Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Diabetes
Treatment: Mounjaro 2.5mg (milligrams)/0.5ml (milliliter) pen
The insurer denied coverage for Mounjaro 2.5mg/0.5ml pen.
The denial is upheld.

The patient is an adult with diabetes. He is taking Janumet, Ozempic, Tresiba and Prandin. His glycated hemoglobin (A1C) is 11.3%. Because multiple medications have not worked for him; his Ozempic was switched to Mounjaro.  

The patient is being treated with Ozempic, and it is being tolerated well. Therefore, it would seem unlikely that Ozempic is causing or will cause an adverse reaction.      

The A1C is still 11.3% and the blood sugar is over the 200-300 range. Therefore, his current medication regimen is ineffective in controlling his blood sugars.     

According to the study cited below, Mounjaro is slightly more effective at lowering the A1c. The expected A1C reduction is 2.01% with Mounjaro, versus 1.86% with Ozempic. While this is statistically significant, this certainly does not argue for switching this patient in this clinical situation. 

"Results: The estimated mean change from baseline in the glycated hemoglobin level was -2.01 percentage points, -2.24 percentage points, and -2.30 percentage points with 5 mg, 10 mg, and 15 mg of tirzepatide, respectively, and -1.86 percentage points with semaglutide; the estimated differences between the 5-milligram (mg), 10-mg, and 15-mg tirzepatide groups and the semaglutide group were -0.15 percentage points (95% confidence interval [CI], -0.28 to -0.03; P (probability) = 0.02), -0.39 percentage points (95% CI, -0.51 to -0.26; P< (less than) 0.001), and -0.45 percentage points (95% CI, -0.57 to -0.32; P<0.001), respectively. Tirzepatide at all doses was noninferior and superior to semaglutide. Reductions in body weight were greater with tirzepatide than with semaglutide (least-squares mean estimated treatment difference, -1.9 kilograms (kg), -3.6 kg, and -5.5 kg, respectively; P<0.001 for all comparisons). The most common adverse events were gastrointestinal and were primarily mild to moderate in severity in the tirzepatide and semaglutide groups (nausea, 17 to 22% and 18%; diarrhea, 13 to 16% and 12%; and vomiting, 6 to 10% and 8%, respectively). Of the patients who received tirzepatide, hypoglycemia (blood glucose level, <54 mg per deciliter) was reported in 0.6% (5-mg group), 0.2% (10-mg group), and 1.7% (15-mg group); hypoglycemia was reported in 0.4% of those who received semaglutide. Serious adverse events were reported in 5 to 7% of the patients who received tirzepatide and in 3% of those who received semaglutide.

Conclusions: In patients with type 2 diabetes, tirzepatide was noninferior and superior to semaglutide with respect to the mean change in the glycated hemoglobin level from baseline to 40 weeks." (Frias, J. P., et al., 2021).

The formulary drugs are not expected to cause adverse effects.

The formulary drugs were tried, and the patient did not have an adverse reaction or contraindication.

The formulary drug is not expected to be ineffective.

The not formulary drug is not expected to be more effective that the formulary alternatives.

The carrier's denial of Request for Formulary Exception for Mounjaro 2.5mg/0.5ml pen to treat diabetes is upheld.