Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Type 2 diabetes mellitus (DM).

Treatment Saxenda (liraglutide).

The insurer denied coverage for Saxenda (liraglutide).

The denial is upheld.

This is the case of a female patient diagnosed with Type 2 diabetes mellitus (DM). She has a history of gastric sleeve, with initial weight loss. She has been on and off Saxenda. It is noted she continued to make poor food choices and likes to snack. The patient has been taking this medication since, however, she has not lost four percent (%) of her body weight. She is requesting the plan's approval for the use of Saxenda.

"Evaluate the change in body weight 16 weeks after initiating Saxenda and discontinue Saxenda if the patient has not lost at least 4% of baseline body weight, since it is unlikely that the patient will achieve and sustain clinically meaningful weight loss with continued treatment." (Saxenda Package Insert)

Currently there are four other Food and Drug Administration (FDA) approved long-term weight loss agent's orlistat, lorcaserin, and fixeddose combinations of phentermine/topiramate and naltrexone/bupropion. All the above mentioned FDA approved weight lowering agents have been shown to cause clinically significant weight loss of at least 5% of initial body weight when used as an adjunct to lifestyle interventions. However, the degree of weight loss over a period of 1 year is variable. A recent network metaanalysis comparing the effectiveness of these five medications demonstrated that liraglutide was one of two medications associated with the highest odds of achieving at least 5% weight loss as compared with placebo. Liraglutide had higher odds of achieving at least 5% weight loss at one year in clinical trials, than with lorcaserin or orlistat, similar odds as compared with naltrexone/bupropion, and slightly lower odds as compared with phentermine/topiramate.

Guidelines from the American Heart Association (AHA)/ American College of Cardiology (ACC)/ The Obesity Society recommend using a multifactorial approach to manage obesity. This includes initiation of comprehensive lifestyle intervention programs and pharmacotherapy in individuals with body mass index (BMI) 30 kg/m2 [kilograms meters squared] or 27 kg/m2 with comorbid conditions like type 2 diabetes, hypertension, dyslipidemia, or obstructive sleep apnea if lifestyle modification alone is not effective." (Mehta, A. et al. 2017)

In this study, 3.0 mg (milligram) of liraglutide, as an adjunct to diet and exercise, was associated with reduced body weight and improved metabolic control." (Pi-Sunyer, X. et al. 2015)   

The use of Saxenda is not considered medically necessary. It is noted this patient has been on therapy but has not obtained weight loss of four percent of her body weight. The plan's criteria for coverage is in line with the FDA approved package labeling indicating the medication should be discontinued without proven effectiveness of the medication. Therefore, the request for Saxenda is not proven to be medically necessary at this time.                                   

The health care plan did act reasonably, with sound medical judgment, and in the best interest of the patient. 

The denial of Saxenda is appropriate in this patient's clinical scenario. Criteria for coverage states the patient should demonstrate effectiveness of the medication for continuation of coverage, which is appropriate.        

The insurer's denial of coverage for Saxenda (liraglutide) is upheld. Medical necessity is not substantiated.