The cost-effectiveness of maternal and neonatal screening for congenital cytomegalovirus infection in Japan.
congenital
cost-effectiveness
cytomegalovirus
hearing loss
quality-adjusted life years: screening
Journal
Journal of medical virology
ISSN: 1096-9071
Titre abrégé: J Med Virol
Pays: United States
ID NLM: 7705876
Informations de publication
Date de publication:
01 2023
01 2023
Historique:
revised:
08
11
2022
received:
08
08
2022
accepted:
06
12
2022
pubmed:
10
12
2022
medline:
11
1
2023
entrez:
9
12
2022
Statut:
ppublish
Résumé
Congenital cytomegalovirus infection is the most common congenital infection. Using a decision tree model, cost-effectiveness of maternal screening with subsequent prenatal valacyclovir treatment and newborn screening with neonatal valganciclovir treatment was evaluated. The incremental cost-effectiveness ratio (ICER) was calculated for (1) universal maternal antibody screening with prenatal valacyclovir treatment compared to targeted newborn screening, and (2) universal newborn screening with postnatal valganciclovir treatment compared to targeted newborn screening. We performed a one-way sensitivity analysis. Compared to targeted newborn screening, the ICERs for universal newborn screening and maternal screening were 2 966 296 Japanese Yen (JPY) (21 188 USD) and 1 026 984 JPY (7336 USD), respectively. In all scenarios in the one-way sensitivity analysis, the ICERs of the maternal screening and the universal newborn screening strategies were less than three gross domestic product per capita compared with the targeted newborn screening strategy. Both maternal and universal newborn screening strategies may be cost-effective than a targeted newborn screening program. The potential utility of the maternal screening with valacyclovir treatment strategy, while potentially cost effective in regions with lower baseline seroprevalence rates, requires further study as the modeling was based on limited evidence.
Substances chimiques
Valganciclovir
GCU97FKN3R
Valacyclovir
MZ1IW7Q79D
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
e28391Informations de copyright
© 2022 Wiley Periodicals LLC.
Références
Neu N, Duchon J, Zachariah P. TORCH infections. Clin Perinatol. 2015;42(1):77-103, viii.
Inagaki K, Blackshear C, Palmer A, Hobbs CV. Risk factors, geographic distribution, and healthcare burden of symptomatic congenital cytomegalovirus infection in the United States: analysis of a nationally representative database, 2000-2012. J Pediatr. 2018;199:118-123.e1.
Meyers J, Sinha A, Samant S, Candrilli S. The economic burden of congenital cytomegalovirus disease in the first year of life: a retrospective analysis of health insurance claims data in the United States. Clin Ther. 2019;41(6):1040-1056.
Smit GSA, Padalko E, Van Acker J, et al. Public health impact of congenital toxoplasmosis and cytomegalovirus infection in Belgium, 2013: a systematic review and data synthesis. Clin Infect Dis. 2017;65(4):661-668.
Manicklal S, Emery VC, Lazzarotto T, Boppana SB, Gupta RK. The “silent” global burden of congenital cytomegalovirus. Clin Microbiol Rev. 2013;26(1):86-102.
Kenneson A, Cannon MJ. Review and meta-analysis of the epidemiology of congenital cytomegalovirus (CMV) infection. Rev Med Virol. 2007;17(4):253-276.
Townsend CL, Forsgren M, Ahlfors K, Ivarsson SA, Tookey PA, Peckham CS. Long-term outcomes of congenital cytomegalovirus infection in Sweden and the United Kingdom. Clin Infect Dis. 2013;56(9):1232-1239.
Numazaki K, Fujikawa T. Chronological changes of incidence and prognosis of children with asymptomatic congenital cytomegalovirus infection in Sapporo, Japan. BMC Infect Dis. 2004;4:22.
Goderis J, De Leenheer E, Smets K, Van Hoecke H, Keymeulen A, Dhooge I. Hearing loss and congenital CMV infection: a systematic review. Pediatrics. 2014;134(5):972-982.
Ssentongo P, Hehnly C, Birungi P, et al. Congenital cytomegalovirus infection burden and epidemiologic risk factors in countries with universal screening: a systematic review and meta-analysis. JAMA Network Open. 2021;4(8):e2120736.
Korndewal MJ, Oudesluys-Murphy AM, Kroes ACM, van der Sande MAB, de Melker HE, Vossen ACTM. Long-term impairment attributable to congenital cytomegalovirus infection: a retrospective cohort study. Dev Med Child Neurol. 2017;59(12):1261-1268.
Koyano S, Morioka I, Oka A, et al. Congenital cytomegalovirus in Japan: more than 2 year follow up of infected newborns. Pediatr Int. 2018;60(1):57-62.
Jin HD, Demmler-Harrison GJ, Coats DK, et al. Long-term visual and ocular sequelae in patients with congenital cytomegalovirus infection. Pediatr Infect Dis J. 2017;36(9):877-882.
Dreher AM, Arora N, Fowler KB, et al. Spectrum of disease and outcome in children with symptomatic congenital cytomegalovirus infection. J Pediatr. 2014;164(4):855-859. doi:10.1016/j.jpeds.2013.12.007
Boppana SB, Ross SA, Shimamura M, et al. Saliva polymerase-chain-reaction assay for cytomegalovirus screening in newborns. N Engl J Med. 2011;364(22):2111-2118.
de Vries JJC, van der Eijk AA, Wolthers KC, et al. Real-time PCR versus viral culture on urine as a gold standard in the diagnosis of congenital cytomegalovirus infection. J Clin Virol. 2012;53(2):167-170.
Yamada H, Tanimura K, Fukushima S, et al. A cohort study of the universal neonatal urine screening for congenital cytomegalovirus infection. J Infect Chemother. 2020;26(8):790-794.
Townsend CL, Peckham CS, Tookey PA. Surveillance of congenital cytomegalovirus in the UK and Ireland. Arch Dis Child Fetal Neonatal Ed. 2011;96(6):F398-F403. doi:10.1136/adc.2010.199901
Sorichetti B, Goshen O, Pauwels J, et al. Symptomatic congenital cytomegalovirus infection is underdiagnosed in British Columbia. J Pediatr. 2016;169:316-317. doi:10.1016/j.jpeds.2015.10.069
Vaudry W, Lee BE, Rosychuk RJ. Congenital cytomegalovirus infection in Canada: active surveillance for cases diagnosed by paediatricians. Paediatr Child Health. 2014;19(1):1-5.
Kimberlin DW, Jester PM, Sánchez PJ, et al. Valganciclovir for symptomatic congenital cytomegalovirus disease. N Engl J Med. 2015;372(10):933-943.
Chiopris G, Veronese P, Cusenza F, et al. Congenital cytomegalovirus infection: update on diagnosis and treatment. Microorganisms. 2020;8(10):1516.
Chen K, Zhong Y, Gu Y, et al. Estimated cost-effectiveness of newborn screening for congenital cytomegalovirus infection in China using a Markov model. JAMA Network Open. 2020;3(12):e2023949.
Gantt S, Dionne F, Kozak FK, et al. Cost-effectiveness of universal and targeted newborn screening for congenital cytomegalovirus infection. JAMA Pediatrics. 2016;170(12):1173-1180.
Tanimura K, Tairaku S, Morioka I, et al. Universal screening with use of immunoglobulin G avidity for congenital cytomegalovirus infection. Clin Infect Dis. 2017;65(10):1652-1658.
Demmler-Harrison GJ, Miller JA. Maternal cytomegalovirus immune status and hearing loss outcomes in congenital cytomegalovirus-infected offspring. PLoS One. 2020;15(10):e0240172.
Shahar-Nissan K, Pardo J, Peled O, et al. Valaciclovir to prevent vertical transmission of cytomegalovirus after maternal primary infection during pregnancy: a randomised, double-blind, placebo-controlled trial. Lancet. 2020;396(10253):779-785. doi:10.1016/S0140-6736(20)31868-7
Ministry of Health LaW, Japan. Vital Statistics based on monthly reports in 2021. Accessed June 13, 2022. https://www.mhlw.go.jp/toukei/saikin/hw/jinkou/geppo/nengai21/index.html
World Health Organization. WHO guide to cost-effectiveness analysis. Accessed June 13, 2022. http://apps.who.int/iris/bitstream/handle/10665/42699/9241546018.pdf;jsessionid=81A5DDE28D1B7413F02B1FCD454D9CDB?sequence=1
Hasegawa M, Komoto S, Shiroiwa T, Fukuda T. Formal implementation of Cost-Effectiveness evaluations in Japan: a unique health technology assessment system. Value Health. 2020;23(1):43-51.
Cabinet Office, Government of Japan. Chapter 1 Aging Situation (Section 2). Accessed June 22, 2022. https://www8.cao.go.jp/kourei/whitepaper/w-2021/html/gaiyou/s1_2.html
Koyano S, Inoue N, Oka A, et al. Screening for congenital cytomegalovirus infection using newborn urine samples collected on filter paper: feasibility and outcomes from a multicentre study. BMJ Open. 2011;1(1):e000118.
Dollard SC, Grosse SD, Ross DS. New estimates of the prevalence of neurological and sensory sequelae and mortality associated with congenital cytomegalovirus infection. Rev Med Virol. 2007;17(5):355-363. doi:10.1002/rmv.544
de Vries JJC, van Zwet EW, Dekker FW, Kroes ACM, Verkerk PH, Vossen ACTM. The apparent paradox of maternal seropositivity as a risk factor for congenital cytomegalovirus infection: a population-based prediction model. Rev Med Virol. 2013;23(4):241-249.
Maltezou PG, Kourlaba G, Kourkouni Ε, et al. Maternal type of CMV infection and sequelae in infants with congenital CMV: systematic review and meta-analysis. J Clin Virol. 2020;129:104518. doi:10.1016/j.jcv.2020.104518
Ministry of Health, Labor and Welfare. Population survey in 2020. Accessed June 20, 2022. https://www.mhlw.go.jp/toukei/saikin/hw/jinkou/kakutei20/dl/03_h1.pdf
Howard J, Hall B, Brennan LE, et al. Utility of newborn screening cards for detecting CMV infection in cases of stillbirth. J Clin Virol. 2009;44(3):215-218.
Yamada H, Tairaku S, Morioka I, et al. Nationwide survey of mother-to-child infections in Japan. J Infect Chemother. 2015;21(3):161-164.
Shah T, Luck S, Sharland M, Kadambari S, Heath P, Lyall H. Fifteen minute consultation: diagnosis and management of congenital CMV. Arch Dis Child Educ Pract Ed. 2016;101(5):232-235.
Ito Y, Kimura H, Torii Y, et al. Risk factors for poor outcome in congenital cytomegalovirus infection and neonatal herpes on the basis of a nationwide survey in Japan. Pediatr Int. 2013;55(5):566-571.
Ministry of Health, Labor and Welfare. Child developmental survey in 2010. Accessed June 20, 2022. https://www.mhlw.go.jp/stf/houdou/0000042861.html
Surén P, Bakken IJ, Aase H, et al. Autism spectrum disorder, ADHD, epilepsy, and cerebral palsy in Norwegian children. Pediatrics. 2012;130(1):e152-e158.
Dakovic I, da Graça Andrada M, Folha T, et al. Clinical features of cerebral palsy in children with symptomatic congenital cytomegalovirus infection. Eur J Paediatr Neurol. 2014;18(5):618-623. doi:10.1016/j.ejpn.2014.04.007
Chatzakis C, Ville Y, Makrydimas G, Dinas K, Zavlanos A, Sotiriadis A. Timing of primary maternal cytomegalovirus infection and rates of vertical transmission and fetal consequences. Am J Obstet Gynecol. 2020;223(6):870-883. doi:10.1016/j.ajog.2020.05.038
Ministry of Education, Culture, Sports, Science and Technology. Special Support Education. (Japanese). Accessed June 8, 2022. https://www.mext.go.jp/component/a_menu/education/micro_detail/__icsFiles/afieldfile/2019/10/28/1406445_000.pdf
Ministry of Education, Culture, Sports, Science and Technology. Situation of Special Support Education in Japan. (Japanese). Accessed June 8, 2022. https://www.mext.go.jp/kaigisiryo/2019/09/__icsFiles/afieldfile/2019/09/24/1421554_3_1.pdf
Ministry of Education, Culture, Sports, Science and Technology. Report of Special Education Classes. (Japanese). Accessed June 8, 2022. https://www.mext.go.jp/a_menu/shotou/tokubetu/__icsFiles/afieldfile/2018/05/14/1402845_03.pdf
Ministry of Education, Culture, Sports, Science and Technology. Allowance for Teachers. (Japanese). Accessed June 8, 2022. https://www.mext.go.jp/b_menu/shingi/chukyo/chukyo3/041/siryo/__icsFiles/afieldfile/2019/05/21/1417088_006.pdf
Ministry of Education, Culture, Sports, Science and Technology. Survey report for Teachers. (Japanese). Accessed June 8, 2022. https://www.mext.go.jp/component/b_menu/other/__icsFiles/afieldfile/2018/03/28/1395303_03.pdf
Kanda Y, Yoshida H, Hara M, et al. Integration rate into regular schools of children with cochlear implants in 2016. Discussion of favorable factors affecting successful integration based consideration from over 150 school visit experiences of children with cochlear implants. Audiology Japan. 2018;61:277-286.
Ministry of Health, Labor and Welfare. National life basic survey. Accessed June 20, 2022. https://www.mhlw.go.jp/toukei/list/dl/20-21-h28_rev2.pdf
Araki S, Nakamura K, Kashiwabara Y, Eguchi H, Shimono M, et al. A field survey of working conditions of parents with children requiring medical care. J UOEH. 2019;41(2):171-178.
Takagi K, Arai I, Okubo T, et al. The consultation system of congenital cytomegalovirus Infection. (Japanese). J Japan Soci Neonatal Health Develop. 2019;55(4):924-928.
Sato T, Nakazawa M, Takahashi S, Mizuno T, Ishikawa K, Yamada T. Outcomes of regional-based newborn hearing screening for 35,461 newborns for 5 years in Akita, Japan. Int J Pediatr Otorhinolaryngol. 2020;131:109870.
Heidari S, Olyaee Manesh A, Rajab F. The sensitivity and specificity of automated auditory brainstem response and otoacoustic emission in neonatal hearing screening a systematic review. Auditory and Vsstibular res. 2015;24(3):141-151.
Adachi N, Ito K, Sakata H, Yamasoba T. Etiology and one-year follow-up results of hearing loss identified by screening of newborn hearing in Japan. Otolaryngol Head Neck Surg. 2010;143(1):97-100. doi:10.1016/j.otohns.2010.02.008
Luck SE, Wieringa JW, Blázquez-Gamero D, et al. Congenital cytomegalovirus: a European expert consensus statement on diagnosis and management. Pediatr Infect Dis J. 2017;36(12):1205-1213. doi:10.1097/INF.0000000000001763
Kimberlin DW, Lin CY, Sánchez PJ, et al. Effect of ganciclovir therapy on hearing in symptomatic congenital cytomegalovirus disease involving the central nervous system: a randomized, controlled trial. J Pediatr. 2003;143(1):16-25. doi:10.1016/s0022-3476(03)00192-6
Cannon MJ, Griffiths PD, Aston V, Rawlinson WD. Universal newborn screening for congenital CMV infection: what is the evidence of potential benefit? Rev Med Virol. 2014;24(5):291-307.
Korver AMH, Konings S, Dekker FW, et al. Newborn hearing screening vs later hearing screening and developmental outcomes in children with permanent childhood hearing impairment. JAMA. 2010;304(15):1701-1708.
Foulon I, Naessens A, Foulon W, Casteels A, Gordts F. A 10-year prospective study of sensorineural hearing loss in children with congenital cytomegalovirus infection. J Pediatr. 2008;153(1):84-88.
Kennedy CR, McCann DC, Campbell MJ, et al. Language ability after early detection of permanent childhood hearing impairment. N Engl J Med. 2006;354(20):2131-2141.
Bureau of Social Welfare and Public Health, Tokyo Metropolitan Government. Annual Report on Maternal and Child Health Services in 2021. Accessed June 20, 2022. https://www.fukushihoken.metro.tokyo.lg.jp/kodomo/koho/boshihoken_nenpo.files/boshi_nenpoR3.pdf
Toriyabe K, Morikawa F, Minematsu T, Ikejiri M, Suga S, Ikeda T. Anti-cytomegalovirus immunoglobulin M titer for congenital infection in first-trimester pregnancy with primary infection: a multicenter prospective cohort study. J Perinatol. 2017;37(12):1272-1277.
Hou B, Zhang Y. Risk of birth defects after use of acyclovir, valacyclovir, and famciclovir in the first trimester. JAMA. 2010;304(20):2242-2243. doi:10.1001/jama.2010.1701
Revello MG, Tibaldi C, Masuelli G, et al. Prevention of primary cytomegalovirus infection in pregnancy. EBioMedicine. 2015;2(9):1205-1210.
Vauloup-Fellous C, Picone O, Cordier AG, et al. Does hygiene counseling have an impact on the rate of CMV primary infection during pregnancy. J Clin Virol. 2009;46(suppl 4):S49-S53. doi:10.1016/j.jcv.2009.09.003
Lin C, Tomio J, Tanaka H, Sonoda M, Sano K, Kobayashi Y. Diagnosis and medical care for congenital cytomegalovirus infection: an observational study using claims data in Japan, 2010 to 2017. Medicine. 2020;99(10):e19419. doi:10.1097/MD.0000000000019419
Leruez-Ville M, Ghout I, Bussières L, et al. In utero treatment of congenital cytomegalovirus infection with valacyclovir in a multicenter, open-label, phase II study. Am J Obstet Gynecol. 2016;215(4):462.e1-462.e10. doi:10.1016/j.ajog.2016.04.003
Faure-Bardon V, Fourgeaud J, Stirnemann J, Leruez-Ville M, Ville Y. Secondary prevention of congenital cytomegalovirus infection with valacyclovir following maternal primary infection in early pregnancy. Ultrasound Obstet Gynecol. 2021;58(4):576-581. doi:10.1002/uog.23685
Zuhair M, Smit GSA, Wallis G, et al. Estimation of the worldwide seroprevalence of cytomegalovirus: a systematic review and meta-analysis. Rev Med Virol. 2019;29(3):e2034. doi:10.1002/rmv.2034
Hyde TB, Schmid DS, Cannon MJ. Cytomegalovirus seroconversion rates and risk factors: implications for congenital CMV. Rev Med Virol. 2010;20(5):311-326. doi:10.1002/rmv.659
Rawlinson WD, Boppana SB, Fowler KB, et al. Congenital cytomegalovirus infection in pregnancy and the neonate: consensus recommendations for prevention, diagnosis, and therapy. Lancet Infect Dis. 2017;17(6):e177-e188. doi:10.1016/S1473-3099(17)30143-3