Alogliptin and Pioglitazone (Oseni)

Alogliptin and Pioglitazone (Oseni)

SELF ADMINISTRATION – ORAL

Indication for Prior Authorization:

• Oseni is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both alogliptin and pioglitazone is appropriate
• Limitations of Use:
  • Oseni 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:

• Oseni should be taken once daily. The tablets must not be split before swallowing
• The recommended starting dose should be individualized
  • For patients with congestive heart failure (NYHA Class I or II): 25 mg/15 mg
• Moderate renal impairment (CrCl ≥30 to <60 mL/min): 12.5 mg/15 mg, 12.5 mg/30 mg, or 12.5 mg/45 mg once daily
• Severe renal impairment or ESRD: not recommended
• Maximum dose: 25 mg/45 mg once daily
  • Maximum recommended dose of Oseni is 25 mg/15 mg daily when used in combination with gemfibrozil or other strong CYP2C8 inhibitors

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:

• Congestive Heart Failure (black box warning): Do not initiate in patients with NYHA Class III or IV heart failure. Oseni is not recommended in patients with symptomatic heart failure
• Pancreatitis: It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Oseni. If pancreatitis is suspected, Oseni should promptly be discontinued and appropriate management should be initiated
• Hepatic Effects: There have been postmarketing reports of fatal and nonfatal hepatic failure in patients taking pioglitazone or alogliptin, although some of the reports contain insufficient information necessary to
  establish the probable cause. Oseni should not be restarted in these patients without another explanation for the liver test abnormalities
• Edema: Oseni should be used with caution in patients with edema
• Fractures: The risk of fracture should be considered in the care of patients, especially female patients, treated with pioglitazone and attention should be given to assessing and maintaining bone health according to current standards of care
• Urinary Bladder Tumors: Oseni should not be used in patients with active bladder cancer and the benefits of glycemic control versus unknown risks for cancer recurrence with Oseni should be considered in patients with a prior history of bladder cancer
• Additional warnings for: macular edema, 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.