Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Obesity.

Treatment: Ozempic 0.25 or 0.5 pen injector.

The insurer denied coverage for Ozempic 0.25 or 0.5 pen injector.

The denial is overturned.

The medical records indicate the patient has a diagnosis of Type 2 Diabetes with Nephropathy, Hypertension (HTN) and Obesity. The patient has tried and failed treatment with Metformin, in the past, but had to stop the medication due to renal insufficiency and diarrhea. The patient also failed treatment with Trulicity. The patient's Hemoglobin A1c was 6.1%. 

The patient has a long history of Type 2 Diabetes and Obesity. The patient has tried and failed treatment with Metformin and Trulicity with side effects noted. The patient underwent gastric surgery; however, the patient has since gained some of their weight back. The patient reports that they have participated in exercise programs and eats a Keto diet. The provider is requesting approval for treatment with Ozempic which is Food and Drug Administration (FDA) approved for the treatment of those with Type 2 Diabetes. As such, the request for Ozempic is medically necessary for this patient. 

"The prevalence of type 2 diabetes is increasing worldwide; 31 and 60 million adults live with type 2 diabetes in the United States of America (USA) and Europe, respectively. India has 77 million people with diabetes mellitus (DM); currently India has the second highest number of diabetes cases in the world preceded only by China. Type 2 diabetes mellitus (T2D) is a complex and progressive disease associated with significant morbidity and mortality; four million deaths worldwide are attributable to diabetes, with half of these in people aged under 60 years. The risk of death among people with diabetes (aged 20-59 years) is at least double that in those without diabetes. A key factor underlying the global rise in diabetes is the increasing prevalence of obesity, which is a significant risk factor for diabetes. Cell resistance to glucagon-like peptide 1 (GLP-1) contributes to progressive failure in the function of cells. The incretin effect is significantly impaired in people with T2D, greatly reducing the capacity for insulin release in response to food intake. Incretin-based therapies work either by preventing enzymatic degradation of GLP-1, thus maintaining plasma levels of endogenous GLP-1 (dipeptidyl peptidase 4 inhibitors, (DPP4is)) or by directly activating GLP-1 receptors and mimicking the action of native GLP-1 (glucagon-like peptide-1 receptor agonists, (GLP-1 RAs)). GLP-1 RAs are preferred second-line agents in patients with T2D with established atherosclerotic cardiovascular diseases (ASCVD) in light of their demonstrated ASCVD benefit, high efficacy, low potential for hypoglycemia and potential for weight loss. More recently, the European Society of Cardiology (ESC) has deemed GLP-1 RAs to be the first-line therapy for cardiovascular risk reduction in patients with T2D with very high/high risk" (Kalra, S. & Sahay, R. 2020).

According to the Food and Drug Administration (FDA) Prescribing Label for Ozempic, "OZEMPIC is a glucagon-like peptide 1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus."

"Conclusions: In participants with overweight or obesity, 2.4 milligrams (mg) of semaglutide once weekly plus lifestyle intervention was associated with sustained, clinically relevant reduction in body weight" (Wilding, J. P. H., et al., 2021).                                                         

Based on the above, the insurer's denial must be reversed. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient.

The medical necessity for Ozempic 0.25 or 0.5 pen injector is substantiated.