title: Estimated medical cost reductions for paliperidone palmitate vs placebo in a randomized, double-blind relapse-prevention trial of patients with schizoaffective disorder.
abstract: OBJECTIVE
  The objective of this economic model was to estimate the difference in medical costs among patients treated with paliperidone palmitate once-monthly injectable antipsychotic (PP1M) vs placebo, based on clinical event rates reported in the 15-month randomized, double-blind, placebo-controlled, parallel-group study of paliperidone palmitate evaluating time to relapse in subjects with schizoaffective disorder.
  
  
  METHODS
  Rates of psychotic, depressive, and/or manic relapses and serious and non-serious treatment-emergent adverse events (TEAEs) were obtained from the long-term paliperidone palmitate vs placebo relapse prevention study. The total annual medical cost for a relapse from a US payer perspective was obtained from published literature and the costs for serious and non-serious TEAEs were based on Common Procedure Terminology codes. Total annual medical cost differences for patients treated with PP1M vs placebo were then estimated. Additionally, one-way and Monte Carlo sensitivity analyses were conducted.
  
  
  RESULTS
  Lower rates of relapse (-18.3%) and serious TEAEs (-3.9%) were associated with use of PP1M vs placebo as reported in the long-term paliperidone palmitate vs placebo relapse prevention study. As a result of the reduction in these clinical event rates, the total annual medical cost was reduced by $7140 per patient treated with PP1M vs placebo. One-way sensitivity analysis showed that variations in relapse rates had the greatest impact on the estimated medical cost differences (range: -$9786, -$4670). Of the 10,000 random cycles of Monte Carlo simulations, 100% showed a medical cost difference <$0 (reduction) for patients using PPIM vs placebo. The average total annual medical differences per patient were -$8321 for PP1M monotherapy and -$6031 for PPIM adjunctive therapy.
  
  
  CONCLUSIONS
  Use of PP1M for treatment of patients with schizoaffective disorder was associated with a significantly lower rate of relapse and a reduction in medical costs compared to placebo. Further evaluation in the real-world setting is warranted.
authors: a a Janssen Scientific Affairs, Health Economics and Outcomes Research , Titusville , NJ , USA.
authors: K
authors: K
authors: Joshi
authors: b b Novosys Health , Green Brook , NJ , USA.
authors: J
authors: J
authors: Lin
authors: b b Novosys Health , Green Brook , NJ , USA.
authors: M
authors: M
authors: Lingohr-Smith
authors: c c Janssen Scientific Affairs, Medical Affairs , Titusville , NJ , USA.
authors: D J
authors: DJ
authors: Fu
mesh_terms: D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000191:economics* / Q000627:therapeutic use*; D003362:Cost-Benefit Analysis; D003692:Delayed-Action Preparations; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D006801:Humans; D007273:Injections, Intramuscular; D000068882:Paliperidone Palmitate / Q000008:administration & dosage / Q000009:adverse effects / Q000191:economics* / Q000627:therapeutic use*; D011618:Psychotic Disorders / Q000188:drug therapy*; D055502:Secondary Prevention
chemical_list: D014150:Antipsychotic Agents; D003692:Delayed-Action Preparations; D000068882:Paliperidone Palmitate
keywords: Economic model; Medical costs; Paliperidone palmitate; Schizoaffective disorder