The impact of quality-of-life data in relative effectiveness assessments of new anti-cancer drugs in European countries.

Autor: Kleijnen S; 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., Leonardo Alves T; Division of Pharmacoepidemiology and Clinical Pharmacology, Faculty of Science, Utrecht Institute for Pharmaceutical Sciences, Utrecht, The Netherlands., Meijboom K; VU University Amsterdam, Amsterdam, The Netherlands., Lipska I; 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., De Boer A; Division of Pharmacoepidemiology and Clinical Pharmacology, Faculty of Science, Utrecht Institute for Pharmaceutical Sciences, Utrecht, The Netherlands., Leufkens HG; Division of Pharmacoepidemiology and Clinical Pharmacology, Faculty of Science, Utrecht Institute for Pharmaceutical Sciences, Utrecht, The Netherlands., Goettsch WG; 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.
Jazyk: angličtina
Zdroj: Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation [Qual Life Res] 2017 Sep; Vol. 26 (9), pp. 2479-2488. Date of Electronic Publication: 2017 Apr 11.
DOI: 10.1007/s11136-017-1574-9
Abstrakt: Purpose: 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.
Methods: Comparative analysis of guidelines and publicly available REAs in six European jurisdictions of anti-cancer drugs approved by EMA between 2011 and 2013.
Results: 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.
Conclusions: 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.
Databáze: MEDLINE
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