Diagnosis:
Endocrine/ Metabolic/ Nutritional
Treatment:
Pharmacy/ Prescription Drugs
Health Plan:
Aetna
Decision:
Overturned overturned
Appeal Type:
Formulary Exception
Gender:
Female
Age Range:
60-69
Decision Year:
2023
Appeal Agent:
IPRO
Case Number:
202305-163384
Coverage Type:
PPO
Summary

Diagnosis: Type 2 diabetes Treatment: Mounjaro (tirzepatide) The insurer denied coverage for Mounjaro (tirzepatide). The denial is overturned. This is an adult diagnosed with type 2 diabetes mellitus (T2DM). This request is for Mounjaro 7.5 milligrams (mg). As per letter patient tried Mounjaro with excellent results and lowered her glycated hemoglobin (A1C). She tried and failed Trulicity due to nausea, vomiting, and abdominal pain. She tried and failed Ozempic due to vomiting, rash and abdominal pain. She tried and failed Victoza due to nausea and irritable bowel syndrome (IBS) symptoms. She tried and failed metformin due to pain and IBS (irritable bowel syndrome) flare up. The formulary drug(s) is likely to cause the patient an adverse reaction. The patient has tried and failed Trulicity, Ozempic, Victoza due to adverse reactions. It is likely that the remaining formulary alternative Rybelsus would cause an adverse reaction due to similarities to failed formulary drugs. The formulary drug(s) has been ineffective based on the patient's clinical history. Trulicity, Ozempic, Victoza have been ineffective because of adverse reactions. The requested drug would be more effective than the formulary drug. The requested medication, Mounjaro, is expected to be more effective because it is of a different class and may not have the same adverse effects as the formulary alternatives to this patient. Furthermore, per appeal note the requested medication has shown to be effective as it lowered the patient's A1C (glycated hemoglobin). The formulary drugs are expected to cause adverse effects. The formulary drugs were tried, and the patient did 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 overturned.

References

1) ElSayed, N.A., et al. (2023). 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes-2023. Diabetes Care, 2023. 46(Suppl 1): p. S140-S157. 2) Frias, J.P., et al., (2021). Tirzepatide versus Semaglutide Once Weekly in Patients with Type 2 Diabetes. N Engl J Med, 2021. 385(6): p. 503-515. 3) Min, T., & Bain, S. C. (2021). The Role of Tirzepatide, Dual GIP and GLP-1 Receptor Agonist, in the Management of Type 2 Diabetes: The SURPASS Clinical Trials. Diabetes therapy : research, treatment and education of diabetes and related disorders, 12(1), 143-157. 4) Rosenstock, J., et al. (2021). Efficacy and safety of a novel dual GIP and GLP-1 receptor agonist tirzepatide in patients with type 2 diabetes (SURPASS-1): a double-blind, randomized, phase 3 trial. Lancet, 2021. 398(10295): p. 143-155.