Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Prediabetes
Treatment: Trulicity 0.75 milligrams (mg) / 0.5 milliliter (ml) subcutaneous (SC) solution pen injector (SOPN)
The insurer denied coverage for Trulicity 0.75 milligrams (mg) / 0.5 milliliter (ml) subcutaneous (SC) solution pen injector (SOPN)
The denial is upheld.

The patient has a history of obesity, gastroesophageal reflux disease (GERD), sleep apnea, and prediabetes. The patient reported gaining ten (10) pounds over two (2) weeks. He reported trying to watch his diet and exercise. His A1C (glycated hemoglobin) was 6.1% [percent]. The patient started taking Trulicity after metformin was ineffective.

TRULICITY 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.
Limitations of Use:

Not recommended as first-line therapy for patients inadequately
controlled on diet and exercise
Has not been studied in patients with a history of pancreatitis.
Consider another antidiabetic therapy.
Not for treatment of type 1 diabetes mellitus or diabetic ketoacidosis.
Not for patients with pre-existing severe gastrointestinal disease". (Trulicity Package Insert).

The most important management in prediabetes is a lifestyle change and promotion of intense weight loss. Reducing weight by 7% through a low-fat diet, in addition to an exercise regimen of about 30 minutes per day, is the overall goal of management. 
Approximately 70% of people with prediabetes will go on to be diagnosed with diabetes mellitus. However, this is not inevitable. Prediabetes managed appropriately can prevent diabetes mellitus and lower the risk of cardiovascular disease.

"There are currently four medications for treating the prediabetes subpopulation, including metformin, pioglitazone, acarbose, and liraglutide. In addition, the American Association of Clinical Endocrinologists (AACE) has also proposed three weight-loss therapies including orlistat, lorcaserin, and phentermine/topiramate ER to manage obesity with the goal of halting the progression of insulin resistance and type 2 diabetes" (Zand, A., 2018).    

Based on the clinical standards of the plan, the information provided concerning the patient, the attending physician's recommendation, and applicable generally accepted practice guidelines developed by the federal government, national or professional medical societies, boards, and associations, the health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. Trulicity is only FDA (Food and Drug Administration) approved for type II diabetes and per national guidelines, is only recommended for treatment of this disorder. The records show the claimant does not have type II diabetes but has prediabetes.      

Trulicity 0.75 milligrams (mg) / 0.5 milliliter (ml) subcutaneous (SC) solution pen injector (SOPN) is not considered medically necessary for this patient. This medication is only FDA approved for management of type II diabetes. The claimant is obese and has prediabetes. He does not have type II diabetes. Therefore, the request for Trulicity is denied.                                                    

The health plan acted reasonably with sound medical judgment in the best interest of the patient.

The insurer's denial of coverage for Trulicity 0.75 milligrams (mg) / 0.5 milliliter (ml) subcutaneous (SC) solution pen injector (SOPN) is upheld. Medical Necessity is not substantiated.