Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Obesity. 
Treatment: Formulary Exception for Mounjaro (tirzepatide). 

The insurer denied coverage for Formulary Exception for Mounjaro (tirzepatide). 

The denial is upheld. 

This case involves an adult male who is being recommended for Mounjaro 12.5 milligram (mg) / 0.5 milliliter (ml) solution pen injector (2 Liters per 28 days) given a diagnosis of obesity. The insurer denied the request and indicated that formulary alternatives included Ozempic, Rybelsus, Trulicity, and Victoza. Requirements for use of Mounjaro (Tirzepatide) include three and a class with three or more alternatives, two in class with two alternatives, or one in a class with only one alternative. The physician stated that the patient's obesity has been complicated by obstructive sleep apnea and mixed hyperlipidemia. His current body mass index is 40.74 kilograms (kg). The patient previously tried and failed metformin extended release (XR) 500 mg and Qsymia 7.5- 46 mg, had an intolerance to Ozempic due to abnormal bowel movements and constipation and was not a candidate for other weight loss medications to include Saxenda, Wegovy, Orlistat, or Contrave due to sleep apnea. The medical rationale for weight loss is that obesity is a serious, chronic, and progressive disease and associated with a significant increase in mortality. The physician noted that many health risks include type 2 diabetes mellitus, hypertension, dyslipidemia, and coronary artery disease. The physician noted that although Mounjaro was not currently approved for weight loss, there is evidence to show that a byproduct of therapy with this medication yielded significant weight loss. 

The formulary drugs are not likely to cause the patient an adverse reaction. 

There is no record that formulary drugs have been ineffective based on the patient's clinical history. Records did not support that the patient has tried any of the formulary medications at this time. 

The Food and Drug Administration (FDA) states that Mounjaro is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Current peer-reviewed medical literature states that Mounjaro is not indicated for weight loss, but the Surmount -1 clinical trial demonstrated significant weight loss in those who received this medication. The treating physician verified that the patient previously tried and failed multiple medications to include metformin XR, Qsymia, and had an intolerance to Ozempic due to abnormal bowel movements and constipation and was not a candidate for other weight loss medications to include Saxenda, Wegovy, Orlistat, and Contrave due to sleep apnea. Therefore, while the use of Mounjaro is being considered for off label use, the intention is to prevent diabetes, and prevent adverse reactions from formulary drugs given that the patient has sleep apnea. However, the FDA does not support that there are any direct warnings or precautions and potential adverse reactions to Saxenda that would cause concern for patients with sleep apnea. The same was noted for Wegovy, orlistat, and Contrave with no specific warnings given towards those individuals diagnosed with sleep apnea. These formulary medications are intended to assist with weight loss in the same way as Mounjaro. It was therefore determined that the requested medication is not supported over formulary drugs as there was no supporting information to indicate that the formulary drugs would likely cause the patient an adverse reaction nor that the former drugs have been ineffective based on the patient's clinical history, nor that the Mounjaro will be more effective than the formulary drugs given that at present, this medication has not been approved by the FDA for weight loss measures. As such, there is no formulary exception for Mounjaro (tirzepatide). 

The carrier's denial of Request for Formulary Exception for Mounjaro (tirzepatide) to treat obesity is upheld.