CurrentAdvanced HealthPolicy N/A

Glucagon-like Peptide-1 (GLP-1) Receptor Agonists and Glucose Dependent Insulinotropic Polypeptide (GIP) Receptor Agonist Drug Use Criteria

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This policy governs prior authorization, step therapy, initial approval, and renewal of selected GLP-1 receptor agonists and tirzepatide for members with type 2 diabetes mellitus. Adult weight-loss use is not covered under this pathway; Wegovy and Zepbound follow separate criteria.

Policy Summary

PayerAdvanced Health

PolicyGLP-1 and GIP Receptor Agonist Drug Use Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization documentation confirming type 2 diabetes, HbA1c greater than 7.5% within 90 days, absence of severe hyperglycemia, completed step therapy, and adherence.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

A1c >7.5%Initial glycemic threshold

90 daysRequired therapy trial

MPR ≥80%Adherence standard

6 months

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CurrentAdvanced HealthPolicy N/A

Glucagon-like Peptide-1 (GLP-1) Receptor Agonists and Glucose Dependent Insulinotropic Polypeptide (GIP) Receptor Agonist Drug Use Criteria

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Sign up for all advancedhealth policy alerts

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Policy Summary

PayerAdvanced Health

PolicyGLP-1 and GIP Receptor Agonist Drug Use Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization documentation confirming type 2 diabetes, HbA1c greater than 7.5% within 90 days, absence of severe hyperglycemia, completed step therapy, and adherence.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

A1c >7.5%Initial glycemic threshold

90 daysRequired therapy trial

MPR ≥80%Adherence standard

6 months

Initial liraglutide approval

6 or 12 fillsRenewal duration

ExcludedAdult weight-loss use

Coverage Criteria

Initial Therapy

Covered when the applicable routing and all of the following medical-necessity criteria are met:

Applicable routing and clinical criteria

Continuation Therapy

Covered for continuation when both of the following are documented:

Continuation criteria

Adult weight-loss requests do not qualify under this diabetes coverage pathway. Medications for weight loss are not a covered Oregon Health Plan benefit; route eligible members to the applicable separate coverage criteria when indicated.

Saxenda (liraglutide) is not covered under this benefit because it is approved for chronic weight management only. Wegovy and Zepbound are evaluated under separate drug-use criteria; this pathway applies to treatment of type 2 diabetes mellitus.

A request does not meet medical necessity when HbA1c is not greater than 7.5%, when the result is not confirmed by laboratory testing completed within the most recent 90 days, or when required medication trials and adherence are not documented.

A request does not meet medical necessity when evidence of severe hyperglycemia is present or HbA1c is greater than 10%. Coverage also requires completion of the applicable oral-therapy and SGLT-2 inhibitor step therapy, including required optimized-dose trials, treatment durations, and adherence documentation.

Clinical Thresholds and Coding Reference

Coding

Initial HbA1cGreater than 7.5%, confirmed by laboratory work completed within the most recent 90 days

Coding

Severe hyperglycemia exclusion thresholdHbA1c greater than 10%

Coding

Metformin dose2,000 mg/day at an optimized dose

Coding

Required trial duration

Authorization, Documentation, and Denial Risks

Prior Authorization

Initial Authorization Required

Prior authorization is required for initial GLP-1/GIP therapy. Submit documentation that the medication is requested for treatment of type 2 diabetes mellitus and that all applicable clinical and step-therapy criteria are met.

Confirm the request is for type 2 diabetes mellitus; adult weight-loss requests outside the applicable Wegovy or Zepbound criteria are not covered.
Submit the member’s current treatment history, laboratory results, adherence records, and documentation of required oral and SGLT-2 inhibitor trials.

Prior Authorization

Renewal Authorization Criteria

For renewal, document ongoing adherence to the prescribed diabetes treatment regimen and a clinical response demonstrated by a reduction in HbA1c within the past 90 days compared with the immediately preceding HbA1c level.

Approval duration is 6 fills for a member not at goal or 12 fills for a member at goal and on maintenance therapy.
If adherence or HbA1c response is not documented, the request does not meet renewal criteria.

Therapeutic Context

These agents are used as add-on therapy to lifestyle measures, including diabetes education and dietary counseling, to improve glycemic control in adults with type 2 diabetes mellitus. The policy also promotes optimization of lower-cost formulary oral therapies and adherence before GLP-1 therapy.

Operational Definitions

Definitions

Good adherenceMedication Possession Ratio (MPR) of at least 80% or no prescription-fill gap exceeding 5 days

Definitions

Completed trialThe specified medication or combination was used at an optimized therapeutic dose for at least 90 days with documented adherence

Definitions

Evidence of severe hyperglycemiaWeight loss, hypertriglyceridemia, ketosis, polyuria, or polydipsia associated with severe hyperglycemia

Initial Therapy

Initial Therapy — Type 2 Diabetes

Initial therapy is covered only when all of the following criteria are met:

Initial type 2 diabetes criteria

Renewal

Renewal is covered when both ongoing adherence and documented glycemic response are present:

Renewal criteria

Required Step-Therapy Sequence

Step	Required therapy	Duration and documentation
1	Metformin at an optimized dose of 2,000 mg/day. If immediate-release metformin is intolerable, use extended-release metformin.	At least 90 days with good adherence: MPR ≥80% or no refill gap exceeding 5 days. Metformin ER must also be tried for at least 90 days when required.

Step	Required therapy	Duration and documentation
2	An optimized preferred formulary oral agent from one of these classes: sulfonylurea, DPP-4 inhibitor, or thiazolidinedione (TZD). Listed agents include glimepiride, glipizide, glyburide, alogliptin, and pioglitazone.	90-day trial at an optimized therapeutic dose.

Step	Required therapy	Duration and documentation
3	Metformin plus one additional formulary oral agent from the listed classes, at optimized doses. If metformin is not tolerated or is contraindicated, use two different oral agents from two distinct therapeutic classes.	90-day trial with documented adherence; HbA1c must remain above 7.5%.

Step	Required therapy	Duration and documentation
4	A preferred SGLT-2 inhibitor, including Brenzavvy or Steglatro, at an optimized therapeutic dose. If not tolerated or contraindicated, use three oral agents from three distinct therapeutic classes.	At least 90 days with good compliance; HbA1c must remain above 7.5%. For the alternative, triple oral therapy is required for at least 90 days.

Authorization Durations and Fill Limits

Quantity limits

LiraglutideInitial approval duration of 6 months

Quantity limits

Covered GLP-1/GIP therapy6 fills when the member is not at goal; 12 fills when the member is at goal and on maintenance therapy

Policy Summary

PayerAdvanced Health

PolicyGLP-1 and GIP Receptor Agonist Drug Use Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization documentation confirming type 2 diabetes, HbA1c greater than 7.5% within 90 days, absence of severe hyperglycemia, completed step therapy, and adherence.

SourceLink

On This Page

Coding

AdherenceMedication Possession Ratio (MPR) of at least 80% or no refill gap exceeding 5 days

Step Therapy

Required Oral Therapy Sequence

Before covered GLP-1/GIP therapy, the member must complete required oral therapy at optimized doses and with documented adherence. The sequence generally begins with metformin and progresses through dual and triple oral therapy when clinically appropriate.

Use metformin at an optimized dose of 2,000 mg/day for at least 90 days with good adherence.
After metformin, complete a 90-day trial of dual therapy with metformin plus one formulary oral agent, with HbA1c remaining above 7.5%.
If SGLT-2 therapy is not tolerated or contraindicated, complete triple therapy with three oral agents from three distinct therapeutic classes for at least 90 days.

Step Therapy

Alternative Therapy Sequence

When metformin is not tolerated or contraindicated, document trials of alternative oral-agent classes instead of metformin. When an SGLT-2 inhibitor is not tolerated or contraindicated, the member must complete the specified three-class oral regimen.

For metformin intolerance, trial extended-release metformin for at least 90 days when appropriate, then complete two different oral agents from two distinct classes.
Acceptable classes include sulfonylureas, DPP-4 inhibitors, and thiazolidinediones; examples include glimepiride, glipizide, glyburide, alogliptin, and pioglitazone.
For SGLT-2 intolerance or contraindication, complete three agents from three distinct classes, such as metformin plus a sulfonylurea plus a DPP-4 inhibitor or TZD.

Documentation Required

Recent Laboratory and Treatment History

Submit recent laboratory and treatment-history documentation supporting medical necessity for the initial request.

Provide HbA1c laboratory results completed within the most recent 90 days.
Document severe-hyperglycemia findings when applicable, including weight loss, hypertriglyceridemia, ketosis, polyuria, or polydipsia.
Include the member’s diabetes medication history, including prior metformin, oral-agent, dual-therapy, triple-therapy, and SGLT-2 inhibitor trials.

Step Therapy

Step-Therapy and Adherence Records

Document optimized doses, minimum trial durations, and adherence for each required step-therapy medication before requesting GLP-1/GIP therapy.

Required trials generally last at least 90 days at an optimized therapeutic dose.
Good adherence means a Medication Possession Ratio (MPR) of at least 80% or no refill gap exceeding 5 days.
For dual and triple therapy, document the regimen, optimized dosing, persistent HbA1c above 7.5%, and adherence.

Documentation Required

Intolerance or Contraindication Documentation

If metformin or an SGLT-2 inhibitor is omitted because of intolerance or contraindication, provide chart-supported clinical documentation and complete the required alternative regimen.

For metformin intolerance, document the indication and the extended-release metformin trial when appropriate; failure to provide documentation or the required trial does not meet criteria.
For metformin contraindication, document the contraindication and completion of two oral agents from two distinct listed classes.
For SGLT-2 intolerance or contraindication, document the condition and completion of three oral agents from three distinct listed classes.

Documentation Required

Renewal Documentation

Renewal requests must include claims history and supporting provider chart notes demonstrating ongoing adherence to the prescribed diabetes regimen and a recent HbA1c response.

Show a reduction in HbA1c within the past 90 days compared with the immediately preceding HbA1c level.
If the member is not at goal, approval may be issued for 6 fills; if at goal and on maintenance therapy, approval may be issued for 12 fills.

Denial Risk

Noncovered Adult Weight-Loss Use

Deny requests for adult weight-loss use when the medication is not being requested for treatment of type 2 diabetes mellitus and the request does not qualify under a separate covered weight-management pathway.

Adult medications for weight loss are not a covered benefit under Guideline Note 5.
Requests for Wegovy or Zepbound should be evaluated under their applicable drug-use criteria.

Denial Risk

Glycemic Threshold Not Met

Deny the request when HbA1c is not greater than 7.5% or when the result is not supported by laboratory work completed within the most recent 90 days.

Submit a timely HbA1c result showing > 7.5% before requesting initial therapy.
A missing, outdated, or qualifying HbA1c result does not meet the initial clinical threshold.

Denial Risk

Severe Hyperglycemia

Deny the request when severe hyperglycemia is present or HbA1c exceeds 10%. Optimize long-acting insulin until HbA1c falls below 10% before reconsidering GLP-1/GIP therapy.

Severe-hyperglycemia indicators include weight loss, hypertriglyceridemia, ketosis, polyuria, or polydipsia.
Document the clinical findings and insulin-optimization plan when this condition applies.

Denial Risk

Step Therapy Not Completed

Deny when required step therapy or adherence documentation is missing or incomplete. The member must complete the applicable metformin, alternative oral-agent, dual-therapy, triple-therapy, and SGLT-2 inhibitor steps before consideration of GLP-1/GIP therapy.

Require optimized metformin for at least 90 days when tolerated, or the documented alternative sequence when metformin is contraindicated or not tolerated.
Require 90-day trials of the applicable preferred oral agents, dual therapy, and triple therapy with good adherence.
Require a 90-day optimized-dose trial of a formulary SGLT-2 inhibitor with HbA1c remaining > 7.5%, unless contraindicated or not tolerated and the three-class alternative is completed.
Require MPR ≥ 80% or no refill gap exceeding 5 days for documented adherence.

Denial Risk

Nonpreferred Agent Requested

After all clinical criteria are met, deny a request for a nonpreferred agent and direct the prescriber to the preferred formulary option.

Initial approval under the source criteria is limited to liraglutide.
Direct the prescriber to generic Victoza (liraglutide), the preferred formulary agent.

Denial Risk

Renewal Response or Adherence Absent

Deny renewal when ongoing adherence or a recent HbA1c response is absent from claims history and supporting chart documentation.

Claims history and provider chart notes must demonstrate ongoing adherence to the prescribed diabetes treatment regimen.
The response requirement is a reduction in HbA1c within the past 90 days versus the immediately preceding HbA1c.
Recommend changing or optimizing the treatment plan to improve HbA1c reduction when response is not documented.