Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Morbid Obesity.
Treatment: Victoza.
The insurer denied the Victoza.
The denial is overturned.

The patient is a female with morbid obesity (body mass index [BMI] of 41), osteoarthritis, dyslipidemia, and asthma who was seen in clinic for follow up of obesity.  Documentation indicates that the patient needs additional weight loss to qualify for knee surgery.  Her glycated hemoglobin (A1C) is 5.  The patient had previously lost 126 pounds on Weight Watchers but can no longer afford the program.  She has followed with nutrition and had a workup at an endocrine weight loss center that was unrevealing.  She has actively been trying to lose weight with 18 pounds weight loss but is unable to lose more.  Liraglutide (0.6 milligram [mg] weekly) was ordered for weight loss.

Victoza was initially denied and a final adverse determination notice was issued.  The letters indicate that Victoza (liraglutide) was denied as not medically necessary for the patient's indication of morbid obesity.  

Appeal materials from the provider indicate that "standard health services or procedures have been ineffective or medically inappropriate."  Two peer reviewed articles are provided to support medical necessity of liraglutide in the setting of obesity from the International Journal of Obesity.

Yes, the proposed treatment is medically necessary.
Robust evidence exists to support the efficacy of liraglutide in weight loss for patients with morbid obesity who do not have concomitant diabetes.  One review of the literature identified six major randomized controlled trials of liraglutide in obese patients with and without diabetes, noting that the largest trial of 3731 overweight/obese non-type II diabetes mellitus (T2DM) showed a mean difference of 5.6 kilograms of weight loss at 56 weeks compared to placebo (Lin et al).  In a meta-analysis of 12 randomized controlled trials (including 8249 patients), liraglutide was found to be associated with a 3.5 kilogram weight loss compared to placebo without an increase in hypoglycemia.  Adverse events were not noted to be different than placebo (Barboza et al).  It is also noted that the Food and Drug Administration (FDA) has approved liraglutide under a different brand name for the treatment of obesity in adults without type II diabetes (FDA).  

This patient has morbid obesity with complications of severe osteoarthritis requiring surgical intervention that has been delayed due to need for additional weight loss pre-operatively.  The documentation reflects that the patient has tried and failed conservative management with diet.  She has lost some weight but is not at goal for surgery with conservative measures alone.  Based on this clinical presentation and the evidence supporting the efficacy and safety of liraglutide, the medication is medically necessary for this patient.

No, the health plan did not act reasonably, with sound medical judgment and in the best interest of the patient.
The health plan denied Victoza (liraglutide) as not medically necessary for the treatment of morbid obesity in this patient without a history of type II diabetes.  Multiple randomized controlled trials support the safe and effective use of liraglutide in the treatment of morbid obesity in patients both with and without type II diabetes.  The patient is morbidly obese with significant complications from obesity (osteoarthritis requiring surgery) and has been noted to have tried and failed lifestyle modification, which is the mainstay of primary therapy for obesity.  Additional weight loss is judged to be in the best interest of the patient, and treatment with liraglutide is a proven and safe treatment option.  Liraglutide is medically necessary.