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

Hampus Hillerstrom, LuMind IDSC Foundation, Burlington, Massachusetts, USA.
Richard Fisher, LuMind IDSC Foundation, Burlington, Massachusetts, USA.
Matthew P. Janicki, Department of Disability and Human Development, University of Illinois Chicago, Chicago, Illinois, USA.
Brian Chicoine, Advocate Health - MidwestFollow
Bradley T. Christian, Waisman Center IDDRC, University of Wisconsin, Madison, Wisconsin, USA.
Anna Esbensen, Division of Developmental and Behavioral Pediatrics, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati Children's Hospital, Cincinnati, Ohio, USA.
Lucille Esralew, California Department of Developmental Services, Sacramento, California, USA.
Juan Fortea, Biomedical Research Institute Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain.
Sigan Hartley, Waisman Center IDDRC, University of Wisconsin, Madison, Wisconsin, USA.
Jason Hassenstab, Departments of Neurology and Psychological & Brain Sciences, Knight Alzheimer Disease Research Center, Washington University, St. Louis, Missouri, USA.
Seth M. Keller, National Task Group on Intellectual Disabilities and Dementia Practices, Rockport, Maine, USA.
Sharon Krinsky-McHale, Department of Psychology, New York State Institute for Basic Research in Developmental Disabilities, Island, New York, USA.
Florence Lai, MGH Neurology Research, Mass General Brigham Hospital, Massachusetts General Hospital, Boston, Massachusetts, USA.
Johannes Levin, Department of Neurology & German Center of Neurodegenerative Diseases (DZNE) e.V., Ludwig-Maximilians University, Munich, Germany.
Mary McCarron, Trinity Centre for Ageing and Intellectual Disability, Trinity College, University of Dublin, Dublin, Ireland.
Eric McDade, Departments of Neurology and Psychological & Brain Sciences, Knight Alzheimer Disease Research Center, Washington University, St. Louis, Missouri, USA.
Anne Sophie Rebillat, Outpatient Department, Institut Jerome Lejeune, Paris, France.
Herminia Diana Rosas, MGH Neurology Research, Mass General Brigham Hospital, Massachusetts General Hospital, Boston, Massachusetts, USA.
Wayne Silverman, Department of Pediatrics, University of California Irvine, Irvine, California, USA.
Andre Strydom, Institute of Psychiatry, Psychology and Neuroscience, Kings College, London, UK.
Shahid H. Zaman, Department of Psychiatry, Cambridge Intellectual and Developmental Disabilities Research Group, Cambridge University, Cambridge, UK.
Henrik Zetterberg, Institute for Stroke and Dementia Research, Sahlgrenska Academy at the University of Gothenburg, Molndal, Sweden.

Affiliations

Advocate Lutheran General Hospital

Abstract

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.

Type

Article

PubMed ID

38480678

Teammate Access


 

Share

COinS