Alogliptin (Nesina)

Alogliptin (Nesina)

SELF ADMINISTRATION – ORAL

Indication for Prior Authorization:

• Nesina is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
• Limitations of Use:
  • Nesina 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 dose: 25 mg once daily
• Moderate renal impairment (CrCl ≥30 to <60 mL/min): 12.5 mg once daily 
• Severe renal impairment (CrCl ≥15 to <30 mL/min) or with end-stage renal disease (ESRD) (CrCl <15 mL/min or requiring hemodialysis): 6.25 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: Acute pancreatitis has been reported in the postmarketing setting and in randomized clinical trials. If pancreatitis is suspected, Nesina should promptly be discontinued and appropriate management should be initiated
• Heart Failure: Consider the risks and benefits of Nesina prior to initiating treatment in patients at risk for heart failure, such as those with a prior history of heart failure and a history of renal impairment, and observe these patients for signs and symptoms of heart failure during therapy
• Hepatic Effects: if the patient is found to have clinically significant liver enzyme elevations and if abnormal liver tests persist or worsen, Nesina should be interrupted and investigation done to establish the probable cause. Nesina should not be restarted in these patients without another explanation for the liver test
  abnormalities 
•  Severe and Disabling Arthralgia: There have been postmarketing reports of severe and disabling arthralgia in patients taking DPP-4 inhibitors. The time to onset of symptoms following initiation of drug therapy varied from one day to years. Patients experienced relief of symptoms upon discontinuation of the medication
• Bullous Pemphigoid: Postmarketing cases of bullous pemphigoid requiring hospitalization have been reported with DPP-4 inhibitor use

Review History:

• 8/18/2020 – 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.