196
Views
0
CrossRef citations to date
0
Altmetric
Antimicrobial Original Research Papers

Rapid health technology assessment of the novel endonuclease inhibitor baloxavir for the treatment of influenza

ORCID Icon, , , , &
Pages 267-282 | Received 30 Mar 2023, Accepted 21 Sep 2023, Published online: 28 Sep 2023

References

  • Paules C, Subbarao K. Influenza. Lancet. 2017;390(10095):697–708.
  • Radosevic D, Sencanski M, Perovic V, et al. Virtual screen for repurposing of drugs for candidate influenza a M2 ion-channel inhibitors. Front Cell Infect Microbiol. 2019;9:67.
  • Bassetti M, Castaldo N, Carnelutti A. Neuraminidase inhibitors as a strategy for influenza treatment: pros, cons and future perspectives. Expert Opin Pharmacother. 2019;20(14):1711–1718.
  • Ferraris O, Lina B. Mutations of neuraminidase implicated in neuraminidase inhibitors resistance. J Clin Virol. 2008;41(1):13–19.
  • Heo YA. Baloxavir: first global approval. Drugs. 2018;78(6):693–697.
  • Johns BA, Kawasuji T, Weatherhead JG, et al. Carbamoyl pyridone HIV-1 integrase inhibitors 3. A diastereomeric approach to chiral nonracemic tricyclic ring systems and the discovery of dolutegravir (S/GSK1349572) and (S/GSK1265744). J Med Chem. 2013;56(14):5901–5916.
  • FDA. Xofluza (baloxavir marboxil) tablets, for oral use [EB/OL]. 2018 October 24. https://www.accessdata.fda.Gov/drugsatfda_docs/label/2018/210854s000lbl.pdf.
  • WHO. Health intervention and technology assessment in support of universal health coverage. https://www.who.int/news/item/24-05-2014-world-health-assembly-closes.
  • Lorenzetti DL, Topfer LA, Dennett L, et al. Value of databases other than medline for rapid health technology assessments. Int J Technol Assess Health Care. 2014;30(2):173–178.
  • Hailey D. A preliminary survey on the influence of rapid health technology assessments. Int J Technol Assess Health Care. 2009;25(3):415–418.
  • Tricco AC, Antony J, Zarin W, et al. A scoping review of rapid review methods. BMC Med. 2015;13(1):224.
  • Shea BJ, Grimshaw JM, Wells GA, et al. Development of AMSTAR: a measurement tool to assess the methodological quality of systematic reviews. BMC Med Res Methodol. 2007;7(1):10.
  • Husereau D, Drummond M, Augustovski F, et al. Consolidated health economic evaluation reporting standards 2022 (CHEERS 2022) statement: updated reporting guidance for health economic evaluations. Value Health. 2022;25(1):3–9.
  • Hailey D. Toward transparency in health technology assessment: a checklist for HTA reports. Int J Technol Assess Health Care. 2003;19(1):1–7.
  • Kuo YC, Lai CC, Wang YH, et al. Clinical efficacy and safety of baloxavir marboxil in the treatment of influenza: a systematic review and meta-analysis of randomized controlled trials. J Microbiol Immunol Infect. 2021;54(5):865–875.
  • Liu JW, Lin SH, Wang LC, et al. Comparison of antiviral agents for seasonal influenza outcomes in healthy adults and children: a systematic review and network meta-analysis. JAMA Netw Open. 2021;4(8):e2119151.
  • Taieb V, Ikeoka H, Wojciechowski P, et al. Efficacy and safety of baloxavir marboxil versus neuraminidase inhibitors in the treatment of influenza virus infection in high-risk and uncomplicated patients - a bayesian network meta-analysis. Curr Med Res Opin. 2021;37(2):225–244.
  • Taieb V, Ikeoka H, Ma F, et al. A network meta-analysis of the efficacy and safety of baloxavir marboxil versus neuraminidase inhibitors for the treatment of influenza in otherwise healthy patients. Curr Med Res Opin. 2019;35(8):1355–1364.
  • Tejada S, Tejo AM, Peña-López Y, et al. Neuraminidase inhibitors and single dose baloxavir are effective and safe in uncomplicated influenza: a meta-analysis of randomized controlled trials. Expert Rev Clin Pharmacol. 2021;14(7):901–918.
  • Zhao Y, Huang G, He W, et al. Efficacy and safety of single-dose antiviral drugs for influenza treatment: a systematic review and network meta-analysis. J Med Virol. 2022;94(7):3270–3302.
  • Dronova M, Ikeoka H, Itsumura N, et al. Cost-effectiveness of baloxavir marboxil compared with laninamivir for the treatment of influenza in patients at high risk for complications in Japan. Curr Med Res Opin. 2021;37(7):1135–1148.
  • Skrzeczek A, Ikeoka H, Hirotsu N, et al. Cost-effectiveness of baloxavir marboxil compared to laninamivir for the treatment of influenza in Japan. J Infect Chemother. 2021;27(2):296–305.
  • Tang Y, Jiang H, Tang M, et al. Cost-effectiveness analysis of baloxavir marboxil as seasonal influenza treatment compared to oseltamivir in China. Value in Health. 2022;25(1):S92.
  • IQWiG. Baloxavir marboxil (Influenza). https://www.iqwig.de/download/a21-21_baloxavir-marboxil_nutzenbewertung-35a-sgb-v_v1-0.pdf.
  • Hayden FG, Sugaya N, Hirotsu N, et al. Baloxavir marboxil for uncomplicated influenza in adults and adolescents. N Engl J Med. 2018;379(10):913–923.
  • Shionogi & Co., Ltd. A study of S-033188 (baloxavir marboxil) compared with placebo or oseltamivir in otherwise healthy patients with influenza (CAPSTONE 1). ClinicalTrialsgov Identifier: NCT02954354; 2017.
  • Ison MG, Portsmouth S, Yoshida Y, et al. Early treatment with baloxavir marboxil in high-risk adolescent and adult outpatients with uncomplicated influenza (CAPSTONE-2): a randomised, placebo-controlled, phase 3 trial. Lancet Infect Dis. 2020;20(10):1204–1214.
  • Burch J, Paulden M, Conti S, et al. Antiviral drugs for the treatment of influenza: a systematic review and economic evaluation. Health Technol Assess. 2009;13(58):1–265. iii-iv.
  • Tappenden P, Jackson R, Cooper K, et al. Amantadine, oseltamivir and zanamivir for the prophylaxis of influenza (including a review of existing guidance no. 67): a systematic review and economic evaluation. Health Technol Assess. 2009;13(11):iii, ix. iii, ix-xii,
  • MHLW. National Health Insurance drug price list. 2020. https://www.mhlw.go.jp/topics/2020/04/tp20200401-01.html.
  • MHLW. Revision of the medical fee index. 2020. https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/0000106602.html.
  • Hasegawa M, Komoto S, Shiroiwa T, et al. Formal implementation of cost-effectiveness evaluations in Japan: a unique health technology assessment system. Value Health. 2020;23(1):43–51.
  • Omoto S, Speranzini V, Hashimoto T, et al. Characterization of influenza virus variants induced by treatment with the endonuclease inhibitor baloxavir marboxil. Sci Rep. 2018;8(1):9633.
  • Suess T, Remschmidt C, Schink SB, et al. Comparison of shedding characteristics of seasonal influenza virus (Sub)types and influenza A(H1N1)pdm09; Germany, 2007-2011. PLoS One. 2012;7(12):e51653.
  • Lau LL, Ip DK, Nishiura H, et al. Heterogeneity in viral shedding among individuals with medically attended influenza a virus infection. J Infect Dis. 2013;207(8):1281–1285.
  • Fielding JE, Kelly HA, Mercer GN, et al. Systematic review of influenza A(H1N1)pdm09 virus shedding: duration is affected by severity, but not age. Influenza Other Respir Viruses. 2014;8(2):142–150.
  • Huang J, Zhang Y, Liu Y, et al. Briefly introduction of mini health technology assessment. Chin J Evid-Based Med. 2014;14(8):901–904.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.