Rybelsus denials in California external review

What the reviewers wrote

Where the denial was overturned

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: A patient has requested authorization and coverage for Rybelsus® tablets. Latent autoimmune diabetes of adulthood (LADA) is characterized by slow autoimmune damage of pancreatic beta cells without insulin treatment in the early clinical stage. The progression of autoimmune pancreatic beta cell destruction in LADA is slower than in classical type 1 diabetes, providing a wider window of opportunities for intervention. Some patients with LADA retain beta cell function and are consequently treated as non-insulin-dependent type 2 diabetics. Therefore, all currently available therapies for the management of type 2 diabetes can be utilized for the treatment of LADA, as necessary. The U.S.

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Rybelsus 7 mg tablet, at a quantity of 30 over 30 days. While lifestyle modification is recommended as the cornerstone of obesity management, many patients do not achieve long-lasting benefits due to difficulty with adherence as well as physiological and neurohormonal adaptation of the body in response to weight loss. Multiple pharmacologic therapies are available for weight management. Rybelsus is a member of a class of medications known as glucagon-like peptide-1 (GLP-1) analogs. As noted in the medical literature, GLP-1 analogs have been shown to improve glycemic control, reduce body weight and decrease cardiovascular risk. Studies have demonstrated Rybelsus’ ability to promote weight loss via reduced appetite and energy intake and delayed gastric emptying.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Rybelsus tablet 14 mg. Prediabetes is a precursor to type 2 diabetes, a disease highly associated with microvascular and macrovascular disease. Patients with prediabetes have a higher average sugar than normal but not as high as those with diabetes. For patients with prediabetes, the American Association of Clinical Endocrinology (AACE) recommends lifestyle changes. Medications for obesity are recommended for patients with a body mass index (BMI) over 27 kg/m2 such as phentermine/topiramate ER, liraglutide, or weekly semaglutide.

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Rybelsus. The American Association of Clinical Endocrinologists (AACE) emphasized the fact that “excessive adiposity can become dysfunctional and predispose the individual to the development of many medical complications including diabetes mellitus and non-alcoholic fatty liver, in addition, it does support the medical therapy of obesity as it increases the risk of multiple chronic diseases. Pharmacotherapy is recommended for weight loss for patients with a BMI of 30 kg/m2 or greater, or a BMI of 27 kg/m2 or greater with adiposity-related complications, to be taken in conjunction with medical nutrition therapy, physical activity, and psychological interventions.

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