Overall effectiveness of pneumococcal conjugate vaccines: An economic analysis of PHiD-CV and PCV-13 in the immunization of infants in Italy

References

• World Health Organization (WHO) . Pneumococcal vaccines WHO position paper 2012. Weekly Epidemiological Record 2012; 87:129-44; PMID:24340399
   PubMedGoogle Scholar
• Moore MR , Link-Gelles R , Schaffner W , Lynfield R , Lexau C , Bennett NM , Petit S , Zansky SM , Harrison LH , Reingold A , et al. Impact of 13-valent pneumococcal conjugate vaccine used in children on invasive pneumococcal disease in children and adults in the United States: Analysis of multisite, population-based surveillance. Lancet Infect Dis 2015; 15:301–9; PMID:25656600; https://doi.org/10.1016/S1473-3099(14)71081-3
   PubMed Web of Science ®Google Scholar
• Jokinen J , Rinta-Kokko H , Siira L , Palmu AA , Virtanen MJ , Nohynek H , Virolainen-Julkunen A , Toropainen M , Nuorti JP. Impact of Ten-Valent Pneumococcal Conjugate vaccination on Invasive Pneumococcal disease in Finnish children - A population-based study. PLoS One 2015; 10:e0120290; PMID:25781031; https://doi.org/10.1371/journal.pone.0120290
   PubMed Web of Science ®Google Scholar
• Moreira M , Castro O , Palmieri M , Efklidou S , Castagna S , Hoet B . A reflection on invasive pneumococcal disease and pneumococcal conjugate vaccination coverage in children in Southern Europe (2009–2016). Human Vaccines & Immunotherapeutics 2017; 13:1242–53; https://dx.doi.org/10.1080/21645515.2016.1263409
   PubMed Web of Science ®Google Scholar
• Savulescu C , Krizova P , Lepoutre A , Mereckiene J , Vestrheim DF , Ciruela P , Ordobas M , Guevara M , McDonald E , Morfeldt E , et al. Effect of high-valency pneumococcal conjugate vaccines on invasive pneumococcal disease in children in SpIDnet countries: an observational multicentre study. The Lancet Respiratory Medicine 2017; 5:648–56; https://doi.org/10.1016/S2213-2600(17)30110-8
   PubMed Web of Science ®Google Scholar
• Alfonsi V , D'Ancona F , Giambi C , Nacca G , Rota MC . Current immunization policies for pneumococcal, meningococcal C, varicella and rotavirus vaccinations in Italy. Health Policy 2011; 103:176-83; PMID:22030308; https://doi.org/10.1016/j.healthpol.2011.10.002
   PubMed Web of Science ®Google Scholar
• Ansaldi F , Sticchi L , Durando P , Carloni R , Oreste P , Vercelli M , Crovari P , Icardi G . Decline in pneumonia and acute Otitis Media after the Introduction of childhood Pneumococcal vaccination in Liguria, Italy. J Int Med Res 2008; 36:1255-60; PMID:19094434; https://doi.org/10.1177/147323000803600612
   PubMed Web of Science ®Google Scholar
• D'Ambrosio F , Del Grosso M , Camilli R , Ingrosso L , Grazia Caporalli M , D'Ancona F , Pantosti A . Surveillance of invasive diseases caused by Streptococcus pneumoniae in Italy: evolution of serotypes and antibiotic resistance in different age groups before and after implementation of PCV7. Microbiologia Medica 2013; 28(1):17–20; https://doi.org/10.4081/mm.2013.2275
   Google Scholar
• Durando P , Alicino C , De Florentiis D , Martini M , Icardi G . Improving the protection against Streptococcus pneumoniae with the new generation 13-valent pneumococcal conjugate vaccine. J Prev Med Hyg 2012; 53:68-77; PMID:23240163
   PubMedGoogle Scholar
• Istituto Superiore di Sanita . Dati di sorveglianza delle malattie batteriche invasive aggiornati al 12 agosto 2015. 2015 [accessed 2015 Dec 22]. http://www.iss.it/binary/mabi/cont/Report_MBI_20150812_V5.pdf
   Google Scholar
• Ministero della Salute . Indicazioni in merito alla somministrazione del vaccino antipneumococcico Prevenar 13 in età pediatrica, Circolare del 27 maggio 2010, prot.n.111432/72AF. 2010 [accessed 2015 Dec 24]. http://www.fimpcalabria.org/public/vaccinazioni/indicazioni%20in%20merito%20alla%20somministrazione%20del%20vaccino%20antipneumococcico%20prevenar%2013%20in%20et%C3%A0%20pediatrica%20%282%29.pdf
   Google Scholar
• Ministero della Salute . Piano Nazionale Prevenzione Vaccinale (PNPV) 2012-2014. Intesa Stato-Regioni del 22 febbraio 2012. Supplemento ordinario alla “Gazzetta Ufficiale„ n. 60 del 12 marzo 2012 - Serie generale. http://www.gazzettaufficiale.it/do/gazzetta/serie_generale/3/pdfPaginato?dataPubblicazioneGazzetta=20120312&numeroGazzetta=60&tipoSerie=SG&tipoSupplemento=SO&numeroSupplemento=47&numPagina=1&edizione=0
   Google Scholar
• Deceuninck G , De Serres G , Boulianne N , Lefebvre B , De Wals P . Effectiveness of three pneumococcal conjugate vaccines to prevent invasive pneumococcal disease in Quebec, Canada. Vaccine 2015; 33:2684-9; PMID:25887086; https://doi.org/10.1016/j.vaccine.2015.04.005
   PubMed Web of Science ®Google Scholar
• Hausdorff WP , Hoet B , Adegbola RA . Predicting the impact of new pneumococcal conjugate vaccines: serotype composition is not enough. Expert Rev Vaccines 2015; 14(3):413-28; https://doi.org/10.1586/14760584.2015.965160
   PubMed Web of Science ®Google Scholar
• Palmu AA , Jokinen J , Borys D , Nieminen H , Ruokokoski E , Siira L , Puumalainen T , Lommel P , Hezareh M , Moreira M , et al. Effectiveness of the ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10) against invasive pneumococcal disease: a cluster randomised trial. Lancet 2013; 381(9862):214-22; PMID:23158882; https://doi.org/10.1016/S0140-6736(12)61854-6
   PubMed Web of Science ®Google Scholar
• Tregnaghi MW , Sàez-Llorens X , López P , Abate H , Smith E , Pósleman A , Calvo A , Wong D , Cortes-Barbosa C , Ceballos A , et al. Efficacy of Pneumococcal Nontypable Haemophilus influenzae Protein D Conjugate Vaccine (PHiD-CV) in young Latin American children: A double-blind randomized controlled trial. PLoS Med 2014; 11:e1001657; PMID:24892763; https://doi.org/10.1371/journal.pmed.1001657
   PubMed Web of Science ®Google Scholar
• Waight PA , Andrews NJ , Ladhani SN , Sheppard CL , Slack MPE , Miller E . Effect of the 13-valent pneumococcal conjugate vaccine on invasive pneumococcal disease in England and Wales 4 years after its introduction: an observational cohort study. Lancet Infect Dis 2015; 15(6):535-43; https://doi.org/10.1016/S1473-3099(15)70044-7
   PubMed Web of Science ®Google Scholar
• Superior Health Council of Belgium . Avis du conseil supérieur de la santé N° 8813: Vaccination de l'enfant et de l'adolescent contre le pneumocoque. 2015 [accessed 2016 Dec 16]. http://www.health.belgium.be/internet2Prd/groups/public/@public/@shc/documents/ie2divers/19103438.pdf
   Google Scholar
• Conseil Supérieur des Maladies Infectieuses . Avis du CSMI pour la vaccination universelle contre le pneumocoque : vaccin 10 ou 13-valent ? 2016 [accessed 2016 Nov 16]. http://www.sante.public.lu/fr/espace-professionnel/recommandations/conseil-maladies-infectieuses/infection-pneumocoques/2016-09-20-vaccination-pneumocoque.pdf
   Google Scholar
• Immunisation Subcommittee of PTAC . Record of the Immunisation Subcommittee of the Pharmacology and Therapeutics Committee (PTAC) meeting held at PHARMAC on 28 October 2015. 2016 [accessed 2016 Nov 17]. https://www.pharmac.govt.nz/assets/ptac-immunisation-subcommittee-minutes-2015-10.pdf
   Google Scholar
• European Medicines Agency (EMA) . Summary of product characteristics (Synflorix). 2015 [accessed 2015 Dec 24]. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000973/WC500054346.pdf
   Google Scholar
• de Oliveira LH , Camacho LA , Coutinho ESF , Martinez-Silveira MS , Carvalho AF , Ruiz-Matus C , Toscano CM . Impact and Effectiveness of 10 and 13-Valent Pneumococcal Conjugate Vaccines on Hospitalization and Mortality in Children Aged Less than 5 Years in Latin American Countries: A Systematic Review. PLoS One 2016; 11:e0166736; PMID:27941979; https://doi.org/10.1371/journal.pone.0166736
   PubMed Web of Science ®Google Scholar
• Prymula R , Peeters P , Chrobok V , Kriz P , Novakova E , Kaliskova E , Kohl I , Lommel P , Poolman J , Prieels JP , et al. Pneumococcal capsular polysaccharides conjugated to protein D for prevention of acute otitis media caused by both Streptococcus pneumoniae and non-typable Haemophilus influenzae: a randomised double-blind efficacy study. Lancet 2006; 367(9512):740-8; PMID:16517274; https://doi.org/10.1016/S0140-6736(06)68304-9
   PubMed Web of Science ®Google Scholar
• Palmu AA , Jokinen J , Nieminen H , Rinta-Kokko H , Ruokokoski E , Puumalainen T , Borys D , Lommel P , Traskine M , Moreira M . Effect of pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10) on outpatient antimicrobial purchases: a double-blind, cluster randomised phase 3-4 trial. Lancet Infect Dis 2014; 14:205-12; PMID:24287186; https://doi.org/10.1016/S1473-3099(13)70338-4
   PubMed Web of Science ®Google Scholar
• Camilli R , Vescio MF , Giufré M , Daprai L , Garlaschi ML , Cerquetti M , Pantosti A . Carriage of Haemophilus influenzae is associated with pneumococcal vaccination in Italian children. Vaccine 2015; 33:4559-64; PMID:26190092; https://doi.org/10.1016/j.vaccine.2015.07.009
   PubMed Web of Science ®Google Scholar
• Drummond MF , Schulpher MJ , Claxton K , Stoddart GL , Torrance GW . Methods for the economic evaluation of health care programmes. 4th edition. Oxford: Oxford University Press; 2015.
   Google Scholar
• Poolman J , Frasch C , Nurkka A , Käyhty H , Biemans R , Schuerman L . Impact of the Conjugation Method on the Immunogenicity of Streptococcus pneumoniae Serotype 19F Polysaccharide in Conjugate Vaccines. Clin Vaccine Immunol 2011; 18:327-36; PMID:21123523; https://doi.org/10.1128/CVI.00402-10
   PubMed Web of Science ®Google Scholar
• Domingues CMA , Verani JR , Montenegro Renoiner EI , de Cunto Brandileone MC , Flannery B , de Oliveira LH , Santos JB , de Moraes JC . Effectiveness of ten-valent pneumococcal conjugate vaccine against invasive pneumococcal disease in Brazil: a matched case-control study. The Lancet Respiratory Medicine 2014; 2:464–71. https://doi.org/10.1016/S2213-6702600(14)70060-8
   PubMed Web of Science ®Google Scholar
• Knol MJ , Wagenvoort GH , Sanders EA , Elberse K , Vlaminckx BJ , de Melker HE , van der Ende A . Invasive pneumococcal disease 3 years after introduction of 10-Valent Pneumococcal Conjugate Vaccine, the Netherlands. Emerg Infect Dis 2015; 21:2040-4; PMID:26488415; https://doi.org/10.3201/eid2111.140780
   PubMed Web of Science ®Google Scholar
• Verani JR , Santos Domingues CMA , Cassio de Moraes J , Group tBPCVES . Indirect cohort analysis of 10-valent pneumococcal conjugate vaccine effectiveness against vaccine-type and vaccine-related invasive pneumococcal disease. Vaccine 2015; 33:6145-8; PMID:26469718; https://doi.org/10.1016/j.vaccine.2015.10.007
   PubMed Web of Science ®Google Scholar
• Knerer G , Ismaila A , Pearce D . Health and economic impact of PHiD-CV in Canada and the UK: a Markov modelling exercise. J Medical Economics 2012; 15:61-76; ; https://doi.org/10.3111/13696998.2011.622323
   PubMedGoogle Scholar
• ISTAT - Istituto Nazionale di Statistica . Popolazione residente in Italia al 1° Gennaio 2015 per età, sesso e stato civile. 2015 [accessed 2015 Dec 22]. http://demo.istat.it/pop2015/index.html
   Google Scholar
• ISTAT - Istituto Nazionale di Statistica . Tavole di mortalità della popolazione italiana. 2015 [accessed 2015 Dec 22]. http://demo.istat.it/index.html
   Google Scholar
• Ministero della Salute . Ufficio V - Malattie infettive e profilassi internazionale - DG Prevenzione Sanitaria. 2016 [accessed 2016 Apr 12]. http://www.salute.gov.it/imgs/C_17_tavole_20_allegati_iitemAllegati_2_fileAllegati_itemFile_0_file.pdf
   Google Scholar
• Health Protection Agency (HPA) . Pneumococcal serotype distribution for samples referred for serotyping epidemiological years (July–June): 2000/1 to 2005/6. 2009 [accessed 2015 Dec 22]. http://webarchivenationalarchivesgov.uk/20100304045635/http://wwwhpaorguk/webw/HPAweb&HPAwebStandard/HPAweb_C/1195733824984?p=1203409671918
   Google Scholar
• Baldo V , Cocchio S , Baldovin T , Buja A , Furlan P , Bertoncello C , Russo F , Saia M . A population-based study on the impact of hospitalization for pneumonia in different age groups. BMC Infect Dis 2014; 14:485; PMID:25192701; https://doi.org/10.1186/1471-2334-14-485
   PubMed Web of Science ®Google Scholar
• Pedianet . Report Dati Pedianet Anno 2006. http://www.pedianet.it/bin=1039/Report-2006.pdf, 2006
   Google Scholar
• Sterrantino C , Trifirò G , Lapi F , Pasqua A , Mazzaglia G , Piccinni C , Cricelli C , Rossi A , Blasi F . Burden of community-acquired pneumonia in Italian general practice. Eur Respiratory J 2013; 42:1739-42; PMID:23949958; https://doi.org/10.1183/09031936.00128713
   PubMed Web of Science ®Google Scholar
• Liese J , Silfverdal S , Giaquinto C , Carmona A , Larcombe J , Garcia-Sicilia J , Fuat A , Garces-Sanchez M , Basanta ML , Hiraldo EM , et al. Incidence and clinical presentation of acute otitis media in children aged <6 years in European medical practices. Epidemiol Infect 2014; 142:1778-88; PMID:24330917; https://doi.org/10.1017/S0950268813002744
   PubMed Web of Science ®Google Scholar
• Marchisio P , Cantarutti L , Sturkenboom M , Girotto S , Picelli G , Dona D , Scamarcia A , Villa M , Giaquinto C . Burden of acute otitis media in primary care pediatrics in Italy: a secondary data analysis from the Pedianet database. BMC Pediatrics 2012; 12:1-8; PMID:22208358; https://doi.org/10.1186/1471-2431-12-185
   PubMed Web of Science ®Google Scholar
• Fortunato F , Martinelli D , Cappelli MG , Cozza V , Prato R . Impact of Pneumococcal Conjugate Universal Routine Vaccination on Pneumococcal Disease in Italian Children. J Immunol Res 2015; 2015:206757; PMID:26351644; https://doi.org/10.1155/2015/206757
   PubMed Web of Science ®Google Scholar
• Black SB , Shinefield HR , Ling S , Hansen J , Fireman B , Spring D , Noyes J , Lewis E , Ray P , Lee J , et al. Effectiveness of heptavalent pneumococcal conjugate vaccine in children younger than five years of age for prevention of pneumonia. Pediatr Infect Dis J 2002; 21:810-5; PMID:12352800; https://doi.org/10.1097/00006454-200209000-00005
   PubMed Web of Science ®Google Scholar
• Eskola J , Kilpi T , Palmu A , Jokinen J , Eerola M , Haapakoski J , Herva E , Takala A , Käyhty H , Karma P , et al. Efficacy of a pneumococcal conjugate vaccine against acute otitis media. N Eng J Med: Massachusetts Medical Society 2001; 344:403–9; https://doi.org/10.1056/NEJM200102083440602
   PubMed Web of Science ®Google Scholar
• Ben-Shimol S , Givon-Lavi N , Leibovitz E , Raiz S , Greenberg D , Dagan R . Near-Elimination of Otitis Media Caused by 13-Valent Pneumococcal Conjugate Vaccine (PCV) Serotypes in Southern Israel Shortly After Sequential Introduction of 7-Valent/13-Valent PCV. Clin Infect Dis 2014; 59:1724-32; PMID:25159581; https://doi.org/10.1093/cid/ciu683
   PubMed Web of Science ®Google Scholar
• Bennett JE , Sumner W, II , Downs SM , Jaffe DM . Parents' utilities for outcomes of occult bacteremia. Arch Pediatrics Adolescent Med 2000; 154:43-8
   PubMedGoogle Scholar
• Oh PI , Maerov P , Pritchard D , Knowles SR , Einarson TR , Shear NH . A cost-utility analysis of second-line antibiotics in the treatment of acute otitis media in children. Clin Therapeutics 1996; 18:160-82; PMID:8851461; https://doi.org/10.1016/S0149-2918(96)80188-3
   PubMed Web of Science ®Google Scholar
• Morrow A , De Wals P , Petit G , Guay M , Erickson LJ . The burden of pneumococcal disease in the Canadian population before routine use of the seven-valent pneumococcal conjugate vaccine. Can J Infect Dis Med Microbiol 2007; 18:121-7; PMID:18923713
   PubMed Web of Science ®Google Scholar
• Cheng AK , Niparko JK . Cost-utility of the cochlear implant in adults: A meta-analysis. Arch Otolaryngol Head Neck Surg 1999; 125:1214-8; https://doi.org/10.1001/archotol.125.11.1214
   PubMed Web of Science ®Google Scholar
• Oostenbrink R , Oostenbrink JB , Moons KGM , Derksen-Lubsen G , Essink-Bot ML , Grobbee DE , Redekop WK , Moll HA . Cost-utility analysis of patient care in children with meningeal signs. Int J Technol Assessment Health Care 2002; 18:485-96; PMID:12391942
   PubMed Web of Science ®Google Scholar
• Decreto-Legge 8 luglio 1974, n. 264 - Norme per l'estinzione dei 760 debiti degli enti mutualistici nei confronti degli enti ospedalieri, il finanziamento della spesa ospedaliera e l'avvio della riforma sanitaria. (GU n.181 del 11-7-1974) Decreto-Legge convertito con modificazioni dalla L. 17 agosto 1974, n. 386 (in G.U. 29/08/1974, n.225). 1976 [accessed 2016 Jan 15]. http://www.normattiva.it/atto/caricaDettaglioAtto?atto.dataPubblicazioneGazzettaD1974-07-11&attocodiceRedazionaleD074U0264&currentPageD1
   Google Scholar
• Federazione nazionale unitaria titolari di farmacia . Prevenar 13. 2016 [accessed 2016 Jan 15]. http://www.federfarma.it/Farmaci-e-farmacie/Cerca-un-farmaco
   Google Scholar
• Ministero della Salute . Remunerazione prestazioni di assistenza ospedaliera per acuti, assistenza ospedaliera di riabilitazione e di lungodegenza post acuzie e di assistenza specialistica ambulatoriale. Gazzetta Ufficiale Serie Generale 2013; 23. http://www.gazzettaufficiale.it/do/gazzetta/serie_generale/3/pdfPaginato?dataPubblicazioneGazzetta=20130128&numeroGazzetta=23&tipoSerie=SG&tipoSupplemento=GU&numeroSupplemento=0&numPagina=1&edizione=0
   Google Scholar
• Mantovani LG , de Portu S , Cortesi PA , Belisari A . Valutazione economica del vaccino coniugato 13-valente. Italian J Public Health 2010; 7:36-45
   Google Scholar