ModifiedCentenePolicy HIM.PA.53

Glucagon-Like Peptide-1 (GLP-1) Receptor Agonists coverage

Medical necessity and prior authorization criteria for glucagon-like peptide-1 (GLP-1) receptor agonists for treatment of type 2 diabetes and related indicated uses for Centene-affiliated health plans.

Policy Summary

PayerCentene

PolicyGlucagon-Like Peptide-1 (GLP-1) Receptor Agonists coverage

Policy CodePolicy HIM.PA.53

Change TypeOperational revisions, dosing/formulation additions, and exception clarifications

Effective DateMar 1, 2018

Next Review Date

Key ActionSubmit prior authorization with supporting chart notes and recent labs demonstrating the member meets initial or continuation criteria; include dosing and evidence of metformin trial or documented exception when applicable.

SourceLink

POLICY UPDATE CHANGES

Removed Bydureon from the policy because the product has been discontinued and added Brenzavvy to Appendix B.

Added new Rybelsus formulation (R2 tablets: 1.5 mg, 4 mg, and 9 mg) and new Ozempic 2 mg pen strength entries; updated Ozempic indication to include chronic kidney disease benefit.

Added bypass of required non-GLP-1 trial agents for members with ASCVD, high ASCVD risk indicators, chronic kidney disease, MASLD, MASH, and heart failure with preserved ejection fraction per ADA guidance.

12 monthsapproval duration for continued therapy

≥3 morequired metformin trial

≥8.5%HbA1c threshold

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Coverage Criteria for GLP-1 Receptor Agonists

Initial Approval — Preferred GLP-1 RA Therapy

Covered when ALL of the following are met

Preferred GLP-1 RA initial criteria: 1) Diagnosis of type 2 diabetes mellitus; 2) Request is for one of the preferred agents (liraglutide/Victoza, dulaglutide/Trulicity, semaglutide/Ozempic or Rybelsus, or combination products Soliqua or Xultophy) as applicable; 3) Age requirement for the requested agent is met (Trulicity and Victoza: >= 10 years; Ozempic, Rybelsus, Soliqua, Xultophy: >= 18 years); 4) If request is for Victoza, member must use generic liraglutide unless contraindicated or intolerant; 5) Requested product is not prescribed concurrently with another GLP-1 receptor agonist; 6) Dose does not exceed the FDA-approved maximum recommended dose (see policy dosing section).

Initial Approval — Type 2 Diabetes Specific (Adlyxin, Bydureon, Byetta, Mounjaro)

Covered when ALL of the following are met

Type 2 diabetes criteria for listed agents: 1) Diagnosis of type 2 diabetes mellitus; 2) Request is for Adlyxin (lixisenatide), Bydureon (exenatide ER) / Bydureon BCise, Byetta (exenatide IR), or tirzepatide (Mounjaro); 3) Age requirement is met (Bydureon BCise: >= 10 years; Adlyxin, Byetta, Mounjaro: >= 18 years); 4) Failure of >= 3 consecutive months of metformin (unless contraindicated or not tolerated) as evidenced by HbA1c > 7% OR for antidiabetic medication‑naive members, intended concurrent use with metformin when HbA1c >= 8.5% (lab within prior 3 months); 5) For agents with demonstrated cardiovascular or renal benefit (e.g., Ozempic, Trulicity, liraglutide/Victoza where applicable), member meets ASCVD, high ASCVD risk indicators, HFpEF, or chronic kidney disease criteria when that benefit is the rationale for use; 6) Dose does not exceed the FDA‑approved maximum recommended dose; 7) Requested product is not prescribed concurrently with another GLP-1 receptor agonist.

Continued Therapy

Covered when ALL of the following are met

Continuation criteria: 1) Member meets one of: a) currently receiving the medication via the Centene benefit or b) member is currently receiving medication and is enrolled in a state/product continuity of care program; 2) Member is responding positively to therapy as documented in the chart; 3) If request is for Victoza, member must use generic liraglutide unless contraindicated or intolerant; 4) If request is for a dose increase, the new dose does not exceed the FDA‑approved maximum recommended dose; 5) Requested product is not prescribed concurrently with another GLP-1 receptor agonist; 6) Approval duration: 12 months.

Other Diagnoses/Indications

Covered when ONE of the following is met

Other indications pathway: 1) For drugs on the formulary/PDL (commercial or marketplace lines), follow the no coverage criteria policy for the relevant line of business (HIM.PA.33) when a recent label change is not yet reflected in this policy; OR 2) For drugs not on the formulary/PDL, follow the non‑formulary policy for the relevant line of business (HIM.PA.103). If the requested use is not listed in section III and criterion 1 does not apply, refer to the off‑label use policy HIM.PA.154.

Initial and continued therapy criteria (preferred and non-preferred split)

Covered when criteria for initial or continued therapy for specified preferred or non-preferred agents are met as detailed in the policy (includes diagnosis, age, non-concurrent GLP-1 use, dose limits, and trial/redirection rules).

Initial approval - preferred agents: Initial approval criteria apply separately for preferred agents (Trulicity, Victoza, Xultophy, Soliqua, Ozempic, Rybelsus) and include: documented diagnosis of type 2 diabetes, age within the product's labeled indication, requested product not prescribed concurrently with another GLP-1 receptor agonist, and dosing within FDA‑approved maximum limits.

Initial approval - non-preferred agents: Non‑preferred agents (Bydureon [removed if discontinued], Bydureon BCise, Byetta, Adlyxin, Mounjaro) are subject to redirection to preferred agents (for example, Rybelsus) unless an exception applies; initial criteria for non‑preferred agents also require diagnosis, age within labeled indication, and dosing within FDA‑approved maximum limits.

Bypass exceptions to non-GLP-1 trial or redirection: Members with established ASCVD, indicators of high ASCVD risk, chronic kidney disease, MASLD, MASH, or heart failure with preserved ejection fraction may bypass required trials of non‑GLP‑1 agents and certain redirection requirements per ADA guidance and policy updates.

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the request is supported by sufficient documentation of efficacy and safety in accordance with the Off‑Label Use policy HIM.PA.154 or applicable evidence of coverage documents. Providers should include clinical rationale and supporting evidence when seeking coverage for off‑label uses; absence of such documentation may result in denial.

Product‑specific use limitations and restrictions are summarized as follows: GLP‑1 receptor agonists should not be used for the treatment of type 1 diabetes. Xultophy and Soliqua are not for the treatment of diabetic ketoacidosis and have not been studied with prandial insulin; they should not be coadministered with other products containing the same GLP‑1 component. Bydureon BCise and Xultophy are not recommended as first‑line therapy for patients inadequately controlled on diet and exercise. Bydureon BCise is an extended‑release exenatide formulation and must not be coadministered with other exenatide products. Trulicity is not indicated for patients with pre‑existing severe gastrointestinal disease; Adlyxin and Soliqua are not recommended in patients with gastroparesis. For agents other than Ozempic, Victoza, and Xultophy, there is limited study in patients with prior pancreatitis and alternative antidiabetic therapies should be considered.

Contraindications and boxed warnings include: hypersensitivity to any product components; personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN2) for all GLP‑1 receptor agonists except Byetta, Adlyxin, and Soliqua. A history of drug‑induced immune‑mediated thrombocytopenia from exenatide products is a contraindication for Bydureon BCise and Byetta. Use during episodes of hypoglycemia is contraindicated for Soliqua and Xultophy. Boxed warnings regarding thyroid C‑cell tumors apply to all GLP‑1 receptor agonists except Byetta, Adlyxin, and Soliqua.

Requests for indications that are not FDA‑approved and not otherwise listed in this policy will only be considered when accompanied by sufficient clinical documentation consistent with the plan’s off‑label use requirements (see HIM.PA.154). Absent that documentation, non‑FDA indications are not authorized under this policy.

A request for a GLP‑1 receptor agonist in a member with a documented contraindication listed in Appendix C will be considered not medically necessary. Contraindications that trigger this determination include hypersensitivity to product components, personal or family history of medullary thyroid carcinoma or MEN2 (where applicable), prior exenatide‑related immune‑mediated thrombocytopenia for exenatide products, and use during hypoglycemia for Soliqua and Xultophy.

Product Listings, Codes, and Dose Limits

HbA1c threshold used for antidiabetic-naive initiation with metformin — value and timing

HbA1c threshold for antidiabetic-naive initiation with metforminFor antidiabetic medication–naive members, a requested GLP‑1/GIP agent may be approvable if intended for concurrent use with metformin when HbA1c ≥ 8.5% (laboratory draw within the past 3 months).

Age limits for agents (examples: Trulicity, Victoza, Bydureon BCise >= 10 years; others >= 18 years)

Age limits for agentsBydureon BCise (exenatide ER) and Trulicity (dulaglutide) and Victoza (liraglutide) — pediatric use ≥ 10 years for specified agents; Adlyxin, Byetta, and Mounjaro (tirzepatide) — approved for use ≥ 18 years (unless otherwise specified).

Maximum dose limits — product-specific maxima and examples

Maximum dose limits — examplesAdlyxin (lixisenatide): 20 mcg/day. Bydureon BCise (exenatide ER): 2 mg/week. Mounjaro (tirzepatide): 15 mg/week. Ozempic (semaglutide): 2 mg/week. Rybelsus (semaglutide): Formulation R1 max 14 mg/day; Formulation R2 max 9 mg/day. Soliqua (lixisenatide/insulin glargine): 60 units insulin/20 mcg lixisenatide per day. Trulicity (dulaglutide): Pediatrics max 1.5 mg/week; Adults up to 4.5 mg/week. Victoza (liraglutide): 1.8 mg/day. Xultophy (liraglutide/insulin degludec): 50 units insulin/1.8 mg liraglutide per day.

Provider Requirements, Prior Authorization, and Redirection Rules

Prior Authorization

Prior Authorization Required with Redirection and Exception Rules

Prior authorization is required for GLP-1 receptor agonists. Requests for non-preferred GLP-1 agents may be redirected to preferred alternatives (for example, redirection to an SGLT2 inhibitor or to Rybelsus for selected non-preferred agents) and may be denied if redirection criteria or exception rules are not met. Prior authorization requests must demonstrate that the member meets the applicable initial or continuation criteria in this policy and that the requested agent is not prescribed concurrently with another GLP-1 receptor agonist.

Prior authorization required for all GLP-1 receptor agonists listed in this policy.
Non-preferred agents may be redirected to preferred agents or to SGLT2 inhibitors per redirection rules.
Failure to meet redirection requirements may result in denial.

Documentation Required

Required Documentation

Provider must submit supporting documentation (office chart notes, laboratory results such as recent HbA1c, medication history, and other relevant clinical information) to demonstrate the member meets all approval criteria. Failure to submit adequate supporting documentation may result in delay or denial of the request.

Background and Clinical Context

GLP‑1 receptor agonists are indicated as an adjunct to diet and exercise to improve glycemic control in type 2 diabetes mellitus. Specific agents may also have additional labeled indications such as cardiovascular or renal risk reduction in adults with type 2 diabetes; refer to individual product labeling for those indications.

Definitions and Abbreviations

GLP‑1 definition

GLP‑1 definitionGLP‑1 = glucagon‑like peptide‑1 receptor agonist

Acronym expansion sourceDefinition listed in Appendix A: GLP‑1 = glucagon‑like peptide‑1

Related peptide termGIP = glucose‑dependent insulinotropic polypeptide (listed in Appendix A)

ASCVD definition

ASCVD definitionASCVD = atherosclerotic cardiovascular disease (includes coronary heart disease, cerebrovascular disease, or peripheral arterial disease of atherosclerotic origin)

Source guidanceDefinition referenced in Appendix A and ADA/ACC guidance in policy text