ModifiedPremera BluecrossPolicy N/A

SGLT2 Inhibitors (pharmacy benefit) - Coverage Criteria

Defines medical necessity and authorization criteria for SGLT2 inhibitor therapies (including empagliflozin, canagliflozin, dapagliflozin, ertugliflozin, bexagliflozin, sotagliflozin and combination products) for treatment of type 2 diabetes, chronic kidney disease, and chronic heart failure under the pharmacy benefit.

Policy Summary

PayerPremera Bluecross

PolicySGLT2 Inhibitors (pharmacy benefit) - Coverage Criteria

Policy CodePolicy N/A

Change TypeMaterial updates: product removals/additions and re-authorization changes

Effective DateJun 1, 2026

Next Review Date

Key ActionObtain prior authorization with documentation of diagnosis and prior therapy per drug-specific criteria; approvals may be issued for up to 12 months.

SourceLink

POLICY UPDATE CHANGES

Removed coverage criteria for brand dapagliflozin, brand dapagliflozin-metformin, Farxiga (dapagliflozin) and Xigduo XR (dapagliflozin-metformin extended-release).

Updated list of preferred alternatives removing Farxiga and Xigduo XR, and adding dapagliflozin and dapagliflozin-metformin extended-release.

Updated re-authorization duration of approval from 3 years to 12 months.

Inpefa (sotagliflozin) moved into this policy and considered medically necessary for treatment of heart failure or type 2 diabetes with chronic kidney disease and cardiovascular risk factors.

Clarified that medications listed are subject to the product's FDA dosage and administration prescribing information.

12 monthsmax approval duration

≥6.5%A1C threshold

≥18 yrsminimum age

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Coverage Criteria — SGLT2 Inhibitors

inv-01: Jardiance (empagliflozin) - Type 2 Diabetes

Covered when ALL of the following are met for empagliflozin (Jardiance) as first-line SGLT2:

Jardiance - Type 2 Diabetes: Individual diagnosed with type 2 diabetes

Related Information

Jardiance - Type 2 Diabetes: Has tried and had an inadequate response or intolerance to metformin unless contraindicated

Jardiance - Type 2 Diabetes: Jardiance is not used in combination with another SGLT2 inhibitor

inv-02: Jardiance (empagliflozin) - Chronic Kidney Disease

Covered when ALL of the following are met for empagliflozin for chronic kidney disease:

Jardiance - CKD: Individual is aged 18 years or older>=18 years

Jardiance - CKD: Has been diagnosed with chronic kidney disease

Related Information

Jardiance - CKD: Receiving concurrent therapy with an ACE inhibitor or ARB unless not tolerated

Jardiance - CKD: Jardiance is not used in combination with another SGLT2 inhibitor

inv-03: Jardiance (empagliflozin) - Chronic Heart Failure

Covered when ALL of the following are met for empagliflozin for chronic heart failure:

Jardiance - Heart Failure: Individual is aged 18 years or older>=18 years

Jardiance - Heart Failure: Has a diagnosis of chronic heart failure (NYHA Class II to IV)NYHA II-IV

Jardiance - Heart Failure: Jardiance is not used in combination with another SGLT2 inhibitor

inv-04: Synjardy and Synjardy XR - Type 2 Diabetes

Covered when ALL of the following are met for Synjardy (empagliflozin-metformin) products for type 2 diabetes:

Synjardy - Type 2 Diabetes: Individual diagnosed with type 2 diabetes

Related Information

Synjardy - Type 2 Diabetes: Has tried and had an inadequate response or intolerance to metformin unless contraindicated

Synjardy - Type 2 Diabetes: Medication is not used in combination with another SGLT2 inhibitor

Synjardy - Type 2 Diabetes: Use is prescribed by or in consultation with a cardiologist or cardiac care specialist (for certain indications)

inv-05: SGLT2 inhibitors - Second Line (various agents)

Covered when ALL of the following are met for listed second-line SGLT2 inhibitors for type 2 diabetes:

Second-line SGLT2 - Type 2 Diabetes: Individual diagnosed with type 2 diabetes

Related Information

Second-line SGLT2 - Type 2 Diabetes: Has tried and had an inadequate response or intolerance to metformin unless contraindicated

Second-line SGLT2 - Type 2 Diabetes: Has tried and had an inadequate response or intolerance to 2 of the following: dapagliflozin; empagliflozin; empagliflozin-metformin products; dapagliflozin-metformin XR2 agents

Specified for certain second-line approvals

Second-line SGLT2 - Type 2 Diabetes:

inv-06: Inpefa (sotagliflozin) - Heart Failure

Covered when ALL of the following are met for Inpefa (sotagliflozin) to reduce CV death/hospitalization for heart failure:

Inpefa - Heart Failure: Individual is aged 18 years or older>=18 years

Inpefa - Heart Failure: Has a diagnosis of chronic heart failure (NYHA Class II to IV)NYHA II-IV

Inpefa - Heart Failure: Will be used in combination with a beta blocker unless contraindicated or not tolerated

Inpefa - Heart Failure: Will be used in combination with an ACE inhibitor, ARB, or sacubitril/valsartan unless contraindicated or not tolerated

inv-07: Inpefa (sotagliflozin) - CKD + T2DM + CV risk

Covered when ALL of the following are met for Inpefa in CKD with T2DM and CV risk factors:

Inpefa - CKD with T2DM: Individual is aged 18 years or older>=18 years

Inpefa - CKD with T2DM: Has a diagnosis of chronic kidney disease

Related Information

Inpefa - CKD with T2DM: Has a diagnosis of type 2 diabetes

Related Information

Inpefa - CKD with T2DM: Has 1 or more cardiovascular risk factors (e.g., obesity, dyslipidemia, or hypertension)

All uses of SGLT2 inhibitor agents that are for conditions not explicitly listed as covered in this policy are considered investigational and are not eligible for coverage under the terms described herein.

For indications that the policy does list as approved (for example, type 2 diabetes, chronic kidney disease, or chronic heart failure), treatment with an SGLT2 inhibitor that does not meet the specific product- and indication-level criteria in this policy is considered not medically necessary and will not be approved.

Effective 06/01/26, coverage criteria that specifically referenced brand dapagliflozin products, Farxiga (dapagliflozin), and Xigduo XR (dapagliflozin–metformin extended‑release) were removed from this policy; the policy’s preferred alternatives list was correspondingly updated to reflect these changes.

In summary, uses of SGLT2 inhibitors that are not listed in this policy are investigational, and uses for approved conditions that do not satisfy the policy’s specified criteria are not medically necessary. Policy history notes that certain brand-specific dapagliflozin products were removed from the criteria as of 06/01/26.

Initial Therapy and Product-Specific Initiation Rules

inv-27: Initial therapy — common requirements, diagnosis documentation and prior trial/intolerance elements

Initial authorization criteria vary by product and indication; common requirements are diagnosis documentation and prior trial/intolerance as specified below:

Initial therapy examples: Medical records document the diagnosis (T2DM, CKD, or chronic heart failure) and include relevant history, physical exam, and medication history

Required documentation

Initial therapy examples: For type 2 diabetes indications: trial and inadequate response or intolerance to metformin unless contraindicated

Step requirement for many agents

Initial therapy examples: For specified second-line agents: trial and inadequate response or intolerance to 2 of the listed SGLT2 options when required2 agents

Continuation and Re-authorization Rules

inv-29: Continuation therapy — re-authorization rules

Re-authorization rules:

Re-authorization: May be approved up to 12 months if medical necessity criteria continue to be met and chart notes show positive clinical response to therapy12 months

Continuation therapy

inv-30: Continuation/reauthorization — updated re-authorization and continuation rules (material change: duration updated to 12 months)

Updated continuation and re-authorization rules:

Duration and non-combination requirement: Re-authorization duration is 12 months; use must not be in combination with another SGLT2 inhibitor.

Material change: duration updated to 12 months

Step Therapy and Prior Trials

Requirement	Details / Applicable Agents
Trial of metformin
Has tried and had an inadequate response or intolerance to metformin unless contraindicated (required for many agents and for type 2 diabetes indications)

Coverage rule	Notes
SGLT2 inhibitor use must not be in combination with another SGLT2 inhibitor
Policy explicitly disallows combination SGLT2 therapy; requests for combination use may be denied per common triggers for denial and policy history clarifications

Coding and Diagnostic Thresholds

Codingmixed

No codes listed

A1C diagnostic threshold — Diagnostic criteria

A1C diagnostic thresholdA1C ≥ 6.5% (≥48 mmol/mol); test performed in an NGSP‑certified lab standardized to the DCCT assay

Fasting plasma glucose (FPG)FPG ≥ 126 mg/dL (≥7.0 mmol/L); fasting = no caloric intake ≥8 hours

2-hour plasma glucose (OGTT)2‑h PG ≥ 200 mg/dL (≥11.1 mmol/L) during a 75 g OGTT per WHO procedures

Random plasma glucoseRandom plasma glucose ≥ 200 mg/dL (≥11.1 mmol/L) with classic hyperglycemia symptoms

A1C — Trial result context (EMPA‑REG)

Mean achieved A1C in EMPA‑REG empagliflozin armMean A1C achieved ≈ 7.8% (benefit realized despite A1C not reaching target)

Provider Requirements and Operational Notes

Prior Authorization

Prior Authorization Required

Prior authorization is required. Approval requests must include documentation of the diagnosis and prior therapy as specified by the drug‑specific coverage criteria. Approvals may be granted for up to 12 months for initial and reauthorization reviews.

Prior authorization required with documentation of diagnosis and prior therapy
Authorizations may be approved up to 12 months

Step Therapy

Step Therapy Requirement

A trial of metformin with inadequate response or documented intolerance is generally required prior to initiation of an SGLT2 inhibitor for type 2 diabetes unless metformin is contraindicated.

Step requirement: trial and inadequate response or intolerance to metformin unless contraindicated

Background — SGLT2 Inhibitor Class

Sodium‑glucose cotransporter‑2 (SGLT2) inhibitors are oral antihyperglycemic agents that act by reducing renal glucose reabsorption, thereby increasing urinary glucose excretion and improving glycemic control in adults with type 2 diabetes. Certain agents in this class (for example, empagliflozin and dapagliflozin) also have FDA‑approved indications and trial evidence supporting benefits for chronic heart failure and/or chronic kidney disease.

Definitions and Diagnostic Criteria

Diagnostic criteria for diabetes (nonpregnant individuals)

Primary A1C thresholdA1C ≥ 6.5% (≥48 mmol/mol)

Fasting plasma glucose criterionFPG ≥ 126 mg/dL (≥7.0 mmol/L) after ≥8 hours fasting

Oral glucose tolerance test criterion2‑h PG ≥ 200 mg/dL (≥11.1 mmol/L) during OGTT with 75 g glucose load

Random glucose with symptomsRandom plasma glucose ≥ 200 mg/dL (≥11.1 mmol/L) in presence of classic hyperglycemia symptoms

Chronic kidney disease (CKD) definition

Duration requirementKidney damage or decreased kidney function present for ≥3 months

Site of Care and Benefit Administration

Note

Pharmacy benefit management (site of care)

All drugs addressed in this policy are managed through the pharmacy benefit.

Site-of-care: pharmacy (home).

Revision History and Policy Changes

2026-06-01material_changeLatest

Removed coverage criteria for brand dapagliflozin, brand dapagliflozin-metformin, Farxiga (dapagliflozin) and Xigduo XR (dapagliflozin-metformin extended-release); updated preferred alternatives list removing Farxiga and Xigduo XR and adding dapagliflozin and dapagliflozin-metformin extended-release.

2025-12-08administrative_update

Removed reference to the Preferred formulary (Formulary ID: 6064; Rx Plan G3) as it was no longer available and clarified applicability of Section 2 to plans with the High Cost Low Value (HCLV) drug list.

2024-12-10