Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Type I Diabetes 

Treatment: Victoza

The insurer denied coverage for Victoza

The denial is overturned

According to the medical records, the patient is a male with diagnoses of type 1 diabetes with retinopathy, and hypertension. The patient presented to the endocrinologist's office for an evaluation.  The patient was using a T-slim pump and Dexcom G6 with control IQ.  Humalog was in the pump.  The patient was also taking Victoza.  The patient used a continuous glucose monitor (CGM) to monitor, and reported that "sugar has recently been off." The patient reported that his glucose levels are very difficult to control on the third day after he changes the infusion set.  The patient has been limiting carbohydrate intake.  The CGM and pump were downloaded and reviewed.  The patient was noted to have postprandial hyperglycemia and hypoglycemia in between meals. The patient's insulin carbohydrate (I:C) ratio was adjusted to increase prandial insulin and decrease basal rates.  A certified diabetes educator (CDE) reviewed possible areas for pump insertion. The patient was recommended to switch sites on the second day if he found that insulin was higher on the third day. As per appeal letter, the patient's treating physician notes that since stopping Victoza, the patient's postprandial blood glucose increased up to 300 and 400 despite an increase in insulin of over 13 units, and the patient has gained 10 lbs. over the past 3 weeks. The physician recommends continuation of Victoza for this patient's treatment. 

The pre-service request for Victoza (liraglutide), a GLP-1 agonist, is considered medically necessary for this patient. As per Janzen et al. (2016), "the use of GLP-1 agonists should be considered in [type 1 diabetes mellitus (T1DM)] patients who are overweight or obese and not at glycemic goals despite aggressive insulin therapy." The greatest benefit is for patients with T1DM and obesity or for patients who cannot achieve good glucose control, such as this patient.

As per Guyton et al. (2019), "[glucagon-like peptide-1 receptor agonists (GLP-1 RA)] therapy represents an important add-on therapy option for achieving decreased insulin doses, weight loss, and modest improvements in [hemoglobin A1c (HbA1c)] levels without significantly increasing hypoglycemia risk in patients with [type 1 diabetes mellitus (T1DM)].  Patients who have detectable C-peptide and/or are overweight or cannot achieve glycemic goals without hypoglycemia have been found to benefit the most from GLP-1 RA therapy."

As per literature review above, Victoza (GLP-1 receptor agonist) is a medication approved to treat type 2 diabetes.  The patient has type 1 diabetes, which Victoza is not Food and Drug Administration (FDA)-approved for type 1 diabetes, and usage of this medication is considered off-label.  However, Victoza has been shown to be beneficial for weight loss in patients with obesity and T1DM.  This has been shown in peer review articles, as well as in this patient's case. As per submitted documentation, the patient's blood sugar and weight increased since stopping Victoza. Considering this patient's refractory hyperglycemia on high doses of insulin and responsiveness to Victoza use, Victoza is considered medically necessary for this patient. 

The health plan did not act reasonably with sound medical judgment, and in the best interest of the patient.

The insurer's denial of coverage for the pre-service request for Victoza to treat type 1 diabetes should be reversed. The medical necessity is substantiated.