SGLT-2 Inhibitors

POLICY NUMBER

L.5.01.469

Brenzavvy (bexagliflozin)

Farxiga (dapagliflozin)

Inpefa (sotagliflozin)

Invokamet (canagliflozin/metformin)

Invokamet XR (canagliflozin/metformin extended-release)

Invokana (canagliflozin)

Jardiance (empagliflozin)

Segluromet (ertugliflozin/metformin)

Steglatro (ertugliflozin)

Synjardy (empagliflozin/metformin)

Synjardy XR (empagliflozin/metformin extended-release)

Xigduo XR (dapagliflozin/metformin extended-release)

Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.

DESCRIPTION

Sodium-glucose co-transporter (SGLT2) is responsible for the majority of the reabsorption of filtered glucose from the tubular lumen. SGLT-2 inhibitors are a class of oral medications used for the treatment of type 2 diabetes. Inhibition of SGLT2 reduces reabsorption of filtered glucose, lowers the renal threshold for glucose, and increases urinary glucose excretion.

Some SGLT2 inhibitors also reduce sodium reabsorption and increase the delivery of sodium to the distal tubule. This may influence several physiological functions including, but not limited to, lowering both pre- and afterload of the heart and downregulation of sympathetic activity, and decreased intraglomerular pressure, which is believed to be mediated by increased tubuloglomerular feedback. As a result of this additional action, SGLT2 inhibitors have gained additional indications for treatment of heart failure and chronic kidney disease.

Related medical policy - 

• DPP-4 Inhibitors and Combinations

POLICY

Prior authorization is required.

The use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements.

Initial Criteria

Farxiga or Xigduo XR may be considered medically necessary when the following are met:

1. ONE of the following:

   1. The individual is ≥10 years of age and being treated as an adjunct to diet and exercise for a documented diagnosis of type 2 diabetes mellitus and ONE of the following;

      1. The individual's medication history shows recent (within the last 6 months) or current use of metformin or insulin;

      2. There is documentation that the individual is currently using the requested SGLT-2 inhibitor product or the requested SGLT-2 inhibitor in another product (combination product) AND the individual is at risk if therapy is changed; OR

      3. The individual has a documented intolerance (see Medication Intolerance in Policy Guidelines section), FDA-labeled contraindication, or hypersensitivity to at least one of the following antidiabetic classes: metformin or insulins; OR

   2. The request is for Farxiga and ALL of the following:

      1. The individual is ≥18 years of age; AND

      2. ONE of the following:

         1. The individual has a documented heart failure diagnosis; OR

         2. The individual has a documented chronic kidney disease diagnosis;

2. The individual does not have any FDA-labeled contraindications to requested agent; AND

3. The dosage prescribed is within the program quantity limits based on approved FDA-labeled dosing.

 Brenzavvy, Inpefa, Invokana, Invokamet, Invokamet XR, Jardiance, Segluromet, Steglatro, Synjardy, and Synjardy XR are considered not medically necessary as other formulary options exist.

Farxiga and Xigduo are considered not medically necessary when used for all other indications not outlined in this policy including, but not limited to:

• use to improve glycemic control in individuals with type 1 diabetes mellitus;

• use to improve glycemic control in individuals with type 2 diabetes mellitus with an eGFR less than 45 mL/min/1.73 m2 as the agent is likely to be ineffective in this setting based upon its mechanism of action;

• the treatment of chronic kidney disease in individuals with polycystic kidney disease or patients requiring or with a recent history of immunosuppressive therapy for kidney disease as the agent is likely to be ineffective in these populations.

POLICY EXCEPTIONS

State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.

Rankin County Board of Supervisors Self-Insured Group: Effective 06/16/2025, Jardiance is covered without Prior Authorization. (FID#: 89804 Formulary Name: BCBSMS COMM-CUSTOM RCBOS)

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B. appropriate with regard to standards of good medical practice; and

C. not solely for the convenience of the Member, his or her Provider; and

D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

BCBSMS may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful, but are not sufficient documentation unless all specific information needed to make a medical necessity determination is included.

Medication IntoleranceMedication intolerance is defined as the inability to digest, metabolize, or mitigate the expected adverse effects of a prerequisite medication for ≥ 4 weeks use as evidenced by documented attempted intervention(s) to minimize sensitivity where appropriate (i.e., dose titration, dose reduction, administered with food, administration at different times of day, use of alternative formulation(s) etc.) and claims history. Experience of common side effects of medication will not be considered medication intolerance for the purpose of this review.

BCBSMS determines patient medication trial and adherence by a review of pharmacy claims data over the preceding twelve months. Additional information may be requested on a case-by-case basis to allow for proper review. If a member is new to BCBSMS and pharmacy records are needed to confirm medication trials and adherence, it is the responsibility of the member and/or requesting provider to obtain said records and to submit them to BCBSMS upon request. Medical records from the provider that list previously prescribed medications will not be sufficient to show medication trials or adherence.

Medication Failure

Medication failure is defined as disease progression despite maximally tolerated dose (>3 months use) as appropriate for disease state being treated. Experience of common side effects of medication will not be considered medication failure for the purpose of this review.

POLICY HISTORY

08/28/2014: New policy added. Effective 10/01/2014.

08/14/2015: Medical policy revised to add ICD-10 codes.

05/31/2016: Policy number L.5.01.469 added. Investigative definition updated in Policy Guidelines.

06/13/2016: Approved by Pharmacy & Therapeutics (P&T) Committee.

09/30/2016: Code Reference section updated to add new ICD-10 diagnosis codes: E11.3521 - E11.3529, E11.3531 - E11.3539, E11.3541 - E11.3549, E11.37X1 - E11.37X9, and E13.37X1 - E13.37X9.

02/07/2017: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.

02/10/2017: Policy description revised. Policy section updated to change "Generic First Program" to "Step Therapy" and add that Jardiance, Synjardy, Xigduo XR, and Glyxambi are currently non-covered on BCBSMS formularies. Removed outdated reference from Sources section.

09/29/2017: Code Reference section updated to add new ICD-10 diagnosis codes E11.10 and E11.11. Effective 10/01/2017.

02/06/2018: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.

07/01/2018: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy updated to add Qtern®, Segluromet®, Steglatro®, and Steglujan®. Policy section updated to add Qtern®, Segluromet®, Steglatro®, and Steglujan® as non-covered on BCBSMS formularies. Policy statement updated to add Glyxambi and Jardiance as covered with prior authorization when certain conditions are met. Sources section updated. Code Reference section updated to remove ICD-10 diagnosis codes E11.10 and E11.11.

02/05/2019: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy section updated with formatting changes. Policy statements unchanged. Sources updated.

01/01/2021: Added drug names to the top of the policy. Added statement to perform a formulary drug search on the patient's member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member's benefit plan. Policy section updated to add that prior authorization is required and that the use of samples by a Member will not be considered current or stable therapy for purposes of Medical Policy review. Policy statement revised to include drugs that are not medically necessary as other formulary options exist. Medically necessary policy statement updated to include Trijardy XR (empagliflozin/linagliptin/metformin XR) and to state that the patient's medication shows recent (within the last 6 months) or current use of metformin. Added renewal criteria. Policy Guidelines updated to define medication failure and medically necessary. Sources updated.

12/01/2021: Policy updated to add coverage guidelines for Farxiga and Xigduo XR.

01/01/2022: Medically necessary statement revised regarding request for Farxiga and members being treated for heart failure. Removed Glyxambi (empagliflozin/linagliptin), Trijardy XR (empagliflozin/linagliptin/metformin extended-release), and the renewal criteria from the policy. Added Invokana, Invokamet, Invokamet XR, and Jardiance as not medically necessary as other formulary options exist.

01/19/2022: Code Reference section updated to add HCPCS code J8499.

10/07/2022: Policy section updated to make the following correction: "aldosterone agonist" changed to "aldosterone antagonist."

02/01/2023: Policy Exceptions updated to add the following: State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.

04/01/2024: Policy updated to include Brenzavvy (bexagliflozin) and Inpefa (sotagliflozin). Policy statement revised to add Brenzavvy and Inpefa as not medically necessary as other formulary options exist. Sources updated.

01/15/2025: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy statement revised to state that the use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements. Medically necessary policy statement updated regarding age requirements and documented diagnoses. Added policy statement that Farxiga and Xigduo are considered not medically necessary when used for all other indications not outlined in this policy including, but not limited to the listed indications. Policy Guidelines updated to define medication failure. Sources updated.

06/16/2025: Added Self-Insured Group exception.

12/02/2025: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy description updated to add related medical policy. Policy section updated to remove Qtern and Steglujan from the not medically necessary policy statement. Sources updated.

SOURCE(S)

1. American Diabetes Association Professional Practice Committee; 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes—2025. Diabetes Care 1 January 2025; 48 (Supplement_1): S181 –S206. https://doi.org/10.2337/dc25-S009 .

2. Brenzavvy prescribing information. TheracosBio, LLC. March 2025. Last accessed September 2025.

3. Farxiga prescribing information. AstraZeneca Pharmaceuticals LP. October 2024. Last accessed September 2025.

4. Inpefa prescribing information. Lexicon Pharmaceuticals, Inc. January 2024. Last accessed September 2025.

5. Heidenreich PA, Bozkurt B, Aguilar D, et al. 2022 ACC/AHA/HFSA Guideline for the Management of Heart Failure. Circulation. 2022;145(18). https://doi.org/10.1161/CIR.0000000000001063 .

6. Invokamet/Invokamet XR prescribing information. Janssen Pharmaceuticals, Inc. August 2025. Last accessed September 2025.

7. Invokana prescribing information. Janssen Pharmaceuticals, Inc. August 2025. Last accessed September 2025.

8. Jardiance prescribing information. Boehringer Ingelheim Pharmaceuticals, Inc. April 2025. Last accessed September 2025.

9. Segluromet prescribing information. Merck Sharp & Dohme LLC. December 2024. Last accessed September 2025.

10. Steglatro prescribing information. Merck Sharp & Dohme LLC. December 2024. Last accessed September 2025.

11. Synjardy prescribing information. Boehringer Ingelheim Pharmaceuticals, Inc. March 2025. Last accessed September 2025.

12. Synjardy XR prescribing information. Boehringer Ingelheim Pharmaceuticals, Inc. March 2025. Last accessed September 2025.

13. Xigduo XR prescribing information. AstraZeneca Pharmaceuticals LP. December 2024. Last accessed September 2025.

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Medically Necessary Codes

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