Adapting prescribing criteria for amyloid‐targeted antibodies for adults with Down syndrome

• DOI: 10.1002/alz.13778
• Publication Date: 2024-03-14T04:40:40Z
• Authors: Hampus Hillerstrom; Richard Fisher; Matthew P. Janicki; Brian Chicoine; Bradley T. Christian; Anna Esbensen; Lucille Esralew; Juan Fortea; Sigan Hartley; Jason Hassenstab; Seth M. Keller; Sharon Krinsky‐Mc...; Florence Lai; Johannes Levin; Mary McCarron; Eric McDade; Anne Sophie Rebillat; Herminia Diana Rosas; Wayne Silverman; Andre Strydom; Shahid H. Zaman; Henrik Zetterberg
• Keywords: Adult; methods [Immunotherapy]; Drug formularies; Prescribing criteria; anti‐amyloid immunotherapeutics; Family Medicine; Anti-amyloid immunotherapeutics; Down syndrome; Alzheimer's disease; Down syndrome; anti-amyloid immunotherapeutics; dementia; drug formularies; prescribing criteria; anti-amyloid immunotherapeutics; 618; Pharmacy and Pharmacology; Alzheimer Disease; 616; drug therapy [Alzheimer Disease]; Humans; ddc:610; prescribing criteria; drug formularies; Antibodies, Monoclonal; Alzheimer's disease; Alzheimer’s disease, anti-amyloid immunotherapeutics, dementia, Down syndrome, drug formularies, prescribing criteria; United States; Ageing; Neurology; Perspective; Dementia; Immunotherapy; Down Syndrome; Alzheimer’s disease; therapeutic use [Antibodies, Monoclonal]; Advocate Family Medicine Faculty - Lutheran General; dementia

AbstractPrior authorization criteria for Federal Drug Administration (FDA) approved immunotherapeutics, among the class of anti‐amyloid monoclonal antibodies (mAbs), established by state drug formulary committees, are tailored for adults with late‐onset Alzheimer's disease. This overlooks adults with Down syndrome (DS), who often experience dementia at a younger age and with different diagnostic assessment outcomes. This exclusion may deny DS adults access to potential disease‐modifying treatments. To address this issue, an international expert panel convened to establish adaptations of prescribing criteria suitable for DS patients and parameters for access to Centers for Medicare & Medicaid Services (CMS) registries. The panel proposed mitigating disparities by modifying CMS and payer criteria to account for younger onset age, using alternative language and assessment instruments validated for cognitive decline in the DS population. The panel also recommended enhancing prescribing clinicians' diagnostic capabilities for DS and initiated awareness‐raising activities within healthcare organizations. These efforts facilitated discussions with federal officials, aimed at achieving equity in access to anti‐amyloid immunotherapeutics, with implications for national authorities worldwide evaluating these and other new disease‐modifying therapeutics for Alzheimer's disease.