CurrentUnitedHealthcarePolicy N/A

Step Therapy - SGLT2 Inhibitors

Defines step therapy and prior authorization criteria for SGLT2 inhibitor medications for UnitedHealthcare members, including indications such as type 2 diabetes, heart failure, and chronic kidney disease; affects providers prescribing listed SGLT2 agents and pharmacy benefit adjudication.

Policy Summary

PayerUnitedHealthcare

PolicyStep Therapy - SGLT2 Inhibitors

Policy CodePolicy N/A

Change TypeNo material change

Effective DateOct 1, 2025

Next Review DateJul 1, 2025

Key ActionObtain and document trials of preferred agents (e.g., Jardiance 30-day; metformin 3-month) or evidence of contraindication/intolerance when requesting prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

16+Medications listed

12 moAuth duration

30d / 3moTrial requirements

State mandatesState updates

Coverage Criteria for SGLT2 Inhibitors

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Chronic kidney disease with diabetes

Covered when ALL of the following are met for Farxiga or Invokana:

CKD with diabetes approval: a. History of suboptimal response, contraindication, or intolerance to an ACE inhibitor (e.g., lisinopril) or an angiotensin receptor blocker (e.g., losartan); b. History of suboptimal response, contraindication, or intolerance to metformin (generic Glucophage, Glucophage XR) after a three-month trial; c. History of therapeutic failure, contraindication, or intolerance to Jardiance after a three-month trial3-month trial for metformin and Jardiance

Authorization will be issued for 12 months

Combination products and other indications

Covered when ANY of the following are met for Glyxambi or specific combination products:

Glyxambi initial approval: History of suboptimal response, contraindication, or intolerance to metformin (after a three-month trial); OR currently on therapy with Glyxambi and requesting continuation3-month trial

Authorization will be issued for 12 months

Bexagliflozin / Brenzavvy / Farxiga / Invokana / Steglatro approval: History of suboptimal response, contraindication, or intolerance to metformin after a three-month trial AND history of therapeutic failure, contraindication, or intolerance to Jardiance after a three-month trial3-month trials

Authorization will be issued for 12 months

Invokamet / Invokamet XR / Xigduo XR / Segluromet approval: History of therapeutic failure, contraindication, or intolerance to Synjardy/Synjardy XR after a three-month trial3-month trial

Qtern or Steglujan approval: History of suboptimal response, contraindication, or intolerance to metformin after a three-month trial AND history of therapeutic failure, contraindication, or intolerance to Glyxambi after a three-month trial3-month trials

Authorization will be issued for 12 months

This policy addresses SGLT2-class products and related combination agents. Listed products include: Bexaglifloxin (Brenzavvy authorized generic), Brenzavvy (bexagliflozin), Farxiga (dapagliflozin), Inpefa (sotagliflozin), Invokana (canagliflozin), Invokamet (canagliflozin/metformin), Invokamet XR (canagliflozin/metformin extended-release), Qtern (dapagliflozin/saxagliptin), Segluromet (ertugliflozin/metformin), Steglatro (ertugliflozin), Steglujan (ertugliflozin/sitagliptin), Xigduo XR (dapagliflozin/metformin extended-release), Glyxambi (empagliflozin/linagliptin), Jardiance (empagliflozin), and Synjardy / Synjardy XR (empagliflozin/metformin). Coverage and utilization management (step therapy/prior authorization) rules in this policy apply to these agents per plan specifics.

Certain products are identified as excluded or subject to tried/failed requirements; plan specifics determine coverage status. The exclusions list has been updated over time: in 7/2024 the program removed Brenzavvy and added Bexagliflozin, and in 7/2025 the master rationale was updated to clarify Brenzavvy authorized generic (bexagliflozin). The policy notes that these agents (for example, Bexaglifloxin/Brenzavvy, Farxiga, Inpefa, Invokana, Invokamet, Qtern, Segluromet, Steglatro, Steglujan, Xigduo XR) are typically excluded from coverage unless tried/failed criteria are satisfied; refer to plan-specific benefits for final coverage determination.

Initial Therapy Requirements

Initial therapy requirements

Initial approvals for various SGLT2 agents require documented trials of preferred agents and evidence of therapeutic failure, intolerance, or contraindication before coverage will be granted.

Initial approval general: History of suboptimal response, contraindication, or intolerance to metformin (after a three-month trial) where specified; and where applicable, history of therapeutic failure, contraindication, or intolerance to Jardiance (after a three-month trial) or Synjardy/Synjardy XR as indicated by the specific product/indication3-month trial (metformin, Jardiance, Synjardy as specified); Jardiance 30-day trial for some heart failure/Inpefa rules

Authorization typically issued for 12 months; prior authorization required when step therapy criteria are not met

Step Therapy Requirements and Lookback

Requirement	Example agents / notes
Documented trial duration for Jardiance (heart failure and Inpefa rules)	30-day trial of Jardiance required as documented therapeutic failure, contraindication, or intolerance
Documented trial duration for metformin and Jardiance (diabetes/CKD rules)	3-month trial required for metformin and where specified a 3-month trial for Jardiance; authorization typically issued for 12 months
General step therapy trial requirement	Documented trial and therapeutic failure, contraindication, or intolerance to specified preferred agents (examples: metformin, Synjardy, Glyxambi) per indication

Step designation	Historical/current notes
Agents designated as step 1 (examples)	Synjardy/Synjardy XR were added as step 1 agents for Xigduo XR (4/2018); Glyxambi step criteria modified to primarily require metformin (8/2018)
Agents designated as step 2 (examples)	Qtern, Segluromet, Steglatro and Steglujan added as step 2 agents (4/2018); subsequent modifications adjusted step placement by indication
Removals and other modifications	Invokana removed from automated lookback (5/2020); Jardiance removed from step therapy requirements (10/2022); Farxiga continues to require step through Jardiance for heart failure per later updates
Recent additions/clarifications	Inpefa added (7/2023); Brenzavvy/Bexagliflozin added and later clarified/updated across 2023–2025 (added 3/2023, removed/updated 7/2024 and 7/2025)

Provider Actions & Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required when step therapy criteria are not met. Approvals are typically issued for 12 months. Providers should submit documentation of prior trials and reason for failure (therapeutic failure, contraindication, or intolerance) consistent with the step-therapy requirements.

Authorization duration: 12 months
Examples of required evidence: chart notes documenting trial duration, medication lists or pharmacy/claims history, documented adverse effects or lab results supporting intolerance/contraindication

Note

Prior Authorization May Be Required for SGLT2 Agents

Prior authorization may be required for SGLT2 agents depending on plan-specific step therapy updates and exclusions. Examples of program changes that can affect requirements include agent additions/removals (e.g., Invokana removed from automated lookback; Brenzavvy/Bexagliflozin additions) and periodic annual reviews.

Recent examples: Invokana removed from automated lookback (7/2020); Brenzavvy/Bexagliflozin added (3/2023, 7/2025)
Check plan-specific drug exclusions and step lists prior to submission

Step Therapy

Step Therapy Documentation Requirements

Step therapy requires documented trials of preferred agents and evidence of therapeutic failure, contraindication, or intolerance. Providers should include claim/medication history and clear documentation of the trial length and clinical rationale for failure or intolerance.

Required trial examples: 30-day trial of Jardiance for certain agents (e.g., Farxiga, Inpefa); three-month trials for metformin or other specified agents where noted (exceptions for CT, KY, MS: 30-day trial)
Documentation examples: pharmacy claims or med lists showing dates and doses, clinician progress notes describing lack of efficacy, lab results or adverse event notes supporting intolerance, ICD-10 diagnosis codes supporting indication

Note

Step Therapy History & Modifications

Program modifications to step therapy (lookback changes, agent list updates, state mandate additions) can change provider workflow and may cause re-review of prior approvals. Providers should monitor updates and verify member-specific benefit applicability before prescribing.

Notable workflow-impacting changes: Invokana removed from automated lookback (7/2020); Jardiance removals/additions and step changes across reviews
Action: confirm current step lists and automated approval logic for the member's plan

Documentation Required

Provider Documentation Recommendations

Ensure claims/medication history, relevant diagnosis codes (ICD-10), and supporting clinical documentation are available when submitting prior authorization requests. Automated approvals may be granted based solely on these data when criteria are met.

Provide: recent pharmacy/claims history, current medication list, ICD-10 codes for the treated condition, clinical notes documenting trials and outcomes
Note: automated approval/re-approval processes vary by program — insufficient documentation may lead to manual review or denial

Denial Risk

Claims Denial Risk if Criteria Not Met

Claims may be denied if automated approval criteria or step/lookback history requirements are not met. Highlight the need for clear documentation of prior trials, dates, and ICD-10 codes; changes to historical lookback rules (e.g., removal of Invokana from lookback) may trigger denials if not accounted for.

Denial risk drivers: missing claims/medication history, absent ICD-10 codes, lack of documented trial duration or clinical rationale
Tip: include both claims-based evidence and chart documentation to reduce denial risk

Definitions

SGLT2 inhibitors — definition and examples

DefinitionSGLT2 inhibitors are sodium-glucose co-transporter 2 inhibitors that lower blood glucose by inhibiting renal glucose reabsorption; they are indicated as adjuncts to diet and exercise to improve glycemic control and some agents have additional indications for heart failure and chronic kidney disease.

Examples — single agentsFarxiga (dapagliflozin); Invokana (canagliflozin); Jardiance (empagliflozin); Steglatro (ertugliflozin); Brenzavvy / bexagliflozin.

Examples — combination with metformin (biguanide)Invokamet / Invokamet XR (canagliflozin + metformin); Synjardy / Synjardy XR (empagliflozin + metformin); Segluromet (ertugliflozin + metformin); Xigduo XR (dapagliflozin + metformin ER).

Examples — combination with DPP-4 inhibitorsGlyxambi (empagliflozin + linagliptin); Qtern (dapagliflozin + saxagliptin); Steglujan (ertugliflozin + sitagliptin).

Notable indication differencesCertain agents (e.g., Farxiga, Invokana, Jardiance, Inpefa) have additional labeled indications beyond glycemic control, including heart failure and/or chronic kidney disease risk reduction.

Background

SGLT2 inhibitors are a class of glucose-lowering agents referenced throughout this policy. Several agents in the class—such as dapagliflozin (Farxiga), empagliflozin (Jardiance), canagliflozin (Invokana), ertugliflozin (Steglatro), and bexagliflozin (Brenzavvy)—have indications beyond glycemic control, including heart failure and chronic kidney disease per individual product labeling. Authorization for these agents is managed by documented trials of preferred agents and indication-specific criteria (for example, a required 30-day trial of Jardiance in certain heart failure and Inpefa rules), with approvals typically issued for 12 months when criteria are met.

Revision History and Policy Updates

2016-10program_creation

Step Therapy - SGLT2 Inhibitors program created (replacing prior Diabetes Medications Step Therapy program).

2017-10update

Added Synjardy/Synjardy XR as step 1 agent for Xigduo XR; program references updated.

2018-04update

Added Qtern, Segluromet, Steglatro and Steglujan as step 2 agents.

2018-08criteria_change

Modified step criteria for Glyxambi to only require metformin, a sulfonylurea or a thiazolidinedione.

2018-12criteria_change

Removed sulfonylurea and thiazolidinedione requirement for Glyxambi and added state mandate language for Florida, Maine and Tennessee.

2019-02update

Modified Qtern and Steglujan step requirements and updated references.

2020-02annual_review

Annual review performed; background and references updated.

2020-05process_change

Invokana removed from automated lookback and step requirements added for Invokana, Invokamet, and Invokamet XR.

2020-07indication_update

Added step requirements for the heart failure indication.

2021-07annual_review

Annual review updated master rationale and modified step therapy for SGLT2 inhibitors for heart failure; failure language revised.

2021-10criteria_change

Added step requirement for chronic kidney disease and updated failure language and state mandate language for CT and KY.

2022-02criteria_change

Added Jardiance into the criteria for chronic kidney disease and updated references; state mandate language reiterated.

2022-04label_update

Jardiance label updated for heart failure indications (reduced and preserved ejection fraction) and criteria adjusted to allow Jardiance for preserved EF.

2022-08criteria_simplification

Combined reduced and preserved heart failure sections and removed the step component for Jardiance.

2022-10criteria_change

Removed Jardiance from step therapy requirements (program no longer requires Jardiance step in some flows).

2023-03product_addition

Added Brenzavvy (bexagliflozin) to the criteria and updated references.

2023-07product_and_mandate_update

Added Inpefa to the program, updated Florida/Maine/Tennessee state mandate language, and removed 'diabetes' from the program name.

2024-07annual_review

Annual review updated excluded products—removed Brenzavvy and added Bexagliflozin; regulatory requirements and references updated.

2025-07annual_reviewLatest

Annual review updated master rationale and clarified inclusion of Brenzavvy authorized generic (bexagliflozin).

OpenPayer

Step Therapy - SGLT2 Inhibitors

Coverage Criteria for SGLT2 Inhibitors

Initial Therapy Requirements

Continuation Therapy

Step Therapy Requirements and Lookback

Provider Actions & Prior Authorization

Definitions

Background

Revision History and Policy Updates