head JofIMAB
Journal of IMAB - Annual Proceeding (Scientific Papers)
Publisher: Peytchinski Publishing Ltd.
ISSN: 1312-773X (Online)
Issue: 2019, vol. 25, issue2
Subject Area: Medicine
-
DOI: 10.5272/jimab.2019252.2511
Published online: 22 April 2019

Original article

J of IMAB. 2019 Apr-Jun;25(2):2511-2515
BUDGET IMPACT ANALYSIS OF INHIBITOR HAEMOPHILIA A THERAPY WITH BYPASSING AGENTS
Konstantin TachkovORCID logo, Guenka PetrovaORCID logo Corresponding Autoremail,
Department of Organization and economy of Pharmacy, Faculty of Pharmacy, Medical University of Sofia, Bulgaria.

ABSTRACT:
The aim of this study is to analyse the budget impact of hemophilia A therapy with either APCC or rFVIIa, in case of persistent inhibitors development. The point of view is that of the Bulgarian health care system for a one-year period.
A budget impact analysis (BIA) was performed following the recommendations of Guideline for Budget impact analysis with some modifications. The analysis is based on combination of literature evidences for both products’ efficacy; regulatory requirements for products standard dosage regimens; public expenditures data, and official approved prices of APPC and rFVIIa.
Results show that the yearly per patient cost of therapy with APCC accounts for 162 573 Euro, while treatment with rFVIIa accounts for 377 487 Euro - almost double the cost. If all the patients with inhibitors in each age group exhibit the same number of bleeding events and consume the same maximal dose, the total yearly cost of therapy with APCC will account for 5 621 068,04 Euro and cost with rFVIIa will account for 12 950 344,55Euro. Therefore, applying APCC instead of rFVIIa would decrease the budget impact by 7.3 million Euro.
In conclusion the treatment of inhibitors hemophilia A with APPC is cost saving for the Bulgarian health care system in comparison with rFVIIa.

Keywords: hemophilia, inhibitors, APCC, rFVIIa,

pdf - Download FULL TEXT /PDF 713 KB/
Please cite this article as: Tachkov K, Petrova G. Budget impact analysis of inhibitor haemophilia a therapy with bypassing agents. J of IMAB. 2019 Apr-Jun;25(2):2511-2515. DOI: 10.5272/jimab.2019252.2511

Corresponding AutorCorrespondence to: Guenka Petrova, Faculty of Pharmacy; 2 Dunav Str., Sofia 1000, Bulgaria; E-mail: guenka.petrova@gmail.com

REFERENCES:
1. Nathwani A, Tuddenham E. Epidemiology of coagulation disorders. Baillieres Clin Haematol. 1992 Apr; 5(2): 383-439. [PubMed]
2.Stonebraker J, Bolton- Maggs P, Soucie M, Walker J, Brooker M., A study of variations in the reported haemophilia A prevalence around the world. Haemophilia. 2010 Jan; 16 (1):20-32. [PubMed] [Crossref]
3.Stonebraker JS1, Bolton-Maggs PH, Soucie JM, Walker I, Brooker M. A study of variations in the reported haemophilia A prevalence around the world. Haemophilia. 2010 Jan;16 (1):20-32. [PubMed] [Crossref]
4.Larner A. The molecular pathology of haemophilia. Q J Med. 1987 Jun; 63 (242): 473-91. [PubMed]
5.Srivastava A, Brewer AK, Mauser-Bunschoten EP, Key NS, Kitchen S, Llinas A, et al. Guidelines for the management of hemophilia. Haemophilia. 2013 Jan;19(1):e1-47. [PubMed] [Crossref]
6.Ragni M. New and emerging agents for the treatment of hemophilia: focus on extended half-life recombinant clotting proteins. Drugs. 2015 Sep;75(14):1587-600. [PubMed] [Crossref]
7.Evatt B. The natural evolution of haemophilia care: developing  and sustaining comprehensive care globally. Haemophilia. 2006 Jul;12 Suppl 3:13-21. [PubMed] [Crossref]
8.Mannucci P. Back to the future: a recent history of haemophilia treatment. Haemophilia. 2008 Jul;14 Suppl 3:10-8. [PubMed] [Crossref]
9.Kempton C, White G 2nd. How we treat a hemophilia A patient with factor VIII inhibitor. Blood. 2009 Jan 1;113 (1):11-7. [PubMed] [Crossref]
10.Manco-Johnson MJ1, Abshire TC, Shapiro AD, Riske B, Hacker MR, Kilcoyne R et al. Prophylaxis versus episodic treatment to prevent joint disease in boys with severe hemophilia. N Engl J Med. 2007 Aug 9; 357(6):535-44. [PubMed] [Crossref]
11.Gringeri A1, Mantovani LG, Scalone L, Mannucci PM; COCIS Study Group. Cost of care and quality of life for patients with hemophilia complicated by inhibitors: the COCIS Study Group. Blood. 2003 Oct 1; 102(7):2358-63. [PubMed] [Crossref]
12.Berntorp E, Boulyjenkov V, Brettler D, Chandy M, Jones P, Lee C, et al. Modern treatment of haemophilia. Bull World Health Organ. 1995; 73(5):691-701. [PubMed]
13.Kempton C, White G 2nd. How we treat a hemophilia A patient with factor VIII inhibitor. Blood. 2009 Jan 1; 113 (1):11-7. [PubMed] [Crossref]
14.FEIBA (Anti-Inhibitor Coagulant Complex) For Intravenous Use, Lyophilized Powder for Solution. Baxter Healthcare. Revised 11/2013. [Internet]
15.NovoSeven 1.2 mg (60 KIU) - powder and solvent for solution for injection. Novo Nordisk. February 23, 2006. European Medicines Agency Approval. [Internet]
16.Antunes SV1, Tangada S, Stasyshyn O, Mamonov V, Phillips J, Guzman-Becerra N,, et al. Randomized comparison of prophylaxis and on-demand regimens with FEIBA NF in the treatment of haemophilia A and B with inhibitors. Haemophilia. 2014 Jan;20 (1):65-72. [PubMed] [Crossref]
17.Sullivan S, Mauskopf J, Augustovski F, Caro J, Lee K, Minchin M, et al. Budget Impact Analysis—Principles of Good Practice: Report of the ISPOR 2012 Budget Impact Analysis Good Practice II Task Force. Value Health. 2014 Jan-Feb;17(1):5-14. [PubMed] [Crossref]
18.Bulgarian hemophilia association. [Strategic plan 2015-2019.] [in Bulgarian] [Internet]
19.National health insurance fund. Information about the number of patients and reimbursed expenditures. [In Bulgarian] [Internet]
20.Ehrenforth S, Kreuz W, Scharrer I, Linde R, Funk M, Güngör T, et al. Incidence of development of factor VIII and factor IX inhibitors in haemophiliacs. Lancet. 1992 Mar 7;339(8793):594-8. [PubMed]
21.Bulgarian medical hematology association. Methodological  recommendationsfor diagnostics and therapy of hematology diseases (Pharmaco-therapeutic guideline). Hematology 2015; LI (3-4): 17-25 [In Bulgarian]
22.Darshan A , Oladapo A, Epstein J, Novack A, Neufeld E, Hay J. A Budget Impact Model of Hemophilia Bypassing Agent  Prophylaxis Relative to Recombinant Factor VIIa On-Demand. J Manag Care Spec Pharm. 2016 Feb;22 (2):149-57. [PubMed] [Crossref]
23.National council on prices and reimbursement. [Registries. Price registry] [in Bulgarian]  [Internet]
24.Villarrubia R, Oyagüez I, Álvarez-Román M, Mingot-Castellano M, Parra R, Casado M. Cost analysis of prophylaxis with activated prothrombin complex concentrate vs. on-demand therapy with activated factor VII in severe haemophiliaA patients with inhibitors, in Spain. Haemophilia. 2015 May;21(3):320-9. [PubMed] [Crossref]
25.Hay JW, Zhou ZY. Economical comparison of APCC vs. rFVIIa for mild-to-moderate bleeding episodes in haemophilia patients with inhibitors. Haemophilia. 2011 Sep;17(5):e969-74. [PubMed] [Crossref]
26.Bonnet PO, Yoon BS, Wong WY, Boswell K, Ewenstein BM. Cost minimization analysis to compare activated prothrombin complex concentrate (APCC) and recombinant factor VIIa for haemophilia patients with inhibitors undergoing major orthopaedic surgeries. Haemophilia. 2009 Sep;15(5):1083-9. [PubMed] [Crossref]
27.Miners A. Revisiting the cost-effectiveness of primary prophylaxis with clotting factor for the treatment of severe haemophilia A. Haemophilia. 2009 Jul;15(4):881-7. [PubMed] [Crossref]
28.Carlsson K, Astermark J, Donfield S, Berntorp E. Cost and outcome: Comparison of two alternative bypassing agents for persons with haemophilia A complicated by an inhibitor. Thromb Haemost. 2008 Jun; 99(6):1060-7. [PubMed] [Crosref]
29.Cavazza M, Kodra Y, Armeni P, De Santis M, López-Bastida J, Linertová R, et al. Social/economic costs and quality of life in patients with haemophilia in Europe. Eur J Health Econ. 2016 Apr;17 Suppl 1:53-65. [PubMed] [Crossref]
30. Petrova G, Tachkov K, Georgieva S, Dimitrova M. Humanistic and economic aspects of haemophilia treatment in Bulgaria. Comparison between two therapeutic approaches: prophylactic vs. on-demand treatment. Biotechnol Biotechnol Equip. 2014 May 4;28(3):576-582. [PubMed] [Crossref].

Received: 19 November 2018
Published online: 22 April 2019

back to Online Journal