title: Comparison of anticancer drug coverage decisions in the United States and United Kingdom: does the evidence support the rhetoric?
abstract: OBJECTIVE
  In contrast to the United States, several European countries have health technology assessment programs for drugs, many of which assess cost effectiveness. Coverage decisions that consider cost effectiveness may lead to restrictions in access.
  
  
  METHODS
  For a purposive sample of five decision-making bodies, we analyzed US and United Kingdom coverage decisions on all anticancer drugs approved by the US Food and Drug Administration (FDA) from 2004 to 2008. Data sources for the timing and outcome of licensing and coverage decisions included published and unpublished documentation, Web sites, and personal communication.
  
  
  RESULTS
  The FDA approved 59 anticancer drugs over the study period, of which 46 were also approved by the European Medicines Agency. In the United States, 100% of drugs were covered, mostly without restriction. However, the United Kingdom bodies made positive coverage decisions for less than half of licensed drugs (National Institute for Health and Clinical Excellence [NICE]: 39%; Scottish Medicines Consortium [SMC]: 43%). Whereas the Centers for Medicare and Medicaid Services (CMS) and the Department of Veterans Affairs (VA) covered all 59 drugs from the FDA license date, delays were evident for some Regence Group decisions that were informed by cost effectiveness (median, 0 days; semi-interquartile range [SIQR], 122 days; n = 22). Relative to the European Medicines Agency license date, median time to coverage was 783 days (SIQR, 170 days) for NICE and 231 days (SIQR, 129 days) for the SMC.
  
  
  CONCLUSIONS
  Anticancer drug coverage decisions that consider cost effectiveness are associated with greater restrictions and slower time to coverage. However, this approach may represent an explicit alternative to rationing achieved through the use of patient copayments.
authors.affiliation: Centre for Health Economics, University of York, York, United Kingdom. arm10@york.ac.uk
authors.forename: Anne
authors.initials: A
authors.lastname: Mason
authors.forename: Michael
authors.initials: M
authors.lastname: Drummond
authors.forename: Scott
authors.initials: S
authors.lastname: Ramsey
authors.forename: Jonathan
authors.initials: J
authors.lastname: Campbell
authors.forename: Dennis
authors.initials: D
authors.lastname: Raisch
mesh_terms: D000970:Antineoplastic Agents / Q000191:economics*; D003362:Cost-Benefit Analysis; D003657:Decision Making; D017277:Drug Approval / Q000191:economics; D006297:Health Services Accessibility / Q000191:economics*; D006801:Humans; D007349:Insurance, Health, Reimbursement / Q000191:economics*; D006278:Medicare / Q000191:economics; D009313:National Health Programs / Q000191:economics*; D013997:Time Factors; D006113:United Kingdom; D014481:United States; D014486:United States Food and Drug Administration / Q000191:economics
chemical_list: D000970:Antineoplastic Agents