ZITUVIO (sitagliptin)

ZITUVIO (sitagliptin)

Self-Administration – oral

Diagnosis considered for coverage:

• T2DM: Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
• Limitations of Use:
  • Zituvio is not recommended in patients with type 1 diabetes mellitus
  • 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

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:

• Recommended dose: 100 mg orally once daily

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:

• Assess renal function prior to initiation of Zituvio and periodically thereafter
• Dosage adjustment is recommended for patients with eGFR less than 45 mL/min/1.73 m2
• Coadministration of Zituvio with an insulin secretagogue (e.g., sulfonylurea) or insulin may require lower doses of the insulin secretagogue or insulin to reduce the risk of hypoglycemia

Policy Updates:

• 03/25/2024 – New policy approved by WHA P&T Committee. (P&T vote, 03/25/2024) 

References:

• Zituvio Prescribing Information. Zydus Lifesciences Limited, Pharmez, Matoda, Amedabad, India. November 2023.