Trulicity denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Trulicity 0.75 ng.0.5 pen injector. Findings: The physician reviewer found that the American Diabetes Association (ADA) support the additional of a second oral agent, “a glucagon-like peptide 1 receptor agonist, or basal insulin” if noninsulin monotherapy at maximum tolerated dose does not achieve or maintain the A1C target after three months. Trulicity is a glucagon-like peptide 1 (GLP-1) receptor agonist (GLP-1RA). It is one of the noninsulin agents in the algorithm for the pharmacological treatment of diabetes. The combination of insulin plus a GLP-1RA has been used for a long time to address the metabolic defects of diabetes. Many studies document the efficacy of the combination of basal insulin plus a GLP-1RA for use in this clinical setting.

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Trulicity (0.75 mg/0.5 mL per injector). Findings: The physician reviewer found that glucagon-like peptide-1 receptor agonists (GLP-1 RAs), such as Trulicity, are one of the preferred approved treatment options for people with type 2 diabetes (T2D) and inadequate glycemic control. The author further notes that GLP-1 RAs help in regulating insulin secretion in proportion to environmental glucose levels, have a low risk of hypoglycemia, facilitate weight loss, and may also have beneficial effects on the cardiorenal system, including reducing cardiovascular risk and improving renal outcomes.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: A patient has requested authorization and coverage for Trulicity. Trulicity is U.S. Food and Drug Administration (FDA)-approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. The issue is whether this patient can be categorized as diabetic based on a two hour glucose tolerance test. According to American Diabetes Association, the diagnosis of diabetes in an asymptomatic, nonpregnant individual (generally type 2 diabetes) can be established with any of the following criteria: fasting plasma glucose (FPG) values greater than or equal to 126 mg/dL (7.0 mmol/L); two hour plasma glucose values greater than or equal to 200 mg/dL (11.1 mmol/L); or A1C values greater than or equal to 6.5%.

Nature of Statutory Criteria/Case Summary: An enrollee has requested Trulicity and Vascepa for treatment of his hypercholesterolemia and diabetes mellitus. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the requested medications. The records document diabetes and hypertriglyceridemia. In this circumstance, treatment with lifestyle changes and medication is appropriate and recommended by current guidelines. The patient has requested coverage for Vascepa. However, the Health Plan denied this requested due to an inadequate trial with two of the following medications: gemfibrozil (Lopid), micronized fenofibrate or Niacin. These alternative medications are effective in the treatment of hypertriglyceridemia, and it is medically appropriate to try these drugs prior to Vascepa.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Trulicity, then check the rights and deadlines that apply to your plan.