation Submission: Provider must submit chart notes, lab results, or other clinical information supporting that the member continues to meet approval criteria

Not Covered - Weight Management

Excluded indication

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

Approval duration: Not applicable

Other Indications / Off-label

Other indications

Other Indications / Off-label Handling: For other diagnoses/indications: if the drug is on the formulary/PDL, follow the no coverage criteria policy for the relevant line of business; if not on the formulary/PDL, follow the non‑formulary policy; if the requested use is not listed and does not meet exclusion criteria, refer to the off‑label use policy for the relevant line of business

Non‑FDA indications require sufficient documentation of efficacy and safety per off‑label use policies

Use of Wegovy (semaglutide) for the treatment of weight management is a benefit exclusion and will not be authorized. Approval duration: Not applicable.

Codes referenced in this clinical policy (for example, C9399 and J3490) are provided for informational purposes only. Inclusion or exclusion of any codes does not guarantee coverage; providers must reference the most up-to-date professional coding guidance when submitting claims or prior authorization requests.

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider submits sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies (for example, HIM.PA.154 for health insurance marketplace and CP.PMN.53 for Medicaid) or evidence of coverage documents.

Coding and Billing References

Referenced HCPCS / billing codesHCPCS

C9399	Unclassified or biologicals drugs.
J3490	Unclassified drugs

Referenced codes (informational)HCPCS

C9399	Unclassified or biologicals drugs.
J3490	Unclassified drugs

BMI — threshold used in criteria

BMI thresholdBMI ≥ 27 kg/m²

Source sectionInitial Approval Criteria — Body mass index (BMI) ≥ 27 kg/m²

Role in criteriaRequired component of initial approval for cardiovascular event prevention

Prior Authorization, Step Therapy, and Documentation Requirements

Prior Authorization

Prior authorization required; step therapy applies

Prior authorization is required for Wegovy; step therapy requirements apply for most members. Requests for prior authorization should follow the plan's PA process and include evidence that step therapy was met unless the request qualifies for an exception (see Illinois HM bypass).

Prior authorization may be required.
Step therapy applies except where a statutory bypass exists for IL HIM members.

Billing Rule

C9399 and J3490 referenced (informational)

When submitting PA requests or claims, providers may see HCPCS codes C9399 and J3490 listed as unclassified/biological drug codes; these code references are informational only.

C9399 — Unclassified or biologicals drugs.
J3490 — Unclassified drugs.

Step Therapy

Operational step therapy: fail ≥3 months of specified GLP-1 RAs

Step therapy requires documented failure of at least 3 consecutive months of other specified GLP-1 receptor agonists (e.g., Ozempic, Trulicity, Victoza) unless contraindicated or clinically significant adverse effects are experienced.

Failure of ≥3 consecutive months of other specified GLP-1 RAs is required prior to Wegovy, unless all are contraindicated or produce clinically significant adverse effects.
Intolerance to common class adverse effects (e.g., gastrointestinal symptoms) is not acceptable justification to bypass step therapy.

Step Therapy

Illinois step therapy bypass for IL HIM per IL HB 5395

Per IL HB 5395, step therapy does not apply for Illinois High-Need/High-Impact Members (IL HIM); providers for IL HIM members may request PA without meeting the GLP-1 step requirement.

Added step therapy bypass for IL HIM per IL HB 5395 (effective 01/01/2026 operational note).

Documentation Required

Submit complete clinical documentation with PA requests

Providers must submit chart notes, lab results, and other clinical information demonstrating that the member meets all approval criteria, including baseline and current body weight in kg and prescriber attestation of cardiovascular standard-of-care management.

Documentation should include baseline body weight in kg and current body weight in kg.
Prescriber attestation that the member is receiving cardiovascular standard-of-care management.
Evidence of enrollment in a physician-directed weight loss program as required by the criteria.

Note

State Medicaid provisions take precedence

For Medicaid members, state Medicaid coverage provisions supersede this policy; providers should consult the applicable state Medicaid manual for any differing requirements or coverage rules.

State Medicaid coverage provisions take precedence when they conflict with this clinical policy.
Refer to the state Medicaid manual for specific Medicaid coverage provisions.

Denial Risk

Insufficient documentation or non‑FDA indications risk denial

Requests that lack documentation showing the member met all approval criteria, or requests for non‑FDA (off‑label) indications without sufficient off‑label justification per the applicable off‑label policies, may be denied.

Insufficient documentation of criteria (e.g., missing chart notes, labs, or weight measures) risks denial.
Non‑FDA indications require sufficient documentation per off‑label use policies (HIM.PA.154 for Marketplace; CP.PMN.53 for Medicaid).

Billing Rule

Coding references are informational only; do not guarantee coverage

Inclusion or exclusion of HCPCS codes (e.g., C9399, J3490) in this policy is informational only and does not guarantee coverage; providers must use current professional coding guidance when submitting claims.

Code listings are informational and not a statement of coverage.
Providers must reference up-to-date coding sources when submitting claims to avoid claim denials.

Background on Semaglutide (Wegovy)

Semaglutide (marketed as Wegovy) is a glucagon‑like peptide‑1 (GLP‑1) receptor agonist. It is indicated in this policy context for reduction of risk of major cardiovascular events in adults with established cardiovascular disease and overweight/obesity, and it is also used to reduce excess body weight. Coadministration with other semaglutide products or other GLP‑1 receptor agonists is not recommended.

Key Definitions

Symptomatic peripheral arterial disease (PAD) definition as used in SELECT trial and this policy

Definition usedSymptomatic PAD defined as intermittent claudication with ankle-brachial index (ABI) < 0.85 at rest, or peripheral arterial revascularization procedure, or amputation due to atherosclerotic disease (per SELECT trial)

Policy usageSymptomatic PAD listed as one qualifying form of established CVD for initial approval of semaglutide (Wegovy)

Appendix referenceSee Appendix D (General Information) and Appendix A (abbreviation: PAD = peripheral arterial disease)

Policy Summary

PayerCentene

PolicySemaglutide (Wegovy) clinical coverage criteria

Policy CodePolicy CP PMN.295

Change TypeStep therapy bypass added for Illinois HIM

Effective DateJun 1, 2024

Next Review Date

Key ActionSubmit prior authorization with chart notes, labs, baseline/current body weight, and prescriber attestation that cardiovascular standard-of-care management is being provided.

SourceLink

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