Pharmacy Prior Authorization Criteria

DPP-4 Inhibitors

Indications for Prior Authorization

Janumet (sitagliptin/metformin), Janumet XR (sitagliptin/metformin extended-release)

• 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: 1) Should not be used in patients with type 1 diabetes mellitus, 2) 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 JANUMET.

Januvia (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: 1) Januvia should not be used in patients with type 1 diabetes, 2) Januvia 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 JANUVIA.

Tradjenta (linagliptin)

• 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: 1) Not recommended in patients with type 1 diabetes mellitus as it would not be effective., 2) Has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using TRADJENTA.

Jentadueto (linagliptin/metformin), Jentadueto XR (linagliptin/metformin extended-release)

• 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: 1) Not recommended in patients with type 1 diabetes mellitus., 2) Has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using JENTADUETO.

Criteria

Janumet, Janumet XR, Januvia, Jentadueto, Jentadueto XR, Tradjenta

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 30 day supply, contraindication, or intolerance to generic metformin

P & T Revisions

2024-06-06, 2023-06-07, 2022-06-17, 2021-08-02, 2021-05-21, 2020-04-29

References

1. Janumet Prescribing Information. Merck & Co., Inc. Whitehouse Station, NJ. July 2022.
2. Janumet XR Prescribing Information. Merck & Co., Inc. Whitehouse Station, NJ. July 2022.
3. Januvia Prescribing Information. Merck & Co., Inc. Whitehouse Station, NJ. July 2023.
4. Jentadueto Prescribing Information. Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT. June 2023.
5. Jentadueto XR Prescribing Information. Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT. June 2023.
6. Tradjenta Prescribing Information. Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT. June 2023.

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Revision History

• 2024-06-06: Annual review: No criteria changes. Updated references and background.
• 2023-06-07: Annual review: Removed metformin ER, glipizide-metformin, glyburide-metformin, pioglitazone-metformin as trial options. Updated trial and failure verbiage to include trial duration of 30 days.
• 2022-06-17: Added criterion "Requested drug is being used for a Food and Drug Administration (FDA)-approved indication." Cosmetic update to guideline name.
• 2021-08-02: Annual review: Updated indications, references, no changes to criteria/clinical intent
• 2021-05-21: Annual review: Updated indications, references, no changes to criteria/clinical intent
• 2020-04-29: annual review no changes to clinical criteria

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