Characteristics and Antipsychotic Treatment Pathways of Patients with Schizophrenia Who Received Once-Every-6-Months Paliperidone Palmitate Within the First Two Years of Approval
BACKGROUND: The United States (US) Food and Drug Administration (FDA) approved once-every-6-months paliperidone palmitate (PP6M) on 09/01/2021. However, limited real-world evidence exists describing the characteristics and antipsychotic treatment pathways of patients with schizophrenia initiated on PP6M.
METHODS: Closed claims from Komodo Research Data (01/01/2016-06/30/2023) identified adults with schizophrenia with ≥12 months of continuous insurance or Medicaid/Medicare eligibility (i.e., baseline period) before initiating PP6M (index date) within the first two years of FDA approval. Patients diagnosed with bipolar disorder or pregnancy were excluded. Demographic characteristics were evaluated at PP6M initiation, and treatment pathways to PP6M, including once-monthly (PP1M) and once-every-three-months paliperidone palmitate (PP3M) use, were evaluated pre-index.
RESULTS: We found 628 patients initiated on PP6M (mean age 41.1 years). Most patients were male (75.2%), the sample was racially and ethnically diverse (32.8% White, 25.0% Black, 17.7% Hispanic), and three-quarters were covered by Medicaid (74.8%). During baseline, 37.9% of patients had substance-related and addictive disorders and 22.0% had anxiety disorders. On average, patients were observed for 4.6 years before initiating PP6M, during which 72.1% used oral antipsychotics, 83.3% used PP1M (average of 21.9 months), and 71.0% used PP3M (average of 27.8 months). Two-thirds of patients transitioned directly from PP3M to PP6M (66.6%) and nearly one-third transitioned directly from PP1M to PP6M (32.0%). Nearly two-thirds of patients (63.5%) initiated PP6M at the higher dose strength of 1,560 mg.
CONCLUSIONS: Within the first two years of approval, a racially and ethnically diverse group of patients with schizophrenia initiated PP6M, with two-thirds transitioning from PP3M.
