Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Prediabetes.
Treatment: Ozempic (0.25 or 0.5 milligrams [mg]/dose) 2 mg/1.5 milliliters (ml) subcutaneous (SC) solution pen-injector (SOPN).

The insurer denied coverage for Ozempic (0.25 or 0.5 mg/dose) 2 mg/1.5 ml SC SOPN.  The denial is upheld.

This is an adult female with a diagnosis of obesity and prediabetes. She is status post gastric bypass surgery. She is intolerant of Metformin. Her body mass index (BMI) is 34.33 kg/m2 (kilograms per square meter). Ozempic is being requested.

Ozempic is neither Food and Drug Administration (FDA) approved nor recommended by current medical literature for use in patients without type 2 diabetes mellitus. This patient has obesity and prediabetes but no documented diagnosis of type 2 diabetes mellitus. Therefore, the request for Ozempic (0.25 or 0.5 milligrams [mg]/dose) 2 mg/1.5 milliliters [ml] subcutaneous (SC) solution pen-injector (SOPN) is not considered medically necessary for this patient.

American Diabetes Association Professional Practice Committee; American Diabetes Association Professional Practice Committee: "There are now multiple large randomized controlled trials reporting statistically significant reductions in cardiovascular events in patients with type 2 diabetes treated with an SGLT2 [sodium-glucose cotransporter-2] inhibitor or GLP-1 RA [glucagon-liked peptide-1 receptor]; see Section 10, "cardiovascular disease and Risk Management" (https://doi.org/10.2337/dc22-S010) for details. Subjects enrolled in many of the cardiovascular outcome's trials had A1C [glycated hemoglobin] 6.5% [percent], with more than 70% taking metformin at baseline. Thus, a practical extension of these results to clinical practice is to use these drugs preferentially in patients with type 2 diabetes and established arteriosclerotic cardiovascular disease (ASCVD) or indicators of high ASCVD risk. For these patients, incorporating one of the SGLT2 inhibitors and/or GLP-1 RAs that have been demonstrated to have cardiovascular disease benefit is recommended (Table 9.2, Fig. 9.3, and Section 10, "cardiovascular disease and Risk Management," https://doi.org/10.2337/dc22-S010). Emerging data suggest that use of both classes of drugs will provide additional cardiovascular and kidney outcomes benefit; thus, combination therapy with an SGLT2 inhibitor and a GLP-1 RA may be considered to provide the complementary outcomes benefits associated with these classes of medication (74). In cardiovascular outcomes trials, empagliflozin, canagliflozin, dapagliflozin, liraglutide, semaglutide, and dulaglutide all had beneficial effects on indices of CKD [chronic kidney disease], while dedicated renal outcomes studies have demonstrated benefit of specific SGLT2 inhibitors. See Section 11, "chronic kidney disease and Risk Management" (https://doi.org/10.2337/dc22-S011) for discussion of how CKD may impact treatment choices. Additional large, randomized trials of other agents in these classes are ongoing."

The health plan acted reasonably, with sound medical judgment, and in the best interest of the patient.

The insurer's denial of coverage for the Ozempic (0.25 or 0.5 mg/dose) 2 mg/1.5 ml SC SOPN is upheld. Medical necessity is not substantiated.