Byetta denials in California external review

What the reviewers wrote

Where the denial was overturned

This is a 61-year-old male patient who was diagnosed with type II diabetes in 2004. He is obese and has hypertension and dyslipidemia. His current medications are metformin 500mg twice per day, glipizide 10mg daily, lisinopril 20mg daily, Plendil 10mg daily, Coreg 25mg twice per day, Aldactazide 25/25 daily and Lipitor 10mg daily.The patient’s endocrinologist started him on oral antidiabetic medications. His first medication was metformin; subsequently glipizide and Actos were added. His blood glucose still was not well controlled with all three medications despite an appropriate diet. Finally, Lantus insulin was added. The dose was titrated up to 70 units per day but the patient’s morning blood glucose levels remained between 150-200mg/dl. The patient gained 35 pounds during this time and developed edema. In October 2005 Actos was discontinued.

The patient is a 59-year-old female with almost a 30-year history of diabetes mellitus type II. Her blood glucose was not controlled on a variety of oral medications. Her HgA1C in October 2004 was 9.3%. Novolog was added in the spring of 2005. The patient’s HgA1C dropped from 9.3% to 8.4% on metformin 1000mg twice a day, glyburide 10mg twice a day, Avandia 8mg once a day, and Novolog twice a day. The patient experienced several hypoglycemic reactions on this regimen. In the summer of 2005 Novolog was discontinued and the patient was started on Byetta 5mcg twice daily and the oral medications were continued as above. Lab results from October 2005 indicate the patient’s HgA1C had dropped to 7.3%. The patient has requested authorization and coverage for Byetta.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Byetta 5 mcg pen-injectors. The Health Plan has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollee’s type 2 diabetes. A review of the records indicates the enrollee is diagnosed with type 2 diabetes. The enrollee has stated that she has been taking Byetta for type 2 diabetes for 9 years. The submitted documentation does not support that the requested medication is medically necessary. The requested medication, Byetta, is a GLP-1 agonist and has a similar mechanism of action as others in its class such as Trulicity or Victoza. GLP-1 agonists like Byetta are FDA approved for use in type 2 diabetes.

The patient is a 66-year-old male with type 2 diabetes mellitus (DM2). His blood glucose levels had previously been under good control on Actos, metformin and glipizide as evidenced by a hemoglobin A1c of 6.0%, excellent fasting blood glucose and occasional postprandial elevations of blood glucose according to his endocrinologist. The patient has macrovascular and mild microvascular disease and he is obese. He has reportedly been unable to lose weight with his current diet and exercise. In July 2006 his endocrinologist started the patient on Byetta for greater blood glucose control and to aid in his weight loss efforts and glipizide was discontinued. The patient’s primary care provider stated in his letter of October 2006 that the patient had lost close to 10 pounds and his provider wished to continue Byetta, presumably for further weight loss.

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 Byetta, then check the rights and deadlines that apply to your plan.