Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Type 1 Diabetes

Treatment: Mounjaro (Tirzepatide)

The insurer denied coverage for Mounjaro (Tirzepatide)

The denial is overturned
 

The patient is an adult with type 1 diabetes mellitus and obesity with body mass index (BMI) of 38.39. Patient is on metformin, basal/bolus insulin regimen and Mounjaro. Since beginning Mounjaro, he has lost 10 lbs and his A1C has come down from 7.5 to 6.5. He has tried and failed Victoza and Trulicity.

The remaining drug in the formulary the patient has not tried is semaglutide. In this case, it is hard to predict how he will do with this medication versus Mounjaro as many patients do well with one and not the other in clinical practice. Given he has now tried 2 glucagon-like peptide (GLP)-1 agonists and seems to be doing well with Mounjaro, it would not be recommended to switch medication. 

The formulary drug, Victoza and Trulicity have been ineffective based on the patient's clinical history. The drugs Victoza and Trulicity have not been as effective as the Mounjaro.     

Current peer reviewed studies show better results with Mounjaro compared with Ozempic. Given, the patient's failure to Victoza and Trulicity, and favorable results with Mounjaro, the request should be approved.

Frias JP, Davies MJ, Rosenstock J, et al. (2021), "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 milligram (mg), 10 mg, and 15 mg of tirzepatide (Mounjaro), respectively, and -1.86 percentage points with semaglutide; the estimated differences between the 5-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; probability ((P) = 0.02), -0.39 percentage points (95% CI, -0.51 to -0.26; P<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."

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 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 Mounjaro (Tirzepatide) is reversed.