TY - JOUR
T1 - Adapting prescribing criteria for amyloid-targeted antibodies for adults with Down syndrome
AU - Hillerstrom, Hampus
AU - Fisher, Richard
AU - Janicki, Matthew P.
AU - Chicoine, Brian
AU - Christian, Bradley T.
AU - Esbensen, Anna
AU - Esralew, Lucille
AU - Fortea, Juan
AU - Hartley, Sigan
AU - Hassenstab, Jason
AU - Keller, Seth M.
AU - Krinsky-McHale, Sharon
AU - Lai, Florence
AU - Levin, Johannes
AU - McCarron, Mary
AU - McDade, Eric
AU - Rebillat, Anne Sophie
AU - Rosas, Herminia Diana
AU - Silverman, Wayne
AU - Strydom, Andre
AU - Zaman, Shahid H.
AU - Zetterberg, Henrik
N1 - Publisher Copyright:
© 2024 The Authors. Alzheimer's & Dementia published by Wiley Periodicals LLC on behalf of Alzheimer's Association.
PY - 2024/5
Y1 - 2024/5
N2 - Prior 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.
AB - Prior 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.
KW - Alzheimer's disease
KW - anti-amyloid immunotherapeutics
KW - dementia
KW - Down syndrome
KW - drug formularies
KW - prescribing criteria
UR - http://www.scopus.com/inward/record.url?scp=85188076047&partnerID=8YFLogxK
U2 - 10.1002/alz.13778
DO - 10.1002/alz.13778
M3 - Article
C2 - 38480678
AN - SCOPUS:85188076047
SN - 1552-5260
VL - 20
SP - 3649
EP - 3656
JO - Alzheimer's and Dementia
JF - Alzheimer's and Dementia
IS - 5
ER -