Approval criteria for GLP-1 receptor agonists
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Defines coverage, prior authorization, renewal, quantity limits, and clinical requirements for formulary and non-formulary GLP-1 receptor agonists for treatment of type 2 diabetes mellitus for AllCare Advantage members.
No material clinical or coverage changes in this revision.
Coverage Criteria for GLP-1 Receptor Agonists
Initial Therapy
Covered when ALL of the following are met
Step therapy and trial durations defined in policy
Renewal Therapy
Covered on renewal when ALL of the following are met
Approval typically granted for 12 months when renewal criteria met
Initiation of a GLP-1 receptor agonist should be avoided in patients with a history of pancreatitis. The policy explicitly states that GLP‑1 receptor agonists “should not be initiated in a patient with a history of pancreatitis,” and such history is a contraindication to starting therapy. (If a member has prior pancreatitis, do not initiate the agent.)
Concurrent use of a GLP‑1 receptor agonist with a dipeptidyl peptidase‑4 (DPP‑IV) inhibitor is not recommended because the combination does not provide additive glucose‑lowering effects; any existing DPP‑IV therapy should be discontinued prior to approval for a GLP‑1 RA. The policy further notes that combination use with prandial insulin has not been well studied and should be considered cautiously.
Follow standard safety precautions and ensure required documentation: prior trials or contraindications to metformin and SGLT2 agents must be documented per the policy before approval, and quantity limits apply to all agents in the class.
GLP‑1 receptor agonists are not considered first‑line therapy for the majority of patients with type 2 diabetes. The policy requires that members have a documented diagnosis of type 2 diabetes and have tried and failed (or have contraindications to) first‑line oral therapy (metformin) and, where indicated, an SGLT2 inhibitor prior to approval for a GLP‑1 RA.
Use of preferred formulary agents is encouraged: requests for non‑preferred formulary agents generally require a trial of a preferred formulary GLP‑1 RA first, and non‑formulary agents must meet the same foundational criteria as formulary agents. For members with established cardiovascular disease, SGLT2 agents with proven CVD benefit are suggested and SGLT2 considerations may affect sequencing.
When a GLP‑1 RA is approved, prior authorization is typically granted for 12 months, and continuation/renewal requires documentation of objective clinical benefit (for example, a reduction in A1C) in recent chart notes. Quantity limits apply and must be observed.
Initial therapy - drug-specific
Initial approval requires:
Formulary Agents, Quantity Limits, and Codes
| Liraglutide | Formulary, Pref |
| Exenatide ER (Bydureon Bcise®) | Formulary, Non-pref |
| Exenatide ER (Bydureon®) | Formulary, Non-pref |
| Dulaglutide (Trulicity®) | Formulary, Non-pref |
| Exenatide (Byetta®) | Formulary, Non-pref |
| Semaglutide (Ozempic®) | Formulary, Non-pref |
| Semaglutide (Rybelsus®) | Formulary, Non-pref |
| Tirzepatide (Mounjaro®) | Formulary, Non-pref |
| QL: 9/28 days | Quantity limit example |
| QL: 3.4/28 days | Quantity limit example |
Provider Requirements, Prior Authorization, and Documentation
Obtain prior authorization for any GLP‑1 RA; approvals are generally for 12 months
Prior authorization is required for all formulary and non-formulary GLP-1 receptor agonists. When criteria are met, approval is typically granted for 12 months; quantity limits apply to all agents in this class. For GLP-1 RA/basal insulin combination agents, members must be established on basal insulin <50 units/day and meet the GLP-1 RA single-agent criteria. Requests for members under age 21 who do not meet criteria must be routed to the Medical Director for review.
- Prior authorization required for formulary and non-formulary GLP-1 receptor agonists.
- Approval typically for 12 months when criteria met; quantity limits apply.
- Combination GLP-1 RA/basal insulin: established on basal insulin <50 units/day and meet single-agent criteria.
- Requests for members <21 years who do not meet criteria require Medical Director review.
Step therapy: document trials of metformin and an SGLT2 inhibitor before GLP‑1 RA
Before a GLP-1 RA will be approved, the member must have tried and failed (or have a documented contraindication to) metformin followed by an SGLT2 inhibitor (adequate SGLT2 trial defined as >3 months at maximally tolerated dose), unless there is documented clinical rationale (e.g., CVD) to prefer SGLT2 therapy first. Preferred formulary agents must be tried prior to non‑preferred; non‑formulary requests must meet formulary criteria and, where specified, include trials of preferred and non‑preferred agents.
- 1st-line: documented trial/failure or contraindication to metformin.
- 2nd-line: documented trial/failure or contraindication to an SGLT2 inhibitor (adequate trial >3 months at maximally tolerated dose).
- Trial of a preferred formulary GLP-1 RA required prior to approval of a non-preferred agent; non-formulary requests must meet formulary step requirements and additional trials as specified.
Provide recent chart notes documenting objective benefit and monitoring at renewal
Include recent chart notes with renewal requests that document objective clinical benefit (for example, a reduced A1C) and evidence of appropriate monitoring. Initial requests must include documentation of prior trials or documented contraindications to metformin and SGLT2 agents as outlined in the policy.
- Renewal: recent chart notes showing objective documentation of benefit (e.g., lowered A1C) and appropriate monitoring.
- Initial PA: documentation of trials or contraindications to metformin and SGLT2 agents per step-therapy requirements.
Requests may be denied if key trials, diagnosis, or renewal documentation are missing
Denials will be issued if required criteria are not met, including absence of a diagnosis of type 2 diabetes, lack of documented trials or contraindications to metformin and SGLT2 agents, absence of objective benefit documentation on renewal, concurrent use of a DPP‑IV agent, or failure to meet required trials for non‑formulary/non‑preferred agents.
- No diagnosis of type 2 diabetes → Deny.
- No documentation of trial/failure or contraindication to metformin or SGLT2 (where required) → Deny.
- Renewal without recent chart notes documenting objective benefit/monitoring → Deny.
- Concurrent use of DPP‑IV agents (must be discontinued) → Deny.
- Non-formulary request without required trials of preferred and specified number of non-preferred agents → Deny.
Step Therapy Requirements
| Step | Required trial / condition | Notes |
|---|---|---|
| 3 | ||
| Trial of a preferred formulary GLP-1 RA required before approval of a non-preferred GLP-1 RA (unless contraindicated) | ||
| Non-preferred and non-formulary requests have additional trial requirements per policy; quantity limits apply to all agents. |
Continuation and Renewal Criteria
Continuation/ Renewal
Renewal requirements
Definitions and Clinical Thresholds
Background
GLP‑1 receptor agonists are indicated in this policy for treatment of type 2 diabetes mellitus when patients have not achieved treatment goals with or cannot tolerate appropriate oral agents. The policy emphasizes that GLP‑1 RAs are generally reserved for patients who have failed or have contraindications to first‑ and second‑line oral therapies (metformin, and where applicable, SGLT2 inhibitors), rather than as routine initial therapy.
Prescribing considerations highlighted by the policy include: confirm a documented diagnosis of type 2 diabetes; document prior trials or contraindications to metformin and to an SGLT2 agent (an adequate SGLT2 trial is defined as >3 months at maximally tolerated dose unless contraindicated); discontinue any DPP‑IV inhibitor therapy prior to GLP‑1 RA use; and observe applicable quantity limits. For GLP‑1 RA/basal insulin combination products, members must be established on basal insulin at <50 units/day and meet single‑agent GLP‑1 criteria.
For renewals, the policy requires recent chart notes demonstrating objective clinical benefit (for example, lowered A1C) and appropriate monitoring to support continued coverage. Prior authorization is required for both formulary and non‑formulary GLP‑1 RAs, and approvals are typically issued for 12 months when criteria are met.
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