Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Obesity and polycystic ovarian syndrome. 
Treatment: Rybelsus 7 milligrams (mg) tablet. 

The insurer denied coverage for Rybelsus 7 milligrams (mg) tablet. 

The denial is upheld. 

The patient is an adult with a medical diagnosis of Obesity. Per encounter notes of the provider, the patient has a medical history of polycystic ovarian syndrome (PCOS), hyperlipidemia and metabolic syndrome. The patient was previously on Metformin. The patient is not currently exercising and is active at work. The patient complained of being fatigued. The patient had glycated hemoglobin (A1C) of 5.2%. Body mass index (BMI) of 35 to 35.9. The provider encouraged the patient to increase activity as tolerated with a goal of 30 minutes per day/five times per week. 

Rybelsus is Food and Drug Administration (FDA) approved only for type 2 diabetes and is not approved for obesity and PCOS. This patient does not have an indication of type 2 diabetes. Therefore, Rybelsus 7 milligrams (mg) tablet is not considered medically necessary for this patient. 

Oral semaglutide (Rybelsus) is a glucagon-like peptide-1 (GLP-1) receptor agonist (GLP-1RA) with 94% homology to human GLP-1. It is the first GLP-1RA developed for oral administration, and it comprises a co-formulation of the peptide semaglutide with the absorption enhancer sodium N-(8-[2-hydroxybenzoyl] amino) caprylate, which overcomes the challenges of peptide absorption in the acidic conditions of the stomach. Oral semaglutide is indicated for use as an add-on combination therapy (with other glucose-lowering agents, including insulin) or as a monotherapy (in patients who are intolerant to metformin) for type 2 diabetes when diet and exercise do not provide adequate glycemic control. In an extensive phase III clinical program including patients from across the disease spectrum, treatment with oral semaglutide resulted in effective glycemic control, reductions in body weight, and decreases in systolic blood pressure when used as monotherapy or in combination with other glucose-lowering therapies. Studies showed that oral semaglutide was well tolerated, with a safety profile consistent with the GLP-1RA drug class. The risk of hypoglycemia was low, and the most common adverse events were gastrointestinal, with nausea and diarrhea generally being the most frequently reported manifestations. Cardiovascular (CV) safety was shown to be noninferior to placebo and observations suggest that the CV profile of oral semaglutide is likely to be similar to that of subcutaneous semaglutide. The evolution of the GLP-1RA class to include an oral agent could facilitate the use of these agents earlier in the diabetes treatment cascade owing to wider acceptance from patients and healthcare professionals (Andersen 2021). 

Over one third of United States adults have obesity. Obesity is associated with a range of comorbidities, including diabetes, cardiovascular disease, obstructive sleep apnea, and cancer; however, modest weight loss in the 5%-10% range, and above, can significantly improve health related outcomes. Many individuals struggle to maintain weight loss, although strategies such as realistic goalsetting and increased consultation frequency can greatly improve the success of weight management programs. Nurse practitioners have key roles in establishing weight loss targets, providing motivation and support, and implementing weight loss programs. (Fruh S. M., 2017). 

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for Rybelsus 7 milligrams (mg) tablet is not substantiated.