Innovative Pharmacotherapy In Alzheimer's Disease: Facilitating Access As Well As Approval

Regulatory approval for a novel therapeutic targeting one or more phenotypes of Alzheimer’s disease (AD) is necessary but insufficient for ensuring both adoption and patient access. The mosaic of stakeholders influencing adoption and patient access—both before and after the approval process—extends across commercial and government organizations and involves groups ranging from payers and health care providers to patients, their family members, and interested advocacy groups, all of whom require access to diverse information to enable informed health care decisions. Consequently, in parallel with the generation of efficacy and safety data required for product registration, an innovator must also create a portfolio of evidence supporting the value proposition of a new chemical, biological, or advanced therapy medicinal product (ATMP) in terms that address the real-world needs and concerns of this broader set of active and engaged stakeholders.