ONGLYZA (saxagliptin)

ONGLYZA (saxagliptin)

SELF ADMINISTRATION – ORAL

Indication for Prior Authorization:

• Onglyza® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
• Limitations of Use:
  • Onglyza® is not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings

Coverage Criteria:

• Patient has a documented diagnosis of type 2 diabetes mellitus, AND
• Patient has experienced an inadequate response, contraindication, or intolerable side effect to two different preferred agents (e.g. Januvia®, Janumet®/XR, Jentadueto®/XR, and Tradjenta®) used for at least 3 months each

Dosing:

• Recommended dosage: 2.5 mg or 5 mg once daily. Onglyza® tablets must not be split or cut
• eGFR <45mL/min/1.73 m²: 2.5 mg once daily
• Coadministered with strong CYP3A4/5 inhibitors: 2.5 mg once daily

Coverage Duration:

• Initial: 1 year
• Reauthorization: 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 Committee.

Additional Information:

• Pancreatitis: There have been postmarketing reports of acute pancreatitis in patients taking Onglyza®. If pancreatitis is suspected, promptly discontinue Onglyza® and initiate appropriate management. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using Onglyza® 
• Heart Failure: Consider the risks and benefits of Onglyza® prior to initiating treatment in patients at a higher risk for heart failure
• Additional warnings for severe and disabling arthralgia and bullous pemphigoid

Review History:

• 8/18/20- Original review

References:

• (American Diabetes Association [ADA] 2020b, Garber et al 2020). (ADA 2020b, Deacon et al 2016, Garber et al 2020, Dungan 2017).
• OptumRX Therapeutic Class Overview – Dipeptidyl Peptidase-4 (DPP-4) Inhibitors.  Publication Date:  April 1, 2020. 
• Dungan K, DeSantis A. Dipeptidyl Peptidase 4 (DPP-4) Inhibitors for the Treatment of Type 2 Diabetes Mellitus. UpToDate; 2020.