
202308-166173
2023
Aetna
EPO
Endocrine/ Metabolic/ Nutritional
Pharmacy/ Prescription Drugs
Formulary Exception
Upheld
Case Summary
Diagnosis: Diabetes Mellitus
Treatment: Mounjaro
The insurer denied Mounjaro.
The determination is upheld.
This is a female patient diagnosed with type 2 diabetes mellitus with hyperglycemia. This request is for Mounjaro 15 milligrams (mg). As per a visit note, she is on Jardiance 25 mg every day, Ozempic 2 mg every day, metformin immediate release (IR) 2000 mg, and Novolog 6-12 units. She is off Levemir because she had hypoglycemia. As documented, she is on continuation therapy of Mounjaro. Her hemoglobin A1C about 2 years ago was 8.5 percent (%) and about 10 months ago was 7.4%. Formulary alternatives are Victoza and Trulicity. At issue is whether the formulary drugs will be or have been ineffective, would not be as effective as the non-formulary drug, or would have adverse effects.
The formulary alternatives would be as effective as the requested medication.
The requested medication Mounjaro (Trizepatide) is Food and Drug Administration (FDA) approved for the treatment of adults with type 2 diabetes. It is a glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor agonist. It has been shown in clinical trials to lead to improvement in hemoglobin A1c as well as weight loss. (1-3)
There are no studies demonstrating the superiority of the requested medication over the formulary alternatives. The most recent American Diabetes Association guidelines recommend using GLP-1 receptor agonists as a first line agent. There is no preference for the requested medication over GLP-1 receptor agonists. (4) The patient can try two more formulary alternatives. The request is not consistent with generally accepted standards of medical practice and is therefore not medically necessary.