Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Body mass index (BMI) of 61.7
Treatment: Wegovy 0.25mg/0.5 Injector
The insurer denied: Wegovy 0.25mg/0.5 Injector
The denial is upheld.

The patient is an adult male with a body mass index (BMI) of 61.7 3 months ago. His glycated hemoglobin (HbA1c) was 6.1% (percent) four months ago and 5.7% two years ago. He is requesting a Wegovy (semaglutide) 0.25 milligrams (mg) / 0.5 milliliters (mL) injector. A review of records indicates that three months ago the patient was evaluated for blurry vision. His body mass index was reported as 61.8. The Provider commented that Wegovy can improve his body mass index and positively impact his obstructive sleep apnea (OSA) treatment options. She further commented: "Unfortunately morbid obesity would be prohibitive to him pursuing other treatments for sleep apnea like the hypoglossal nerve stimulator."
The health plan wrote to the patient that the request for Wegovy 0.25 milligrams / 0.5 milliliters (mL) injector was denied, in part, because of the shortage of various doses needed to ramp up to the 2.4-milligram dose. It also mentioned the requirement to enroll in a weight management program for at least three months. However, no additional clinical information was provided. 

The requested health service is not medically necessary.

A review of the medical literature indicates that per the United States Food and Drug Administration (FDA) approval, Wegovy is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index of 30 kilograms per meter squared (kg/m2) or greater (obesity) or a body mass index of 27 kilograms per meter squared (kg/m2) or greater (overweight) in the presence of at least one weight-related comorbid condition 
(e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia).
A randomized controlled trial reported that the mean change in body weight from baseline to week 68 was 14.9% in the semaglutide group as compared with 2.4% with placebo, for an estimated treatment difference of 12.4 percentage points (95% confidence interval [CI], 13.4 to 11.5; P< (less than)0.001). More participants in the semaglutide group than in the placebo group achieved weight reductions of 5% or more (1047 participants [86.4%] versus 182 [31.5%]), 10% or more (838 [69.1%] versus 69 [12.0%]), and 15% or more (612 [50.5%] versus 28 [4.9%]) at week 68 
(P<0.001 for all three comparisons of odds). The change in body weight from baseline to week 68 was 15.3 kilograms in the semaglutide group as compared with 2.6 kilograms in the placebo group (estimated treatment difference, 12.7 kilograms; 95% CI, 13.7 to 11.7). Participants who received semaglutide had a greater improvement concerning cardiometabolic risk factors and a greater increase in participant-reported physical functioning from baseline than those who received a placebo. The study concluded: "In participants with overweight or obesity, 2.4 mg of semaglutide once weekly plus lifestyle intervention was associated with sustained, clinically relevant reduction in body weight." Other studies on semaglutide, mostly on diabetic patients, support similar findings.
The review of medical literature indicates that the use of Wegovy/semaglutide is best achieved with a concurrent weight management program. There is no documentation of a weight management program for this patient. The medical literature also supports that the plan rationale regarding the effective dose of Wegovy/Semaglutide is 2.4 milligrams. The requested dose is lower than the recommended dose. Therefore, the requested health service is not medically necessary.