Appeal type: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Victoza (liraglutide) injection.Findings:  Two of the three physician reviewers found Victoza (liraglutide) injection is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Nonalcoholic fatty liver disease (NAFLD) ranges from the more benign condition of nonalcoholic fatty liver (NAFL) to NASH, which is at the more severe end of the spectrum. Weight loss is the primary therapy for most patients with NAFLD because weight loss can lead to improvement in liver biochemical tests, liver histology, serum insulin levels, and quality of life. Patients who are overweight or obese are advised to lose five to seven percent of body weight at a rate of one to two pounds weekly through lifestyle modifications including dietary therapy and exercise. Increasing physical activity has been linked to a survival benefit for patients with NAFLD. For patients with suspected or biopsy-proven NASH, the weight loss goal is seven to ten percent of body weight. All patients with NASH should undergo dietary counseling. Patients with NASH or advanced fibrosis may be referred for bariatric surgery if they do not meet their weight loss goals after six months of lifestyle interventions, including visits for nutritional counseling. Pharmacologic options for the treatment of obesity include semaglutide or liraglutide, orlistat, combination phentermine-extended release topiramate, combination extended-release bupropion-naltrexone, phentermine, benzphetamine, phendimetrazine, and diethylpropion. While randomized controlled trials appear to note that all active drug interventions are effective at reducing weight when compared with placebo, many of these trials have serious limitations including a short duration of study, high attrition rates, heterogeneity, and inadequate reporting of important clinical outcomes such as cardiovascular outcomes. There are few head-to-head trials comparing the individual therapies, and it is uncertain whether people who fail to respond to one therapy will respond to another. In this case, the provider is recommending liraglutide for the treatment of NAFLD, not specifically for obesity. The American Association for the Study of Liver Diseases (AASLD) practice guidance on the diagnosis and management of NAFLD states, It is premature to consider glucagon-like peptide-1 (GLP-1) agonists to specifically treat liver disease in patients with NAFLD or NASH. Therefore, Victoza (liraglutide) injection is not likely to be more beneficial for treatment of the patients condition than any available standard therapy.Final Result: The reviewers determined that the requested medication is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: Physician reviewers 1, 2, and 3 are board certified in internal medicine with sub-specialty certification in gastroenterology. The reviewers are experts 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.