For the first time, the Food and Drug Administration has approved a drug to treat agitation related to Alzheimer’s disease dementia. Patient advocates are hailing the news, but prescribing the drug, an antipsychotic, may put long-term care clinicians in a bind.
The approval, announced Thursday, is an added indication for Rexulti (brexpiprazole), which is also used for treating schizophrenia. In clinical trials, patients with dementia who took 2 mg or 3 mg daily showed a 31% greater reduction in the frequency of agitation symptoms compared with placebo at 12 weeks. Participants were aged 51 to 90 years.
The recommended target dose of the drug is 2 mg, which can be increased to 3 mg. Notably, Rexulti will retain a boxed warning for medications in this class explaining that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death, the FDA stated.
Prescribing antipsychotic drugs
Rexulti may find a spot in the long-term care clinician’s toolbox. Agitation related to dementia is among the most common causes for placement in skilled nursing facilities, assisted living communities and memory care communities and is a quality of life issue for facility residents. In a statement, the FDA called it one of the most “persistent, complex, stressful and costly aspects of care among patients with behavioral and psychological symptoms of dementia.”
Yet the decision to use antipsychotics can come with undesirable consequences for nursing facilities. They are required to report use of antipsychotics to the Centers for Medicare & Medicaid Services — except when treating schizophrenia, Huntington’s disease and Tourette syndrome. These data then are tied to public-facing quality measures as an incentive to reduce overreliance on the drugs.
This requirement can leave clinicians who treat nursing home residents for Alzheimer’s disease and other non-exempt conditions in an awkward spot: prescribe a drug like Rexulti and risk looking less responsible to consumers. The issue has become more urgent as more facilities admit residents with behavioral health issues, and new medications that can benefit residents are approved, experts told McKnight’s Long-Term Care News in March.
Quality measure review in store?
There are signs that CMS may be considering whether a broader quality measure is needed. The agency has confirmed to McKnight’s that it convened a technical expert panel, or TEP, in February to review whether more exemptions should be added to the measure. The panel’s findings have not yet been posted publicly.
In the meantime, the Alzheimer’s Association praised the newly approved indication for Rexulti. An estimated 45% of people who live with Alzheimer’s disease experience symptoms of agitation, it said in a statement.
“People living with moderate and severe Alzheimer’s and other dementia need and deserve treatment that improves the quality of their life, including effective treatments for behavioral and psychiatric symptoms associated with dementia,” said Nicole Purcell, DO, senior director of clinical practice.
A milestone for patients
The approval helps to fill an unmet need, said drugmaker Otsuka Pharmaceutical, which developed Rexulti with partner Lundbeck.
“Today marks a major milestone for patients, caregivers and families navigating the complexities of agitation associated with dementia due to Alzheimer’s disease,” Makoto Inoue, president and representative director of Otsuka said.