Inaccurate Characterization of Scientific Evidence

ICER has mis-characterized the ARIA-E and ARIA-H data and mis- interpreted the weight given to it compared with the potential benefits of the therapy. [...] ICER notes that 41.3% of participants experienced ARIA-E and ARIA-H compared with 10.3% in the placebo arm; that 74.0% of ARIA-E cases in the high-dose aducanumab arm and 89.7% of cases in the placebo arm were asymptomatic; and that most ARIA-E symptoms and MRI findings were mild or moderate in severity and transient (98% resolved) in the high-dose aducanumab arm. [...] The FDA’s rigorous review of any potential treatment significantly weights the safety but does so in the context of the full data package and in the context of expert guidance. [...] Failure to Account for True Value The misunderstanding and misrepresentation of the scientific evidence surrounding aducanumab has a dramatic effect on ICER’s assumption of the value attributed to the drug, as measured by the assumed QALY gain. [...] For example, approval and coverage of the first reductase inhibitor for lowering LDL cholesterol--and thus delaying the onset of heart disease, the leading cause of death in the United States--spurred the development of at least six additional therapies.