Interventions of Interest:
- mavacamten (Camzyos™, MyoKardia and Bristol-Myers Squibb)
Concerns about long-term safety influenced majority of independent appraisal committee to vote that evidence is not currently adequate to demonstrate a net health benefit of mavacamten added to background therapy. Using estimates from modeling of short-term benefits, mavacamten does show an overall benefit but would have to be priced below $15,000 per year to reach common thresholds for cost-effectiveness.
Recommendations on appropriate insurance coverage support an evidence-based requirement for patients to be adequately treated with background therapy prior to consideration of mavacamten, but highlight reasons that formal step therapy through disopyramide, septal ablation, or myectomy would not be reasonable
ICER’s Chief Medical Officer David Rind, MD stated:
“Hypertrophic cardiomyopathy is a genetic disorder of the heart muscle that can cause shortness of breath and chest pain, and also arrhythmias that can result in strokes or even sudden death. The evidence suggests that mavacamten may deliver important health benefits for patients with a lower rate of side effects than seen with some other medications for HCM, but clinical experts differ in their opinions about the long-term clinical implications of mavacamten reducing left ventricular ejection fraction in some patients. Additional safety data are needed to resolve these issues.”