
201906-117935
2019
Fidelis Care New York
Medicaid
Endocrine/ Metabolic/ Nutritional
Pharmacy/ Prescription Drugs
Medical necessity
Overturned
Case Summary
Diagnosis: Diabetes
Issue under review: Jardiance
Determination:
Jardiance is medically necessary.
This patient has uncontrolled type 2 diabetes with hyperglycemia-related complications, as manifested by a history of a right first toe amputation. This patient has tried, and is currently on, insulin therapy, metformin, and dipeptidyl peptidase 4 inhibitor therapy. The use of Jardiance in this clinical situation is supported by the American Diabetes Association clinical guidelines.
Steglatro is the formulary alternative. Steglatro is also in the class of sodium glucose co-transporter-2 inhibitors. Steglatro has not been shown in a randomized clinical trial to reduce the risk of cardiovascular events or risk of death from a cardiovascular event, whereas in a study of 7.020 patients, Jardiance reduced the primary composite outcome of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke as compared to placebo [1].
This patient has uncontrolled type 2 diabetes, which is a significant risk factor for cardiovascular disease [2]. A cardiovascular event could be life-threatening. Therefore, yes, the proposed treatment is medically necessary.