Diagnosis: Type 2 Diabetes Mellitus Treatment: Qsymia (phentermine-topiramate) The insurer is denied coverage for Qsymia (phentermine-topiramate). The denial is overturned. This female patient has a history of type 2 diabetes mellitus, hyperlipidemia and morbid obesity (status post lap band surgery over 10 years ago). She has taken Saxenda for more than a year and lost 5% of her body weight initially. Based on a review of phentermine-topiramate in Up to Date: "In 2012, the US Food and Drug Administration (FDA) approved the preparation of phentermine and extended-release topiramate (in one capsule) for adults with a body mass index (BMI) greater than or equal to 30 kg/m2 [kilograms per square meter] or with a BMI greater than or equal to 27 kg/m2 with at least one weight-related comorbidity (eg, hypertension, diabetes, dyslipidemia) called Qsymia (phentermine-topiramate). It is not recommended to use phentermine-topiramate for patients with cardiovascular disease (hypertension or coronary heart disease). Phentermine-topiramate may be considered for individuals with obesity who do not have cardiovascular disease, particularly those who do not tolerate orlistat or liraglutide." Note that this patient is on liraglutide-Saxenda with inadequate weight loss. Furthermore, as per Up to Date "A combination of controlled-release phentermine-topiramate (7.5/46 mg [milligrams] or 15/92 mg) was compared with placebo in 2487 adults with body mass index (BMI) of 27 to 45 kg/m2 and two or more comorbidities. After one year, mean weight loss was greater in those assigned to active treatment (8 to 10 versus 1.4 kg with placebo [8 to 10 percent versus 1.2 percent of baseline body weight]). Only 61 percent of participants completed one year of treatment. In a 52-week extension of the above trial (78 percent of eligible subjects participating), mean total weight loss (from baseline to 108 weeks) was significantly better than placebo (9.6, 10.9, and 2.1 kg [9.3, 10.5, and 1.8 percent of baseline body weight] for low dose, high dose, and placebo, respectively). Of note, phentermine-topiramate was less effective for weight loss in the second year of use, although most individuals were able to maintain the weight they lost in year 1. In those subjects who were able to participate in the second year of the trial, the therapy was well tolerated. In another trial, patients with BMI greater than or equal to 35 kg/m2 were randomly assigned to controlled-release phentermine-topiramate (3.75/23 mg or 15/92 mg) or placebo. After 56 weeks, mean weight loss was greater in the active treatment groups (mean reduction 6, 12.6, and 1.9 kg [5.1, 10.9, and 1.6 percent of baseline body weight]). Among those assigned to active treatment, 45 to 67 percent lost at least 5 percent of baseline weight compared with 17 percent of placebo patients." This patient as noted has been on Saxenda with limited weight loss. Initiation of Qsymia has not resulted in 3% weight loss. She has been on 7.5/46 mg dose without losing 3% of her weight. Thus, escalation to the next higher dose is consistent with the Food and drug Administration (FDA) recommended dosing schedule. The requested drug is likely to produce a more clinically beneficial outcome. The health plan did not act reasonably, with sound medical judgment, or in the best interest of the patient. The insurer's denial of coverage for request for formulary exception for Qsymia (phentermine-topiramate) is overturned. Medical necessity is substantiated.

1) http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022580s000lbl… (Accessed on July 18, 2012). 2) Obesity in Adults: Drug Therapy. Up to Date. April 2021.