ModifiedmhnPolicy CP.PMN.14

Sodium-Glucose Co-Transporter 2 (SGLT2) Inhibitors

Clinical policy governing prior authorization and medical necessity criteria for sodium-glucose co-transporter 2 (SGLT2) inhibitor agents for Medicaid line of business; affects prescribers and prior authorization reviewers.

Policy Summary

Payermhn

PolicySodium-Glucose Co-Transporter 2 (SGLT2) Inhibitors

Policy CodePolicy CP.PMN.14

Change TypeCoverage criteria and product list updates (eGFR threshold, added product, pediatric extensions, PA/step edits)

Effective Date03.01.19

Next Review Date

Key ActionSubmit prior authorization with documentation showing member meets the applicable initial or continued therapy criteria, including eGFR for CKD and prior trial of generic dapagliflozin when required.

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 Brenzavvy as product exception for renal impairment contraindication in Appendix C to align with prescriber information.

Revised type 2 diabetes mellitus criteria to reflect pediatric extensions (age ≥ 10 years) for several products including Jardiance, Synjardy, Invokana, Invokamet, and Invokamet XR per prescribing information.

Updated heart failure (HF) criteria per Farxiga's revised indication for HF regardless of ejection fraction and allowed use of Jardiance for HFrEF per guidelines.

Redirected initial therapy for type 2 diabetes from Steglatro or Segluromet to generic dapagliflozin and added prior authorization requirement for Steglatro and Segluromet.

12 monthsstandard approval duration

≥20CKD eGFR threshold

≥10

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

pediatric age threshold

multiplePA-required products

Type 1 (Inpefa)Not authorized

Coverage and Medical Necessity Criteria

Initial Approval — Chronic Kidney Disease

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

ALL of the following

Diagnosis of CKD.
Request is for Farxiga or Jardiance;* If request is for Synjardy, Synjardy XR, or Xigduo XR, please refer to Type 2 Diabetes Mellitus criteria (I.A). If request is for Inpefa, please refer to criteria set I.D below.
Age ≥ 18 years.
Both of the following
- eGFR ≥ 20 mL/min/1.73 m2≥ 20 mL/min/1.73 m2
- Urine albumin creatinine ratio (UACR) ≥ 200 mg/g≥ 200 mg/g
Failure of generic dapagliflozin, unless contraindicated or clinically significant adverse effects are experienced.
Member does not have a diagnosis of type 1 diabetes mellitus or polycystic kidney disease.
Member has not received immunosuppressive therapy for the treatment of kidney disease in the past 6 months.
Member is currently receiving an angiotensin converting enzyme inhibitor or angiotensin receptor blocker at maximally tolerated doses for ≥ 4 weeks, unless clinically significant adverse effects are experienced or all are contraindicated.
ACE inhibitor or ARB requirement may be waived if contraindicated or not tolerated.
Dose
- Does not exceed 10 mg per day.
- 1 tablet per day.

Initial Approval — Inpefa for Non-HF Indications

Initial Approval — Inpefa for Non-HF Indications (must meet all):

ALL of the following

Diagnosis of both of the following: (a) Type 2 diabetes mellitus; and (b) CKD with eGFR between 25 and 60 mL/min/1.73 m2.
Request is for Inpefa.
Age ≥ 18 years.
Cardiovascular risk requirements (one of the following applies)
- If age 18 to 54 years: Member has at least one major CV risk factor (see Appendix E).
- If age ≥ 55 years: Member has at least two minor CV risk factors (see Appendix E).

Initial Approval — Other diagnoses/indications

Initial Approval — Other diagnoses/indications (must meet 1 or 2):

At least 1 of the following

If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies: (a) For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.PMN.255 for Medicaid; or (b) For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.PMN.16 for Medicaid;
If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.PMN.53 for Medicaid.

Requests for Inpefa for Diagnoses Other Than Heart Failure

Requests for Inpefa for Diagnoses Other Than Heart Failure (Initial Approval) (must meet all):

ALL of the following

Diagnosis of both of the following: (a) Type 2 diabetes mellitus; and (b) CKD with eGFR between 25 and 60 mL/min/1.73 m2.
Request is for Inpefa.
Age ≥ 18 years.
Cardiovascular risk requirements (one of the following)
- If age 18 to 54 years: Member has at least one major CV risk factor (see Appendix E).

Other diagnoses/indications (must meet 1 or 2)

Other diagnoses/indications (Continued Therapy) (must meet 1 or 2):

At least 1 of the following

If this drug has recently (within the last 6 months) undergone a label change that is not yet reflected in this policy, follow the applicable formulary/non-formulary policy: CP.PMN.255 (Medicaid no coverage criteria) or CP.PMN.16 (non-formulary).
If the requested continued use is NOT specifically listed under section III AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.PMN.53 for Medicaid.

Notable coverage criteria updates

Notable coverage criteria updates:

ALL of the following

1Q 2025 annual review: 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; references reviewed and updated.
RT4 (06.27.23 / 08.23): Updated HF criteria per Farxiga's revised indication for HF regardless of ejection fraction; added Inpefa to policy; updated diabetes criteria per Jardiance and Synjardy pediatric extensions (age ≥ 10).
RT4 (09.26.23): Updated policy to reflect the new FDA approval of Jardiance for CKD; contraindications and limitations of use for Jardiance revised per updated prescribing information.
Per March SDC (03.12.24 / 05.24): Revised redirection from Steglatro or Segluromet to generic dapagliflozin for type 2 diabetes mellitus initial and continued therapy; added redirection to preferred agents for all indications; updated Appendix B with therapeutic alternatives; added Steglatro and Segluromet as PA-required products.

Dosing, Age, and eGFR Thresholds

eGFR — >= 20 mL/min/1.73 m2

eGFR threshold>= 20 mL/min/1.73 m2

ContextRequired for CKD initial and continued therapy approval (Farxiga or Jardiance).

DocumentationProvider must submit recent eGFR supporting this value for CKD requests.

Inpefa eGFR range for CKD indication — 25 to 60 mL/min/1.73 m2

Inpefa CKD eGFR range25 to 60 mL/min/1.73 m2

IndicationApplies when requesting Inpefa for non-HF CKD-related indications.

Dose limit linkage

Prior Authorization, Documentation, and Step Therapy

Prior Authorization

Prior Authorization Required

Prior authorization is required for select SGLT2 inhibitors (including Steglatro and Segluromet). Provider must document that the member meets the applicable approval criteria for the requested indication (e.g., diabetes, heart failure, CKD).

Steglatro and Segluromet are PA-required as of 03.12.24; initial therapy is redirected to generic dapagliflozin when specified in criteria.

Prior Authorization

Approval Contingent on Meeting Indication-Specific Criteria

Approval of SGLT2 inhibitors is contingent on meeting the listed criteria for the specific indication (Type 2 diabetes, heart failure, CKD, or other covered indications). Requests that do not meet the criteria in the corresponding Initial or Continued Therapy sections may be denied.

Step Therapy

Clinical Background and Definitions

SGLT2 inhibitors are a class of antihyperglycemic agents used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Several agents in the class have additional FDA‑approved indications for cardiorenal risk reduction, including reductions in heart failure hospitalization, cardiovascular mortality, and progression of chronic kidney disease. Limitations of use include lack of indication and increased risk for diabetic ketoacidosis in type 1 diabetes, and agent‑specific efficacy and safety restrictions tied to eGFR thresholds and other contraindications as described in product labeling.

SGLT2 inhibitors — class definition and notes

Class definitionSGLT2 inhibitors: antihyperglycemic agents used as adjunct to diet and exercise to improve glycemic control in type 2 diabetes; some agents have HF and CKD indications

Pediatric approvalsSeveral agents (Farxiga, Invokana, Invokamet, Invokamet XR, Jardiance, Synjardy, Xigduo XR) have pediatric indication down to age 10

Clinical uses beyond glycemic controlCertain agents reduce HF hospitalization and CV death or slow CKD progression depending on agent-specific evidence

Policy Summary

Payermhn

PolicySodium-Glucose Co-Transporter 2 (SGLT2) Inhibitors

Policy CodePolicy CP.PMN.14

Change TypeCoverage criteria and product list updates (eGFR threshold, added product, pediatric extensions, PA/step edits)

Effective Date03.01.19

Next Review Date

SourceLink

On This Page

Failure of generic dapagliflozin, unless contraindicated or clinically significant adverse effects are experienced (see Appendix D).

Dose

Does not exceed 400 mg per day.
1 tablet per day.

If age ≥ 55 years: Member has at least two minor CV risk factors (see Appendix E).

Failure of generic dapagliflozin, unless contraindicated or clinically significant adverse effects are experienced (see Appendix D).

Dose

Does not exceed 400 mg per day.
1 tablet per day.

1Q 2021 and subsequent updates: Removed lower limb amputation boxed warning for canagliflozin per updated prescribing information; other editorial and references updates as noted in revision history.

Inpefa dosing and max dose requirements apply (see product dosing).

Age thresholds — agent-specific

Pediatric threshold (selected agents)Age >= 10 years for Farxiga, Invokana, Invokamet, Invokamet XR, Jardiance, Synjardy, and Xigduo XR

Adult threshold (other agents)Age >= 18 years for all other SGLT2 inhibitors

Policy notePediatric extensions were added per product prescribing information and applied to diabetes criteria and redirection rules.

Dose limits examples

Farxiga / Jardiance example10 mg per day; limit 1 tablet per day

Inpefa example400 mg per day; limit 1 tablet per day

General policyDose increases must not exceed FDA-approved maximums as listed in dosing table.

Maximum daily doses (examples)

Farxiga / Jardiance maximum (HF/CKD)10 mg/day

Inpefa maximum400 mg/day

Dosing table referenceSee Section V dosing and administration for product-specific maximums.

eGFR for CKD coverage — >= 20 mL/min/1.73 m2

CKD coverage eGFR requirement>= 20 mL/min/1.73 m2 (updated guidance)

Applies toInitial and continued therapy requests for CKD when Farxiga or Jardiance are requested

Source of changeUpdated per 2024 KDIGO guideline recommendations (policy revision noted).

eGFR threshold (CKD coverage) — updated guidance

Updated minimum eGFRMinimum eGFR updated to at least 20 mL/min/1.73 m2 per 2024 KDIGO recommendations

Policy impactReplaced prior 25-75 mL/min/1.73 m2 range for CKD coverage criteria

Documentation requiredProvider must document eGFR to support CKD coverage requests.

Step Therapy Requirements (dapagliflozin trial required)

Step therapy requires failure (or contraindication/adverse reaction) to generic dapagliflozin prior to approval of many other SGLT2 products. For some requests (e.g., canagliflozin-containing products for certain high-risk CV patients) there are specific step or exception rules noted in the diabetes criteria.

Failure = inadequate response after trial duration specified in criteria (see Initial Therapy: ≥3 months metformin requirement and specific dapagliflozin failure requirements).
Exceptions: contraindication or clinically significant adverse effects to dapagliflozin documented.
Redirection: initial and continued therapy may be redirected to generic dapagliflozin per policy updates.

Documentation Required

Documentation Required from Provider

Provider must submit supporting documentation: office chart notes, lab results (including eGFR and UACR when applicable), and other clinical information showing member meets criteria, is responding to therapy, or has contraindications to preferred agents.

For CKD indications: documentation of eGFR ≥ 20 mL/min/1.73 m2 and UACR ≥ 200 mg/g is required.
For heart failure continued therapy: documentation that member has received the medication for at least 30 days is required.
Proof of current therapy: documentation that the member is currently receiving the medication via Centene benefit or previously met initial approval criteria (or continuity-of-care applicability) is required.

heart failure — definition / reference

DefinitionHeart failure (HF): clinical diagnosis required for HF-specific SGLT2 indications and criteria sets

HF agent eligibilityFor HF initial and continued therapy, requests may be for Farxiga, Inpefa, or Jardiance with specified provider and hospitalization requirements for Inpefa

Dose and duration notesHF requests require documentation of at least 30 days ongoing therapy for continued requests; dose limits apply (Farxiga/Jardiance 10 mg/day; Inpefa 400 mg/day)

chronic kidney disease — definition / reference

DefinitionChronic kidney disease (CKD): diagnosis required for CKD-specific SGLT2 coverage criteria

CKD thresholdsPolicy requires eGFR >= 20 mL/min/1.73 m2 and UACR >= 200 mg/g for Farxiga or Jardiance initial approval

Exclusions and requirementsMember must not have type 1 diabetes or polycystic kidney disease; must be on ACE inhibitor or ARB at maximally tolerated dose for >=4 weeks unless contraindicated