Abilify® (aripiprazole), a second generation atypical antipsychotic, has been a high cost medication until a recent and dramatic reduction in price. Aripiprazole is FDA approved for schizophrenia and acute mania, and as an adjunct second-line therapy for bipolar maintenance and major depressive disorder. It also has non-FDA medically accepted uses of borderline personality disorder and drug-induced hyperprolactinemia caused by antipsychotics. While aripiprazole has been commercially available as a generic agent since 2015, the cost has still been high and provided an obstacle for settlement and closure of claims. Please refer to the table below outlining a significant difference in the lowest average wholesale price (AWP) between the previous and current AWP.
If utilized for the aforementioned indications listed above, maintenance use of aripiprazole would be included by Center for Medicare and Medicaid Services (CMS) in a Workers Compensation Medicare Set-Aside Arrangement (WCMSA). The dramatic reduction in cost would markedly reduce the Part D allocation of the updated WCMSA and potentially facilitate settlement.
The Official Disability Guidelines (ODG) on antipsychotics
The ODG recommends providers use caution concerning the use of antipsychotics for patients who do not have a diagnosis of psychosis, since the drugs are associated with serious adverse effects. The second-generation agents [such as aripiprazole, quetiapine (Seroquel®), olanzapine (Zyprexa®), and risperidone (Risperdal®)] cause weight gain and lipid/glucose dysregulation, while the first-generation antipsychotics have an increased risk of extrapyramidal symptoms with first-generation antipsychotic. Moreover, antipsychotics may be linked to increased rates of stroke and all-cause mortality in patients with dementia.
The FDA required a boxed warning on the aripiprazole product label for the various formulations, signifying the drug carries a significant risk of serious or even life-threatening adverse effects. For the oral formulation, the black box warning states elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Aripiprazole is not approved for the treatment of patients with dementia-related psychosis. Furthermore, there is an increased mortality in elderly patients with dementia-related psychosis and suicidal thoughts and behaviors with antidepressant drugs.
As part of best practices, ExamWorks Compliance Solutions continually monitor CMS’ recognized proprietary source, Red Book, for real-time changes for newly generic agents and for average wholesale price (AWP) for medications used to treat the injured worker, as well as PharmD review of all Part D medications for the indication for use for potential exclusion from the WCMSA.
ExamWorks Compliance Solutions strives to provide the most accurate and defensible MSA by utilizing technology and compendia databases which are recognized and supported by the CMS to support inclusion or exclusion of a drug under the Part D benefit. We will continue to monitor changes in medication pricing as well as availability of generic equivalents within the marketplace.