Appeal type: Medical Necessity
Decision: Overturned Decision of Health Plan

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Saxenda. Findings: In this case, the records document that this patient has not responded well to treatment of obesity with phentermine, topiramate, and Wellbutrin. The provider noted that the patient was treated with phentermine with loss of 15 pounds but they regained the weight. The patient was subsequently treated with phentermine on two occasions with loss of 10 pounds followed by loss of three to four pounds. The patient has also been managed with a combination of Topamax and phentermine without significant weight loss. Treatment with Wellbutrin for depression resulted in weight gain. Therapeutic lifestyle changes including behavior modification, dietary restriction and increased physical activity are modalities for the treatment of patients with obesity, but weight loss is difficult to achieve and maintain. The treatment of obesity with weight loss medications can be considered when a patients body mass index (BMI) is 30 kg/m2 or greater or if the BMI is 27 or greater and with concomitant weight-related medical problems such hypertension, hyperlipidemia, glucose intolerance, diabetes mellitus, sleep apnea. One clinical study found that Saxenda resulted in a greater proportion of patients who lost at least 5-10% of their initial body weight compared to placebo. Successful weight loss involves maintenance of weight loss. The current medications approved for long-term use have been demonstrated to be effective in weight-loss maintenance, which is essential for long-term weight loss. In any patient, successful weight loss depends on treatment with medications that do not cause complications. The U.S. Food and Drug Administration (FDA) noted that treatment with Locaserin has a warning for use in patients with depression. Similarly, Contrave is not recommended for patients with depression. When this patient attempted treatment with Wellbutrin for depression, she gained weight. The patient is unlikely to respond well to Contrave, which is also contraindicated due to depression. The patient tolerated Saxenda without side effects and she lost 20 pounds, which is about 10% of their body weight. Furthermore, the patients prediabetes has resolved. Discontinuation of Saxenda is likely to result in regain of weight. Thus, long-term treatment with Saxenda is appropriate in this patient. Given these findings, the requested Saxenda is medically necessary for treatment of this patient. Final Result: The reviewer determined that the requested medication is medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: The reviewer is board certified in internal medicine with subspecialty certification in endocrinology, diabetes, and metabolism and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.