Adapting prescribing criteria for amyloid-targeted antibodies for adults with Down syndrome
Hillerstrom, Hampus (LuMind IDSC Foundation)
Fisher, Richard (LuMind IDSC Foundation)
Janicki, Matthew P. (National Task Group on Intellectual Disabilities and Dementia Practices)
Chicoine, Brian (Advocate Lutheran General Hospital Family Medicine Residency)
Christian, Bradley T. (University of Wisconsin)
Esbensen, Anna (Children's Hospital)
Esralew, Lucille (California Department of Developmental Services)
Fortea, Juan (Institut de Recerca Sant Pau)
Hartley, Sigan (University of Wisconsin)
Hassenstab, Jason (Washington University)
Keller, Seth M. (Neurology Associates of South Jersey)
Krinsky-McHale, Sharon (New York State Institute for Basic Research in Developmental Disabilities)
Lai, Florence (Massachusetts General Hospital (Boston))
Levin, Johannes (Sahgrenska University Hospital)
McCarron, Mary (University of Dublin)
McDade, Eric (Washington University)
Rebillat, Anne-Sophie (Institut Jerome Lejeune)
Rosas, Herminia Diana (Harvard Medical School)
Silverman, Wayne (University of California Irvine)
Strydom, Andre (King's College London. Institute of Psychiatry, Psychology and Neuroscience)
Zaman, Shahid (Cambridge University)
Zetterberg, Henrik (Munich Cluster for Systems Neurology (SyNergy))
Universitat Autònoma de Barcelona

Data:	2024
Resum:	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.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Alzheimer's disease ; Anti-amyloid immunotherapeutics ; Dementia ; Down syndrome ; Drug formularies ; Prescribing criteria
Publicat a:	Alzheimer's & dementia, Vol. 20 Núm. 5 (may 2024) , p. 3649-3656, ISSN 1552-5279

DOI: 10.1002/alz.13778
PMID: 38480678

8 p, 245.4 KB

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