title: Using effectiveness and cost-effectiveness to make drug coverage decisions: a comparison of Britain, Australia, and Canada.
abstract: BACKGROUND
  National public insurance for drugs is often based on evidence of comparative effectiveness and cost-effectiveness. This study describes how that evidence has been used across 3 jurisdictions (Australia, Canada, and Britain) that have been at the forefront of evidence-based coverage internationally.
  
  
  OBJECTIVE
  To describe how clinical and cost-effectiveness evidence is used in coverage decisions both within and across jurisdictions and to identify common issues in the process of evidence-based coverage.
  
  
  METHODS
  Descriptive analysis of retrospective data from the Common Drug Review (CDR) of Canada, National Institute for Health and Clinical Excellence (NICE) in Britain, and Pharmaceutical Benefits Advisory Committee (PBAC) of Australia. All publicly available information as of December 31, 2008, was gathered from each committee's Web site (data set begins in January 2004 [CDR], February 2001 [NICE], and July 2005 [PBAC]).
  
  
  METHODS
  Listing recommendations for each drug by disease indication.
  
  
  RESULTS
  NICE recommended 87.4% (174/199) of submissions for listing compared with a listing rate of 49.6% (60/121) and 54.3% (153/282) for the CDR and PBAC, respectively. Significant uncertainty around clinical effectiveness, typically resulting from inadequate study design or the use of inappropriate comparators and unvalidated surrogate end points, was identified as a key issue in coverage decisions. Recommendations varied considerably across countries, possibly because of differences in the medications reviewed; different agency processes, including the willingness to negotiate on price; and the approach to "me too" drugs. The data suggest that the 3 agencies make recommendations that are consistent with evidence on effectiveness and cost-effectiveness but that other factors are often important.
  
  
  CONCLUSIONS
  NICE, PBAC, and CDR face common issues with respect to the quality and strength of the experimental evidence in support of a clinically meaningful effect. However, comparative effectiveness and cost-effectiveness, along with other relevant factors, can be used by national agencies to support drug decision making. The results of the evaluation process in different countries are influenced by the context, agency processes, ability to engage in price negotiation, and perhaps differences in social values.
authors.affiliation: Department of Medicine, University of Calgary, Calgary, Alberta, Canada.
authors.forename: Fiona M
authors.initials: FM
authors.lastname: Clement
authors.forename: Anthony
authors.initials: A
authors.lastname: Harris
authors.forename: Jing Jing
authors.initials: JJ
authors.lastname: Li
authors.forename: Karen
authors.initials: K
authors.lastname: Yong
authors.forename: Karen M
authors.initials: KM
authors.lastname: Lee
authors.forename: Braden J
authors.initials: BJ
authors.lastname: Manns
mesh_terms: D026683:Advisory Committees; D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D061067:Antibodies, Monoclonal, Humanized; D001315:Australia; D050071:Bone Density Conservation Agents / Q000627:therapeutic use; D002170:Canada; D003362:Cost-Benefit Analysis; D017277:Drug Approval; D016527:Drug Costs; D055317:Evidence-Based Practice; D006077:Government Agencies; D006291:Health Policy / Q000191:economics*; D006302:Health Services Research; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D007155:Immunologic Factors / Q000627:therapeutic use; D007328:Insulin / Q000031:analogs & derivatives / Q000627:therapeutic use; D000069036:Insulin Glargine; D049528:Insulin, Long-Acting; D007349:Insurance, Health, Reimbursement; D007356:Insurance, Pharmaceutical Services; D000069579:Ranibizumab; D019379:Teriparatide / Q000627:therapeutic use; D006113:United Kingdom
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D050071:Bone Density Conservation Agents; D007004:Hypoglycemic Agents; D007155:Immunologic Factors; D007328:Insulin; D049528:Insulin, Long-Acting; D019379:Teriparatide; D000069036:Insulin Glargine; D000069579:Ranibizumab