title: Methods for Health Economic Evaluation of Vaccines and Immunization Decision Frameworks: A Consensus Framework from a European Vaccine Economics Community.
abstract: BACKGROUND
  Incremental cost-effectiveness and cost-utility analyses [health economic evaluations (HEEs)] of vaccines are routinely considered in decision making on immunization in various industrialized countries. While guidelines advocating more standardization of such HEEs (mainly for curative drugs) exist, several immunization-specific aspects (e.g. indirect effects or discounting approach) are still a subject of debate within the scientific community.
  
  
  OBJECTIVE
  The objective of this study was to develop a consensus framework for HEEs of vaccines to support the development of national guidelines in Europe.
  
  
  METHODS
  A systematic literature review was conducted to identify prevailing issues related to HEEs of vaccines. Furthermore, European experts in the field of health economics and immunization decision making were nominated and asked to select relevant aspects for discussion. Based on this, a workshop was held with these experts. Aspects on 'mathematical modelling', 'health economics' and 'decision making' were debated in group-work sessions (GWS) to formulate recommendations and/or--if applicable--to state 'pros' and 'contras'.
  
  
  RESULTS
  A total of 13 different aspects were identified for modelling and HEE: model selection, time horizon of models, natural disease history, measures of vaccine-induced protection, duration of vaccine-induced protection, indirect effects apart from herd protection, target population, model calibration and validation, handling uncertainty, discounting, health-related quality of life, cost components, and perspectives. For decision making, there were four aspects regarding the purpose and the integration of HEEs of vaccines in decision making as well as the variation of parameters within uncertainty analyses and the reporting of results from HEEs. For each aspect, background information and an expert consensus were formulated.
  
  
  CONCLUSIONS
  There was consensus that when HEEs are used to prioritize healthcare funding, this should be done in a consistent way across all interventions, including vaccines. However, proper evaluation of vaccines implies using tools that are not commonly used for therapeutic drugs. Due to the complexity of and uncertainties around vaccination, transparency in the documentation of HEEs and during subsequent decision making is essential.
authors.affiliation: Department for Infectious Disease Epidemiology, Immunisation Unit, Robert Koch Institute (RKI), Seestr. 10, 13353, Berlin, Germany. UltschB@rki.de.
authors.forename: Bernhard
authors.initials: B
authors.lastname: Ultsch
authors.affiliation: Bielefeld University, Bielefeld, Germany.
authors.forename: Oliver
authors.initials: O
authors.lastname: Damm
authors.affiliation: University of Antwerp, Antwerp, Belgium.
authors.forename: Philippe
authors.initials: P
authors.lastname: Beutels
authors.affiliation: University of Antwerp, Antwerp, Belgium.
authors.forename: Joke
authors.initials: J
authors.lastname: Bilcke
authors.affiliation: Steinbeis University Berlin (SHB), Berlin, Germany.
authors.forename: Bernd
authors.initials: B
authors.lastname: Brüggenjürgen
authors.affiliation: Institute for Quality and Efficiency in Health Care (IQWiG), Cologne, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Gerber-Grote
authors.affiliation: Bielefeld University, Bielefeld, Germany.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Greiner
authors.affiliation: Belgian Health Care Knowledge Centre (KCE), Brussels, Belgium.
authors.forename: Germaine
authors.initials: G
authors.lastname: Hanquet
authors.affiliation: World Health Organization (WHO), Geneva, Switzerland.
authors.forename: Raymond
authors.initials: R
authors.lastname: Hutubessy
authors.affiliation: London School of Hygiene and Tropical Medicine (LSHTM), London, UK.|Public Health England (PHE), London, UK.
authors.forename: Mark
authors.initials: M
authors.lastname: Jit
authors.affiliation: Centre for Infectious Disease Control (RIVM), Bilthoven, The Netherlands.
authors.forename: Mirjam
authors.initials: M
authors.lastname: Knol
authors.affiliation: Ludwig Maximilians University (LMU), Munich, Germany.
authors.forename: Rüdiger
authors.initials: R
authors.lastname: von Kries
authors.affiliation: University of Hannover, Hannover, Germany.
authors.forename: Alexander
authors.initials: A
authors.lastname: Kuhlmann
authors.affiliation: Institut de Veille Sanitaire (InVS), Saint-Maurice Cedex, France.
authors.forename: Daniel
authors.initials: D
authors.lastname: Levy-Bruhl
authors.affiliation: Federal Joint Committee (G-BA), Berlin, Germany.
authors.forename: Matthias
authors.initials: M
authors.lastname: Perleth
authors.affiliation: University of Groningen, Groningen, The Netherlands.
authors.forename: Maarten
authors.initials: M
authors.lastname: Postma
authors.affiliation: National Institute for Health and Welfare (THL), Helsinki, Finland.
authors.forename: Heini
authors.initials: H
authors.lastname: Salo
authors.affiliation: University for Health Sciences, Medical Informatics and Technology (UMIT), Hall in Tirol, Austria.|ONCOTYROL, Center for Personalized Cancer Medicine, Innsbruck, Austria.
authors.forename: Uwe
authors.initials: U
authors.lastname: Siebert
authors.affiliation: University of Duisburg-Essen, Essen, Germany.
authors.forename: Jürgen
authors.initials: J
authors.lastname: Wasem
authors.affiliation: Department for Infectious Disease Epidemiology, Immunisation Unit, Robert Koch Institute (RKI), Seestr. 10, 13353, Berlin, Germany.
authors.forename: Ole
authors.initials: O
authors.lastname: Wichmann
mesh_terms: D003362:Cost-Benefit Analysis / Q000379:methods* / Q000592:standards*; D003657:Decision Making; D005060:Europe; D006801:Humans; D007114:Immunization / Q000191:economics*; D018803:Models, Economic; D014612:Vaccines / Q000191:economics*
chemical_list: D014612:Vaccines