Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Diabetes

Treatment: Mounjaro 5MG/0.5ML SC SOPN

The insurer denied coverage for Mounjaro 5MG/0.5ML SC SOPN

The denial is upheld

 
This patient is an adult with a history of Type 2 diabetes mellitus (DM). The treating provider is requesting the plan's approval for therapy with Mounjaro, which is under medical necessity review.

In an appeal letter from the treating provider it was noted "the patient has a history of type 2 diabetes mellitus. The patient has had a trial and failure of Ozempic, Rybelsus, Trulicity, and Metformin. These alternatives did not control the patient's diabetes. The patient is stable on the current treatment with Mounjaro." Of note, no other clinical documentation was included for review (office notes, labs, etc.)

Per guidelines, the patient has to try and fail all formulary medications Rybelsus, Trulicity, Ozempic, and Victoza prior to use of the requested therapy. The patient has not tried and failed Victoza. The patient must try and fail the last formulary medication before requesting non-formulary. 

There was no indication in the documentation that the formulary drugs are likely to cause the patient an adverse reaction.      

The formulary drug(s) has not been ineffective based on the patient's clinical history.

Per notes, the medications trialed did not control glucose; however, no glycated hemoglobin (A1c) or glucose logs were sent.     

There is no evidence that the requested drug, Mounjaro, would be more effective than the formulary drug option. No glucagon-like peptide 1 (GLP-1) therapy has been shown to be superior to the other, per the medical literature review.

"INDICATIONS AND USAGE: Victoza is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)." (Victoza Package Insert).

"The final recommendations recognize that obesity is a complex, adiposity-based chronic disease, where management targets both weight-related complications and adiposity to improve overall health and quality of life. The detailed evidence-based recommendations allow for nuanced clinical decision-making that addresses real-world medical care of patients with obesity, including screening, diagnosis, evaluation, selection of therapy, treatment goals, and individualization of care. The goal is to facilitate high-quality care of patients with obesity and provide a rational, scientific approach to management that optimizes health outcomes and safety." (Garvey, W. T. et al. 2016).

"Glucagon-like peptide-1 receptor agonists (also known as GLP-1 receptor agonists, GLP-1DAs, incretin mimetics, or GLP-1 analogs)) are a class of medications utilized in the treatment of type 2 diabetes mellitus and obesity. Clinical trials show the superiority of GLP-1 RA to other antihyperglycemic drugs in improving glycemic efficacy, reducing weight and blood pressure, and having a cardioprotective effect, all without the risk of hypoglycemia. These drugs have transformed the guidelines for the management of patients with diabetes.." (Latif, W. et al. 2023). 


The carrier's denial of a request for a Formulary Exception for Mounjaro 5MG/0.5ML SC SOPN to treat diabetes is upheld.