Glucagon-Like Peptide-1 (GLP-1) Receptor Agonists
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Defines medical necessity, prior authorization, and coverage criteria for GLP-1 receptor agonist agents for Peach State Health Plan Medicaid members, including initial and continuation therapy rules and limitations of use.
Added Ozempic tablets (rebranding of Rybelsus R2 formulation) and clarified Ozempic tablets vs injection.
Updated step therapy so non-preferred agents require failure of all preferred agents, with bypass available for preferred agents.
Added bypass of required non-GLP-1 trial agents for members with MASLD, MASH, and HFpEF per 2025 ADA guidelines.
Added requirement that requested GLP-1 product is not prescribed concurrently with another GLP-1 receptor agonist.
Added requirement prohibiting concurrent use with DPP-4 inhibitors (duplicate therapy edit).
Coverage Criteria — GLP-1 Receptor Agonists
Initial Therapy — Covered when ALL of the following are met for Initial Approval — Type 2 Diabetes Mellitus
Covered when ALL of the following are met for Initial Approval — Type 2 Diabetes Mellitus:
Detailed nested AND/OR logic preserved from policy.
Continuation Therapy — Covered when ALL of the following are met for Continued Therapy — Type 2 Diabetes Mellitus
Covered when ALL of the following are met for Continued Therapy — Type 2 Diabetes Mellitus:
Approval duration: 12 months.
Indications aligned to guideline recommendations — Guideline-based coverage considerations and when GLP-1 receptor agonists are recommended
Guideline-based coverage considerations and when GLP-1 receptor agonists are recommended
Refer to agent-specific cardiovascular/renal evidence (Ozempic noted for CKD trial benefit)
Dosing conformity — Agent-specific dosing and maximum dose criteria
Agent-specific dosing and maximum dose criteria
See dosing tables in policy (Section V).
Initial and Continued Therapy Criteria (high-level) — step therapy requirements and guideline bypasses
Covered when criteria and step therapy requirements are met; bypasses allowed per guideline-specified conditions
Preferred-agent sequence and requirement revised; discontinued products removed where applicable.
Guideline-based bypasses added.
Requirement applied to both initial and continued therapy.
Product-specific limitations: Xultophy and Soliqua are not indicated for treatment of diabetic ketoacidosis, have not been studied in combination with prandial insulin, and are not recommended for concomitant use with other GLP‑1 receptor agonist products. Bydureon BCise (exenatide ER) should not be coadministered with other exenatide-containing products. Victoza and Xultophy both contain liraglutide and should not be coadministered with other liraglutide-containing products.
Contraindications and boxed warnings are described in Appendix C. Key exclusions include hypersensitivity to product components; personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (applies to all GLP‑1 receptor agonists except Byetta and Soliqua); use during episodes of hypoglycemia for Xultophy and Soliqua; and a history of drug‑induced immune‑mediated thrombocytopenia for exenatide products (Bydureon BCise and Byetta). A boxed warning for thyroid C‑cell tumors applies to all listed GLP‑1 agents except Byetta and Soliqua.
Products discontinued or removed from redirection have been excluded from step/redirection requirements (for example, Bydureon was removed from criteria after discontinuation). The policy also documents prior edits removing redirections to specific discontinued formulations and clarifies current preferred‑agent redirection sequencing (liraglutide then Trulicity) for step therapy and prior authorization purposes.
Requests for uses that are not FDA‑approved and not addressed within this policy will not be authorized unless the provider supplies sufficient supporting documentation in accordance with the off‑label use policy CP.PMN.53 or other applicable evidence of coverage documents.
The policy prohibits concurrent prescribing of two GLP‑1 receptor agonists; requests may be denied if a GLP‑1 agent is prescribed concurrently with another GLP‑1 receptor agonist or with a DPP‑4 inhibitor. This duplicate‑therapy exclusion applies to both initial and continued therapy and must be met for authorization.
Initial Therapy Requirements
Initial Therapy — Initial approval criteria for Type 2 Diabetes Mellitus
Initial approval criteria for Type 2 Diabetes Mellitus
Approval duration: 12 months.
Initial therapy requirements — Initial prescribing and titration
Initial prescribing and titration
See dosing tables in Section V for agent-specific schedules and maximum doses.
Initial Therapy — requires attempts of preferred agents and absence of contraindicated concurrent therapy; some patients qualify for bypass
Initial authorization requires attempts of preferred agents and absence of contraindicated concurrent therapy; some patients qualify for bypass
Step therapy requirement modified from one preferred agent to all preferred agents; discontinued products removed from redirection.
Continuation / Maintenance Therapy
Continued Therapy — continued therapy criteria and duration
Continued therapy criteria and duration
Ongoing documentation of benefit required per policy.
Continuation therapy considerations — continuation/maintenance principles per guidelines
Continuation/maintenance principles per guidelines
Policy aligns continuation with guideline reassessment timelines and clinical benefit.
Continued Therapy — requires ongoing adherence to coverage rules including no concurrent GLP-1 use and meeting prior authorization criteria
Continued Therapy — requires ongoing adherence to coverage rules including no concurrent GLP-1 use and meeting prior authorization criteria
Duplicate therapy and DPP‑4 concurrent use prohibitions added to both initial and continued therapy.
Step Therapy and Treatment Sequencing
| Step therapy requirement | Details / timing | Exceptions / bypass |
|---|---|---|
| Failure of two non-GLP-1 agents (general pathway) | ||
| Member must have trial and failure of ≥ 3 consecutive months of two agents from non-GLP-1 classes (examples: biguanides, sulfonylureas, TZD, DPP-4 inhibitor, or SGLT2 inhibitor) before coverage of a GLP-1 receptor agonist for members without high-risk conditions | ||
| Bypass allowed for members with ASCVD, indicators of high ASCVD risk, chronic kidney disease, MASLD/MASH, or HFpEF per ADA guidance; see policy for documentation |
| Metformin first-line | Escalation trigger (HbA1c) | Timing to reassess / escalate |
|---|---|---|
| Metformin is recommended for all patients with type 2 diabetes and is the preferred first-line agent | ||
| Consider initiating dual therapy (metformin plus another agent) when baseline HbA1c is ≥ 1.5% above target | ||
| Reassess response approximately every 3 months; if glycemic targets are not achieved after ~3 months, advance therapy per ADA guidance (add/switch agents or escalate to combination therapy) |
| Non-preferred GLP-1 requirement | Required prior preferred agents | Bypass / exceptions |
|---|---|---|
| Prior failure of preferred GLP-1 agents required before non-preferred GLP-1 coverage | ||
| Member must have documented failure of liraglutide (Victoza) for ≥ 3 consecutive months; if liraglutide is failed, member must also fail Trulicity (dulaglutide) for ≥ 3 consecutive months, unless contraindicated or clinically significant adverse effects occur | ||
| Bypass of preferred-agent step therapy is allowed for members meeting bypass criteria (e.g., established ASCVD/high ASCVD risk, CKD, MASLD/MASH, HFpEF) or when preferred agents are contraindicated or produce clinically significant adverse effects |
Preferred-agent sequence and required trials
Step therapy requires documented trials of preferred GLP‑1 agents in sequence: first liraglutide (Victoza), and if the member has failed liraglutide, then trial and failure of Trulicity (dulaglutide). Each preferred agent must be used for ≥ 3 consecutive months unless contraindicated or clinically significant adverse effects occur; non‑preferred agents require failure of all preferred agents unless bypass criteria apply.
- Sequence: 1) Liraglutide (Victoza) → 2) Trulicity (dulaglutide)
- Each preferred agent trial ≥ 3 consecutive months unless contraindicated or clinically significant adverse effects experienced
- Bypass of preferred-agent trials allowed per policy (e.g., ADA-specified conditions)
Provider Actions, Documentation & Prior Authorization
Prior authorization required for listed GLP‑1 agents
Prior authorization is required for the GLP‑1 receptor agonist agents listed in the policy, including dulaglutide (Trulicity), exenatide ER (Bydureon BCise), exenatide IR (Byetta), liraglutide (Victoza), Xultophy, semaglutide (Ozempic, Rybelsus), tirzepatide (Mounjaro), and Soliqua (insulin glargine/lixisenatide).
- Includes combination agents and discontinuation notice for Bydureon BCise/Byetta per manufacturer communications
Include agent‑specific dosing and product details with PA
When requesting coverage, reference the policy’s dosing, maximum dose, and product availability tables (Section V) to ensure the requested product, dose, and formulation align with labeled regimens and available strengths.
- See Dosage and Administration (Section V) for agent‑specific starting doses, titration schedules, and FDA maximums
- See Product Availability for pen, syringe, vial, and tablet formulations and strengths
PA + step therapy for non‑preferred GLP‑1s: failure of all preferred agents required
Non‑preferred GLP‑1 agents require prior authorization with documentation of failure of all preferred GLP‑1 agents (liraglutide first, then Trulicity if liraglutide failed), each used for ≥ 3 consecutive months unless contraindicated or clinically significant adverse effects occur; bypass criteria may apply.
- Non‑preferred requests must document trials of all preferred agents in the required sequence
- Bypass of these step requirements allowed per specified clinical conditions (see policy)
Require ≥3‑month failures of specified non‑GLP‑1 agents prior to GLP‑1
For members without ASCVD/CKD/high‑risk conditions, the policy requires failure of a ≥ 3‑month trial of two non‑GLP‑1 agents (examples: biguanide, sulfonylurea, TZD, DPP‑4 inhibitor, or SGLT2 inhibitor) before GLP‑1 coverage will be authorized, unless contraindicated or adverse effects are documented.
- Each trial of non‑GLP‑1 agent(s) must be ≥ 3 consecutive months unless contraindications or clinically significant adverse effects are documented
- ASCVD/CKD/other guideline‑based bypasses may waive this requirement
Escalate therapy per ADA: metformin first, advance if HbA1c ≥1.5% above target
Follow guideline‑based escalation: metformin is recommended first‑line for most patients; consider dual therapy when baseline HbA1c is ≥ 1.5% above target and reassess after approximately 3 months to escalate therapy per ADA guidance.
- Metformin recommended as initial therapy for type 2 diabetes
- Initiate combination therapy (e.g., include GLP‑1) when baseline HbA1c ≥ 1.5% above target or per ADA guidance
Submit chart notes, labs, and other clinical evidence with PA
Provider must submit supporting clinical documentation such as office chart notes, laboratory results, and other clinical information demonstrating that the member meets all approval criteria.
- Include clinical notes and labs showing diagnosis, prior therapy trials, duration of trials, and reasons for discontinuation or adverse effects
Document agent, dose, frequency, and indication consistent with dosing tables
Document the prescribed agent, exact dose, dosing frequency, and the clinical indication; ensure the regimen matches the product‑specific dosing and maximum dose listed in the policy’s dosing tables.
- State agent name, dose, frequency, and indication on the PA request
- Confirm dose does not exceed FDA‑approved maximum per policy Section V
Coverage decisions subject to plan documents and state Medicaid provisions
Coverage determinations are subject to the member’s plan documents and applicable state Medicaid rules; providers must follow plan administrative policies and submit clinical justification per plan processes.
- This policy is a guide to medical necessity and does not guarantee payment; follow evidence of coverage and state/federal requirements
Off‑label requests require CP.PMN.53 support or sufficient evidence
Requests for non‑FDA approved (off‑label) indications that are not covered by this policy may be denied unless supported by the health plan’s off‑label use policy CP.PMN.53 or sufficient evidence of efficacy and safety is provided.
- Reference CP.PMN.53 when submitting off‑label requests and include supporting literature or evidence
Verify contraindications and boxed warnings before PA
Ensure the member does not have any listed contraindications or boxed warnings prior to requesting coverage: hypersensitivity to product components; personal/family history of medullary thyroid carcinoma or MEN2 (except Byetta and Soliqua); use during hypoglycemia episodes for Xultophy and Soliqua; history of drug‑induced immune‑mediated thrombocytopenia from exenatide products (Bydureon BCise and Byetta).
- Boxed warning for thyroid C‑cell tumors applies to all GLP‑1 RAs except Byetta and Soliqua
- Document absence of relevant contraindications or rationale if present
Avoid duplicate/concurrent GLP‑1 or DPP‑4 therapy — risk of denial
Do not prescribe the requested GLP‑1 concurrently with another GLP‑1 receptor agonist or with a DPP‑4 inhibitor; requests may be denied if concurrent use is observed.
- Concurrent prescribing of two GLP‑1 agents is not allowed
- Concurrent use with DPP‑4 inhibitors is prohibited per duplicate therapy edit
Emphasize submission of chart notes, labs, and clinical justification
Provider must submit office chart notes, lab results, or other clinical information supporting that the member has met all approval criteria (emphasized requirement).
- Include documentation of prior trials, durations, adverse events, and reasons for intolerance or contraindication
Quantity Limits & Formulation-Specific Dosing
Coding, Definitions and Clinical Thresholds
Site of Care & Dispensing Formats
Specify outpatient/home‑use formulation (pens, syringes, vials, tablets) on PA
Products are available for outpatient/home administration in multiple formats; indicate the requested formulation (prefilled pen, single‑dose pen/syringe, prefilled syringe, or vial) on the PA to ensure correct product dispensing.
- Examples: single‑patient pens, single‑dose prefilled syringes, prefilled pens, tablets (Ozempic/Rybelsus)
- Specify formulation and strength on the request
Background
GLP‑1 receptor agonists are indicated as adjuncts to diet and exercise to improve glycemic control in type 2 diabetes mellitus. Several agents additionally have FDA‑recognized cardiovascular and/or renal outcome benefits for adults with type 2 diabetes and established atherosclerotic cardiovascular disease or at high cardiovascular risk; for example, certain semaglutide products have demonstrated renal and cardiovascular outcome effects. Use of GLP‑1 receptor agonists should follow ADA/AACE guideline recommendations, prioritizing agents with proven cardiorenal benefit for members with established ASCVD, high ASCVD risk, chronic kidney disease, heart failure with preserved ejection fraction (in select obese patients), or MASLD/MASH when clinically appropriate.
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