- Analyses indicate ongoing need for approved
treatments with favorable benefit-risk profile for treating
patients with dementia-related hallucinations and delusions
Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) announced today that
three data presentations featuring new analyses of Medicare claims
data on dementia-related psychosis (DRP) outcomes were presented at
Psych Congress 2021, held virtually and in-person October
29-November 1, 2021 in San Antonio, TX. The presentations
demonstrate the suboptimal outcomes associated with the off-label
use of currently available atypical antipsychotic treatments in
managing dementia-related hallucinations and delusions, along with
the related cost burdens.
“The suboptimal outcomes and costs associated with off-label use
of dopaminergic atypical antipsychotics underscore the challenges
health care providers face in appropriately treating patients with
dementia-related psychosis, including hallucinations and
delusions,” said Ponni Subbiah, M.D., M.P.H., Senior Vice
President, Global Head of Medical Affairs and Chief Medical Officer
at Acadia.
Details of the posters presented are as follows:
Poster: Treatment Emergent Adverse Events and
Associated Adverse Event-Specific Per-Patient-Per-Year Costs:
Analysis of Medicare Beneficiaries Treated with Off-Label Atypical
Antipsychotics for Dementia-Related Psychosis: Data from a
Medicare claims analysis of 23,267 patients with dementia-related
psychosis initiating atypical antipsychotic monotherapy from
January 2014 through December 2017 showed that over 70% had one or
more adverse events (AEs) within one year, with 64% experiencing
dyslipidemia, 50% experiencing peripheral vascular disease (PVD)
and 40% experiencing cerebrovascular adverse events (CVAEs) such as
stroke and transient ischemic attacks. Median per-patient-per-year
(PPPY) costs of hyperlipidemia, PVD, and CVAE were $5,565, $227 and
$3,682, respectively.
Poster: Incremental Cost of Treatment Emergent
Falls/Fractures, Stroke and Cerebrovascular Adverse Events Among
Patients on Atypical Antipsychotics: Analysis of Medicare Patients
with Dementia-Related Psychosis: A Medicare claims analysis of
23,267 treated DRP patients showed approximately one in five
patients experienced falls/fractures or stroke (23% and 17%,
respectively) while nearly two in five patients (38%) experienced
other CVAEs including stroke or transient ischemic attacks. The
incremental median annual total costs were significantly higher
among patients with AEs compared to those without AEs after
treatment initiation for falls or fractures ($70,932 vs. $44,221),
CVAE ($68,308 vs. $40,061) and stroke ($74,234 vs. $45,999). These
results suggest that patients experiencing these AEs had over 60%
higher total annual costs compared with those who did not
experience the AEs (p<0.05).
Poster: Incremental Cost of Suboptimal Treatment Outcomes
Among Patients with Dementia-Related Psychosis: Analysis of
Medicare Beneficiaries: An analysis of Medicare claims of
35,100 atypical antipsychotic new start patients with DRP found
that nearly two out of three patients experienced at least one
suboptimal treatment outcomes (e.g., treatment augmentation,
discontinuation or psychosis-specific hospitalizations). Median
annual total costs were nearly two times higher ($29,898) among
patients with suboptimal outcomes compared with patients who did
not experience suboptimal outcomes ($14,158; p<0.05). Total
costs also doubled or quadrupled with the occurrence of two or more
or four or more suboptimal outcome-events, respectively.
About Dementia-Related Psychosis
Approximately 8 million people in the United States are living
with dementia, a condition with a core feature of declining
cognition (changes in memory, decision-making abilities, language,
etc.) resulting in functional impairment. Dementia is a
manifestation of an underlying condition which is often progressive
and neurodegenerative in nature.1 In addition to cognitive decline,
dementing illnesses almost universally lead to neuropsychiatric
symptoms, which may include hallucinations, delusions, and changes
in behavior.
It is estimated that 2.4 million Americans (or 30% of people
with dementia) experience dementia-related hallucinations and
delusions.2,3 These symptoms may be frequent and severe and may
recur over time. A hallucination is defined as a perception-like
experience that occurs without an external stimulus and is sensory
(seen, heard, felt, tasted, sensed) in nature. A delusion is
defined as a false, fixed belief that is resolutely held despite
evidence to the contrary. Dementia-related psychosis occurs in many
types of dementia, including Alzheimer’s disease, dementia with
Lewy bodies, Parkinson’s disease dementia, vascular dementia, and
frontotemporal dementia. Serious consequences have been associated
with psychosis in patients with dementia, such as repeated hospital
admissions, increased likelihood of nursing home placement, faster
progression of dementia, and increased risk of morbidity and
mortality.4
About Acadia Pharmaceuticals
Acadia is trailblazing breakthroughs in neuroscience to elevate
life. For more than 25 years we have been working at the forefront
of healthcare to bring vital solutions to people who need them
most. We developed and commercialized the first and only approved
therapy for hallucinations and delusions associated with
Parkinson’s disease psychosis. Our late-stage development efforts
are focused on dementia-related psychosis, negative symptoms of
schizophrenia and Rett syndrome, and in early-stage clinical
research we are exploring novel approaches to pain management, and
cognition and neuropsychiatric symptoms in central nervous system
disorders. For more information, visit us at www.acadia-pharm.com
and follow us on LinkedIn and Twitter.
Forward-Looking Statements
Statements in this press release that are not strictly
historical in nature are forward-looking statements. These
statements include but are not limited to statements regarding the
timing of future events. These statements are only predictions
based on current information and expectations and involve a number
of risks and uncertainties. Actual events or results may differ
materially from those projected in any of such statements due to
various factors, including the risks and uncertainties inherent in
drug development, approval and commercialization. For a discussion
of these and other factors, please refer to Acadia’s annual report
on Form 10-K for the year ended December 31, 2020 as well as
Acadia’s subsequent filings with the Securities and Exchange
Commission. You are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof.
This caution is made under the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995. All
forward-looking statements are qualified in their entirety by this
cautionary statement and Acadia undertakes no obligation to revise
or update this press release to reflect events or circumstances
after the date hereof, except as required by law.
References
1Dementia. (2019, September 19). Retrieved from
https://www.who.int/news-room/fact-sheets/detail/dementia.
2Plassman BL, et al. Prevalence of dementia in the United States:
The Aging Demographics, and Memory study. Neuroepidemiology.
2007;29(1-2):125-132. 32017 Alzheimer’s Disease Facts and Figures
and Acadia market research. 4Connors MH et al. Am J Geriatr
Psychiatry 2018;26(3). Peters ME et al. Am J Psychiatry
2015;172(5). Haupt M et al. Int J Geriatr Psychiatry 1996;11(11).
Naimark D et al. J Am Geriatr Soc 1996;44(3). Stern Y et al.
Neurology 1994;44(12).
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Media Contact: Acadia Pharmaceuticals Inc. Deb Kazenelson (818)
395-3043 media@acadia-pharm.com
Investor Contact: Acadia Pharmaceuticals Inc. Mark Johnson, CFA
(858) 261-2771 ir@acadia-pharm.com
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