title: Has NICE got it right? An international perspective considering the case of Technology Appraisal No. 98 by the National Institute for Health and Clinical Excellence (NICE).
abstract: BACKGROUND
  The National Institute for Health and Clinical Excellence (NICE) has been widely recognised as setting an international standard for high-quality health technology assessments (HTAs) including economic evaluation.
  
  
  METHODS
  A previous critical analysis of NICE Technology Appraisal No. 98 (TA98), evaluating methylphenidate, dexamphetamine and atomoxetine for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children, revealed a number of issues, which must cast doubt on the robustness of the NICE approach when addressing a complex clinical decision problem. The exploration of potential underlying problems will be followed by a discussion of lessons for international healthcare policy-makers, and is intended to be an invitation to further debate and inquiry, not a presentation of definitive conclusions.
  
  
  METHODS
  Pertaining to the technology assessment report, potential problems were identified relating to an unnecessarily narrow scope, data search and selection strategy, the distinction between efficacy and effectiveness, data synthesis across studies and clinical effect measures, and limitations of the economic model. The appraisal process moderated the asserted 'clear conclusions' of the assessment but could not compensate for some of its gaps.
  
  
  CONCLUSIONS
  It is suggested that key issues contributing to these problems may have included a separation of clinical and economic perspectives, a highly standardised reference case analysis that was followed schematically, the absence of an effective system for quality assurance of technology assessments, and transparency deficits of the economic evaluation. Further considerations for international policy-makers looking at NICE as a potential role model for HTAs are discussed, such as institutional context, the objectives of collectively financed healthcare and related value judgments, the reliance on QALYs as a universal and comprehensive measure of health benefits, the appropriate perspective for analysis, and process-related implications.
authors.affiliation: Institute for Innovation & Valuation in Health Care, Eschborn, Germany. michael.schlander@innoval-hc.com
authors.forename: Michael
authors.initials: M
authors.lastname: Schlander
mesh_terms: D000069445:Atomoxetine Hydrochloride; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy* / Q000191:economics; D000697:Central Nervous System Stimulants / Q000627:therapeutic use*; D003362:Cost-Benefit Analysis; D003913:Dextroamphetamine / Q000627:therapeutic use*; D005858:Germany; D006801:Humans; D038622:Internationality; D008774:Methylphenidate / Q000627:therapeutic use*; D011437:Propylamines / Q000627:therapeutic use*; D019057:Quality-Adjusted Life Years; D013673:Technology Assessment, Biomedical / Q000592:standards*; D014481:United States
chemical_list: D000697:Central Nervous System Stimulants; D011437:Propylamines; D008774:Methylphenidate; D000069445:Atomoxetine Hydrochloride; D003913:Dextroamphetamine