Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Obesity. 
Treatment: Qsymia (phentermine-topiramate extended-release). 
The insurer denied coverage for Qsymia (phentermine-topiramate extended-release). 
The denial is upheld. 

This is an adult diagnosed with obesity. The request is for Qsymia. As reported, the patient's body mass index (BMI) is 28.51 kilogram (kg) per square meter (m2) consistent with class overweight. The patient is reported to have tried at least 6 months of lifestyle modifications with no weight loss results. The patient's most recent weight was 82.6 kg; BMI was 28.51. The patient's previous weights were: 81.2 kg, 82.6 kg and 85.3 kg respectively. 

Qsymia is indicated for the treatment of obesity[1-6]. The Food and Drug Administration (FDA) label [7] is as follows: 

INDICATIONS AND USAGE: Qsymia is a combination of phentermine, a sympathomimetic amine anorectic, and topiramate extended-release, an antiepileptic drug, indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of: . 30 kg/meters squared (m2) or greater (obese) (1) or . 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbidity such as hypertension, type 2 diabetes mellitus, or dyslipidemia (1) Limitations of Use: . The effect of Qsymia on cardiovascular morbidity and mortality has not been established (1). . The safety and effectiveness of Qsymia in combination with other products intended for weight loss, including prescription and over the-counter drugs, and herbal preparations, have not been established (1). 

The patient has a BMI of 28.51 with a weight-related comorbidity of hyperlipidemia. However, there is no documentation of current participation in lifestyle modifications such as diet and exercise per the medical records. 

As per Up to Date "Individuals with a BMI between 25 and 29.9 kg/m2 and with one or more risk factors for cardiovascular disease (CVD) (diabetes, hypertension, dyslipidemia), or with a BMI of 30 to 34.9 kg/m2, are at moderate risk. Such patients should be offered or referred to intensive, multicomponent behavioral intervention [27]. This includes tools and strategies to make dietary changes, increase physical activity, and support and maintain weight loss. Pharmacologic therapy should also be considered." 

Up to Date also provides an example of Comprehensive lifestyle intervention. "One example of a successful comprehensive lifestyle intervention program is the Diabetes Prevention Program (DPP) [6], subsequently used in the Look AHEAD (Action for Health in Diabetes) study [22]. The two major goals of the DPP lifestyle intervention were a minimum of 7 percent weight loss through a low-fat, hypocaloric diet and a minimum of 150 minutes of exercise per week (such as brisk walking). Several behavioral components were used to help achieve these goals, including behavioral self-management training, individual case managers, group and/or individual sessions, individualized adherence strategies, and a network of training, feedback, and clinical support [29]. Using this approach, lifestyle intervention was more effective for preventing diabetes than a pharmacologic intervention." 

Finally with regard to drug therapy they state "Drug therapy is often a helpful component in the treatment regimen for people with obesity; it can be considered for those with a BMI >30 kg/m2, or a BMI of 27 to 29.9 kg/m2 with weight-related comorbidities, who have not met weight loss goals (loss of at least 5 percent of total body weight at three to six months) with a comprehensive lifestyle intervention." 

The request does not meet the standard of care and is therefore not medically necessary.  

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. The medical necessity for Qsymia (phentermine-topiramate extended-release) is not substantiated.