title: A Time-Trend Economic Analysis of Cancer Drug Trials.
abstract: BACKGROUND
  Scientific advances have led to the discovery of novel treatments with high prices. The cost to publicly fund high-cost drugs may threaten the sustainability of drug budgets in different health care systems. In oncology, there are concerns that health-benefit gains are diminishing over time and that the economic evidence to support funding decisions is too limited.
  
  
  METHODS
  To assess the additional costs and benefits gained from oncology drugs over time, we used treatment protocols and efficacy results from U.S. Food and Drug Administration records to calculate cost-effectiveness ratios for drugs approved to treat first- and second-line metastatic or advanced breast, colorectal, and non-small cell lung cancer during the years 1994-2013. We assessed reimbursement recommendations reached by health technology assessment agencies in the U.K., Australia, and Canada.
  
  
  RESULTS
  Cost-effectiveness ratios were calculated for 50 drugs approved by the U.S. regulator. The more recent approvals were often based on surrogate efficacy outcomes and had extremely high costs, often triple the costs of drugs approved in previous years. Over time, the effectiveness gains have increased for some cancer indications; however, for other indications (non-small cell lung and second-line colorectal cancer), the magnitude of gains in effectiveness decreased. Reimbursement recommendations for drugs with the highest cost-effectiveness ratios were the most inconsistent.
  
  
  CONCLUSIONS
  Evaluation of the clinical benefits that oncology drugs offer as a function of their cost has become highly complex, and for some clinical indications, health benefits are diminishing over time. There is an urgent need for better economic evidence from oncology drug trials and systematic processes to inform funding decisions.
  
  
  CONCLUSIONS
  High-cost oncology drugs may threaten the ability of health care systems to provide access to promising new drugs for patients. In order to make better drug-funding decisions and enable equitable access to breakthrough treatments, discussions in the oncology community should include economic evidence. This study summarizes the extra benefits and costs of newly approved drugs from pivotal trials during the postgenomic era of drug discovery. The reader will gain an appreciation of the need for economic evidence to make better drug-reimbursement decisions and the dynamics at play in today's oncology drug market.
authors.affiliation: Canadian Centre for Applied Research in Cancer Control, British Columbia Cancer Research Centre, Vancouver, British Columbia, Canada; Vancouver Island Cancer Centre, Victoria, British Columbia, Canada; School of Population and Public Health, University of British Columbia, Vancouver, British Columbia, Canada; Pharmacoeconomics Research Unit, Cancer Care Ontario, Toronto, Ontario, Canada; Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario, Canada; Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada; Sindi Ahluwalia Hawkins Centre for the Southern Interior, Kelowna, British Columbia, Canada scressman@bccrc.ca.
authors.forename: Sonya
authors.initials: S
authors.lastname: Cressman
authors.affiliation: Canadian Centre for Applied Research in Cancer Control, British Columbia Cancer Research Centre, Vancouver, British Columbia, Canada; Vancouver Island Cancer Centre, Victoria, British Columbia, Canada; School of Population and Public Health, University of British Columbia, Vancouver, British Columbia, Canada; Pharmacoeconomics Research Unit, Cancer Care Ontario, Toronto, Ontario, Canada; Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario, Canada; Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada; Sindi Ahluwalia Hawkins Centre for the Southern Interior, Kelowna, British Columbia, Canada.
authors.forename: George P
authors.initials: GP
authors.lastname: Browman
authors.affiliation: Canadian Centre for Applied Research in Cancer Control, British Columbia Cancer Research Centre, Vancouver, British Columbia, Canada; Vancouver Island Cancer Centre, Victoria, British Columbia, Canada; School of Population and Public Health, University of British Columbia, Vancouver, British Columbia, Canada; Pharmacoeconomics Research Unit, Cancer Care Ontario, Toronto, Ontario, Canada; Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario, Canada; Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada; Sindi Ahluwalia Hawkins Centre for the Southern Interior, Kelowna, British Columbia, Canada.
authors.forename: Jeffrey S
authors.initials: JS
authors.lastname: Hoch
authors.affiliation: Canadian Centre for Applied Research in Cancer Control, British Columbia Cancer Research Centre, Vancouver, British Columbia, Canada; Vancouver Island Cancer Centre, Victoria, British Columbia, Canada; School of Population and Public Health, University of British Columbia, Vancouver, British Columbia, Canada; Pharmacoeconomics Research Unit, Cancer Care Ontario, Toronto, Ontario, Canada; Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario, Canada; Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada; Sindi Ahluwalia Hawkins Centre for the Southern Interior, Kelowna, British Columbia, Canada.
authors.forename: Laurel
authors.initials: L
authors.lastname: Kovacic
authors.affiliation: Canadian Centre for Applied Research in Cancer Control, British Columbia Cancer Research Centre, Vancouver, British Columbia, Canada; Vancouver Island Cancer Centre, Victoria, British Columbia, Canada; School of Population and Public Health, University of British Columbia, Vancouver, British Columbia, Canada; Pharmacoeconomics Research Unit, Cancer Care Ontario, Toronto, Ontario, Canada; Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario, Canada; Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada; Sindi Ahluwalia Hawkins Centre for the Southern Interior, Kelowna, British Columbia, Canada.
authors.forename: Stuart J
authors.initials: SJ
authors.lastname: Peacock
mesh_terms: D000970:Antineoplastic Agents / Q000191:economics*; D001315:Australia; D001943:Breast Neoplasms / Q000188:drug therapy; D002170:Canada; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy; D002986:Clinical Trials as Topic / Q000191:economics; D015179:Colorectal Neoplasms / Q000188:drug therapy; D003362:Cost-Benefit Analysis; D016527:Drug Costs; D005260:Female; D006801:Humans; D007349:Insurance, Health, Reimbursement; D008175:Lung Neoplasms / Q000188:drug therapy; D014481:United States
chemical_list: D000970:Antineoplastic Agents
keywords: Biomedical; Cost-benefit analysis; Drug costs; Economics; Medical oncology; Pharmaceutical; Technology assessment