Considering challenges for the new Alzheimer's drugs: Clinical, population, and health system perspectives.

Recent approvals of amyloid immunotherapy drugs for early Alzheimer's disease (AD) have been highly controversial. In this piece, we consider challenges from the clinical, population health, and health systems perspectives to the role that the new AD drugs might be expected to play, now and in the future, in alleviating the morbidity caused by AD in the population. Clinically, short-term effects are small, adverse events are frequent, treatment regimens are burdensome, and, crucially, long-term effects are unknown. At a population level, there is always likely to be a trade-off between breadth of access and magnitude of benefit for any given individual. At a health system level, roll out of treatment even for only narrowly-defined patient groups will involve considerable resources to identify and treat eligible patients, with profound opportunity costs. Our considered view on current evidence is that there are challenges from each perspective to imagining a foreseeable future in which amyloid immunotherapy significantly alleviates AD morbidity at scale. HIGHLIGHTS: Recent approvals of Alzheimer's drugs have met with excitement but also controversy. Trial effects are small, adverse effects concerning, and long-term effects unknown. Results from trial cohorts may not generalize to broader, more complex patients. Significant resource requirements of eligibility assessment and drug administration. Use in "presymptomatic" populations is not supported by current evidence.