WHA

Dipeptidyl Peptidase 4 (DPP-4) Inhibitors (KAZANO, Brand ALOGLIPTIN/METFORMIN, Brand KOMBIGLYZE XR, Generic saxagliptin/metformin ER, NESINA, ALOGLIPTIN, Brand ONGLYZA, Generic saxagliptin, OSENI, ALOGLIPTIN/PIOGLITAZONE, ZITUVIO, Brand Sitagliptin/Metformin)

Self-Administration – oral

Preferred agents: Januvia, Janumet, Janumet XR, Jentadueto, Jentadueto XR, Tradjenta

Diagnosis considered for coverage:

KAZANO, ALOGLIPTIN/METFORMIN

  • T2DM: Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus 

KOMBIGLYZE XR, saxagliptin/metformin ER

  • T2DM: 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

NESINA, ALOGLIPTIN

  • T2DM: Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

ONGLYZA, saxagliptin

  • T2DM: Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

OSENI, ALOGLIPTIN/PIOGLITAZONE

  • T2DM: Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

ZITUVIO

  • T2DM: Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

Brand Sitagliptin/Metformin

  • T2DM: Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
Coverage Criteria:

For diagnosis of T2DM:

  • 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
Dosing:

T2DM:

  • Alogliptin and metformin formulations: 
    • Maximum daily dose: 25 mg alogliptin and 2,000 mg metformin hydrochloride
    • Kazano should be taken orally twice daily
  • Saxagliptin and metformin formulations: 
    • Maximum daily dose: 5 mg for saxagliptin and 2,000 mg for metformin extended-release
  • Alogliptin formulations: 
    • 25 mg taken once daily
  • Saxagliptin formulations: 
    • 5 mg once daily
  • Alogliptin and pioglitazone formulations: 
    • Maximum daily dose: 25 mg/45 mg once daily
  • Zituvio: 
    • 100 mg once daily
  • Sitagliptin and metformin formulations:
    • Maximum: 100 mg sitagliptin and 2,000 mg metformin 
       
Coverage Duration: 
  • 1 year
Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 
  • Not recommended for use in patients with type 1 diabetes mellitus
  • Onglyza is not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings
  • Zituvio 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 
Policy Updates:
  • Effective 6/1/2024 – New combined policy for non-preferred dipeptidyl peptidase 4 (DPP-4) inhibitors approved by WHA P&T Committee. (P&T, 5/21/2024) 
  • 09/01/2024 – Addition of Brand Sitagliptin/Metformin ABA product (P&T 8/20/2024) (P&T Meeting August)
References:
  1. Januvia Prescribing Information. Merck & Co., Inc. Whitehouse Station, NJ. July 2022. 
  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. April 2022. 
  5. Janumet XR Prescribing Information. Merck & Co., Inc. Whitehouse Station, NJ. July 2022. 
  6. Jentadueto Prescribing Information. Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT. April 2022. 
  7. Jentadueto XR Prescribing Information. Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT. October 2021. 
  8. Oseni Prescribing Information. Takeda Pharmaceuticals America, Inc. Lexington, MA. March 2022. 
  9. Kazano Prescribing Information. Takeda Pharmaceuticals America, Inc. Lexington, MA. March 2022. 
  10. Nesina Prescribing Information. Takeda Pharmaceuticals America, Inc. Lexington, MA. March 2022. 
  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. July 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. 

Last review date: September 1, 2024