CADTH Reimbursement Recommendation - Setmelanotide (Imcivree) - Indication: For weight management in adult and pediatric patients 6 years of

Considerations for the initiation of therapy The patients included in the pivotal trial had a clinical The experts noted that although the majority of patients do pursue diagnosis of BBS. [...] However, the sample sizes were small and the 95% CI of the difference was very wide and included the null value in the cases of the percent change in hunger over 24 hours, mean change in morning hunger, and percent change in morning hunger. [...] • Ethical considerations in the context of BBS highlighted the significant physical, emotional, and psychosocial burden of living with, and attending to, BBS (and, more specifically, BBS-related obesity and hyperphagia) for patients and their caregivers; diagnostic challenges due to the heterogenous nature of BBS and the progressive onset of some of its clinical features (i.e., vision loss); chall. [...] • Clinical trial evidence regarding the effect of setmelanotide on weight, hyperphagia, and quality of life is generally supportive of improvements to patient outcomes, but there is uncertainty around the durability and magnitude of effect and safety that limits the ability to make definitive statements on the benefits, harms, or cost-effectiveness of setmelanotide. [...] This disclaimer and any questions or matters of any nature arising from or relating to the content or use (or misuse) of this document will be governed by and interpreted in accordance with the laws of the Province of Ontario and the laws of Canada applicable therein, and all proceedings shall be subject to the exclusive jurisdiction of the courts of the Province of Ontario, Canada.