Xenical denials in California external review

What the reviewers wrote

Where the denial was overturned

Findings: The physician reviewer found that an enrollee has requested authorization and coverage for Xenical (orlistat capsule 120 mg). The Health Plan has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollee’s obesity. At issue in this case is whether the requested medication Xenical (orlistat capsule 120mg) is medically necessary for treatment of the enrollee’s medical condition.According to the FDA, Xenical is approved as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, dyslipidemia).

Nature of Statutory Criteria/Case Summary: The patient requested authorization and coverage for the Xenical capsules.Obesity and its repercussions constitute an important source of morbidity, impaired quality of life and its complications can have a major bearing on life expectancy. Xenical (orlistat) was approved as a prescription product by the U.S. Food and Drug Administration (FDA) in 1999 for obesity management in conjunction with a reduced caloric diet, and to reduce the risk of regaining weight after prior weight loss. Xenical is indicated for patients with a body mass index (BMI) of at least 30 kg/m2 or 28 kg/m2 in the presence of obesity-associated complications, such as hypertension, diabetes mellitus, hyperlipidemia, and obstructive sleep apnea (OSA).

Where the denial was upheld

The patient is a 57-year-old male with depression and migraine headaches. He reports a recent weight gain of 30 pounds. The patient’s medical therapy includes, Cymbalta, Wellbutrin, lithium, Ritalin, Neurontin, Propecia, Provigil, Xenical, Ativan, Zyprexa and Ambien. He would like to lose the weight he has gained, and has reportedly had good results with Xenical in the past. The patient’s request for authorization of Xenical was denied by the Health Plan based upon a determination that the medication is not medically necessary.There is no medical indication for Xenical therapy at this time. The record does not suggest that the patient has failed to lose weight with dietary management or a simple exercise program. He stated that he could not participate in an exercise program, but did not fully explain why or describe unsuccessful dietary changes he had made.

The patient is a 53-year-old female with a history of obesity (5’5” and weighing 189 pounds with a body mass index of 31), and tendonitis. She has no documented history of diabetes, sleep apnea, hyperlipidemia, hypertension or arthritis. The patient has requested authorization and coverage for the medication Xenical. The Health Plan has denied this request indicating the requested medication is not medically necessary for treatment of the patient’s obesity.The Health Plan’s denial should be upheld. With a BMI of 31 and no significant comorbid conditions, the patient does not meet medical necessity criteria for Xenical. Additionally, there has been no submitted documentation indicating the patient has tried and failed lifestyle interventions such as diets, exercise programs, or behavior modification for weight control.

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