Elimination of the clozapine risk evaluation and mitigation strategy (REMS) – Improving access to care for those with treatment-refractory schizophrenia

Abstract

A variety of pharmacological treatment options exist for schizophrenia, although as many as 20 % to 40 % of individuals with schizophrenia experience treatment-refractory symptoms. Typically defined by non-response to at least two sequential, adequate trials of antipsychotics, treatment-refractory schizophrenia represents a significant clinical challenge. Currently, clozapine (Clozaril) is the only evidence-based treatment strategy available for treatment-refractory schizophrenia. Nonetheless, clozapine has long remained underutilized due to administrative barriers such as the Food and Drug Administration (FDA) Risk Evaluation and Mitigation Strategy (REMS) program, a historical requirement for clozapine prescribing. The FDA has eliminated the clozapine REMS program effective February 2025. This editorial provides an update on clozapine and recognizes that elimination of the clozapine REMS program will reduce barriers to clozapine prescribing.