Cost effectiveness analysis of heptavalent pneumococcal conjugate vaccine in Germany considering herd immunity effects
Tóm tắt
In Germany the heptavalent pneumococcal conjugate vaccine (PCV7) has been recommended as a general infant vaccination since 2006. Data from similar programmes in the USA have reported a reduction of pneumococcal diseases in both vaccinated and unvaccinated populations, suggesting herd immunity effects. This study analyses the cost-effectiveness of a general vaccination with PCV7 in Germany based on these findings. A Markov model adapts efficacy and herd immunity data to the German population. Further main model inputs are incidence, vaccination uptake, serotype distribution, case fatality rates, and vaccination and health-care costs. A general vaccination with PCV7 would avoid about 232,000 pneumococcal infections and 1,879 premature deaths per year in Germany. From the health-care payer's perspective, direct cost savings would outweigh vaccination expenditures by a ratio of 1:1.16. The sensitivity analysis shows that these estimates are quite conservative. Based on the health-economic evaluation, the authors recommend the continuation of the general recommendation of PCV7 according to the 3 + 1 schedule within the German Statutory Health Insurance.
Tài liệu tham khảo
Asensi, F., De Jose, M., Lorente, M., Moraga, F., Ciuryla, V., Arikian, S., Casciano, R., Vento, M.: A pharmacoeconomic evaluation of seven-valent pneumococcal conjugate vaccine in Spain. Value. Health. 7, 36–51 (2004)
Balk, R.A.: Severe sepsis and septic shock. Crit. Care Clin. 16, 179–192 (2000)
Barker, L., Luman, E., Zhao, Z., Smith, P., Linkins, R., Santoli, J., Rodewald, L., McCauley, M.: National, state, and urban area vaccination coverage levels among children aged 19–35 months—United States, 2001. Morb. Mortal. Wkly. Rep. 51, 664–666 (2002)
Baxter, R., Black, S., Shinefield, H., Fireman, B.: Impact of seven-valent pneumococcal conjugate vaccine (PCV) on antibiotic resistance within Northern California Kaiser Permanente (NCKP) (abstract). In: 41st Annual Meeting of IDSA, San Diego, 9–12 October 2003
Bernard, G.R., Vincent, J.L., Laterre, P.F., LaRosa, S.P., Dhainaut, J.F., Lopez-Rodriguez, A., Steingrub, J.S., Garber, G.E., Helterbrand, J.D., Ely, E.W., Fisher, C.J. Jr.: Efficacy and safety of recombinant human activated protein C for severe sepsis. N. Engl. J. Med. 344, 699–709 (2001)
Beutels, P., Van Damme, P., Oosterhuis-Kafeja, F.: Effects and costs of pneumococcal conjugate vaccination of Belgian children. Health. Technol. Assess. (HTA). Brussels (2006)
Black, S.: Decline in invasive pneumococcal disease after the introduction of protein-polysaccharide conjugate vaccine. J. Pediatr. 143, 688–689 (2003)
Black, S., Shinefield, H., Fireman, B., Lewis, E., Ray, P., Hansen, J.R., Elvin, L., Ensor, K.M., Hackell, J., Siber, G., Malinoski, F., Madore, D., Chang, I., Kohberger, R., Watson, W., Austrian, R., Northern California Kaiser Permanente Vaccine Study Center Group: efficacy, safety and immunogenicity of heptavalent pneumococcal conjugate vaccine in children. Pediatr. Infect. Dis. J. 19, 187–195 (2000)
Black, S.B., Shinefield, H.R., Ling, S., Hansen, J., Fireman, B., Spring, D., Noyes, J., Lewis, E., Ray, P., Lee, J., Hackell, J.: Effectiveness of heptavalent pneumococcal conjugate vaccine in children younger than five years of age for prevention of pneumonia. Pediatr. Infect. Dis. J. 21, 810–815 (2002)
Bos, J.M., Rumke, H., Welte, R., Postma, M.J.: Epidemiologic impact and cost-effectiveness of universal infant vaccination with a 7-valent conjugated pneumococcal vaccine in the Netherlands. Clin. Ther. 25, 2614–2630 (2003)
Breiman, R.F., Spika, J.S., Navarro, V.J., Darden, P.M., Darby, C.P.: Pneumococcal bacteremia in Charleston county, South Carolina. A decade later. Arch. Intern. Med. 150, 1401–1405 (1990)
Bundesverband der Pharmazeutischen Industrie e.V. (BPI) (Hrsg.): Pharma-Daten 2006, 36. überarbeitete Auflage. Berlin (2006)
Butler, J.R., McIntyre, P., MacIntyre, C.R., Gilmour, R., Howarth, A.L., Sander, B.: The cost-effectiveness of pneumococcal conjugate vaccination in Australia. Vaccine 22, 1138–1149 (2004)
Claes, C., Schulenburg, J.M. Graf von der.: Cost effectiveness of pneumococcal vaccination for infants and children with the conjugate vaccine PnC-7 in Germany. Pharmacoeconomics 21, 587–600 (2003)
Committee for Proprietary Medicinal Products: European Public Assessment Report (EPAR). Prevenar. URL: http://www.emea.europa.eu/humandocs/Humans/EPAR/prevenar/prevenar.htm. Accessed 10 Jan 2008)
De Wals, P., Petit, G., Erickson, L.J., Guay, M., Tam, T., Law, B., Framarin, A.: Benefits and costs of immunization of children with pneumococcal conjugate vaccine in Canada. Vaccine 21, 3757–3764 (2003)
Deutsche Rentenversicherung Bund (Hrsg.): Rentenversicherung in Zahlen 2007. Berlin (2007)
Eisenmenger, M.: Sterbetafel 2001/2003. Wirtschaft und Statistik. 5, 463–478 (2005)
Eisenmenger, M., Poetzsch O., Sommer B.: 11. Koordinierte Bevölkerungs-Vorausberechnung. Annahmen und Ergebnisse, Wiesbaden (2006)
Eskola, J., Kilpi, T., Palmu, A., Jokinen, J., Haapakoski, J., Herva, E., Takala, A., Käyhty, H., Karma, P., Kohberger, R., Siber, G., Mäkelä, P.H.: Finnish Otitis Media Study Group: efficacy of a pneumococcal conjugate vaccine against acute otitis media. N. Engl. J. Med. 344, 403–409 (2001)
Ess, S.M., Schaad, U.B., Gervaix, A., Pinosch, S., Szucs, T.D.: Cost-effectiveness of a pneumococcal conjugate immunisation program for infants in Switzerland. Vaccine 21, 3273–3281 (2003)
Fedson, D.S., Musher, D.M.: Pneumococcal vaccine. In: Plotkin, S.A., Mortimer, E Jr. (eds.) Vaccine, 2nd edn pp. 517–564. Saunders, Philadelphia (1994)
Fireman, B., Black, S.B., Shinefield, H.R., Lee, J., Lewis, E., Ray, P.: Impact of the pneumococcal conjugate vaccine on otitis media. Pediatr. Infect. Dis. J. 22, 10–16 (2003)
Ford, M.W., Grace, E., Wand, E.C.: The clinical and economic impact of pneumococcal conjugate vaccine associated herd immunity in Canada. J. Med. Econ. 7, 85–92 (2004)
Gemeinsamer Bundesausschuss (Hrsg.): Beschluss des Gemeinsamen Bundesausschusses über eine Richtlinie über Schutzimpfungen nach § 20 d Abs. 1. SGB V (Schutzimpfungs-Richtlinie / SiR): Regelung des Anspruches der Versicherten auf Leistungen für Schutzimpfungen gemäß § 29 Abs. 1 Satz 2 Nr. 15 SGB V vom 21. Juni 2007. URL: http://www.g-ba.de/cms/front_content.php?idcat=56 (Accessed 10 Jan 2008)
Gesetz zur Stärkung des Wettbewerbs in der gesetzlichen Krankenversicherung (GKV-Wettbewerbsstärkungsgesetz — GKV-WSG) vom 26. März 2007. Bundesgesetzblatt Teil 1 Nr. 11, 378–473 (2007)
Grijalva, C.G., Nuorti, J.P., Arbogast, P.G., Martin, S.W., Edwards, K.M., Griffin, M.R.: Decline in pneumonia admissions after routine childhood immunisation with pneumococcal conjugate vaccine in the USA: a time-series analysis. Lancet 369, 1179–1186 (2007)
Grijalva, C.G., Poehling, K.A., Nuorti, J.P., Zhu, Y., Martin, S.W., Edwards, K.M., Griffin, M.R.: National impact of universal childhood immunization with pneumococcal conjugate vaccine on outpatient medical care visits in the United States. Pediatrics 118, 865–873 (2006)
Hallauer, J.F.: Aktueller Stand de Pneumokokkenerkrankungen in Deutschland und der Nutzung der konjugierten Pneumokokkenvakzine. Gesundheitsökonomie und Qualitätsmanagement 11, 43–55 (2006)
Hueston, W.J., Mainous, A.G. III, Brauer, N.: Predicting cost-benefits before programs are started: looking at conjugate vaccine for invasive pneumococcal infections. J. Community. Health. 25, 23–33 (2000)
Hülße, C., Ley, S., Stück, B.: Ärztemerkblatt Pneumokokken. Verlag im Kilian, Marburg (1999)
IMS Health Deutschland: Verschreibungsindex für Pharmazeutika (VIP). URL: http://www.imshealth.de (Accessed 10 Jan 2008)
Imran, M.N., Leng, P.H., Yang, S., Kurup, A., Eng, P.: Early predictors of mortality in pneumococcal bacteraemia. Ann. Acad. Med. Singapore. 34, 426–431 (2005)
Institut für das Entgeltsystem im Krankenhaus gGmbH (InEK): G-DRG-System 2007, Reportbrowser 2005/2007. URL: http://www.g-drg.de (Accessed 10 Jan 2008)
Kalies, K., Hermann, M., Schmitt, H.J., Kries, R.V.: Prävention invasiver Pneumokokken Infektionen im Kindersalter. Welche Impfstrategie ist zu empfehlen? Kinderärztliche Praxis. 72, 90–98 (2001)
Kalin, M., Ortqvist, A., Almela, M., Aufwerber, E., Dwyer, R., Henriques, B., Jorup, C., Julander, I., Marrie, T.J., Mufson, M.A., Riquelme, R., Thalme, A., Torres, A., Woodhead, M.A.: Prospective study of prognostic factors in community-acquired bacteremic pneumococcal disease in 5 countries. J. Infect. Dis. 182, 840–847 (2000)
Kaplan, V., Angus, D.C., Griffin, M.F., Clermont, G., Scott, W.R., Linde-Zwirble, W.T.: Hospitalized community-acquired pneumonia in the elderly: age- and sex-related patterns of care and outcome in the United States. Am.J. Respir. Crit. Care Med. 165, 766–772 (2002)
von Kries, R., Siedler, A., Schmitt, H.J., Reinert, R.R.: Proportion of invasive pneumococcal infections in German children preventable by pneumococcal conjugate vaccines. Clin. Infect. Dis. 31, 482–487 (2000)
von Kries, R., Toschke, A.M., Siedler, A., Reinert, R.R.: Population-based nationwide study on invasive pneumococcal infections among children in Germany (1997–2003). (2005)
Lebel, M.H., Kellner, J.D., Ford-Jones, E.L., Hvidsten, K., Wang, E.C., Ciuryla, V., Arikian, S., Casciano, R.: A pharmacoeconomic evaluation of 7-valent pneumococcal conjugate vaccine in Canada. Clin. Infect. Dis. 36, 259–268 (2003)
Lexau, C.A., Lynfield, R., Danila, R., Pilishvili, T., Facklam, R., Farley, M.M., Harrison, L.H., Schaffner, W., Reingold, A., Bennett, N.M., Hadler, J., Cieslak, P.R., Whitney, C.G.: Changing epidemiology of invasive pneumococcal disease among older adults in the era of pediatric pneumococcal conjugate vaccine. J. Am. Med. Assoc. 294, 2043–2051 (2005)
Ley, S., Stück, B.: Pneumokokken-Infektionen: Ältere Menschen. Immunologie & Impfen. 2, 128–133 (1999)
Lieu, T.A., Ray, G.T., Black, S.B., Butler, J.C., Klein, J.O., Breiman, R.F., Miller, M.A., Shinefield, H.R.: Projected cost-effectiveness of pneumococcal conjugate vaccination of healthy infants and young children. J. Am. Med. Assoc. 283, 1460–1468 (2000)
Lloyd, A., Patel, N., Scott, D.A., Runge, C., Claes, C., Rose, M.: Cost-effectiveness of heptavalent conjugate pneumococcal vaccine (Prevenar) in Germany: considering a high-risk population and herd immunity effects. Eur. J. Health. Econ. [Epub ahead of print] (2007)
Marchetti, M., Colombo, G.L.: Cost-effectiveness of universal pneumococcal vaccination for infants in Italy. Vaccine 23, 4565–4576 (2005)
McIntosh, E.D., Conway, P., Willingham, J., Hollingsworth, R., Lloyd, A.: Pneumococcal pneumonia in the UK—how herd immunity affects the cost-effectiveness of 7-valent pneumococcal conjugate vaccine (PCV). Vaccine 23, 1739–1745 (2005)
McIntosh, E.D., Conway, P., Willingham, J., Lloyd, A.: The cost-burden of paediatric pneumococcal disease in the UK and the potential cost-effectiveness of prevention using 7-valent pneumococcal conjugate vaccine. Vaccine 21, 2564–2572 (2003)
Melegaro, A., Edmunds, W.J.: Cost-effectiveness analysis of pneumococcal conjugate vaccination in England and Wales. Vaccine 22, 4203–4214 (2004)
Moore, D., Bigham, M., Patrick, D.: Modelling the costs and effects of a universal infant immunization program using conjugated pneumococcal vaccine in British Columbia. Can. Commun. Dis. Rep. 29, 97–104 (2003)
Navas, E., Salleras, L., Gisbert, R., Dominguez, A., Timoner, E., Ibanez, D., Prat, A.: Cost-benefit and cost-effectiveness of the incorporation of the pneumococcal 7-valent conjugated vaccine in the routine vaccination schedule of Catalonia (Spain). Vaccine 23, 2342–2348 (2005)
Overturf, G.D., American Academy of Pediatrics, Committee on Infectious Diseases: technical report: prevention of pneumococcal infections, including the use of pneumococcal conjugate and polysaccharide vaccines and antibiotic prophylaxis. Pediatrics 106, 367–376 (2000)
Pelton, S.I.: Acute otitis media in the era of effective pneumococcal conjugate vaccine: will new pathogens emerge? Vaccine 19, S96–S99 (2000)
Poethko-Müller, C., Kuhnert, R., Schlaud, M.: Durchimpfung und Determinanten des Impfstatus in Deutschlang. Ergebnisse des Kinder-und Jugendgesundheitssurveys (KiGGS). Bundesgesundheitsblatt — Gesundheitsforschung — Gesundheitsschutz 50, 851–862 (2007)
Prosser, L.A., Ray, G.T., O’Brien, M., Kleinman, K., Santoli, J., Lieu, T.A.: Preferences and willingness to pay for health states prevented by pneumococcal conjugate vaccine. Pediatrics. 113, 283–290 (2004)
Ray, G.T., Whitney, C.G., Fireman, B.H., Ciuryla, V., Black, S.B.: Cost-effectiveness of pneumococcal conjugate vaccine: evidence from the first 5 years of use in the United States incorporating herd effects. Pediatr. Infect. Dis. J. 25, 494–501 (2006)
Reinert, R.R., Haupts, S., van der Linden, M., Heeg, C., Cil, M.Y., Al-Lahham, A., Fedson, D.S.: Invasive pneumococcal disease in adults in North-Rhine Westphalia, Germany, 2001–2003. Clin. Microbiol. Infect. 11, 985–991 (2005)
Robert Koch Institut (RKI): Zur Impfung gegen Pneumokokken-Infektionen. Epidemiol. Bull. 12, 97–99 (2000)
Rote Liste® Service GmbH (Hrsg.): Rote Liste. Arzneimittelinformationen für Deutschland (einschließlich EG-Zulassungen und bestimmter Medizinprodukte). Frankfurt (2005)
Rote Liste® Service GmbH (Hrsg.): Rote Liste online. Arzneimittelinformationen für Deutschland (einschließlich EG-Zulassungen und bestimmter Medizinprodukte). URL: http://www.rote-liste.de (Accessed 10 Jan 2008)
Ryan, K.J., Ray, C.G., Sherris, J.C.: (eds.): Sherris Medical Microbilogoy: an introduction to infectious diseases. McGraw-Hill, Cincinnati (2004)
Rüggeberg, J.U., Ketteler, K., MacKenzie, C.R., von Kries, R., Reinert, R.R., Schroten, H.: Blood culture sampling rates at a German pediatric university hospital and incidence of invasive pneumococcal disease. Infection 32, 78–81 (2004)
Salo, H., Sintonen, H., Pekka Nuorti, J., Linna, M., Nohynek, H., Verho, J., Kilpi, T.: Economic evaluation of pneumococcal conjugate vaccination in Finland. Scand. J. Infect. Dis. 37, 821–832 (2005)
Schnoor, M., Hedicke, J., Dalhoff, K., Raspe, H., Schafer, T.: Approaches to estimate the population-based incidence of community acquired pneumonia. J. Infect. 55, 233–239 (2007)
Scholz, H.: Akute Otitis media — Krankheitsbild und Behandlung im Kindesalter. In: Stück B., von Voss H. (eds.) Pneumokokken-Erkrankungen bei Säuglingen und Kleinkindern, pp. 15–22. Verlag im Kilian, Marburg (2001)
Schulenburg, J.M. Graf von der, Greiner, W., Jost, F., Klusen, N., Kubin, M., Leidl, R., Mittendorf, T., Rebscher, H., Schöffski, O., Vauth, C., Volmer, T., Wahler, S., Wasem, J., Weber, C., und die Mitglieder des Hannoveraner Konsens. Deutsche Empfehlungen zur gesundheitsökonomischen Evaluation — dritte und aktualisierte Fassung des Hannoveraner Konsens. Gesundheitsökonomie und Qualitätsmanagement 12, 285–290 (2007)
Schulze-Gattermann, H.: Kosten-Nutzen-Analyse der Cochlea-Implantation bei Kindern. Dissertation, Medizinische Hochschule Hannover (2000)
Schulze-Gattermann, H., Illg, A., Schoenermark, M., Lenarz, T., Lesinski-Schiedat, A.: Cost-benefit analysis of pediatric cochlear implantation: German experience. Otol. Neurotol. 23, 674–681 (2002)
Statistisches Bundesamt (Hrsg.): Bevölkerung nach Altersgruppen, Familienstand und Religionszugehörigkeit. URL: http://www.destatis.de (Accessed 10 Jan 2008)
Statistisches Bundesamt (Hrsg.): Diagnosedaten der Krankenhäuser nach Behandlungsort ab 2000 (Fälle/Sterbefälle, Pflegetage, durchschnittliche Verweildauer. Gliederungsmerkmale: Jahre, Behandlungsort, Alter, Geschlecht, Verweildauer, ICD10. URL: http://www.gbe-bund.de (Accessed 10 Jan 2008)
Statistisches Bundesamt (Hrsg.): Leben und Arbeiten in Deutschland. Sonderheft 2: Vereinbarkeit von Familie und Beruf. Ergebnisse des Mikrozensus 2005. Wiesbaden (2006)
Statistisches Bundesamt (Hrsg.): Statistisches Jahrbuch 2006. Für die Bundesrepublik Deutschland. Wiesbaden (2006)
Ständige Impfkommission am Robert Koch-Institut (STIKO): Empfehlung der Ständigen Impfkommission (STIKO) am Robert Koch Institut, Stand: Juli 2006. Epidemiol. Bull. 235–254 (2006)
Weycker, D., Richardson, E., Oster, G.: Childhood vaccination against pneumococcal otitis media and pneumonia: an analysis of benefits and costs. Am. J. Manage. Care. 6, S526–S535 (2000)
Whitney, C.G.: Effect of pneumococcal conjugate vaccine on invasive disease in the U.S. (abstract). 4th international symposium on pneumococci and pneumococcal diseases, Helsinki 9–13 May 2004
Whitney, C.G.: Impact of conjugate pneumococcal vaccines. Pediatr. Infect. Dis. J. 24, 729–730 (2005)
Whitney, C.G., Farley, M.M., Hadler, J., Harrison, L.H., Bennett, N.M., Lynfield, R., Reingold, A., Cieslak, P.R., Pilishvili, T., Jackson, D., Facklam, R.R., Jorgensen, J.H., Schuchat, A.: Decline in invasive pneumococcal disease after the introduction of protein-polysaccharide conjugate vaccine. N. Engl. J. Med. 348, 1737–1746 (2003)
Wisloff, T., Abrahamsen, T.G., Bergsaker, M.A., Lovoll, O., Moller, P., Pedersen, M.K., Kristiansen, I.S.: Cost effectiveness of adding 7-valent pneumococcal conjugate (PCV-7) vaccine to the Norwegian childhood vaccination program. Vaccine 24, 5690–5699 (2006)
Zentralinstitut (ZI): Abrechnungsdatentraeger-Panel (ADT-Panel). URL: http://www.zi-berlin.de (Accessed 10 Jan 2008)