ModifiedmhnPolicy CP.PMN.14

Clinical Policy: Sodium-Glucose Co-Transporter 2 (SGLT2) Inhibitors

Policy governs prior authorization and medical necessity criteria for sodium-glucose co-transporter 2 (SGLT2) inhibitor products for Medicaid members, including indications for type 2 diabetes, heart failure, and chronic kidney disease.

Policy Summary

Payermhn

PolicyClinical Policy: Sodium-Glucose Co-Transporter 2 (SGLT2) Inhibitors

Policy CodePolicy CP.PMN.14

Change TypeMaterial clinical revisions and product updates

Effective Date03.01.19

Next Review Date

Key ActionSubmit prior authorization with documentation showing member meets indication-specific clinical criteria, including required labs and evidence of trial of generic dapagliflozin when applicable.

SourceLink

POLICY UPDATE CHANGES

For CKD, updated eGFR requirement from 25-75 mL/min/1.73 m2 to at least 20 mL/min/1.73 m2 per 2024 KDIGO guideline recommendations.

Added Brenzavvy to policy and added product exception for renal impairment contraindication in Appendix C to align with prescriber information.

Removed requirement for prior use of standard heart failure therapy for HFrEF as SGLT2 inhibitors are now recommended first-line per 2022 AHA/ACC/HFSA guidelines.

Updated pediatric age indications for several agents (Jardiance, Synjardy, Invokana/Invokamet products, Farxiga/Xigduo XR) to reflect pediatric extensions for age ≥10 years where applicable.

Removed bypass for trial of dapagliflozin for canagliflozin-containing product requests for members with multiple CV risk factors.

12 monthsstandard approval duration

dapagliflozinrequired prior trial

>=20

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age ≥10pediatric extension

2022HF guideline adoption

Coverage and Medical Necessity Criteria

Initial Therapy — Type 2 Diabetes

Initial approval — Type 2 Diabetes Mellitus (must meet all):

T2DM Initial: Member has diagnosis of type 2 diabetes mellitus; request is for an SGLT2 inhibitor other than Inpefa; age criteria met (Farxiga, Invokana, Invokamet, Invokamet XR, Jardiance, Synjardy, or Xigduo XR: ≥10 years; all other SGLT2 inhibitors: ≥18 years); AND one of the following: (a) failure of ≥3 consecutive months of metformin unless contraindicated or clinically significant adverse effects; (b) antidiabetic medication–naïve with intended concurrent use with metformin due to HbA1c ≥8.5% (drawn within past 3 months); (c) request is for an agent with proven CV benefit (dapagliflozin-, canagliflozin-, or empagliflozin-containing products) and member has established ASCVD, indicators of high ASCVD risk, heart failure, or chronic kidney disease; AND failure of ≥3 consecutive months of generic dapagliflozin unless contraindicated or clinically significant adverse effects; AND dose does not exceed the FDA‑approved maximum recommended dose (see Section V).

See Appendix D for ASCVD/high-risk indicators; see Section V for maximum doses.

Initial Therapy — Heart Failure

Initial approval — Heart Failure (must meet all):

HF Initial: Member has diagnosis of heart failure; request is for Farxiga, Inpefa, or Jardiance; prescribed by or in consultation with a cardiologist; age ≥18 years; failure of generic dapagliflozin unless contraindicated or clinically significant adverse effects; AND if request is for Farxiga or Jardiance, HF is NYHA Class II–IV; AND if request is for Inpefa: member has type 2 diabetes and was recently (within the last 30 days) hospitalized or had an urgent HF visit for intravascular volume overload (examples: dyspnea, jugular venous distention, pitting edema >1+, rales, radiographic pulmonary congestion); member does not have type 1 diabetes mellitus; AND dose does not exceed product‑specific limits (Farxiga/Jardiance 10 mg/day and 1 tablet/day; Inpefa 400 mg/day and 1 tablet/day).

Inpefa-specific recent hospitalization/urgent visit requirement; see Section V for dosing limits.

Initial Therapy — Chronic Kidney Disease

Initial approval — Chronic Kidney Disease (must meet all):

CKD Initial: Member has diagnosis of chronic kidney disease; request is for Farxiga or Jardiance; age ≥18 years; both of the following: eGFR ≥20 mL/min/1.73 m2 AND urine albumin‑creatinine ratio (UACR) ≥200 mg/g; failure of generic dapagliflozin unless contraindicated or clinically significant adverse effects; member does not have type 1 diabetes mellitus or polycystic kidney disease; member has not received immunosuppressive therapy for treatment of kidney disease in the past 6 months; member is currently receiving an ACE inhibitor or ARB at maximally tolerated doses for ≥4 weeks unless contraindicated; AND dose does not exceed 10 mg per day and 1 tablet per day.eGFR>=20; UACR>=200

ACE inhibitor/ARB requirement applies unless contraindicated; see Section V for dosing guidance.

Initial Therapy — Inpefa for T2DM + CKD

Initial approval — Inpefa for diagnoses other than HF (must meet all):

Inpefa Non-HF Initial: Member has both type 2 diabetes mellitus AND CKD with eGFR between 25 and 60 mL/min/1.73 m2; request is for Inpefa; age ≥18 years; cardiovascular risk criteria met (if age 18–54: at least one major CV risk factor; if age ≥55: at least two minor CV risk factors, per Appendix E); failure of generic dapagliflozin unless contraindicated or clinically significant adverse effects; AND dose does not exceed 400 mg per day and 1 tablet per day.eGFR 25-60

Approval duration: 12 months; see Appendix E for CV risk factor definitions.

Continued Therapy — Type 2 Diabetes

Continued therapy — Type 2 Diabetes Mellitus (must meet all):

T2DM Continued: Member currently receiving medication via Centene benefit or previously met initial approval criteria OR member is currently receiving medication and is enrolled in a state/product with continuity of care regulations; request is for an SGLT2 inhibitor other than Inpefa; if request is for an agent other than a preferred dapagliflozin product, failure of generic dapagliflozin unless contraindicated or clinically significant adverse effects; member is responding positively to therapy; if request is for a dose increase, new dose does not exceed the FDA‑approved maximum recommended dose.

Approval duration: 12 months.

Continued Therapy — Heart Failure

Continued therapy — Heart Failure (must meet all):

HF Continued: Member is currently receiving medication via Centene benefit, or documentation supports current use of Farxiga, Inpefa, or Jardiance for HF for at least 30 days; request is for Farxiga, Inpefa, or Jardiance; failure of generic dapagliflozin unless contraindicated or clinically significant adverse effects; member is responding positively to therapy; if request is for a dose increase, new dose does not exceed product‑specific limits (Farxiga/Jardiance 10 mg/day and 1 tablet/day; Inpefa 400 mg/day and 1 tablet/day).

Approval duration: 12 months.

Continued Therapy — Chronic Kidney Disease

Continued therapy — Chronic Kidney Disease (must meet all):

CKD Continued: Member currently receiving medication via Centene benefit or previously met initial approval criteria OR member is currently receiving medication and is enrolled in a state/product with continuity of care regulations; request is for Farxiga or Jardiance; failure of generic dapagliflozin unless contraindicated or clinically significant adverse effects; member is responding positively to therapy; if request is for a dose increase, new dose does not exceed 10 mg per day and 1 tablet per day.

Approval duration: 12 months.

Dose increase / continuation and CKD

Criteria for dose increase and continued therapy (general and CKD-specific rules):

Dose increase and continued therapy general rules

Farxiga or Jardiance dose limits: 10 mg per day; 1 tablet per day
Inpefa dose limits: 400 mg per day; 1 tablet per day

Chronic Kidney Disease specific criteria: Member currently receiving medication via Centene benefit or previously met initial approval criteria OR member is currently receiving medication and enrolled in a state/product with continuity of care regulations; request is for Farxiga or Jardiance; failure of generic dapagliflozin unless contraindicated or clinically significant adverse effects; member is responding positively to therapy; dose increase does not exceed 10 mg/day and 1 tablet/day; approval duration: 12 months.

Inpefa requests (non-HF)

Requests for Inpefa for non‑heart‑failure diagnoses (must meet all):

Inpefa (non-HF) continued/renewal: Member currently receiving medication via Centene benefit or previously met initial approval criteria OR member is currently receiving medication and is enrolled in a state/product with continuity of care regulations; request is for Inpefa; failure of generic dapagliflozin unless contraindicated or clinically significant adverse effects; member is responding positively to therapy; if request is for a dose increase, new dose does not exceed 400 mg per day and 1 tablet per day.

Specific to Inpefa requests; approval duration as per policy (12 months for initial sets).

Other indications / label changes

Other diagnoses/indications not specifically listed:

Other indications handling: 1) If the drug label changed within the last 6 months and the change is not yet reflected in this policy, refer to: a) CP.PMN.255 (No coverage criteria policy) for drugs on the formulary/PDL, or b) CP.PMN.16 (Non‑formulary policy) for drugs not on the formulary/PDL; OR 2) If the requested use is not listed under Section III and criterion 1 does not apply, refer to the off‑label use policy CP.PMN.53.

Administrative routing for unlisted uses.

Other than Inpefa, SGLT2 inhibitors are contraindicated for use in patients with type 1 diabetes and are not authorized for the treatment of diabetic ketoacidosis. The prescribing information warns that SGLT2 inhibitors may increase the risk of diabetic ketoacidosis and several products are unlikely to be effective below product-specific renal function thresholds (see individual agent limits).

Uses that are not FDA‑approved and are not specifically addressed in this policy are not authorized unless the provider supplies sufficient documentation per the off‑label use policy (CP.PMN.53) or applicable evidence‑of‑coverage rules. In addition, Inpefa is not authorized for type 1 diabetes as listed under non‑authorized indications.

The agent Qternmet XR was removed from the market and has been removed from coverage under this policy; it is no longer a covered product.

SGLT2 inhibitors should not be used in patients with type 1 diabetes or for treatment of diabetic ketoacidosis. In addition, several products are expected to be ineffective below their labeled renal thresholds; examples include recommendations that Farxiga is not recommended for glycemic control when eGFR is <45 mL/min/1.73 m2 and that other agents are not recommended when eGFR is <30 mL/min/1.73 m2 depending on the product. These eGFR‑based effectiveness limits inform the policy’s coverage thresholds.

Specifically, Inpefa is explicitly not authorized for type 1 diabetes and the policy lists Inpefa for type 1 diabetes among diagnoses for which coverage is not authorized. Providers should not request Inpefa for patients with type 1 diabetes under this policy.

Clinical Parameters, Dosing Limits, and Risk Markers

eGFR thresholds for CKD criteria

Farxiga / Jardiance (CKD) minimum eGFReGFR ≥ 20 mL/min/1.73 m2

Inpefa (T2DM + CKD) eGFR rangeeGFR 25–60 mL/min/1.73 m2

CKD initial therapy age requirementAge ≥ 18 years for CKD criteria (Farxiga or Jardiance)

UACR threshold

UACR threshold for CKD approvalUACR ≥ 200 mg/g

Major CV marker example with UACRUACR ≥ 300 mg/g is listed as a major cardiovascular risk marker

UACR range noted as minor CV marker

Prior Authorization, Documentation, and Step Therapy Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for the listed SGLT2 inhibitor agents. Providers must request PA for any of the following products: bexagliflozin (Brenzavvy), canagliflozin (Invokana), canagliflozin/metformin (Invokamet, Invokamet XR), dapagliflozin (Farxiga), dapagliflozin/metformin (Xigduo XR), dapagliflozin/saxagliptin (Qtern), ertugliflozin (Steglatro), ertugliflozin/metformin (Segluromet), empagliflozin (Jardiance), empagliflozin/linagliptin (Glyxambi), empagliflozin/linagliptin/metformin (Trijardy XR), empagliflozin/metformin (Synjardy, Synjardy XR), ertugliflozin/sitagliptin (Steglujan), and sotagliflozin (Inpefa).

Prior authorization required for all SGLT2 inhibitor agents listed above.

Documentation Required

Documentation Required to Support Approval

Providers must document that the member meets the applicable initial or continued therapy criteria, including required trials, dosing limits, and evidence of response. Requests for initiation or continuation must include supporting documentation (office chart notes, recent lab results such as HbA1c, eGFR, UACR, and other clinical information) or the request may be denied.

Background and Clinical Context

SGLT2 inhibitors are a class of antihyperglycemic agents that lower renal glucose reabsorption and are approved as adjuncts to diet and exercise to improve glycemic control in adults and, for certain products, in pediatric patients. Several agents in the class also have FDA indications or evidence supporting reductions in heart failure hospitalization, cardiovascular death, and progression of chronic kidney disease depending on the specific product and indication. Individual products carry distinct age and renal function limits and other population‑specific restrictions that are reflected in the coverage criteria.

Definitions and Glossary

SGLT2 inhibitors — class summary and product lists

Class definitionSGLT2 inhibitors are antihyperglycemic agents that reduce renal glucose reabsorption and have agent‑specific FDA indications for type 2 diabetes, and for some agents, heart failure and chronic kidney disease

Common products listedExamples include dapagliflozin (Farxiga, Xigduo XR), empagliflozin (Jardiance, Synjardy), canagliflozin (Invokana, Invokamet), and sotagliflozin (Inpefa)

Pediatric indications noteSeveral agents have pediatric (age ≥10 years) FDA indications (e.g., Farxiga, Jardiance, Invokana, Invokamet, Synjardy, Xigduo XR)

eGFR — definition

DefinitioneGFR = estimated glomerular filtration rate

Use in policy

Policy Summary

Payermhn

PolicyClinical Policy: Sodium-Glucose Co-Transporter 2 (SGLT2) Inhibitors

Policy CodePolicy CP.PMN.14

Change TypeMaterial clinical revisions and product updates

Effective Date03.01.19

Next Review Date

SourceLink

On This Page

UACR 30–299 mg/g is listed as a minor cardiovascular risk marker

HbA1c threshold for antidiabetic‑naïve concurrent use

HbA1c threshold for antidiabetic‑naïve concurrent useHbA1c ≥ 8.5% (drawn within the past 3 months) to allow concurrent initiation with metformin

Context of useApplies when member is antidiabetic medication–naïve and intended for concurrent use with metformin

Documentation timingHbA1c must be drawn within the past 3 months

Dose limits

Farxiga / Jardiance maximum dose10 mg per day; 1 tablet per day

Inpefa maximum dose400 mg per day; 1 tablet per day

Dose limits referenced for CKD and HF criteriaCKD: Farxiga/Jardiance limited to 10 mg/day (see CKD criteria); HF: product‑specific limits apply (Farxiga/Jardiance 10 mg/day; Inpefa 400 mg/day)

Major cardiovascular risk marker examples

Ejection fractionEjection fraction ≤ 40% documented within the past year

NT‑proBNPN‑terminal pro‑B‑type natriuretic peptide ≥ 400 pg/mL (47 pmol/L)

Coronary artery calcium (CAC)CAC score ≥ 300 Agatston units

Minor cardiovascular risk marker examples

Body mass indexBody mass index ≥ 35 kg/m2

UACR (minor range)UACR 30–299 mg/g

CAC (minor range)Coronary artery calcium score >100 and <300 Agatston units

Updated eGFR minimum

Updated minimum eGFR for CKD criteriaAt least 20 mL/min/1.73 m2 (updated from prior range) per 2024 KDIGO guidance

Applies toFarxiga and Jardiance CKD initial approval criteria

Effective documentationeGFR value must be provided to demonstrate meets threshold

Documentation required: office notes, labs (HbA1c, eGFR, UACR), and other clinical information supporting diagnosis and prior therapy.
Failure to submit supporting documentation may result in denial.

Step Therapy

PA Requirements: Dose, Trial, and Response

For initial and continued therapy, PA approvals require meeting dose, trial, and response rules: dose must not exceed FDA‑approved maximums; trials of preferred agents (generic dapagliflozin) are required where specified; and evidence of positive clinical response must be provided for continuation.

Dose limits: do not exceed FDA‑approved maximum recommended doses (see policy Section V). Example limits referenced in criteria: Farxiga/Jardiance ≤ 10 mg/day (1 tablet/day); Inpefa ≤ 400 mg/day (1 tablet/day).
Step therapy: failure of ≥ 3 months of generic dapagliflozin is required for many indications unless contraindicated or intolerant.
Continued therapy requires evidence member is responding positively to therapy.

Prior Authorization

Prior Authorization Updates and Preferred Agent Redirection

Some agents were added or had prior authorization requirements updated; providers should be aware of recent redirections and product exceptions.

Steglatro and Segluromet: PA is now required.
Redirection: requests for non‑preferred agents (including Steglatro/Segluromet in many cases) may be redirected to preferred generic dapagliflozin for initial and continued therapy unless criteria for the non‑preferred agent are met.
Appendix C: Brenzavvy added as a product exception for renal impairment contraindication per prescriber information.

Denial Risk

Non‑FDA Indications and Inpefa Limitations

Requests for non–FDA‑approved indications and certain products are not authorized under this policy unless sufficient off‑label evidence is provided per the off‑label use policy. In addition, Inpefa is not authorized for type 1 diabetes.

Non‑FDA indications: Not authorized unless there is sufficient documentation of efficacy and safety per CP.PMN.53 (Medicaid) or applicable evidence of coverage documents.
Inpefa (sotagliflozin): Not authorized for type 1 diabetes.

Denial Risk

Denial Risk: Renal Function Thresholds

Requests may be denied if the member's renal function falls below the policy threshold or other criteria are not met. For CKD indications, the policy now requires eGFR ≥ 20 mL/min/1.73 m2 in accordance with KDIGO; products contraindicated at lower eGFR may be handled as product exceptions.

CKD indication requirement: eGFR must be ≥ 20 mL/min/1.73 m2 and UACR ≥ 200 mg/g as specified in criteria.
Requests may be denied if member eGFR is below the updated CKD threshold (< 20 mL/min/1.73 m2) or if documentation does not support safety/efficacy.

Note

Evidence of Prior Use Under Centene Benefit

Evidence that the member previously received the medication under a Centene benefit or has previously met initial approval criteria can support continued therapy approvals. Continuity of care rules may apply per state and product-specific addendums.

For continued therapy, acceptable evidence includes current receipt of medication via Centene benefit or prior documentation that member met initial approval criteria.
State/product continuity of care provisions may permit continuation when applicable (refer to CC.PHARM.03A and CC.PHARM.03B addendums).

eGFR values are used as numeric thresholds for CKD and Inpefa criteria (e.g., ≥20 mL/min/1.73 m2; 25–60 mL/min/1.73 m2)

Abbreviation sourceDefined in Appendix A: Abbreviation/Acronym Key

UACR — definition

DefinitionUACR = urine albumin creatinine ratio

Policy thresholdsUsed to define CKD eligibility (UACR ≥ 200 mg/g) and as CV risk marker ranges (minor 30–299 mg/g; major ≥300 mg/g)

Abbreviation sourceDefined in Appendix A: Abbreviation/Acronym Key

SGLT2 inhibitors with evidence for cardiovascular/renal benefits

Agents with evidence for CV/renal benefitDapagliflozin, empagliflozin, canagliflozin, and sotagliflozin have cited evidence for cardiovascular and/or renal benefits in T2DM, HF, or CKD

Indication examplesDapagliflozin: reduces HF hospitalization and kidney outcomes; Empagliflozin: reduces CV death and HHF; Canagliflozin: reduces risk of ESKD and CV events in diabetic nephropathy; Sotagliflozin (Inpefa): reduces CV death, HHF, and urgent HF visit

Reference to evidence appendixClinical trials and guideline references are cited (see references and Appendix material) supporting benefits