Pharmacy Prior Authorization Criteria

SGLT2 Inhibitors - ST, NF

Indications for Prior Authorization

Brenzavvy (bexagliflozin)

• For diagnosis of Type 2 Diabetes
  Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use: Brenzavvy is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus.

Invokamet (canagliflozin/metformin)

• For diagnosis of Type 2 Diabetes
  Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

  Canagliflozin is indicated to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD).

  Canagliflozin is indicated to reduce the risk of end-stage kidney disease (ESKD), doubling of serum creatinine, cardiovascular (CV) death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria greater than 300 mg/day.

  Limitations of Use: Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus.

Invokamet XR (canagliflozin/metformin)

• For diagnosis of Type 2 Diabetes
  Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

  Canagliflozin is indicated to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD).

  Canagliflozin is indicated to reduce the risk of end-stage kidney disease (ESKD), doubling of serum creatinine, cardiovascular (CV) death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria greater than 300 mg/day.

  Limitations of Use: Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus.

Invokana (canagliflozin)

• For diagnosis of Type 2 Diabetes
  Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Indicated to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD). Indicated to reduce the risk of end-stage kidney disease (ESKD), doubling of serum creatinine, cardiovascular (CV) death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria greater than 300 mg/day.

  Limitations of use:

  Invokana is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. Not recommended for use to improve glycemic control in adults with type 2 diabetes mellitus with an eGFR less than 30 mL/min/1.73 m 2. INVOKANA is likely to be ineffective in this setting based upon its mechanism of action.

Qtern (dapagliflozin and saxagliptin)

• For diagnosis of Type 2 Diabetes
  Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

  Limitations of Use:

  QTERN is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus

Segluromet (ertugliflozin and metformin)

• For diagnosis of Type 2 Diabetes
  Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

  Limitations of Use:

  Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus.

Steglatro (ertugliflozin)

• For diagnosis of Type 2 Diabetes
  Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

  Limitations of use: Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus

Steglujan (ertugliflozin and sitagliptin)

• For diagnosis of Type 2 Diabetes
  Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

  Limitations of Use: Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. Has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using STEGLUJAN.

Inpefa

• For diagnosis of Heart failure or Type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors
  Indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with: 1) heart failure, or 2) type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors

Criteria

Brand Bexagliflozin, Brenzavvy, Qtern, Segluromet, Steglatro, Steglujan, Invokamet, Invokamet XR, Invokana

Step Therapy

Length of Approval: 12 Month(s)

• Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
AND
• One of the following:
• Trial and failure of a minimum 30-day supply, contraindication, or intolerance to one of the following generics:
• metformin
• metformin ER
• glipizide-metformin
• glyburide-metformin
• pioglitazone-metformin
OR
• Patient has one of the following (Applies to Invokamet, Invokamet XR, and Invokana only):
• History of atherosclerotic cardiovascular disease (ASCVD)
• High risk for ASCVD with multiple risk factors (e.g., obesity, hypertension, smoking, dyslipidemia, albuminuria)
• Established chronic kidney disease (CKD)
• Heart failure
AND
• Trial and failure of a minimum 90 day supply, or intolerance to any one of the following preferred brands:
• Farxiga
• Xigduo XR
AND
• Trial and failure of a minimum 90 day supply, or intolerance to one of the following:
• Glyxambi
• Jardiance
• Synjardy
• Synjardy XR
• Trijardy XR

Inpefa

Step Therapy

Length of Approval: 12 Month(s)

• Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
AND
• Trial and failure of a minimum 90 day supply, contraindication, or intolerance to both of the following:
• Farxiga
• Jardiance

Brand Bexagliflozin, Brenzavvy, Qtern, Segluromet, Steglatro, Steglujan, Invokamet, Invokamet XR, Invokana

Non Formulary

Length of Approval: 12 Month(s)

• Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
AND
• Submission of medical records (e.g., chart notes) or paid claims confirming one of the following:
• Trial and failure of a minimum 30-day supply, contraindication, or intolerance to one of the following generics:
• metformin
• metformin ER
• glipizide-metformin
• glyburide-metformin
• pioglitazone-metformin
OR
• Patient has one of the following (Applies to Invokamet, Invokamet XR, and Invokana only):
• History of atherosclerotic cardiovascular disease (ASCVD)
• High risk for ASCVD with multiple risk factors (e.g., obesity, hypertension, smoking, dyslipidemia, albuminuria)
• Established chronic kidney disease (CKD)
• Heart failure
AND
• Submission of medical records (e.g., chart notes) or paid claims confirming trial and failure of a minimum 90 day supply, or intolerance to any one of the following preferred brands:
• Farxiga
• Xigduo XR
AND
• Submission of medical records (e.g., chart notes) or paid claims confirming trial and failure of a minimum 90 day supply, or intolerance to one of the following:
• Glyxambi
• Jardiance
• Synjardy
• Synjardy XR
• Trijardy XR

Inpefa

Non Formulary

Length of Approval: 12 Month(s)

• Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
AND
• Submission of medical records (e.g., chart notes) or piad claims confirming trial and failure of a minimum 90 day supply, contraindication, or intolerance to both of the following:
• Farxiga
• Jardiance

P & T Revisions

2024-07-11, 2024-04-05, 2024-03-06, 2024-01-16, 2023-12-15, 2023-09-22, 2023-08-22, 2023-08-04, 2023-05-01, 2023-02-09, 2022-07-06, 2022-05-04, 2022-04-27, 2022-04-19, 2021-12-02, 2021-10-22, 2021-08-02, 2021-06-01, 2020-08-07, 2020-06-19, 2020-04-29, 2020-04-29, 2020-01-31, 2019-11-06, 2019-07-25

References

1. Invokana Prescribing Information. Janssen. Titusville, NJ. July 2023.
2. Invokamet Prescribing Information. Janssen. Titusville, NJ. January 2024.
3. Invokamet XR Prescribing information. Janssen Ortho, LLC. Titusville, NJ. January 2024.
4. Qtern Prescribing Information. AstraZeneca Pharmaceuticals LP. Wilmington, DE. September 2023.
5. Segluromet Prescribing Information. Merck & Co., Inc. Whitehouse Station, NJ. June 2024.
6. Steglatro Prescribing Information. Merck & Co., Inc. Whitehouse Station, NJ. June 2024.
7. Steglujan Prescribing Information. Merck & Co., Inc. Whitehouse Station, NJ. June 2024.
8. Yancy CW, Jessup M, Bozkurt B, et al. 2017 ACC/AHA/HFSA focused update of the 2013 ACCF/AHA guideline for the management of heart failure: A report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America. Circulation. 2017;136:e137–e161.
9. Maddox TM, Januzzi JL, Allen LA, et al. 2021 Update to the 2017 ACC Expert Consensus Decision Pathway for Optimization of Heart Failure Treatment: Answers to 10 Pivotal Issues About Heart Failure With Reduced Ejection Fraction. J Am Coll Cardiol. 2021;77 (6): 772–810.
10. Heidenreich PA, Bozkurt B, Aguilar D, et al. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure. Journal of Cardiac Failure. Published online April 2022.
11. Brenzavvy Prescribing Information. TheracosBio, LLC. Marlborough, MA. February 2024.
12. Inpefa Prescribing Information. Lexicon Pharmaceuticals, Inc. The Woodlands, TX. January 2024.

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Revision History

• 2024-07-11: Annual review: No criteria changes. Updated background.
• 2024-04-05: Update to Inpefa t/f requirement
• 2024-03-06: Addition of NF criteria
• 2024-01-16: Updated guideline
• 2023-12-15: Added Inpefa 400 mg to step therapy criteria and added Brand Bexagliflozin to criteria as well.
• 2023-09-22: No criteria changes. Background update.
• 2023-08-22: Addition of Brenzavvy to guideline
• 2023-08-04: Annual review: Updated criteria, removed Jardiance/Farxiga (and combination products) as target drugs from guideline, Added Inpefa criteria, updated references and background. Attached EHB formulary.
• 2023-05-01: Background and references updated for Synjardy/XR new indication
• 2023-02-09: No criteria changes. Updated task note.
• 2022-07-06: Annual review: Updated indications to align with PI, updated references. Updated Jardiance criteria for heart failure section (1.2.2) to allow additional option of heart failure with mildly reduced ejection fraction (new HF type). Background updates.
• 2022-05-04: Addition of FDA approved diagnosis check. Updated Xigduo XR criteria for new indication
• 2022-04-27: Addition of ST criteria for Xigduo XR new HFrEF indication and updated Jardiance criteria; GPI update
• 2022-04-19: Addition of ST criteria for Xigduo XR new HFrEF indication and updated Jardiance criteria
• 2021-12-02: Added Entresto as a ST option for Jardiance and Farxiga HF indication
• 2021-10-22: Added ST criteria for Jardiance new HFrEF indication.
• 2021-08-02: Annual review: updated references, updated indications, updated Farxiga criteria due to new indication
• 2021-06-01: Annual review: updated references, updated indications, updated Farxiga criteria due to new indication
• 2020-08-07: updated verbiage to add day supply requirement
• 2020-06-19: Update Farxiga based on new indication
• 2020-04-29: revised for 7/1 to add Trijardy as a option mirroring glyxambi
• 2020-04-29: New product. Added Trijardy XR indication and ST to mirror Glyxambi: Any one of the following generics: metformin, metformin ER, glipizide-metformin, glyburide-metformin, pioglitazone-metformin.
• 2020-01-31: Update search words
• 2019-11-06: no updates
• 2019-07-25: New QTERN GPI added to policy.

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