WHA

DPP-4 Inhibitors - ST, NF

Indications for Prior Authorization

Brynovin (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) BRYNOVIN is not recommended in patients with type 1 diabetes. 2) BRYNOVIN has not been studied in patients with a history of pancreatitis.

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.

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.

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.

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.

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

Brynovin, 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
  • One of the following:
    • Both of the following:
      • Trial and failure of a minimum 90 day supply, intolerance, or contraindication to any one of the following preferred brands:
        • Janumet
        • Janumet XR
        • Januvia
        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
      OR
    • Patient is unable to swallow a solid dosage form (e.g., oral tablet, capsule) due to one of the following (applies to Brynovin only) [A]:
      • Age
      • Physical impairment (e.g., difficulties with motor or oral coordination)
      • Dysphagia
      • Patient is using a feeding tube or nasal gastric tube
Brynovin, 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
  • One of the following:
    • Both of the following:
      • 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:
        • Janumet
        • Janumet XR
        • Januvia
        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
      OR
    • Submission of medical records confirming patient is unable to swallow a solid dosage form (e.g., oral tablet, capsule) due to one of the following (applies to Brynovin only) [A]:
      • Age
      • Physical impairment (e.g., difficulties with motor or oral coordination)
      • Dysphagia
      • Patient is using a feeding tube or nasal gastric tube

  • Guideline ID
    GL-404192

  • Formulary
    Premium

  • Effective date
    Oct 1, 2025

  • P&T approval date
    Feb 20, 2007

P & T Revisions

2025-09-24, 2025-08-28, 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

  1. Onglyza Prescribing Information. AstraZeneca Pharmaceuticals LP. Wilmington, DE. October 2024.
  2. Oseni Prescribing Information. Takeda Pharmaceuticals America, Inc. Lexington, MA. February 2025.
  3. Kazano Prescribing Information. Takeda Pharmaceuticals America, Inc. Lexington, MA. February 2025.
  4. Nesina Prescribing Information. Takeda Pharmaceuticals America, Inc. Lexington, MA. October 2024.
  5. Kombiglyze XR Prescribing Information. AstraZeneca Pharmaceuticals LP. Wilmington, DE. October 2024.
  6. Zituvio Prescribing Information. Zydus Lifesciences Limited, Pharmez, Matoda, Amedabad, India. January 2025.
  7. Zituvimet Prescribing Information. Zydus Lifesciences Limited, Pharmez, Matoda, Amedabad, India. June 2025.
  8. Zituvimet XR Prescribing Information. Zydus Lifesciences Limited, Pharmez, Matoda, Amedabad, India. July 2024.
  9. Brynovin Prescribing Information. Azurity Pharmaceuticals, Inc. Woburn, MA. January 2025.
  1. Metformin immediate release is available as an oral solution as well as an oral tablet, which may be crushed for administration. Jentadueto XR and Janumet XR should not be crushed/dissolved, and labeling for Tradjenta and Januvia do not clearly specify the products can be crushed/dissolved.
  • 2025-09-24: Update to incorporate Annual review 2025 background revisions.
  • 2025-08-28: Addition of Brynovin to guideline. Addition of criterion to both ST/NF (applies to Brynovin only, as the only oral DPP-4 solution in guideline) to allow for bypass of trial requirements of BOTH preferred brands (i.e., Januvia family AND Tradjenta family) if patient is unable to swallow solid oral dosage forms.
  • 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