September 22, 2023
Earlier this year, the FDA expanded the list of approved indications for brexpiprazole (Rexulti®) to include the treatment of dementia-related agitation due to Alzheimer’s disease, making it the first antipsychotic (or any drug class for that matter) to gain FDA approval for treating agitation in patients with any type of dementia. Despite its new approval, brexpiprazole will retain the same boxed warning as all other antipsychotics stating that elderly patients with dementia who receive antipsychotic drugs are at increased risk of death.
Antipsychotics have long been prescribed off-label (i.e., not FDA approved) to manage dementia-related agitation, specifically when symptoms are severe enough that it’s deemed that their possible benefits outweigh the known risks. Now that there’s an FDA approved option, prescribers are highly likely to gravitate in that direction. In a survey of healthcare providers, more than 80% said that it’s important to them that the drug they’re prescribing for a particular indication is FDA approved. In other words, if you haven’t yet encountered a hospice patient with dementia on brexpiprazole, get ready – you will.
The Centers for Medicare and Medicaid Services (CMS) expect hospices to pay for medications that are “related” to patients’ terminal illnesses. Clearly, when an antipsychotic is prescribed to manage agitation due to dementia its use is “related” to dementia. That said, if you want specific guidance, CMS notified hospices that antipsychotics are to be covered for patients with cerebral degenerative conditions in their 2016 and 2017 wage indexes.
Unsurprisingly (but nonetheless disappointingly), brexpiprazole is expensive (AWP $1,703 per 30 count bottle; $47 per day as of July 2023). Outside of hospice, many will undoubtedly take advantage of the manufacturer savings program for the drug to reduce their out of pocket costs. But, in the hospice setting, where a capitated per diem reimbursement is provided to hospices to provide related care (including medications), these types of manufacturer cards don’t work.
Therein lies the dilemma: when dementia is the primary diagnosis or is contributing to a patient’s terminal prognosis, hospices are on the hook for the costs of antipsychotic prescriptions, but brexpiprazole is so expensive that regular use would blow up most hospices’ budgets. One fairly straightforward solution is to switch to another antipsychotic.
In this case, when switching from brexpiprazole to another antipsychotic, the reason comes down solely to cost, so we’re looking to find the nearest facsimile that is affordable to hospices. As such, aripiprazole (generic Abilify®) makes sense because its molecular structure, pharmacodynamics, and adverse effect profile are highly similar to brexpiprazole – at a fraction of the cost. Though aripiprazole lacks FDA approval for managing agitation in patients with dementia, it’s considered a first line antipsychotic for this indication and a 7.5mg dose is approximately equal to 1mg of brexpiprazole. Finally, brexpiprazole lacks anticholinergic effects and has a relatively long elimination half-life of almost 4 days, so when switching to another antipsychotic like aripiprazole, a direct switch is permissible.
Hope this helps you prepare for when the next Rexulti® (brexpiprazole) prescription comes your way!