title: Cost Analyses in the US and Japan: A Cross-Country Comparative Analysis Applied to the PRONOUNCE Trial in Non-Squamous Non-Small Cell Lung Cancer.
abstract: BACKGROUND
  Health technology assessment is not required for regulatory submission or approval in either the United States (US) or Japan. This study was designed as a cross-country evaluation of cost analyses conducted in the US and Japan based on the PRONOUNCE phase III lung cancer trial, which compared pemetrexed plus carboplatin followed by pemetrexed (PemC) versus paclitaxel plus carboplatin plus bevacizumab followed by bevacizumab (PCB).
  
  
  METHODS
  Two cost analyses were conducted in accordance with International Society For Pharmacoeconomics and Outcomes Research good research practice standards. Costs were obtained based on local pricing structures; outcomes were considered equivalent based on the PRONOUNCE trial results. Other inputs were included from the trial data (e.g., toxicity rates) or from local practice sources (e.g., toxicity management). The models were compared across key input and transferability factors.
  
  
  RESULTS
  Despite differences in local input data, both models demonstrated a similar direction, with the cost of PemC being consistently lower than the cost of PCB. The variation in individual input parameters did affect some of the specific categories, such as toxicity, and impacted sensitivity analyses, with the cost differential between comparators being greater in Japan than in the US.
  
  
  CONCLUSIONS
  When economic models are based on clinical trial data, many inputs and outcomes are held consistent. The alterable inputs were not in and of themselves large enough to significantly impact the results between countries, which were directionally consistent with greater variation seen in sensitivity analyses. The factors that vary across jurisdictions, even when minor, can have an impact on trial-based economic analyses.
  
  
  BACKGROUND
  Eli Lilly and Company.
authors.affiliation: Eli Lilly and Company, Indianapolis, IN, USA. hess_lisa_m@lilly.com.
authors.forename: Lisa M
authors.initials: LM
authors.lastname: Hess
authors.affiliation: Eli Lilly and Company, Indianapolis, IN, USA.
authors.forename: Narayan
authors.initials: N
authors.lastname: Rajan
authors.affiliation: Eli Lilly and Company, Indianapolis, IN, USA.
authors.forename: Katherine
authors.initials: K
authors.lastname: Winfree
authors.affiliation: PRISMA Consulting Group, Chatswood, NSW, Australia.
authors.forename: Peter
authors.initials: P
authors.lastname: Davey
authors.affiliation: PRISMA Consulting Group, Chatswood, NSW, Australia.
authors.forename: Mark
authors.initials: M
authors.lastname: Ball
authors.affiliation: RTI Health Solutions, Inc., Research Triangle Park, NC, USA.
authors.forename: Hediyyih
authors.initials: H
authors.lastname: Knox
authors.affiliation: RTI Health Solutions, Inc., Research Triangle Park, NC, USA.
authors.forename: Christopher
authors.initials: C
authors.lastname: Graham
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000191:economics* / Q000627:therapeutic use*; D000068258:Bevacizumab / Q000191:economics / Q000627:therapeutic use; D016190:Carboplatin / Q000191:economics / Q000627:therapeutic use; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D003365:Costs and Cost Analysis; D003431:Cross-Cultural Comparison; D006801:Humans; D007564:Japan; D008175:Lung Neoplasms / Q000188:drug therapy*; D017059:Models, Econometric; D017239:Paclitaxel / Q000191:economics / Q000627:therapeutic use; D000068437:Pemetrexed / Q000191:economics / Q000627:therapeutic use; D014481:United States
chemical_list: D000068437:Pemetrexed; D000068258:Bevacizumab; D016190:Carboplatin; D017239:Paclitaxel
keywords: Bevacizumab; Chemotherapy; Cost analysis; Induction therapy; Lung cancer; Non-small cell lung cancer; Oncology; Pemetrexed