WHA

KOMBIGLYZE XR (saxagliptin and metformin hydrochloride, extended release)

SELF ADMINISTRATION - ORAL

Indication for Prior Authorization:
  • KOMBIGLYZE XR® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate
Limitations of use:
  • KOMBIGLYZE XR® is not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.
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:
  • KOMBIGLYZE XR should generally be administered once daily with the evening meal, with gradual dose titration to reduce the gastrointestinal side effects associated with metformin.
  • Max dose per day: 2,000 mg of metformin; 5 mg of saxagliptan.
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:
  • KOMBIGLYZE XR is contraindicated in patients with:
    • Severe renal impairment (eGFR below 30 mL/min/1.73 m2).
    • Hypersensitivity to metformin hydrochloride.
    • Acute or chronic metabolic acidosis, including diabetic ketoacidosis. Diabetic ketoacidosis should be treated with insulin.
    • History of a serious hypersensitivity reaction to KOMBIGLYZE XR or saxagliptin, such as anaphylaxis, angioedema, or exfoliative skin conditions
    • Lactic acidosis
Review History:
  • 8/18/20-Original Review
References:

  • Buse JB, Wexler DJ, Tsapas A, Rossing P, Mingrone G, Mathieu C, D’Alessio DA, Davies MJ. 2019 update to: management of hyperglycemia in type 2 diabetes, 2018. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2020 Feb 1;43(2):487-93.

  • Deacon CF, Lebovitz HE. Comparative review of dipeptidyl peptidase?4 inhibitors and sulphonylureas. Diabetes, Obesity and Metabolism. 2016 Apr;18(4):333-47.

  • Dungan K, DeSantis A. Dipeptidyl Peptidase 4 (DPP-4) Inhibitors for the Treatment of Type 2 Diabetes Mellitus. UpToDate; 2020.

  • Garber AJ, Handelsman Y, Grunberger G, Einhorn D, Abrahamson MJ, Barzilay JI, Blonde L, Bush MA, DeFronzo RA, Garber JR, Garvey WT. Consensus statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the comprehensive type 2 diabetes management algorithm–2020 executive summary. Endocrine Practice. 2020 Jan;26(1):107-39.

  • OptumRX Therapeutic Class Overview – Dipeptidyl Peptidase-4 (DPP-4) Inhibitors.  Publication Date:  April 1, 2020.