Summary  
The patient is a 32-year-old female who presented to her provider on 8/31/21. The records noted 
that the patient was 66.5 inches tall and weighed 296.6 pounds, with a body mass index (BMI) of 
47.15 kg/m2. The patient has requested authorization and coverage for (1) Mounjaro 7.5 mg, (2) 
Ozempic 2 mg, and (3) Rybelsus 7 mg. The Health Insurer has denied this request and reported 
that the requested medications are not medically necessary for the treatment of this patient. This 
denial is the subject of this appeal and determination. The physician reviewer found that the 
submitted documentation does not support the medical necessity of the requested medications. 
Prediabetes is defined as an elevated hemoglobin A1C in the range of 5.7% to 6.4%. Some 
individuals with prediabetes may progress to developing diabetes mellitus. The American Diabetes 
Association (ADA) guidelines on the prevention of type 2 diabetes recommend that individuals 
with prediabetes undergo counseling on lifestyle changes including weight loss and routine 
exercise. The ADA recommends that the only pharmacologic agent to be considered for use for 
prediabetes is metformin for those at high risk for developing diabetes. Obesity is a disease 
associated with many health risks, including type 2 diabetes mellitus, hypertension, dyslipidemia, 
and coronary heart disease. Weight loss in  patients with obesity or who are overweight is 
associated with a reduction in mortality. The American Association of Clinical Endocrinologists 
guidelines for the medical care of patients with obesity notes that patients with obesity or who are 
overweight  and  with  dyslipidemia  should  be  considered  for  treatment  with  a  weight-loss 
medication combined with lifestyle therapy when necessary to achieve sufficient improvements in 
lipids. The guidelines further note that for patients who struggle with weight loss and who would 
receive health benefit from weight loss, management of medications that are contributing to weight 
gain and the use of approved medications for chronic weight management along with lifestyle 
changes are appropriate. Medications for weight loss are generally considered an option for 
patients with a BMI over 27 kg/m2 with comorbidities such as diabetes or sleep apnea, or a BMI 
over 30 kg/m2 without comorbidities. There are multiple medications approved by the U.S. Food 
and  Drug Administration  (FDA)  for  the  treatment  of  obesity  including  orlistat,  naltrexone-
bupropion, lorcaserin, phentermine, phentermine with topiramate, liraglutide and semaglutide. 
WIlding and colleagues note that semaglutide has demonstrated impressive efficacy in weight 
reduction, along with improvement in blood sugars and cholesterol levels. Semaglutide is available 
under the brand name Wegovy, Ozempic and Rybelsus. The FDA approves the use of Wegovy to 
assist patients with obesity, or who are overweight with weight-related medical problems, to lose 
weight when added to diet and exercise. The FDA approves the use of Ozempic and Rybelsus to 
lower blood sugar levels in adults with type 2 diabetes, in addition to diet and exercise. The FDA 
approves  the  use  of  tirzepatide  (Mounjaro),  a  unique  dual  glucagon-like  peptide-1  (GLP-
1)/glucagon receptor (GIP) agonist, for the treatment of type 2 diabetes.  In an open-label, parallel-
group, randomized, active-controlled trial examining the benefits on weight loss of tirzepatide 
versuss semaglutide in over 1,800 patients with type 2 diabetes over 40 weeks, Frias and colleagues 
concluded that reductions in body weight were greater with tirzepatide than with semaglutide. 
While concurrent medications for weight loss may be appropriate for patients with a BMI over 27 
kg/m2 with comorbidities, in this case, the patients most recent BMI is 25.8 kg/m2 and the patient 
reports that her comorbidities of hypertension and hyperlipidemia have resolved. While published 
studies support the use of Mounjaro, Ozempic, and Rybelsus as effective for weight loss, given 
the lack of data available on their benefits over FDA approved medications for weight loss in 
patients without diabetes or obesity, the requested medications are not medically indicated.  Therefore, (1) Mounjaro 7.5 mg, (2) Ozempic 2 mg, and (3) Rybelsus 7 mg are not medically 
necessary for the treatment of this patient.