Pharmacy Prior Authorization Criteria

DPP-4 Inhibitors - ST, NF

Indications for Prior Authorization

Zituvimet (sitagliptin/metformin), Zituvimet XR (sitagliptin/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: 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.

Onglyza (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: Not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.

Kazano (alogliptin/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 in patients with type 1 diabetes mellitus.

Kombiglyze XR (saxagliptin/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 when treatment with both saxagliptin and metformin is appropriate. Limitations of use: Not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.

Nesina (alogliptin)

• 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 in patients with type 1 diabetes.

Oseni (alogliptin/pioglitazone)

• 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: Should not be used in patients with type 1 diabetes mellitus.

Zituvio (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) 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 increased risk for the development of pancreatitis while using ZITUVIO.

Criteria

Kazano, Brand Alogliptin/Metformin, Brand Kombiglyze XR, Nesina, Alogliptin, Brand Onglyza, Oseni, Alogliptin/Pioglitazone, Zituvio, Brand Sitagliptin, Brand Sitagliptin/Metformin, Zituvimet, Zituvimet XR

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, intolerance, or contraindication to one of the following generics:
• metformin
• metformin ER
• glipizide-metformin
• glyburide-metformin
• pioglitazone-metformin
AND
• Trial and failure of a minimum 90 day supply, intolerance, or contraindication to any one of the following preferred brands:
• Januvia
• Janumet
• Janumet XR
AND
• Trial and failure of a minimum 90 day supply, intolerance, or contraindication to any one of the following preferred brands:
• Jentadueto
• Jentadueto XR
• Tradjenta

Kazano, Brand Alogliptin/Metformin, Brand Kombiglyze XR, Nesina, Alogliptin, Brand Onglyza, Oseni, Alogliptin/Pioglitazone, Zituvio, Brand Sitagliptin

Non Formulary

Length of Approval: 12 Month(s)

• Submission of medical records (e.g., chart notes) confirming 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 trial and failure of a minimum 30 day supply, intolerance, or contraindication to one of the following generics:
• metformin
• metformin ER
• glipizide-metformin
• glyburide-metformin
• pioglitazone-metformin
AND
• Submission of medical records (e.g., chart notes) or paid claims confirming trial and failure of a minimum 90 day supply, intolerance, or contraindication to any one of the following preferred brands:
• Januvia
• Janumet
• Janumet XR
AND
• Submission of medical records (e.g., chart notes) or paid claims confirming trial and failure of a minimum 90 day supply, intolerance, or contraindication to any one of the following preferred brands:
• Jentadueto
• Jentadueto XR
• Tradjenta

P & T Revisions

2025-03-05, 2024-11-05, 2024-07-31, 2024-06-19, 2024-05-01, 2024-02-01, 2023-10-06, 2023-09-01, 2023-06-07, 2022-06-17, 2021-08-02, 2021-05-21, 2020-08-07, 2020-04-29

References

1. Onglyza Prescribing Information. AstraZeneca Pharmaceuticals LP. Wilmington, DE. October 2019.
2. Oseni Prescribing Information. Takeda Pharmaceuticals America, Inc. Lexington, MA. December 2023.
3. Kazano Prescribing Information. Takeda Pharmaceuticals America, Inc. Lexington, MA. July 2023.
4. Nesina Prescribing Information. Takeda Pharmaceuticals America, Inc. Lexington, MA. July 2023.
5. Kombiglyze XR Prescribing Information. AstraZeneca Pharmaceuticals LP. Wilmington, DE. October 2019.
6. Zituvio Prescribing Information. Zydus Lifesciences Limited, Pharmez, Matoda, Amedabad, India. November 2023.
7. Zituvimet Prescribing Information. Zydus Lifesciences Limited, Pharmez, Matoda, Amedabad, India. July 2024.
8. Zituvimet XR Prescribing Information. Zydus Lifesciences Limited, Pharmez, Matoda, Amedabad, India. July 2024.

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Revision History

• 2025-03-05: Removed Januvia/Tradjenta family and generic saxagliptin/combo as target drugs from guideline
• 2024-11-05: Addition of Zituvimet/XR as target drugs.
• 2024-07-31: Addition of Brand Sitagliptin/Metformin
• 2024-06-19: Annual review: Added drug-specific NF criteria for Kazano, Brand alogliptin-metformin, Brand Kombiglyze XR, Nesina, Alogliptan, Brand Onglyza, Oseni, Alogliptan/Pioglitazone, Zituvio, Brand Sitagliptan as they are excluded on premium formulary. Updated GL name to include “-ST, NF.” Updated references and background.
• 2024-05-01: Addition of Brand Sitagliptin (ABA for Zituvio)
• 2024-02-01: Added Zituvio as target to guideline
• 2023-10-06: Added generic Kombiglyze to guideline
• 2023-09-01: added generic Onglyza and Kombiglyze XR to clinical criteria
• 2023-06-07: Annual review: Updated trial and failure verbiage to include "contraindication" where applicable. Updated background.
• 2022-06-17: Annual review: Added criterion "Requested drug is being used for a Food and Drug Administration (FDA)-approved indication."
• 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
• 2020-08-07: updated verbiage and step therapies
• 2020-04-29: annual review no changes

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