Approval Criteria for formulary SGLT2 Inhibitors
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Defines AllCare Advantage coverage, prior authorization, and renewal criteria for formulary and non-formulary SGLT2 inhibitor drugs for treatment of type 2 diabetes, including special considerations for heart failure and chronic kidney disease.
No material clinical or coverage changes in this revision.
Coverage and Exclusions
Initial and Renewal Therapy
Covered when ALL of the following are met according to the stepwise prior authorization flow:
Initial Authorization
- Non-preferred agent exceptions: A) Patient has heart failure and is requesting an SGLT2 with demonstrated cardiovascular benefit -> continue to cost/contraindication check; B) Patient has chronic kidney disease and is requesting an SGLT2 with demonstrated renal and cardiovascular benefits -> continue to cost/contraindication check; C) Preferred agent is contraindicated and the requested non-preferred SGLT2 is the lowest cost option -> Approve up to 1 year.
If none of these exceptions apply -> Deny.
If both met -> Approve up to 1 year; otherwise -> Deny.
Coverage of non-formulary SGLT2 inhibitors is allowed only when the requested use is consistent with FDA‑approved indications and there is documentation of treatment failure or contraindication to two formulary agents. This aligns with the policy requirement that non‑formulary agents be reserved for cases where formulary options have been tried and proven ineffective or cannot be used.
Use of an SGLT2 inhibitor is not approved if the member has not trialed metformin or there is no documentation of a diagnosis of type 2 diabetes. Non‑preferred agents are denied unless one of the explicit exceptions applies: demonstrated heart failure or chronic kidney disease benefit for the requested agent, contraindication to the preferred agent, or the requested non‑preferred agent is the lowest‑cost option after contraindication is documented.
Prior Authorization, Documentation, and Denials
Obtain prior authorization per stepwise criteria
Prior authorization is required for all formulary and non‑formulary SGLT2 inhibitors and is granted only after the stepwise criteria in the policy are met; approvals may be issued for up to 1 year.
- Follow the stepwise PA flow (diagnosis, metformin trial/contraindication, agent status, and any HF/CKD or cost checks).
- Renewals follow the renewal path and require chart support of continued benefit.
Require metformin trial and preferred‑agent failure for non‑preferred
Members must have previously tried or currently be taking metformin; for non‑preferred agents, the member must have tried and failed a preferred formulary agent unless a specific exception applies.
- Preferred formulary SGLT2s: approve if metformin trial/inadequate control or contraindication to metformin is documented.
- Non‑preferred: require failure of preferred agent unless HF/CKD benefit, contraindication to preferred agent, or lowest‑cost non‑preferred applies.
Submit chart documentation of diagnosis, metformin trial/contraindication, and renewal support
Include chart notes that document a diagnosis of type 2 diabetes, evidence of a trial of metformin or a contraindication to metformin, and — for renewals — recent notes supporting continued benefit from the SGLT2 therapy.
- Diagnosis documentation: chart notes confirming type 2 diabetes.
- Metformin documentation: notes showing inadequate HbA1c on metformin or contraindication to metformin.
- Renewal documentation: recent chart notes demonstrating ongoing medical necessity or clinical benefit.
Requests lacking diabetes diagnosis, metformin trial, or renewal support will be denied
Deny the request if there is no documentation of a type 2 diabetes diagnosis or if the member has not tried and failed metformin (unless contraindicated). Also deny renewals when recent chart notes do not support continued benefit.
- Initial denials: absence of documented type 2 diabetes or failure to meet metformin trial/contraindication requirement -> Deny.
- Renewal denials: failure to meet initial PA criteria at renewal or lack of recent notes supporting continuation -> Deny.
Additional denial risks for HF/CKD requests and non‑preferred agents
Deny when a patient with heart failure or chronic kidney disease requests an SGLT2 without demonstrated cardiovascular or renal benefit, or when a preferred agent is not contraindicated and a lower‑cost preferred agent is available.
- HF/CKD exceptions: approval only if the requested SGLT2 has demonstrated cardiovascular (HF) or renal and cardiovascular benefits.
- Cost/contraindication check: deny if preferred agent is not contraindicated and requested non‑preferred is not the lowest cost.
Initial Authorization Criteria
Initial Therapy
Initial authorization criteria
Initial agent criteria
- Criteria #5-#7 (non-preferred): #5: If patient has heart failure and requests an SGLT2 with demonstrated cardiovascular benefit -> go to #7; otherwise deny. #6: If patient has chronic kidney disease and requests an SGLT2 with demonstrated renal and cardiovascular benefits -> go to #7; otherwise deny. #7: Is the preferred agent contraindicated and is the requested non-preferred SGLT2 the lowest cost option? If yes -> Approve up to 1 year; if no -> Deny.
Coverage of non-formulary agents requires use consistent with FDA indications and failure/contraindication to 2 formulary agents (policy applies).
Renewal (Continuation) Criteria
Renewal Therapy
Renewal criteria
If both criteria are met -> Approve up to 1 year; if either is not met -> Deny.
Step Therapy and Preferred Agent Requirements
| Step | Requirement | Action |
|---|---|---|
| 1 | ||
| Member must have previously tried or currently be taking metformin (trial of metformin with inadequate HbA1c control or documented contraindication) | ||
| If metformin not tried or no documentation of type 2 diabetes → Deny |
Definitions and Indications
Clinical Background
Sodium‑glucose co‑transporter‑2 (SGLT2) inhibitors are FDA‑approved for glucose lowering in type 2 diabetes and certain agents have demonstrated cardiovascular and renal benefits. The policy requires monitoring for factors that predispose to ketoacidosis (for example, pancreatic insulin deficiency, prolonged fasting, or alcohol use) and consideration of temporary discontinuation in precipitating clinical situations. Approvals for SGLT2 inhibitors under the stepwise prior authorization flow are issued for up to 1 year when criteria are met.
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