title: Comparing the Approval and Coverage Decisions of New Oncology Drugs in the United States and Other Selected Countries.
abstract: Global pharmaceutical sales for anticancer drugs were $74.4 billion in 2014, ranking first for drugs by therapeutic class. Countries may differ substantially in the approval and coverage decisions for anticancer drugs.
  
  
  
  To compare the approval and coverage decisions for new anticancer drugs between the United States and 4 other countries: the United Kingdom, France, Australia, and Canada.
  
  
  
  We identified all new anticancer drug indications approved by the FDA between January 1, 2009, and December 31, 2013. For each country, we reviewed the organizations, processes, criteria, and special considerations used to make approval and coverage decisions for the drug indications approved. We further quantified and compared the variations across the 5 countries in the approval and coverage decisions as of June 30, 2014, for new anticancer drug indications.
  
  
  
  "Of 45 anticancer drug indications approved in the United States between January 1, 2009, and December 31, 2013, 67% (30) were approved by the European Medicines Agency, and 53% (24) were approved in Canada and Australia before December 31, 2013. The U.S. Medicare program covered all 45 drug indications, and as of June 30, 2014, the United Kingdom covered 87% (26) of those approved in Europe- 58% (26) of the drug indications covered by Medicare. France, Canada, and Australia covered 42% (19), 29% (13), and 24% (11) of the drug indications covered by Medicare, respectively". [corrected].
  
  
  
  Approval and reimbursement decisions vary substantially by country. The United States had the fewest access restrictions, and Australia was the most restrictive of the 5 countries that were examined.
  
  
  
  No outside funding supported this study, and the authors report no conflicts of interest. Study concept and design were contributed primarily by Zhang, along with Hernandez and Hueser. All authors participated in data collection, and data interpretation was performed by Zhang and Hernandez, along with Hueser. The manuscript was written and revised by Zhang and Hernandez, along with Hueser.
authors.affiliation: 1 Department of Health Policy and Management, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania.
authors.forename: Yuting
authors.initials: Y
authors.lastname: Zhang
authors.affiliation: 2 Department of Biological Sciences, Dietrich School of Arts and Sciences, University of Pittsburgh, Pittsburgh, Pennsylvania.
authors.forename: Hana Chantel
authors.initials: HC
authors.lastname: Hueser
authors.affiliation: 3 Department of Pharmacy and Therapeutics, School of Pharmacy, University of Pittsburgh, Pittsburgh, Pennsylvania.
authors.forename: Inmaculada
authors.initials: I
authors.lastname: Hernandez
mesh_terms: D000970:Antineoplastic Agents / Q000191:economics*; D017277:Drug Approval / Q000191:economics*; D014943:Global Health / Q000191:economics*; D006801:Humans; D019458:Insurance Coverage / Q000191:economics*; D006278:Medicare / Q000191:economics; D014481:United States
chemical_list: D000970:Antineoplastic Agents