Indirect Treatment Comparison of Damoctocog Alfa Pegol versus Turoctocog Alfa Pegol as Prophylactic Treatment in Patients with Hemophilia A

References

• Makris M. Prophylaxis in haemophilia should be life-long. Blood Transfus. 2012;10(2):165–168.
   PubMed Web of Science ®Google Scholar
• Srivastava A, Brewer AK, Mauser-Bunschoten EP, et al. Guidelines for the management of hemophilia. Haemophilia. 2013;19(1):e1–e47.
   PubMed Web of Science ®Google Scholar
• Chen SL. Economic costs of hemophilia and the impact of prophylactic treatment on patient management. Am J Manag Care. 2016;22(5 Suppl):s126–s133.
   PubMed Web of Science ®Google Scholar
• Report ES. Express scripts 2015 drug trend report; 2016. Available from: https://californiahealthline.org/wp-content/uploads/sites/3/2018/02/express-scripts-2015-commercial-dtr.pdf. Accessed October 10, 2020.
   Google Scholar
• Medicaid Health Plans of America Center for Best Practices. Clinical brief. Addressing the Needs of members with hemophilia in Medicaid managed care: issues and implications for health plans; 2013. Available from: https://www.hca.wa.gov/assets/program/bdc_MHPA_hemophilia_issue_brief_082113.pdf. Accessed October 10, 2020.
   Google Scholar
• Graf L. Extended half-life factor VIII and factor IX preparations. Transfus Med Hemotherapy. 2018;45(2):86–91. doi:10.1159/000488060
   Web of Science ®Google Scholar
• Konkle BA, Stasyshyn O, Chowdary P, et al. Pegylated, full-length, recombinant factor VIII for prophylactic and on-demand treatment of severe hemophilia A. Blood. 2015;126(9):1078–1085. doi:10.1182/blood-2015-03-630897
   PubMed Web of Science ®Google Scholar
• Reding MT, Ng HJ, Poulsen LH, et al. Safety and efficacy of BAY 94-9027, a prolonged-half-life factor VIII. J Thromb Haemost. 2017;15(3):411–419. doi:10.1111/jth.13597
   PubMed Web of Science ®Google Scholar
• Batt K, Gao W, Ayyagari R, et al. Matching-adjusted indirect comparisons of annualized bleeding rate and utilization of BAY 94-9027 versus three recombinant factor VIII agents for prophylaxis in patients with severe hemophilia A. J Blood Med. 2019;10:147–159. doi:10.2147/JBM.S206806
   PubMed Web of Science ®Google Scholar
• U.S. Food and Drug Administration. ESPEROCT (STN: BL 125671); 2019. Available from: https://www.fda.gov/vaccines-blood-biologics/esperoct. Accessed June 30, 2021.
   Google Scholar
• Lalezari S, Reding MT, Pabinger I, et al, BAY 94-9027 prophylaxis is efficacious and well tolerated for up to >5 years with extended dosing intervals: PROTECT VIII extension interim results. Haemophilia. 2019;25(6):1011–1019. doi:10.1111/hae.13853
   Web of Science ®Google Scholar
• Coyle TE, Reding MT, Lin JC, Michaels LA, Shah A, Powell J. Phase I study of BAY 94-9027, a PEGylated B-domain-deleted recombinant factor VIII with an extended half-life, in subjects with hemophilia A. J Thromb Haemost. 2014;12(4):488–496. doi:10.1111/jth.12506
   PubMed Web of Science ®Google Scholar
• Giangrande P, Andreeva, T., Chowdary, P., Ehrenforth, S., Hanabusa, H., Leebeek, FW, Lentz, SR, Nemes, L., Poulsen, LH, Santagostino, E., You, CW, Clausen, WH, Jönsson, PG, Oldenburg, J. Clinical evaluation of glycoPEGylated recombinant FVIII: efficacy and safety in severe haemophilia A. Thromb Haemost. 2017;117(2):252–261. doi:10.1160/TH16-06-0444
   PubMed Web of Science ®Google Scholar
• Curry N, Albayrak, C., Escobar, M., Holme, PA, Kearney, S., Klamroth, R., Misgav, M., Négrier, C., Wheeler, A., Santagostino, E., Shima, M., Landorph, A., Tønder, SM, Lentz SR. Once-weekly prophylaxis with glycoPEGylated recombinant factor VIII (N8‐GP) in severe haemophilia A: safety and efficacy results from pathfinder 2 (randomized phase III trial). Haemophilia. 2019;25:373–381. doi:10.1111/hae.13712
   PubMed Web of Science ®Google Scholar
• Phillippo D, Ades AE, Dias S, Palmer S, Abrams KR, Welton NJ. Nice DSU Technical Support Document 18: Methods for Population-Adjusted Indirect Comparisons in Submissions to Nice. NICE DSU; 2016.
   Google Scholar
• Keipert C, Müller-Olling M, Gauly F, Arras-Reiter C, Hilger A. Annual bleeding rates: pitfalls of clinical trial outcomes in hemophilia patients. Clin Transl Sci. 2020. doi:10.1111/cts.12794
   Web of Science ®Google Scholar
• Hakimi Z, Santagostino E, Postma MJ, Nazir J. Recombinant FVIIIFc versus BAY 94-9027 for treatment of patients with haemophilia A: comparative efficacy using a matching adjusted indirect comparison. Adv Ther. 2021;38(2):1263–1274. doi:10.1007/s12325-020-01599-1
   PubMed Web of Science ®Google Scholar
• Solms A, Shah A, Berntorp E, et al. Direct comparison of two extended half-life PEGylated recombinant FVIII products: a randomized, crossover pharmacokinetic study in patients with severe hemophilia A. Ann Hematol. 2020;99(11):2689–2698. doi:10.1007/s00277-020-04280-3
   PubMed Web of Science ®Google Scholar
• Shah A, Solms A, Wiegmann S, et al. Direct comparison of two extended-half-life recombinant FVIII products: a randomized, crossover pharmacokinetic study in patients with severe hemophilia A. Ann Hematol. 2019;98(9):2035–2044. doi:10.1007/s00277-019-03747-2
   PubMed Web of Science ®Google Scholar
• Mei B, Pan C, Jiang H, et al. Rational design of a fully active, long-acting PEGylated factor VIII for hemophilia A treatment. Blood. 2010;116(2):270–279. doi:10.1182/blood-2009-11-254755
   PubMed Web of Science ®Google Scholar
• Thorat T, Neumann PJ, Chambers JD. Hemophilia burden of disease: a systematic review of the cost-utility literature for hemophilia. J Manag Care Spec Pharm. 2018;24(7):632–642. doi:10.18553/jmcp.2018.24.7.632
   PubMed Web of Science ®Google Scholar
• Arima K, Gupta S, Gadkari A, et al. Burden of atopic dermatitis in Japanese adults: analysis of data from the 2013 national health and wellness survey. J Dermatol. 2018;45(4):390–396. doi:10.1111/1346-8138.14218
   PubMed Web of Science ®Google Scholar
• Noone D, O’Mahony B, Prihodova L. A survey of the outcome of prophylaxis, on-demand or combined treatment in 20-35 year old men with severe haemophilia in four European countries. Haemophilia. 2011;17(5):e842–e843.
   PubMed Web of Science ®Google Scholar