ModifiedmhnPolicy CP.CPA.347

Sodium-Glucose Co-Transporter 2 (SGLT2) Inhibitors

Defines prior authorization requirements, clinical criteria for initial and continued coverage, and limitations for SGLT2 inhibitor products for Commercial line of business; affects prescribers and pharmacists requesting coverage through Centene-affiliated health plans.

Policy Summary

Payermhn

PolicySodium-Glucose Co-Transporter 2 (SGLT2) Inhibitors

Policy CodePolicy CP.CPA.347

Change TypeAnnual review with product additions and criteria updates

Effective DateNov 1, 2020

Next Review Date

Key ActionSubmit prior authorization with clinical documentation (office notes, labs, or other information) demonstrating the member meets the policy approval criteria.

SourceLink

POLICY UPDATE CHANGES

Added Brenzavvy and Inpefa to the policy as covered products.

Updated Appendix C to add product exceptions to the renal impairment contraindication for Brenzavvy, Steglatro, and Invokana per prescribing information.

Updated Appendix D with literature supporting use of Farxiga (but not Jardiance) in T2DM patients with multiple cardiovascular risk factors.

Updated pediatric age criteria for Invokana, Invokamet, and Invokamet XR to reflect extension to age ≥ 10 years.

1Q 2023 annual review: added bypass of metformin for members with ASCVD, indicators of high ASCVD risk, HF, or chronic kidney disease per ADA guidelines; references reviewed and updated.

RT4: added Brenzavvy, Inpefa, and other newer products to the policy; product exceptions for renal impairment were added for some agents in 1Q 2024.

1Q 2025 annual review: updated type 2 diabetes mellitus criteria for Invokana, Invokamet, and Invokamet XR to reflect pediatric extensions for age ≥ 10 years per PI.

12 monthsstandard approval duration

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min age (some agents)

≥18 yrsmin age (most agents / Inpefa HF)

400 mg/dayInpefa max dose

3 monthsrequired step failure

guideline-alignedmetformin bypass added

Coverage Criteria and Approval Rules

Initial Therapy — Type 2 Diabetes Mellitus

Covered when ALL of the following are met:

ALL of the following

Diagnosis of type 2 diabetes mellitus
Request is for an SGLT2 inhibitor other than Inpefa
Age meets one of the following: a) Invokana, Invokamet, or Invokamet XR: ≥ 10 years; b) All other SGLT2 inhibitors: ≥ 18 years
Member meets one of the following: a) Failure of ≥ 3 consecutive months of metformin, unless contraindicated or clinically significant adverse effects are experienced; b) For antidiabetic medication-naïve members, requested agent is approvable if intended for concurrent use with metformin due to HbA1c ≥ 8.5% (drawn within the past 3 months); c) Request is for an agent with proven cardiovascular benefit (dapagliflozin-, canagliflozin-, empagliflozin-containing products), and member has established ASCVD, indicators of high ASCVD risk (see Appendix D), heart failure, or chronic kidney disease
If request is for Qtern or Steglujan, failure of ≥ 3 consecutive months of Glyxambi or Trijardy XR, unless clinically significant adverse effects are experienced or both are contraindicated
If request is for Glyxambi or Trijardy XR, failure of ≥ 3 consecutive months of an empagliflozin-, dapagliflozin-, or sitagliptin-containing product, unless clinically significant adverse effects are experienced or all are contraindicated

Initial Therapy — Inpefa for Heart Failure

Covered when ALL of the following are met:

ALL of the following

Diagnosis of heart failure
Request is for Inpefa
Prescribed by or in consultation with a cardiologist
Age ≥ 18 years
Member has a diagnosis of type 2 diabetes mellitus
Member was recently (within the last 30 days) hospitalized or had an urgent HF visit to an emergency department, HF unit, or infusion center due to intravascular volume overload (examples of clinical signs and symptoms of congestion include but are not limited to: dyspnea, jugular venous distention, pitting edema in lower extremities (> 1+), rales on auscultation, radiographic pulmonary congestion)

Initial Therapy — Inpefa for T2DM with CKD

Covered when ALL of the following are met:

ALL of the following

Diagnosis of both: a) Type 2 diabetes mellitus; and b) Chronic kidney disease with eGFR between 25 and 60 mL/min/1.73 m^2
Request is for Inpefa
Age ≥ 18 years
Cardiovascular risk based on age: a) If age 18 to 54 years: member has at least one major CV risk factor (see Appendix E); b) If age ≥ 55 years: member has at least two minor CV risk factors (see Appendix E)
Failure of Farxiga, unless clinically significant adverse effects are experienced or is contraindicated

Initial and general coverage

Covered when clinical criteria and product-specific prescribing information are met. Note: metformin trial may be bypassed for certain high-risk groups (see Metformin bypass criteria).

ALL of the following

Requested product is an SGLT2 inhibitor and the request meets the relevant Initial or Continued Therapy criteria in this policy
Prescriber documentation includes relevant diagnoses, prior therapies, reasons for treatment selection, and supportive clinical data (e.g., recent HbA1c, eGFR)
Therapy is not for a diagnosis/indication specifically excluded by this policy (see Diagnoses/Indications for which coverage is NOT authorized)
Dose requested does not exceed product-specific maximums per prescribing information

Metformin bypass criteria

Metformin trial may be bypassed (i.e., requirement for \u2265 3 months of metformin is waived) when ANY of the following high-risk conditions are present:

ANY of the following

Member has established atherosclerotic cardiovascular disease (ASCVD) or indicators of high ASCVD risk (see Appendix D)
Member has heart failure
Member has chronic kidney disease

Policy updates affecting coverage criteria

Policy updates and rationale:

ALL of the following

1Q 2021 annual review: removed lower limb amputation boxed warning for canagliflozin from Appendix C per updated prescribing information; references reviewed and updated (Date = 10.28.20)
Removed heart failure therapies from Appendix B: Therapeutic Alternatives when policy did not address the heart failure indication for Farxiga and Jardiance (Date = 09.08.21)
1Q 2022 annual review: removed Qternmet XR as it is no longer on market; references reviewed and updated (Date = 09.16.21)
1Q 2023 annual review: added bypass of metformin for members with ASCVD, indicators of high ASCVD risk, heart failure, or chronic kidney disease per ADA guidelines; template changes applied to other diagnoses/indications and continued therapy section (Date = 10.26.22)

Clinical Thresholds, Dosing Limits and Code-Like Values

eGFR thresholds used in criteria

Inpefa non-HF CKD eGFR rangeeGFR between 25 and 60 mL/min/1.73 m2 (required for Inpefa when used for T2DM with CKD)

eGFR limiting use for Glyxambi/InvokanaReferences to eGFR < 30 mL/min/1.73 m2 as limitation for Glyxambi and Invokana (not recommended below this threshold)

General role of eGFReGFR is used to assess renal function and determine product-specific eligibility and dosing limits

HbA1c threshold

HbA1c threshold for antidiabetic-naïveHbA1c ≥ 8.5% (drawn within the past 3 months) allows approval for antidiabetic medication–naïve members when intended for concurrent use with metformin

Context of useApplied when member is antidiabetic medication–naïve and starting SGLT2 therapy with metformin

Prior Authorization, Documentation, and Step Therapy Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required for all listed SGLT2 inhibitors and their combination products. Providers must request PA prior to dispensing; coverage is determined based on the medical necessity criteria in this policy.

Affected products include: bexagliflozin (Brenzavvy), canagliflozin (Invokana), canagliflozin/metformin (Invokamet, Invokamet XR), dapagliflozin/saxagliptin (Qtern), empagliflozin/linagliptin (Glyxambi), empagliflozin/linagliptin/metformin (Trijardy XR), ertugliflozin/sitagliptin (Steglujan), ertugliflozin (Steglatro), ertugliflozin/metformin (Segluromet), and sotagliflozin (Inpefa).
Submit complete PA requests per Health Plan procedures.

Prior Authorization

PA Determinations Guided by Medical Necessity

Prior authorization approvals are based on medical necessity as defined in this clinical policy. The policy outlines initial and continuation criteria (e.g., diagnosis, age limits, prior therapy failures, HbA1c thresholds, and specific indications such as ASCVD, HF, or CKD) that must be met for approval.

PA determinations follow the policy’s medical necessity criteria for initial and continued therapy.

Background and Scope

Sodium‑glucose co‑transporter 2 (SGLT2) inhibitors are oral agents indicated primarily as adjuncts to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus; select agents also have FDA‑approved cardiovascular or renal indications or pediatric extensions. This policy defines prior authorization requirements, initial and continued therapy criteria (including product‑specific step‑therapy and dosing limits), and contraindications that affect prescribers and pharmacists seeking coverage through Centene‑affiliated Health Plans. Providers should supply clinical documentation (office notes, laboratory results such as eGFR and UACR, and prior therapy trials) to demonstrate that members meet the stated criteria, and must recognize that product labeling and annual policy updates (for example, additions such as Inpefa or product‑specific renal exceptions) may affect coverage decisions.

Definitions and Abbreviations

Definition — eGFR

eGFR definitionEstimated glomerular filtration rate (eGFR) — used to assess renal function and referenced in dosing/indication limits

Application in policyeGFR thresholds determine eligibility for Inpefa CKD indication and product-specific renal contraindications

Referenced appendiceseGFR appears in clinical criteria and Appendix C (contraindications) and dosing limits

Definition — ASCVD

ASCVD definitionASCVD = atherosclerotic cardiovascular disease — used to identify members with established cardiovascular disease for certain approvals

Role in metformin bypassEstablished ASCVD is one of the conditions that allows bypass of metformin initiation per ADA guidance

Policy Summary

Payermhn

PolicySodium-Glucose Co-Transporter 2 (SGLT2) Inhibitors

Policy CodePolicy CP.CPA.347

Change TypeAnnual review with product additions and criteria updates

Effective DateNov 1, 2020

Next Review Date

Key ActionSubmit prior authorization with clinical documentation (office notes, labs, or other information) demonstrating the member meets the policy approval criteria.

SourceLink

On This Page

Failure of Farxiga and Jardiance, unless clinically significant adverse effects are experienced or both are contraindicated

Member does not have a diagnosis of type 1 diabetes mellitus

Dose does not exceed: a) 400 mg per day; b) 1 tablet per day

RT4 updates: added Brenzavvy to policy (Date = 03.07.23); added Inpefa to policy (Date = 06.27.23)

1Q 2024 annual review: aligned Appendix C renal impairment exceptions for Brenzavvy, Steglatro, and Invokana with product PI; updated Appendix D literature regarding Farxiga in patients with T2DM and multiple CV risk factors (Date = 10.23.23)

1Q 2025 annual review: updated Type 2 diabetes mellitus criteria for Invokana, Invokamet, and Invokamet XR to reflect pediatric extensions for age ≥ 10 years per prescribing information (Date = 01.06.25); no significant changes otherwise

Timing of labHbA1c must be documented within the past 3 months

UACR thresholds

Major UACR cutoffUACR ≥ 300 mg/g (major cardiovascular/renal risk factor)

Minor UACR rangeUACR ≥ 30 mg/g and < 300 mg/g (minor cardiovascular risk factor)

Use in risk assessmentUACR categories are used to classify CV/renal risk in Appendix E criteria

BMI threshold (minor CV risk factor)

BMI minor CV risk factorBody mass index ≥ 35 kg/m2 is classified as a minor cardiovascular risk factor

Role in age-based criteriaUsed to meet minor CV risk factor counts for Inpefa non-HF indications (age ≥55 years requires ≥2 minor factors)

Source appendixDefined in Appendix E (CV risk factor definitions)

NT-proBNP threshold for HF criteria

NT-proBNP major cutoffN-terminal pro-B-type natriuretic peptide ≥ 400 pg/mL (47 pmol/L) is listed as a major CV risk factor

Use in risk stratificationNT-proBNP ≥ 400 pg/mL counts as a major factor when assessing CV risk in appendices

Unit conversion notedNT-proBNP 47 pmol/L equivalent provided alongside pg/mL

High-sensitivity troponin T thresholds

High-sensitivity troponin T major cutoffsHigh-sensitivity troponin T > 15.0 pg/mL for men and > 10.0 pg/mL for women (major CV risk factor)

Sex-specific thresholdsDifferent numeric cutoffs specified for men and women in Appendix E

Role in CV risk assessmentElevated hs‑troponin T is used to identify major CV risk in members considered for agents with CV benefit

Coronary artery calcium (CAC) score thresholds

Major CAC cutoffCoronary artery calcium (CAC) score ≥ 300 Agatston Units is a major CV risk factor

Minor CAC rangeCAC score > 100 and < 300 Agatston Units is considered a minor CV risk factor

Use in appendix criteriaCAC thresholds are defined in Appendix E for CV risk classification

Product dosing maxima (appendix references)

Jardiance (empagliflozin) maximum doseJardiance maximum listed as 25 mg/day

Farxiga (dapagliflozin) maximum doseFarxiga maximum listed as 10 mg/day

Brenzavvy (bexagliflozin) maximum doseBrenzavvy maximum listed as 20 mg/day

Inpefa (sotagliflozin) maximum doseInpefa maximum listed as 400 mg/day (titrate from 200 mg to 400 mg as tolerated)

Coverage decisions remain subject to member benefit terms, exclusions, and limitations.

Documentation Required

Documentation Required with PA Requests

Providers must submit supporting clinical documentation with the PA request. Lack of adequate documentation demonstrating that the member meets the approval criteria may result in denial.

Acceptable documentation: office chart notes, lab results (e.g., HbA1c, UACR, NT-proBNP), imaging reports (e.g., echocardiogram), and medication history.
Include dates and values for CV risk indicators and prior therapy trial durations.

Denial Risk

Contraindications May Trigger Denial

Requests may be denied if the member has contraindications or boxed warnings per the policy and product labeling. Common denial triggers include history of serious hypersensitivity to the requested product and product-specific renal impairment restrictions.

Contraindications: history of serious hypersensitivity reaction to the requested drug product.
Renal impairment: moderate to severe renal impairment, end-stage renal disease, or dialysis (exceptions: Brenzavvy, Inpefa, Invokana, and Steglatro may differ per PI).
Metformin-containing products: chronic or acute metabolic acidosis, including diabetic ketoacidosis (and boxed warning for lactic acidosis).

Documentation Required

Clinical Documentation to Support Indications

Provide clinical evidence to support the requested indication and any applicable step therapy exceptions. Documentation should demonstrate prior medication trials or reasons to bypass them, relevant labs, and evidence of ASCVD, high ASCVD risk indicators, heart failure, or chronic kidney disease when claimed.

Clinical support for ASCVD/high risk/HF/CKD: prior imaging reports, UACR, NT-proBNP, CAC score, ECG/echo findings, hs-troponin, CRP.
Evidence of prior therapy: dates, durations (e.g., ≥3 consecutive months), and intolerance/adverse effects if trials were not completed.

Step Therapy

Step Therapy and Agent-Specific Failures

Supporting documentation must include evidence of prior therapy failures when required by step therapy rules, or clear justification for bypass. For many agents, approval requires documented failure of ≥3 consecutive months of specified alternative agents unless contraindicated or not tolerated.

Examples: failure of ≥3 months of metformin unless contraindicated; for certain agent switches, failure of ≥3 months of listed comparator SGLT2 or combination products is required.
Agent-specific step rules and historical updates are detailed in the appendices; providers should reference appendices for therapeutic alternatives and dosing maxima.

Prior Authorization

Metformin Bypass for High-Risk Patients

Per ADA guidance and recent policy updates, metformin may be bypassed for initiating an SGLT2 inhibitor in high-risk patients. Providers must supply documentation showing established ASCVD, indicators of high ASCVD risk, heart failure, or chronic kidney disease if requesting a metformin bypass.

High-risk criteria and examples are in Appendix D (e.g., hospitalization for HF, LVEF ≤40%, CAC score, UACR thresholds, NT-proBNP).
Include HbA1c value drawn within past 3 months when relevant (e.g., HbA1c ≥8.5% for antidiabetic-naïve patients).

Use in agent selectionPresence of ASCVD or indicators of high ASCVD risk supports use of agents with proven CV benefit (dapagliflozin, canagliflozin, empagliflozin)

Definition — UACR

UACR definitionUACR = urine albumin creatinine ratio — laboratory measure of albuminuria used to classify major and minor CV/renal risk (see Appendix E)

Risk thresholdsUACR ≥ 300 mg/g (major) and UACR ≥ 30 and < 300 mg/g (minor) as defined in Appendix E

Clinical relevanceUACR levels inform eligibility for renal/CKD-related indications and risk stratification

Definition — eGFR (glossary)

eGFR (glossary duplicate)eGFR (estimated glomerular filtration rate) — appears in the glossary as the same renal function measure used for dosing and eligibility

Policy usageRepeated glossary entry reinforces eGFR as the standard renal function metric across criteria sets

Measurement unitsExpressed in mL/min/1.73 m2 when specifying thresholds (eg, 25–60; <30)

Definition — Health Plan

Health Plan definition'Health Plan' means a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or affiliates

Policy roleThis clinical policy is a guide to medical necessity to assist in coverage decisions and administering benefits, not a guarantee of payment

Coverage dependencyCoverage decisions are subject to terms, conditions, exclusions, limitations of the member's coverage documents and applicable law