title: The impact of quality-of-life data in relative effectiveness assessments of new anti-cancer drugs in European countries.
abstract: The aim of this study is to investigate the role of health-related quality-of-life (QoL) data in relative effectiveness assessments (REAs) of new anti-cancer drugs across European jurisdictions, during health technology assessment procedures.
  
  
  
  Comparative analysis of guidelines and publicly available REAs in six European jurisdictions of anti-cancer drugs approved by EMA between 2011 and 2013.
  
  
  
  Fourteen anti-cancer drugs were included, adding up to 79 REAs. Whilst all guidelines state that QoL is a relevant endpoint to determine the relative effectiveness of new cancer drugs, QoL data were included in only 54% of the 79 reports and their impact on the recommendations was limited.
  
  
  
  Whilst national guidelines recognize the relevance of QoL to determine the relative effectiveness of new anti-cancer drugs, this is not well-reflected in current assessments. Developing and implementing into REAs specific evidence requirements for QoL data would improve the use of this patient-centred outcome in future reimbursement and pricing decisions.
authors.affiliation: Heath Care Department, Zorginstituut Nederland, Eekholt 4, 1112 XH, Diemen, The Netherlands. skleijnen@zinl.nl.|Division of Pharmacoepidemiology and Clinical Pharmacology, Faculty of Science, Utrecht Institute for Pharmaceutical Sciences, Utrecht, The Netherlands. skleijnen@zinl.nl.
authors.forename: Sarah
authors.initials: S
authors.lastname: Kleijnen
authors.affiliation: Division of Pharmacoepidemiology and Clinical Pharmacology, Faculty of Science, Utrecht Institute for Pharmaceutical Sciences, Utrecht, The Netherlands.
authors.forename: Teresa
authors.initials: T
authors.lastname: Leonardo Alves
authors.affiliation: VU University Amsterdam, Amsterdam, The Netherlands.
authors.forename: Kim
authors.initials: K
authors.lastname: Meijboom
authors.affiliation: Division of Pharmacoepidemiology and Clinical Pharmacology, Faculty of Science, Utrecht Institute for Pharmaceutical Sciences, Utrecht, The Netherlands.|Center for Innovation in Regulatory Science, London, UK.
authors.forename: Iga
authors.initials: I
authors.lastname: Lipska
authors.affiliation: Division of Pharmacoepidemiology and Clinical Pharmacology, Faculty of Science, Utrecht Institute for Pharmaceutical Sciences, Utrecht, The Netherlands.
authors.forename: Anthonius
authors.initials: A
authors.lastname: De Boer
authors.affiliation: Division of Pharmacoepidemiology and Clinical Pharmacology, Faculty of Science, Utrecht Institute for Pharmaceutical Sciences, Utrecht, The Netherlands.
authors.forename: Hubertus G
authors.initials: HG
authors.lastname: Leufkens
authors.affiliation: Heath Care Department, Zorginstituut Nederland, Eekholt 4, 1112 XH, Diemen, The Netherlands.|Division of Pharmacoepidemiology and Clinical Pharmacology, Faculty of Science, Utrecht Institute for Pharmaceutical Sciences, Utrecht, The Netherlands.
authors.forename: Wim G
authors.initials: WG
authors.lastname: Goettsch
mesh_terms: D000970:Antineoplastic Agents / Q000494:pharmacology / Q000627:therapeutic use*; D003430:Cross-Sectional Studies; D005060:Europe; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000523:psychology; D011788:Quality of Life / Q000523:psychology*; D012189:Retrospective Studies
chemical_list: D000970:Antineoplastic Agents
keywords: Antineoplastic agents; Comparative effectiveness; Health technology assessment; Patient-centred outcome research; Quality of life; Reimbursement