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PharmacoEconomics
Published in: PharmacoEconomics 3/2016

Open Access 01-03-2016 | Consensus Statement

Methods for Health Economic Evaluation of Vaccines and Immunization Decision Frameworks: A Consensus Framework from a European Vaccine Economics Community

Authors: Bernhard Ultsch, Oliver Damm, Philippe Beutels, Joke Bilcke, Bernd Brüggenjürgen, Andreas Gerber-Grote, Wolfgang Greiner, Germaine Hanquet, Raymond Hutubessy, Mark Jit, Mirjam Knol, Rüdiger von Kries, Alexander Kuhlmann, Daniel Levy-Bruhl, Matthias Perleth, Maarten Postma, Heini Salo, Uwe Siebert, Jürgen Wasem, Ole Wichmann

Published in: PharmacoEconomics | Issue 3/2016

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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.
Footnotes
1
Since an expert consensus was not reached, we used the term ‘expert opinion’.
 
Literature
1.
2.
3.
4.
5.
6.
7.
8.
9.
Nohynek H, Wichmann O, D Ancona F, Gatekeepers VN. National Advisory Groups and their role in immunization policy-making processes in European countries. Clin Microbiol Infect. 2013;19(12):1096–105.
10.
11.
Takla A, Wichmann O, Carrillo-Santisteve P, Cotter S, Lévy-Bruhl D, Paradowska-Stankiewicz I, et al. Characteristics and practices of National Immunisation Technical Advisory Groups in Europe and potential for collaboration, April 2014. Evaluation (GRADE). 2015;5:6.
12.
13.
14.
15.
16.
17.
Bauch CT, Anonychuk AM, Van Effelterre T, Pham BZ, Merid MF. Incorporating herd immunity effects into cohort models of vaccine cost-effectiveness. Med Decis Making. 2009;29(5):557–69.PubMedCrossRef
18.
Beutels P, Edmunds WJ, Antoñanzas F, De Wit GA, Evans D, Feilden R, et al. Economic evaluation of vaccination programmes: a consensus statement focusing on viral hepatitis. PharmacoEconomics. 2002;20(1):1–7.PubMedCrossRef
19.
20.
Beutels P, Van Doorslaer E, Van Damme P, Hall J. Methodological issues and new developments in the economic evaluation of vaccines. Expert Rev Vaccines. 2003;2(5):649–60.PubMedCrossRef
21.
Black S. The role of health economic analyses in vaccine decision making. Vaccine. 2013;31(51):6046–9.PubMedCrossRef
22.
Brisson M, Edmunds WJ. Impact of model, methodological, and parameter uncertainty in the economic analysis of vaccination programs. Med Decis Making. 2006;26(5):434–46.PubMedCrossRef
23.
de Vries R, Kretzschmar M, Schellekens JFP, Versteegh FGA, Westra TA, Roord JJ et al. Cost-effectiveness of adolescent pertussis vaccination for the netherlands: Using an individual-based dynamic model. PLoS One. 2010;5(10):1–11.
24.
Debicki D, Ferko N, Demarteau N, Gallivan S, Bauch C, Anonychuk A, et al. Comparison of detailed and succinct cohort modelling approaches in a multi-regional evaluation of cervical cancer vaccination. Vaccine. 2008;26(Suppl 5):16–28.CrossRef
25.
26.
Duintjer Tebbens RJ, Thompson KM, Hunink MG, Mazzuchi TA, Lewandowski D, Kurowicka D, et al. Uncertainty and sensitivity analyses of a dynamic economic evaluation model for vaccination programs. Med Decis Making. 2008;28(2):182–200.PubMedCrossRef
27.
Edmunds WJ, Medley GF, Nokes DJ. Evaluating the cost-effectiveness of vaccination programmes: a dynamic perspective. Stat Med. 1999;18(23):3263–82.PubMedCrossRef
28.
29.
Halloran ME, Struchiner CJ, Longini IM Jr. Study designs for evaluating different efficacy and effectiveness aspects of vaccines. Am J Epidemiol. 1997;146(10):789–803.PubMedCrossRef
30.
Jit M, Brisson M. Modelling the epidemiology of infectious diseases for decision analysis: A primer. PharmacoEconomics. 2011;29(5):371–86.PubMedCrossRef
31.
32.
Kauf TL. Methodological concerns with economic evaluations of meningococcal vaccines. PharmacoEconomics. 2010;28(6):449–61.PubMedCrossRef
33.
34.
Kim SY, Goldie SJ. Cost-effectiveness analyses of vaccination programmes : a focused review of modelling approaches. PharmacoEconomics. 2008;26(3):191–215.PubMedCrossRef
35.
36.
Krol M, Brouwer W. How to estimate productivity costs in economic evaluations. PharmacoEconomics. 2014;32(4):335–44.PubMedCrossRef
37.
Mauskopf J, Talbird S, Standaert B. Categorization of methods used in cost-effectiveness analyses of vaccination programs based on outcomes from dynamic transmission models. Expert Rev Pharmacoecon Outcomes Res. 2012;12(3):357–71. doi:10.​1586/​erp.​12.​11.PubMedCrossRef
38.
O’Mahony JF, de Kok IM, van Rosmalen J, Habbema JD, Brouwer W, van Ballegooijen M. Practical implications of differential discounting in cost-effectiveness analyses with varying numbers of cohorts. Value Health. 2011;14(4):438–42.PubMedCrossRef
39.
Parouty M, Le H, Krooshof D, Postma M. Differential time preferences for money and quality of life. PharmacoEconomics. 2014;32(4):411–9.
40.
Philips Z, Bojke L, Sculpher M, Claxton K, Golder S. Good practice guidelines for decision-analytic modelling in health technology assessment. Pharmacoeconomics. 2006;24(4):355–71.PubMedCrossRef
41.
Phillips KA, Holtgrave DR. Using cost-effectiveness/cost-benefit analysis to allocate health resources: a level playing field for prevention? Am J Prev Med. 1997;13(1):18–25.PubMed
42.
Pitman R, Fisman D, Zaric GS, Postma M, Kretzschmar M, Edmunds J, et al. Dynamic transmission modeling: a report of the ISPOR-SMDM Modeling Good Research Practices Task Force Working Group-5. Med Decis Making. 2012;32(5):712–21. doi:10.​1177/​0272989X12454578​.PubMedCrossRef
43.
44.
Postma MJ. Public health economics of vaccines in the Netherlands: methodological issues and applications. J Public Health. 2008;16(4):267–73.CrossRef
45.
Postma MJ, Westra TA, Quilici S, Largeron N. Economic evaluation of vaccines: specificities and future challenges illustrated by recent European examples. Expert Rev Vaccines. 2013;12(5):555–65.PubMedCrossRef
46.
Pradas-Velasco R, Antoñanzas-Villar F, Martínez-Zárate MP. Dynamic modelling of infectious diseases: an application to the economic evaluation of influenza vaccination. PharmacoEconomics. 2008;26(1):45–56.PubMedCrossRef
47.
48.
Szucs TD. Health economic research on vaccinations and immunisation practices—an introductory primer. Vaccine. 2005;23(17–18):2095–103.PubMedCrossRef
49.
Tasset A, Nguyen VH, Wood S, Amazian K. Discounting: technical issues in economic evaluations of vaccination. Vaccine. 1999;17(SUPPL. 3):75–80.CrossRef
50.
51.
Taylor DC, Pawar V, Kruzikas DT, Gilmore KE, Sanon M, Weinstein MC. Incorporating calibrated model parameters into sensitivity analyses: deterministic and probabilistic approaches. PharmacoEconomics. 2012;30(2):119–26.PubMedCrossRef
52.
53.
Vanni T, Karnon J, Madan J, White RG, Edmunds WJ, Foss AM, et al. Calibrating models in economic evaluation. Pharmacoeconomics. 2011;29(1):35–49.PubMedCrossRef
54.
55.
Weinstein MC. Recent developments in decision-analytic modelling for economic evaluation. PharmacoEconomics. 2006;24(11):1043–53.PubMedCrossRef
56.
West RR. Economic rate of discount and estimating cost benefit of viral immunisation programmes. Rev Med Virol. 1999;9(1):51–5.PubMedCrossRef
57.
Westra TA, Parouty M, Brouwer WB, Beutels PH, Rogoza RM, Rozenbaum MH, et al. On discounting of health gains from human papillomavirus vaccination: effects of different approaches. Value Health. 2012;15(3):562–7.PubMedCrossRef
58.
Ahmed F, Temte JL, Campos-Outcalt D, Schünemann HJ, Group AEBRW. Methods for developing evidence-based recommendations by the Advisory Committee on Immunization Practices (ACIP) of the US Centers for Disease Control and Prevention (CDC). Vaccine. 2011;29(49):9171–6.PubMedCrossRef
59.
Burchett HE, Mounier-Jack S, Griffiths UK, Mills AJ. National decision-making on adopting new vaccines: a systematic review. Health Policy Plan. 2012;27(Suppl 2):62–76.
60.
Dempsey AF, Cowan AE, Stokley S, Messonnier M, Clark SJ, Davis MM. The role of economic information in decision-making by the Advisory Committee on Immunization Practices. Vaccine. 2008;26(42):5389–92.PubMedCrossRef
61.
Drummond M. Funding processes for new vaccines: The need for greater understanding of the economic issues. J Public Health. 2008;16(4):261–5.CrossRef
62.
63.
64.
Freed GL. The structure and function of immunization advisory committees in Western Europe. Human Vaccines. 2008;4(4):292–7.PubMedCrossRef
65.
Goetghebeur M, Wagner M, Khoury H, Levitt R, Erickson L, Rindress D. Evidence and value: impact on DEcisionMaking—the EVIDEM framework and potential applications. BMC Health Serv Res. 2008;8(1):270.PubMedCentralPubMedCrossRef
66.
Hall AJ. The United Kingdom Joint Committee on vaccination and immunisation. Vaccine. 2010;28(Suppl 1):54–7.CrossRef
67.
Houweling H, Verweij M, Ruitenberg EJ. National Immunisation Programme Review Committee of the Health Council of the N. Criteria for inclusion of vaccinations in public programmes. Vaccine. 2010;28(17):2924–31.PubMedCrossRef
68.
Hutubessy R, Henao AM, Namgyal P, Moorthy V, Hombach J. Results from evaluations of models and cost-effectiveness tools to support introduction decisions for new vaccines need critical appraisal. BMC Med. 2011;9:55.
69.
Ismail SJ, Langley JM, Harris TM, Warshawsky BF, Desai S, FarhangMehr M. Canada’s National Advisory Committee on Immunization (NACI): evidence-based decision-making on vaccines and immunization. Vaccine. 2010;28(Suppl 1):58–63.CrossRef
70.
Jacobs P. Are economic evaluations an important tool in vaccine policy decisions? Expert Rev Pharmacoecon Outcomes Res. 2011;11(5):507–11.PubMedCrossRef
71.
Caro J, Eddy DM, Kan H, Kaltz C, Patel B, Eldessouki R, et al. Questionnaire to assess relevance and credibility of modeling studies for informing health care decision making: an ISPOR-AMCP-NPC Good Practice Task Force Report. Value Health. 2014;17(2):174–82.CrossRef
72.
Kimman TG, Boot HJ, Berbers GA, Vermeer-de Bondt PE, Ardine de Wit G, de Melker HE. Developing a vaccination evaluation model to support evidence-based decision making on national immunization programs. Vaccine. 2006;24(22):4769–78.PubMedCrossRef
73.
Newall AT, Reyes JF, Wood JG, McIntyre P, Menzies R, Beutels P. Economic evaluations of implemented vaccination programmes: key methodological challenges in retrospective analyses. Vaccine. 2014;32(7):759–65.PubMedCrossRef
74.
Nohynek H. The Finnish decision-making process to recommend a new vaccine: from vaccine research to vaccination policy. J Public Health. 2008;16(4):275–80.CrossRef
75.
76.
Piso B, Zechmeister I, Geiger-Gritsch S. Criteria for vaccine introduction: results of a DELPHI discussion among international immunisation experts on a stepwise decision-making procedure. J Public Health. 2011;19(1):73–80.CrossRef
77.
Spicher VM. The Federal Vaccination Commission in Switzerland: an officially appointed independent commission ensuring evidence-based recommendations and transparent procedures. Vaccine. 2010;28(Suppl 1):48–53.CrossRef
78.
79.
Welte R, Trotter CL, Edmunds WJ, Postma MJ, Beutels P. The role of economic evaluation in vaccine decision making: focus on meningococcal group C conjugate vaccine. PharmacoEconomics. 2005;23(9):855–74.PubMedCrossRef
80.
81.
82.
Brennan A, Chick SE, Davies R. A taxonomy of model structures for economic evaluation of health technologies. Health Econ. 2006;15(12):1295–310.PubMedCrossRef
83.
Willem L, Stijven S, Vladislavleva E, Broeckhove J, Beutels P, Hens N. Active learning to understand infectious disease models and improve policy making. PLoS Comput Biol. 2014;10(4):e1003563.PubMedCentralPubMedCrossRef
84.
Zechmeister I, Blasio BFd, Garnett G, Neilson AR, Siebert U. Cost-effectiveness analysis of human papillomavirus-vaccination programs to prevent cervical cancer in Austria. Vaccine. 2009;27(37):5133–41. doi:10.​1016/​j.​vaccine.​2009.​06.​039.
85.
86.
87.
88.
Rothberg MB, Virapongse A, Smith KJ. Cost-effectiveness of a vaccine to prevent herpes zoster and postherpetic neuralgia in older adults. Clin Infect Dis. 2007;44(10):1280–8. doi:10.​1086/​514342.PubMedCrossRef
89.
Brisson M, Pellissier JM, Levin MJ. Cost-effectiveness of herpes zoster vaccine: flawed assumptions regarding efficacy against postherpetic neuralgia. Clin Infect Dis. 2007;45(11):1527–9. doi:10.​1086/​523011.PubMedCrossRef
90.
Brisson M, Pellissier JM, Camden S, Quach C, De Wals P. The potential cost-effectiveness of vaccination against herpes zoster and post-herpetic neuralgia. Human Vaccines. 2008;4(3):238–45.PubMedCrossRef
91.
92.
93.
94.
Ultsch B, Weidemann F, Reinhold T, Siedler A, Krause G, Wichmann O. Health economic evaluation of vaccination strategies for the prevention of herpes zoster and postherpetic neuralgia in Germany. BMC Health Serv Res. 2013;13(1):359.PubMedCentralPubMedCrossRef
95.
96.
97.
Brisson M, Edmunds W. Economic evaluation of vaccination programs: the impact of herd-immunity. Med Decis Making. 2003;23(1):76–82.PubMedCrossRef
98.
Brisson M, Edmunds WJ. The cost-effectiveness of varicella vaccination in Canada. Vaccine. 2002;20(7–8):1113–25.PubMedCrossRef
99.
100.
101.
Poletti P, Melegaro A, Ajelli M, del Fava E, Guzzetta G, Faustini L et al. Perspectives on the impact of varicella immunization on herpes zoster. A model-based evaluation from three european countries. PLoS One. 2013;8(4):1–13.
102.
103.
104.
Basu S, Galvani AP. Re: “Multiparameter calibration of a natural history model of cervical cancer”. Am J Epidemiol. 2007;166(8):983. doi:10.​1093/​aje/​kwm240 (author reply-4).
105.
106.
Weinstein MC, O’Brien B, Hornberger J, Jackson J, Johannesson M, McCabe C, et al. Principles of good practice for decision analytic modeling in health-care evaluation: report of the ISPOR Task Force on Good Research Practices—modeling studies. Value Health. 2003;6(1):9–17.PubMedCrossRef
107.
Stout NK, Knudsen AB, Kong CY, McMahon PM, Gazelle GS. Calibration methods used in cancer simulation models and suggested reporting guidelines. Pharmacoeconomics. 2009;27(7):533–45.PubMedCentralPubMedCrossRef
108.
109.
110.
111.
112.
113.
Skoupá J, Annemans L, Hájek P. Health economic data requirements and availability in the european union: results of a survey among 10 European countries. Value Health Reg Issues. 2014;4:53–7.CrossRef
114.
115.
Bos JM, Beutels P, Annemans L, Postma MJ. Valuing prevention through economic evaluation: some considerations regarding the choice of discount model for health effects with focus on infectious diseases. PharmacoEconomics. 2004;22(18):1171–9.PubMedCrossRef
116.
Weinke T, Glogger A, Bertrand I, Lukas K. The societal impact of herpes zoster and postherpetic neuralgia on patients, life partners, and children of patients in Germany. Sci World J. 2014;2014:749698. doi:10.​1155/​2014/​749698.CrossRef
117.
Hornberger J, Robertus K. Cost-effectiveness of a vaccine to prevent herpes zoster and postherpetic neuralgia in older adults. Ann Intern Med. 2006;145(5):317–25.PubMedCrossRef
118.
Damm O, Ultsch B, Horn J, Mikolajczyk R, Greiner W, Wichmann O. Systematic review of models assessing the economic value of routine varicella and herpes zoster vaccination in high-income countries. BMC Public Health. 2015;15(1):1–19. doi:10.​1186/​s12889-015-1861-8.CrossRef
119.
Annemans L, Bresse X, Gobbo C, Papageorgiou M. Health economic evaluation of a vaccine for the prevention of herpes zoster (shingles) and post-herpetic neuralgia in adults in Belgium. J Med Econ. 2010;13(3):537–51.PubMedCrossRef
120.
Szucs TD, Kressig RW, Papageorgiou M, Kempf W, Michel JP, Fendl A, et al. Economic evaluation of a vaccine for the prevention of herpes zoster and post-herpetic neuralgia in older adults in Switzerland. Hum Vaccines. 2011;7(7):749–56. doi:10.​4161/​hv.​7.​7.​15573.CrossRef
Metadata
Title
Methods for Health Economic Evaluation of Vaccines and Immunization Decision Frameworks: A Consensus Framework from a European Vaccine Economics Community
Authors
Bernhard Ultsch
Oliver Damm
Philippe Beutels
Joke Bilcke
Bernd Brüggenjürgen
Andreas Gerber-Grote
Wolfgang Greiner
Germaine Hanquet
Raymond Hutubessy
Mark Jit
Mirjam Knol
Rüdiger von Kries
Alexander Kuhlmann
Daniel Levy-Bruhl
Matthias Perleth
Maarten Postma
Heini Salo
Uwe Siebert
Jürgen Wasem
Ole Wichmann
Publication date
01-03-2016
Publisher
Springer International Publishing
Published in
PharmacoEconomics / Issue 3/2016
Print ISSN: 1170-7690
Electronic ISSN: 1179-2027
DOI
https://doi.org/10.1007/s40273-015-0335-2

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