Determining the Utilization, Cost, and Safety of Antipsychotics Among the Elderly with Dementia Post-Brexpiprazole Approval for Agitation in Alzheimer's Disease - Project Summary The management of behavioral symptoms is a common and challenging aspect of care in older adults with Alzheimer's disease and Alzheimer's disease-related dementias (AD/ADRD). Ensuring safe and effective treatment is a top priority to improve patients' quality of life, alleviate caregiver burden, and support longer community living. Practice guidelines recommend non-pharmacological interventions, such as caregiver education and psychosocial interventions, as a first step. If symptoms persist, medications may be considered. Antipsychotics have been commonly used off-label to manage behavioral symptoms in people with AD/ADRD, despite none being FDA-approved for this indication until recently. In May 2023, brexpiprazole, initially approved by the FDA in 2015 for treating schizophrenia and as an adjunctive therapy to antidepressants for major depressive disorder, received supplemental approval for treating agitation associated with dementia due to AD. The availability of this first FDA-approved pharmacological option may have several implications. Brexpiprazole, the sole approved antipsychotic for treating agitation in individuals with AD in the US, is likely to emerge as a highly favored pharmacological therapy, resulting in heightened utilization among people with AD/ADRD, not limiting to AD. Furthermore, the FDA approval might impact clinical practice regarding the prescription of antipsychotics for older adults across various specialties, probably making non-psychiatrist providers more inclined to prescribe antipsychotics for this population. As a result, overall antipsychotic prescriptions may potentially increase, reversing years of federal and state efforts aimed at reducing widespread antipsychotic use among elderly individuals, especially in nursing homes. If brexpiprazole is likely to replace older, commonly used, and inexpensive antipsychotics, the expenditure on antipsychotics in this population may significantly rise, particularly in the absence of a commercially available generic version. Importantly, like other antipsychotics, brexpiprazole still carries a “boxed warning” for the increased risk of mortality and clinical trials were based on predominantly White (95%) participants. Furthermore, brexpiprazole is not intended for `as needed' use but rather a daily maintenance strategy, with titration taking two weeks to reach the recommended dose without an established optimal treatment duration, potentially leading to increased long-term use. Hence, it is crucial to assess safety outcomes involving diverse populations through an extended follow-up period in real-world settings. Our overarching objective is to determine the impact of the first FDA-approved antipsychotic medication to treat agitation associated with AD with three specific aims focusing on: i) utilization, ii) financial burden, and iii) long-term safety outcomes of antipsychotics among Medicare beneficiaries with AD/ADRD in Texas. This state-level analysis will provide timely and informative insights into antipsychotic use in the era of brexpiprazole's approval for stakeholders in Texas, and expected outcomes will serve as the foundation for future national-level research endeavors.
