title: The definition and role of quality of life in Germany's early assessment of drug benefit: a qualitative approach.
abstract: OBJECTIVE
  In 2011, Germany introduced a new form of drug benefit assessment, linking reimbursement prices to drug benefit and making quality of life (QoL) one of the main benefit criteria. Thus, QoL outcomes co-determine drug prices in Germany. QoL has, however, not been defined in the regulations. This study analyzed the definition and role of QoL in Germany's drug benefit assessment. It serves as a case study on the complexity of QoL as a parameter of health technology and drug assessments, which have become mandatory in almost all industrialized countries.
  
  
  METHODS
  In a qualitative analysis, the publicly available dossiers (summaries), dossier evaluations, protocols of the oral hearings, the final resolutions of the Federal Joint Committee (G-BA) and its rationale of all benefit assessments completed by 2013 (n = 66) were processed. Additionally, quantitative data on the decision outcomes were collected.
  
  
  RESULTS
  Only two decisions drew on QoL outcomes as "main justifications" for additional benefit. It was due to a lack of valid and statistically significant QoL results, a deficient presentation of QoL data, or differing understandings of QoL, that QoL benefit was not demonstrated in more than two cases. While manufacturers applied wider definitions of QoL, the assessment institutions questioned evidence if it was not reported with the help of validated QoL questionnaires or deviated from their definition of QoL.
  
  
  CONCLUSIONS
  The German experience with QoL as a drug benefit criterion highlights the importance of a clear QoL definition and according methodological regulations.
authors.affiliation: Institute for Health Services Research in Dermatology and Nursing (IVDP), German Center for Health Services Research in Dermatology (CVderm), University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany. d.lohrberg@uke.de.
authors.forename: David
authors.initials: D
authors.lastname: Lohrberg
authors.affiliation: Institute for Health Services Research in Dermatology and Nursing (IVDP), German Center for Health Services Research in Dermatology (CVderm), University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany.
authors.forename: Matthias
authors.initials: M
authors.lastname: Augustin
authors.affiliation: Institute for Health Services Research in Dermatology and Nursing (IVDP), German Center for Health Services Research in Dermatology (CVderm), University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany.
authors.forename: Christine
authors.initials: C
authors.lastname: Blome
mesh_terms: D003362:Cost-Benefit Analysis / Q000191:economics*; D004345:Drug Industry / Q000191:economics*; D005858:Germany; D006801:Humans; D004364:Pharmaceutical Preparations / Q000191:economics*; D011788:Quality of Life
chemical_list: D004364:Pharmaceutical Preparations
keywords: AMNOG; Early benefit assessment; Qualitative content analysis; Quality of life