Criteria for Prior Authorization — Type 2 Diabetes Mellitus Agents
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Defines prior authorization requirements, initial and renewal criteria, lengths of approval, and drug-specific age and dosing limits for Type 2 diabetes medications (SGLT2 inhibitors, GLP-1 receptor agonists, combination products, and related agents) for Kansas members.
No material clinical or coverage changes in this revision.
Coverage and Medical Necessity Criteria
Initial Approval Criteria
Covered when ALL of the following are met:
See Table 1 for product-specific age and dosing limits.
Providers must document prior use of preferred product or justification for non-preferred selection.
Indication groups
- Glycemic control: Prescriber provides a prespecified HbA1c goal (6.5%, 7.0%, or 8.0%); patient has a baseline HbA1c obtained within the past 6 months that is greater than the prespecified goal; AND patient has either had an adequate trial of generic metformin IR or ER for at least 90 consecutive days within the past 120 days, is prescribed generic metformin IR or ER with the requested drug and has an HbA1c ≥ 1.5% above the prespecified goal, or has a documented contraindication to metformin.HbA1c options:6.5|7.0|8.0
For HbA1c >10% or glucose ≥300 mg/dL, initiating injectable therapy (GLP-1 RA or basal insulin) is recommended but not required.
- Risk reduction (CV/CKD): For agents with an FDA indication for cardiovascular disease or chronic kidney disease risk reduction (see Table 1), the patient must have history of clinical ASCVD, a diagnosis of chronic kidney disease, diagnosis of heart failure, or meet indicators of high risk for ASCVD (for example: age ≥55 with coronary/carotid/lower extremity artery stenosis >50%, left ventricular hypertrophy, or 10-year ASCVD risk ≥15%).NA
For GLP-1 receptor agonist agents, the patient must not currently be taking a DPP-4 inhibitor.
Renewal Criteria
Covered when ONE of the following is met:
Length of approval: 12 months if at goal; 6 months if not at goal but ≥1% reduction since last approval.
Ensure patient does not exceed age or dosing limits in Table 1.
Requests for a GLP-1 receptor agonist will not be approved if the patient is currently receiving a DPP-4 inhibitor; the DPP-4 agent must be discontinued before approval will be granted. This restriction applies to all GLP-1–containing products at initial review and is documented as an exclusion in the PA criteria.
In addition, approval is contingent on meeting the product-specific FDA indication, age, and dosing limits listed in Table 1, and on any required preferred PDL trial (unless the non-preferred criteria are met). Prescribers must also supply the required documentation described elsewhere in the policy (e.g., prespecified HbA1c goal and recent baseline HbA1c).
Use that does not meet the agent’s FDA indication, age, or dosing limits listed in Table 1 may be considered not medically necessary. Requests will also be denied when required step-therapy has not been completed — for example, the policy requires an adequate trial of generic metformin IR or ER for at least 90 consecutive days in the past 120 days, or documentation that metformin is being co-prescribed with the requested agent when the HbA1c is ≥ 1.5% above the prespecified goal, or a documented contraindication to metformin.
The policy additionally requires that the preferred PDL drug that treats the PA indication be used when applicable; failure to try the preferred PDL agent (unless non-preferred PA criteria are met) is a basis for denial.
Drug Listings, HbA1c Requirements, and Code Table
| Canagliflozin (Invokana®) | SGLT2 inhibitor; indication and age/dosing limits listed in Table 1 |
| Canagliflozin/Metformin (Invokamet®, Invokamet® XR) | Combination product; indication and age/dosing limits listed in Table 1 |
| Dapagliflozin (Farxiga®) | SGLT2 inhibitor; indication and age/dosing limits listed in Table 1 |
| Dapagliflozin/Metformin (Xigduo XR®) | Combination product; indication and age/dosing limits listed in Table 1 |
| Dapagliflozin/Saxagliptin (Qtern®) | Combination product; indication and age/dosing limits listed in Table 1 |
| Empagliflozin (Jardiance®) | SGLT2 inhibitor; indication and age/dosing limits listed in Table 1 |
| Empagliflozin/Linagliptin (Glyxambi®) | Combination product; indication and age/dosing limits listed in Table 1 |
| Empagliflozin/Linagliptin/Metformin (Trijardy XR®) | Combination product; indication and age/dosing limits listed in Table 1 |
| Empagliflozin/Metformin (Synjardy, Synjardy XR®) | Combination product; indication and age/dosing limits listed in Table 1 |
| Ertugliflozin (Steglatro®) | SGLT2 inhibitor; indication and age/dosing limits listed in Table 1 |
Prescriber Requirements and Prior Authorization Actions
Prior authorization required for listed T2DM agents
Prior authorization is required for all current and future dose forms of the listed Type 2 diabetes agents; medication-specific criteria including indication, age, and dosing limits are defined in Table 1. The preferred PDL drug that treats the PA indication must be used when applicable unless the patient meets non-preferred PDL PA criteria.
- PA covers all current and future dose forms of the listed agents.
- Agent must be approved for the indication, age, and not exceed dosing limits listed in Table 1.
- Preferred PDL trial is required when applicable unless non-preferred PDL criteria are met.
Metformin trial or documented exception required
Patient must have had an adequate trial of generic metformin IR or ER for at least 90 consecutive days during the past 120-day period, or be prescribed metformin with the requested drug and have HbA1c ≥1.5% above the prespecified goal, or have a contraindication to metformin.
- Adequate trial: ≥90 consecutive days of generic metformin IR or ER within the past 120 days.
- Alternate: concomitant prescription of metformin with the requested agent plus HbA1c ≥1.5% above prespecified goal.
- Or documented contraindication to metformin.
Submit prespecified HbA1c goal and recent baseline value
Prescriber must provide a prespecified HbA1c goal (one of: 6.5%, 7.0%, or 8.0%) and a baseline HbA1c obtained within the past 6 months that is greater than the prespecified goal.
- Acceptable prespecified goals: 6.5%, 7.0%, or 8.0%.
- Baseline HbA1c must be from the past 6 months and exceed the chosen prespecified goal.
Non‑concordance with indication, age, dosing, or step therapy may lead to denial
Requests that do not meet the agent's FDA indication, age, or dosing limits listed in Table 1, or where required step-therapy (preferred PDL or metformin trial) has not been met, may be denied.
- Nonconcordance with Table 1 (indication, age, dosing limits) risks denial.
- Failure to trial the preferred PDL drug when required or to meet metformin requirements may result in denial.
Concurrent DPP-4 inhibitor use prevents approval of GLP-1 agents
For GLP-1 receptor agonist agents, approval is prevented if the patient is currently receiving a DPP-4 inhibitor; DPP-4 therapy must be discontinued before approval will be granted.
- All requested GLP-1 RA containing agents require that the patient not currently be on a DPP-4 inhibitor.
- GLP-1 requests while on DPP-4 therapy are excluded from approval until DPP-4 is discontinued.
Clinical Background
Type 2 diabetes mellitus (T2DM) management includes medications aimed at improving glycemic control and agents with evidence for reducing cardiovascular and renal outcomes. This policy aligns PA requirements with FDA indications and product labeling by requiring that agents be used within their approved indication, age, and dosing limits and by prioritizing preferred PDL products where applicable.
For glycemic control, prescribers must provide a prespecified HbA1c goal (one of 6.5%, 7.0%, or 8.0%) and a baseline HbA1c from the prior 6 months that is above that goal; initial approval for glycemic control is for 6 months. For agents indicated to reduce cardiovascular events or progression to end-stage kidney disease, the policy requires appropriate qualifying diagnoses (e.g., clinical ASCVD, CKD, or heart failure, or high ASCVD risk) and these risk-reduction approvals are granted indefinitely (no renewal required).
Key Definitions
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