Alogliptin-Metformin (Kazano)

Alogliptin-Metformin (Kazano)

SELF ADMINISTRATION - ORAL

Indication for Prior Authorization:

• 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 metformin is appropriate
• Limitations of Use:
  • Kazano 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:

• Kazano should be taken twice daily with food with gradual dose escalation to reduce the gastrointestinal (GI) side effects due to metformin. Kazano tablets must not be split before swallowing
• Maximum recommended daily dose: 25 mg alogliptin and 2000 mg metformin
• Kazano is contraindicated in patients with an estimated glomerular filtration rate (eGFR) below 30
  mL/min/1.73 m² 
• Kazano is not recommended in patients with an eGFR between 30 and 60 mL/min/1.73 m² because
  these patients require a lower daily dosage of alogliptin than what is available in the fixed combination
  Kazano product 

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:

• Kazano is contraindicated in patients with:
  • Severe renal impairment (eGFR below 30 mL/min/1.73 m²)
  • Acute or chronic metabolic acidosis, including diabetic ketoacidosis. Diabetic ketoacidosis should be treated with insulin
  • History of a serious hypersensitivity reaction to alogliptin or metformin, components of Kazano, such as anaphylaxis, angioedema, or severe cutaneous adverse reactions
• Lactic acidosis (black box warning): Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant us e of certain drugs (e.g., carbonic anhydras e inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, and hepatic impairment
• Pancreatitis: Acute pancreatitis has been reported in the postmarketing setting and in randomized clinical trials. If pancreatitis is suspected, alogliptin should promptly be discontinued and appropriate management
  should be initiated
• Heart Failure: Consider the risks and benefits of Kazano 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

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.