Appeal type: Medical necessity
Decision: Overturned

Diagnosis: morbid obesity

Treatment: Wegovy injection 2.4 milligrams

The insurer is denied coverage for Wegovy injection 2.4 milligrams

The denial is overturned. 

This male patient has a history of morbid obesity, hypothyroidism, hypertension, hypercholesterolemia and type 2 diabetes mellitus.

According to Perreault, "a number of medications are approved by the US Food and Drug Administration (FDA) for the treatment of overweight or obesity. It is essential that the medications are used in conjunction with healthy eating, physical activity, and behavior modification, as medication usage without such changes are generally ineffective. UpToDate notes that candidates for drug therapy include those individuals with a body mass index (BMI) >=30 or a BMI of 27 to 29.9 with weight-related comorbidities, who have not met weight-loss goals (loss of at least 5 percent of total body weight at three to six months) with a comprehensive lifestyle intervention alone. It was also noted that single agents are preferred over combination medications as initial pharmacotherapy. Semaglutide, another Glucagon-like peptide 1 (GLP-1) agonist approved for the treatment of obesity, is administered as a once weekly subcutaneous injection. It has demonstrated efficacy in weight reduction, as well improvement in glycemia and lipids. Similar to liraglutide, the FDA-approved dose for type 2 diabetes has also demonstrated cardiovascular benefits, with the exception of individuals with a history of heart failure. UpToDate noted that the GLP-1 receptor agonists are approved for the treatment of obesity in the United States and include semaglutide and liraglutide. For patients with or without diabetes mellitus, the authors suggested these agents as preferred first-line pharmacotherapy for the treatment of obesity. For patients with diabetes in particular, the side effects, need for injections, and expense are balanced by improved glycemia and weight loss. The author notes that they prefer treatment with semaglutide rather than liraglutide; administration of semaglutide is once weekly rather than once daily, and although there are no trials directly comparing the two agents, semaglutide may have slightly greater efficacy for weight loss than liraglutide. "Semaglutide has demonstrated efficacy in weight loss in trials involving patients with type 2 diabetes. In the United States, both the oral and injectable preparations are approved for the treatment of type 2 diabetes, whereas only the injectable form is approved for the treatment of obesity." UpToDate noted several trails including: "STEP 1, a randomized controlled trial including 1961 adults without diabetes and a BMI of >=30 kg/m2 (or >=27 with >=1 weight-related comorbidity), participants were randomly assigned to 68 weeks of treatment with once-weekly subcutaneous 2.4 mg semaglutide or placebo, plus lifestyle intervention. Mean weight loss was greater in the semaglutide group compared with placebo (-15.3 versus -2.6 kg: estimated treatment difference -12.7 kg, 95% CI[chloride] -13.7 to -11.7). More participants in the semaglutide group achieved a weight reduction of >=5 percent (86.4 versus 31.5 percent), >=10 percent (69.1 versus 12.0 percent), and >=15 percent (50.5 versus 4.9 percent) compared with placebo. More participants in the semaglutide group discontinued treatment due to gastrointestinal side effects compared with those in the placebo group (4.5 versus 0.8 percent)."  

The health plan did not act reasonably with sound medical judgment, and in the best interest of the patient.

The carrier's denial of coverage for Wegovy injection 2.4 milligrams is overturned.  The medical necessity is substantiated.