Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Diabetes

Treatment: Mounjaro (tirzepatide)

The insurer denied coverage for Mounjaro (tirzepatide)

The denial is upheld 

The patient has a diagnosis of Type 2 Diabetes and Hyperglycemia. 

An office visit note indicates the patient has Diabetes and has tried multiple medications to control her blood sugar. She is currently receiving treatment with Lantus and Ozempic, which is reported to be insufficient. She has tried and failed Trulicity, Metformin and Victoza. Her current body mass index (BMI) is documented to be 40-49. The patient's Hemoglobin A1c (glycated hemoglobin) was 7.3% (percent), two years ago and 5.6%, more recently.

According to the appeal letter, completed by the treating provider, the patient does not currently have controlled blood sugars; however, evidence suggests otherwise.  Per provider notes, the patient had a Hemoglobin A1c of 5.6% while being treated with Ozempic weekly and Lantus daily. Objectively, there is no documentation of a medication failure or adverse effects to Ozempic, solely from the medical records. As such, there is no justification for the request for Mounjaro.

"Tirzepatide (Mounjaro) is a derivative of the human glucose-dependent insulinotropic polypeptide (GIP) hormone with a position-20 is being modified with 1,20-eicosanedioic acid via a chemical linker. It is acting as glucagon-like peptide-1 (GLP-1) receptor and GIP receptor agonist. It has recently been approved by Food and Drug Administration (FDA) as an adjunct therapy to exercise and diet to improve glycemic control in patients with type II diabetes mellitus (T2DM). It represents a new transforming paradigm in the management of T2DM. This mini review will shed light on its different pharmacokinetic and pharmacodynamic aspects." (Al-Horani, R. A., & Chedid, M. 2022).

"The incretin pathway is a self-regulating feedback system connecting the gut with the brain, pancreas, and liver. Its predominant action is on the postprandial glucose levels, with extraglycemic effects on fat metabolism and endovascular function. Of the two main incretin hormones released with food ingestion, the actions of glucagon-like peptide-1 (GLP-1) have been exploited for therapeutic benefit. However, little attention has been paid to glucose-dependent insulinotropic polypeptide (GIP) until the recent experimental introduction of dual agonists, or "twincretins". Interestingly, simultaneous activation of both receptors is not only replicative of normal physiology, it seems to be an innovative way to enhance their mutual salubrious actions. In patients with type 2 diabetes, dual agonists can have powerful benefits for glucose control and weight reduction. Additionally, there is mounting evidence of their favorable cardiovascular impact, making them potentially appealing pharmacologic agents of choice in the future. Although we seem to be poised on the horizons of exciting new breakthroughs, much knowledge has yet to be gained before these novel agents are ready for prime time." (Rizvi, A. A., & Rizzo, M. 2022).                                                          

The formulary drug is not likely to cause an adverse reaction.

The formulary drug has been effective based on the records provided.

There is no evidence that the non-formulary drug is more effective.

The carrier's denial of a request for a Formulary Exception for Mounjaro (tirzepatide) is upheld.