Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Type 2 Diabetes Mellitus
Treatment: Mounjaro 5 mg (milligrams)/0.5 ml (milliliters)
The insurer denied: Mounjaro 5 mg/0.5 ml
The denial is overturned.

This is an adult male with type II diabetes. The request for continuation of Mounjaro is under review. The prior request was denied because "Coverage for this medication is denied for the following reason(s). We reviewed the information we received about your condition and circumstances. We used the plan approved policy when making this decision. The policy states that this medication may be approved when: the member has a clinical condition or needs a specific dosage form for which there is no alternative on the formulary or; the listed formulary alternatives are not recommended based on published guidelines or clinical literature or; the formulary alternatives will likely be ineffective or less effective for the member or; the formulary alternatives will likely cause an adverse effect or; the member is unable to take the required number of formulary alternatives for the given diagnosis due to a trial and inadequate treatment response or an expected adverse reaction or contraindication or; the member has tried and failed the required number of formulary alternatives. Based on the policy and the information we have, your request is denied. We did not receive any documentation that you meet any of the criteria outlined above. Examples of alternatives to the requested drug listed on your plan's formulary are: Ozempic, Trulicity, Victoza. Your prescriber will be responsible for determining what alternative is appropriate for you. This list may not include all alternatives covered by your plan and may include alternatives that require prior authorization. Please refer to your plan documents for a complete list of alternatives. Requirement: you must have tried 3 alternatives if there are 3 or more covered alternatives, 2 alternatives if there are 2 covered alternatives, or 1 alternative if there is only 1 covered alternative."

The provider is appealing this determination. The patient has tried and failed metformin. His glycated hemoglobin (A1C) was 13.7% 5 months ago. The patient is being treated with Mounjaro and Farxiga.

The health plan should cover the proposed Mounjaro.

This request is for continuation of Mounjaro for the treatment of type two diabetes. The prior request was denied as the patient has not tried and failed Ozempic, Trulicity, and Victoza.

Mounjaro has been shown to be superior to Ozempic, the most potent glucagon-like peptide 1 (GLP-1) receptor agonist [1]. The mean change from baseline in the glycated hemoglobin level was 2.01 percentage points, 2.24 percentage points, and 2.30 percentage points with 5 milligrams (mg), 10 milligrams, and 15 milligrams of Mounjaro, respectively, and 1.86 percentage points with Ozempic; the estimated differences between the 5 milligrams, 10 milligrams, and 15 milligrams Mounjaro groups and the Ozempic group were 0.15 percentage points (95% confidence interval [CI], 0.28 to 0.03; P=0.02), 0.39 percentage points (95% CI, 0.51 to 0.26; P less than 0.001), and 0.45 percentage points (95% CI, 0.57 to 0.32; P less than 0.001), respectively. This is of clinical importance to this patient with a glycated hemoglobin (A1C) of 13.7%, who requires a very large drop in glycated hemoglobin to achieve a glycated hemoglobin of less than 7%. The formulary alternatives are not clinically appropriate in this clinical situation as they are not sufficiently potent to lower glucose in this patient with very uncontrolled type 2 diabetes. Without Mounjaro, this patient will remain at high risk of uncontrolled hyperglycemia, which can cause retinopathy, neuropathy, and nephropathy. Therefore, yes, the health plan should cover the proposed Mounjaro.