title: Health Technology Assessment (HTA) Case Studies: Factors Influencing Divergent HTA Reimbursement Recommendations in Australia, Canada, England, and Scotland.
abstract: OBJECTIVE
  To evaluate the national regulatory, health technology assessment (HTA), and reimbursement pathways for public health care in Australia, Canada, England, and Scotland, to compare initial Canadian national HTA recommendations with the initial decisions of the other HTA agencies, and to identify factors for differing national HTA recommendations between the four HTA agencies.
  
  
  METHODS
  Information from the public domain was used to develop a regulatory process map for each jurisdiction and to compare the HTA agencies' reimbursement recommendations. Medicines that were reviewed by all four agencies and received a negative recommendation from only one agency were selected as case studies.
  
  
  RESULTS
  All four countries have a national HTA agency. Their reimbursement recommendations are guided by both clinical efficacy and cost-effectiveness, and the necessity for patient input. Their activities, however, vary because of different mandates and their unique political, social, and population needs. All have an implicit or explicit quality-adjusted life-year threshold. The seven divergent case studies demonstrate examples in which new medicine-indication pairs have been rejected because of uncertainties surrounding a range of factors including cost-effectiveness, comparator choice, clinical benefit, safety, trial design, and submission timing.
  
  
  CONCLUSIONS
  The four HTA agencies selected for inclusion in this study share common factors, including a focus on clinical efficacy and cost-effectiveness in their decision-making processes. The differences in recommendations could be considered to be due to an individual agency's approach to risk perception, and the comparator choice used in clinical and cost-effectiveness studies.
authors.affiliation: School of Pharmacy and Pharmaceutical Sciences, Cardiff University, Cardiff, UK; Centre for Innovation in Regulatory Science, London, UK.
authors.forename: Nicola
authors.initials: N
authors.lastname: Allen
authors.affiliation: School of Pharmacy and Pharmaceutical Sciences, Cardiff University, Cardiff, UK; Centre for Innovation in Regulatory Science, London, UK.
authors.forename: Stuart R
authors.initials: SR
authors.lastname: Walker
authors.affiliation: Centre for Innovation in Regulatory Science, London, UK.
authors.forename: Lawrence
authors.initials: L
authors.lastname: Liberti
authors.affiliation: Department of Pharmacy, Pharmacology and Postgraduate Medicine, School of Life and Medical Sciences, University of Hertfordshire, Hatfield, UK; Institute for Medicines Development, Cardiff, UK. Electronic address: mssalek@gmail.com.
authors.forename: Sam
authors.initials: S
authors.lastname: Salek
mesh_terms: D001315:Australia; D002170:Canada; D003362:Cost-Benefit Analysis; D003657:Decision Making; D003659:Decision Making, Organizational; D017277:Drug Approval / Q000191:economics / Q000379:methods* / Q000458:organization & administration*; D004739:England; D006077:Government Agencies; D006291:Health Policy; D006801:Humans; D038622:Internationality; D019982:Organizational Case Studies; D055553:Prescription Drugs; D012606:Scotland; D013673:Technology Assessment, Biomedical / Q000191:economics / Q000458:organization & administration*
chemical_list: D055553:Prescription Drugs
keywords: Australia; Canada; England; Scotland; divergent recommendations; health technology assessment