title: A randomized controlled trial of the cost-utility of second-generation antipsychotics in people with psychosis and eligible for clozapine.
abstract: OBJECTIVE
  To assess whether clozapine is likely to be more cost-effective than other second-generation antipsychotics (SGAs) in people with schizophrenia.
  
  
  METHODS
  An integrated clinical and economic multicenter, rater-blind, randomized controlled trial (RCT) compared clozapine to the class of other SGAs, using the perspectives of the National Health Service, social support services, and patients. The practice setting was secondary and primary care in the United Kingdom; patients were followed for 1 year. Incremental cost-effectiveness ratios (ICERs), net benefit statistics, and cost acceptability curves were estimated.
  
  
  RESULTS
  The ICER for clozapine was 33,240 pound per quality-adjusted life-year (QALY) (range 23,000-70,000 pound for the sensitivity analyses). The proportion of simulations when clozapine was more cost-effective than other SGAs reached 50% if decision-makers are prepared to pay 30,000 pound to 35,000 pound per QALY. This is at the top of the range of acceptable willingness-to-pay values per QALY implied by decisions taken by the National Institute for Health and Clinical Excellence (NICE).
  
  
  CONCLUSIONS
  This study adds to a limited body of evidence comparing clozapine to other SGAs and is the first economic and clinical RCT to compare clozapine to the class of other SGAs using the lower cost of generic clozapine and a pragmatic trial design. Policy decisions by the NICE suggest that additional reasons would be needed to accept clozapine as effective and efficient if it had a high probability of having ICERs more than 35,000 pound per QALY. The results and limitations of the analysis suggest that there is still a need for further economic evaluation of clozapine.
authors.affiliation: University of Manchester, Manchester, Greater Manchester, UK. Linda.davies@manchester.ac.uk
authors.forename: Linda M
authors.initials: LM
authors.lastname: Davies
authors.forename: Thomas R E
authors.initials: TR
authors.lastname: Barnes
authors.forename: Peter B
authors.initials: PB
authors.lastname: Jones
authors.forename: Shôn
authors.initials: S
authors.lastname: Lewis
authors.forename: Fiona
authors.initials: F
authors.lastname: Gaughran
authors.forename: Karen
authors.initials: K
authors.lastname: Hayhurst
authors.forename: Alison
authors.initials: A
authors.lastname: Markwick
authors.forename: Helen
authors.initials: H
authors.lastname: Lloyd
mesh_terms: D014150:Antipsychotic Agents / Q000191:economics* / Q000627:therapeutic use*; D003024:Clozapine / Q000191:economics* / Q000627:therapeutic use*; D003362:Cost-Benefit Analysis / Q000191:economics*; D006305:Health Status Indicators; D006801:Humans; D018803:Models, Economic; D011618:Psychotic Disorders / Q000188:drug therapy* / Q000191:economics*; D019057:Quality-Adjusted Life Years; D006113:United Kingdom
chemical_list: D014150:Antipsychotic Agents; D003024:Clozapine