Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Morbid obesity

Treatment: Wegovy 0.25 milligram (mg) / 0.5 milliliter (ml) subcutaneous (SC) pen injector

The insurer denied coverage for Wegovy 0.25 milligram (mg) / 0.5 milliliter (ml) subcutaneous (SC) pen injector

The denial is overturned

This is patient who has a history of morbid obesity. The patient requested coverage for Wegovy.  

On office visit patient weighs 605 pounds (lb) 6.4 ounces (oz). Patient has done calorie counting, meal replacements, portion control, and walks 20 minutes. Treatment plan is for Wegovy and scheduled appointment with a bariatric surgeon. 

The insurer has denied coverage for Wegovy 0.25 milligram (mg) / 0.5 milliliter (ml) subcutaneous (SC) pen injector. In a Final Adverse Determination letter, they stated that the patient has not taken and had a poor response to the medications on the preferred drug list. Preferred medications are Trulicity, Ozempic, and Victoza. 

The patient is appealing. In an appeal letter, the patient stated that they weigh over 608 pounds and has a body mass index (BMI) over 100. The patient has tried calorie counting and increasing daily activity. The progress was slow. The physician recommended Wegovy, which is Food and Drug Administration (FDA) approved for weight loss. The alternatives are not FDA approved for treatment of obesity per se.

Request for Formulary Exception for Wegovy 0.25 milligram (mg) / 0.5 milliliter (ml) subcutaneous (SC) pen injector is medically necessary. 

The plan preferred medications, Trulicity, Ozempic, and Victoza are not appropriate for this patient. Ozempic is indicated for diabetes, but the patient is not a diabetic. Trulicity and Victoza are also for diabetics and lack weight loss indications. The patient is extremely morbidly obese and is not a diabetic. As such, the request for Wegovy is appropriate and more effective than the medications on the formulary which are being offered.

"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 (BMI) of
	30 kg/m2 or greater (obesity) or
	27 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) (1).
 pediatric patients aged 12 years and older with an initial BMI at the 95th percentile or greater for age and sex (obesity) (1)." 

"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" (3).

"The STEP 5 trial assessed the efficacy and safety of once-weekly subcutaneous semaglutide 2.4 mg versus placebo (both plus behavioral intervention) for long-term treatment of adults with obesity, or overweight with at least one weight-related comorbidity, without diabetes. In summary, in adults with overweight (with at least one weight-related comorbidity) or obesity, semaglutide treatment led to substantial, sustained weight loss over 104 weeks versus placebo" (2). 

The formulary drugs are not expected to cause adverse effects.
 
The formulary drugs were not tried, and the patient did not have an adverse reaction or contraindication.

The formulary drug is not expected to be ineffective.

The non formulary drug is expected to be more effective than the formulary alternatives.

The carrier's denial of a request for a Formulary Exception for Wegovy 0.25 milligram (mg) / 0.5 milliliter (ml) subcutaneous (SC) pen injector is reversed.