Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Type 2 Diabetes Mellitus.

Treatment: Ozempic (0.25 or 0.5 milligrams (mg) /dose) 2mg/1.5 milliliters (mL) subcutaneous (SC) solution pen injector (SOPN).

The insurer denied coverage for Ozempic (0.25 or 0.5mg/dose) 2mg/1.5mL SC SOPN.

The denial is overturned.

According to the medical records, the patient is female with diagnosis of type 2 diabetes mellitus. The patient had an office visit with her Endocrinologist for management of type 2 diabetes mellitus. Per the visit notes, the patient had tried samples of Ozempic and did well. The hemoglobin A1c (HbA1c) (glycated hemoglobin) was 7.8 percent (%). The plan was to restart Ozempic. Her endocrinologist is requesting coverage for Ozempic (0.25 or 0.5mg/dose) 2 mg/1.5mL SC.

In an appeal letter, it is stated that the patient has had an inadequate response to therapy with metformin. The letter states that the patient has been diagnosed with diabetes type 2 a few years ago. She was initially diagnosed with gestational diabetes when pregnant with her first child at an early age. This patient has had an inadequate response to therapy with metformin. She has been compliant and yet she has no significant improvement in her HbA1c, which was 7.7%. Prior to that, her reading was 9.1%. Currently she is taking Metformin 500 mg, one tablet twice daily. She was given a goal HbA1c of 6.5 in addition to changing her current Metformin XR (external release) 500 mg two tablets daily with breakfast. With this new therapy change and addition of Ozempic we believe that the patient will achieve her goal. 

The patient had completed over three months of metformin therapy and it failed to control her diabetes. The claimant also tried taking Ozempic, as samples, and it did provide improved glucose control and HbA1C reduction. According to the American Academy of Clinical Endocrinology (AACE) guidelines, patients with type 2 diabetes not adequately controlled with metformin should be placed on glucagon-like peptide 1 (GLP-1) analogs, such as Ozempic, due to their proven cardiovascular benefits and weight loss benefits.

"Background: Semaglutide is a novel glucagon-like peptide-1 (GLP-1) analogue, suitable for once-weekly subcutaneous administration, in development for treatment of type 2 diabetes. We assessed the efficacy and safety of semaglutide versus the dipeptidyl peptidase-4 (DPP-4) inhibitor sitagliptin in patients with type 2 diabetes inadequately controlled on metformin, thiazolidinediones, or both...Interpretation: Once-weekly semaglutide was superior to sitagliptin at improving glycaemic control and reducing bodyweight in participants with type 2 diabetes on metformin, thiazolidinediones, or both, and had a similar safety profile to that of other GLP-1 receptor agonists. Semaglutide seems to be an effective add-on treatment option for this patient population." (Ahren, B., et al. 2017)

The treatment with Ozempic 0.25/0.5 mg is medically necessary for the patient; and the patient will be using a dose of 0.25 mg injected into the skin once weekly. It should also be noted that the formulary choices are often associated with weight gain (Up to Date) in contrast to the Ozempic which results in weight loss which is particularly relevant in this patient with obesity. 

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

The insurer's denial of coverage for Ozempic (0.25 or 0.5mg/dose) 2mg/1.5mL SC SOPN is reversed. Medical necessity is substantiated.