Pharmacy Prior Authorization Criteria

DPP-4 Inhibitors - ST, NF

Indications for Prior Authorization

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

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.

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.

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.

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

Januvia, Janumet, Janumet XR, 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, intolerance, or contraindication to one of the following generics:
• metformin
• metformin ER
• glipizide-metformin
• glyburide-metformin
• pioglitazone-metformin

Kazano, Brand Alogliptin/Metformin, Brand Kombiglyze XR , Generic saxagliptin/metformin ER, Nesina, Alogliptin, Brand Onglyza, Generic saxagliptin, 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

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. Januvia Prescribing Information. Merck & Co., Inc. Whitehouse Station, NJ. July 2023.
2. Janumet Prescribing Information. Merck & Co., Inc. Whitehouse Station, NJ. July 2022.
3. Onglyza Prescribing Information. AstraZeneca Pharmaceuticals LP. Wilmington, DE. October 2019.
4. Tradjenta Prescribing Information. Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT. June 2023.
5. Janumet XR Prescribing Information. Merck & Co., Inc. Whitehouse Station, NJ. July 2022.
6. Jentadueto Prescribing Information. Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT. June 2023.
7. Jentadueto XR Prescribing Information. Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT. June 2023.
8. Oseni Prescribing Information. Takeda Pharmaceuticals America, Inc. Lexington, MA. December 2023.
9. Kazano Prescribing Information. Takeda Pharmaceuticals America, Inc. Lexington, MA. July 2023.
10. Nesina Prescribing Information. Takeda Pharmaceuticals America, Inc. Lexington, MA. July 2023.
11. Kombiglyze XR Prescribing Information. AstraZeneca Pharmaceuticals LP. Wilmington, DE. October 2019.
12. Saxaglipitin hydrochloride/metformin hydrochloride ER Prescribing Information . Dr. Reddys Laboratories Princeton, NJ. January 2023
13. Saxaglipitin hydrochloride/metformin hydrochloride ER Prescribing Information . Aurobindo Pharma USA, Inc. East Windsor, NJ. April 2023
14. Zituvio Prescribing Information. Zydus Lifesciences Limited, Pharmez, Matoda, Amedabad, India. November 2023.
15. Zituvimet Prescribing Information. Zydus Lifesciences Limited, Pharmez, Matoda, Amedabad, India. July 2024.
16. Zituvimet XR Prescribing Information. Zydus Lifesciences Limited, Pharmez, Matoda, Amedabad, India. July 2024.

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Revision History

• 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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