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Erschienen in: Journal of Thrombosis and Thrombolysis 1/2020

29.10.2019

Cost comparison of andexanet versus prothrombin complex concentrates for direct factor Xa inhibitor reversal after hemorrhage

verfasst von: Jennifer A. Frontera, Prachi Bhatt, Rebecca Lalchan, Shadi Yaghi, Tania Ahuja, John Papadopoulos, Danielle Joset

Erschienen in: Journal of Thrombosis and Thrombolysis | Ausgabe 1/2020

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Abstract

Andexanet-alpha is a specific reversal agent for direct factor Xa inhibitors (dFXaI). We aimed to project utilization rates and cost of andexanet for reversal of dFXaI-related major hemorrhage compared to 4-factor prothrombin complex concentrates (4F-PCC). A retrospective, multicenter review was conducted between 1/1/2014 and 7/15/2018 of patients who received 4F-PCC for reversal of dFXaI-related life-threatening hemorrhages. Total hospital reimbursements/patient were calculated based on national average MS-DRG payments adjusting for Medicare discounts. The projected cost for andexanet (based on dose and insurance) and % reimbursement/patient was compared to the actual cost of 4F-PCC. Hemostasis at 24 h (excellent/good vs. poor) and 30-day thrombotic complications were assessed. Of 126 patients who received 4F-PCC to reverse dFXaI, 46 (~ 10 per-year) met inclusion criteria. The median projected cost of andexanet was $22,120/patient, compared to $5670/patient for 4F-PCC (P < 0.001). The median hospital reimbursement was $11,492/hospitalization. The projected cost of andexanet alone would exceed the entire hospital reimbursement in 74% of patients by a median of $7604, while 4F-PCC cost exceeded the total hospital payments in 7% of patients in the same cohort (P < 0.001). Hemostasis was excellent/good in 72% of patients post-4F-PCC, compared to 82% in andexanet trials. Thromboembolic events occurred in 4% of patients following 4F-PCC versus 10% in andexanet trials. The projected cost of andexanet would exceed the national average hospital reimbursement/patient in nearly 75% of patients by over $7500/hospitalization. 4F-PCC was significantly less expensive, had lower rates of thrombosis, but also lower rates of good/excellent hemostasis compared to published data for andexanet.
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Literatur
1.
Zurück zum Zitat Connolly SJ, Crowther M, Eikelboom JW, Gibson CM, Curnutte JT, Lawrence JH, Yue P, Bronson MD, Lu G, Conley PB, Verhamme P, Schmidt J, Middeldorp S, Cohen AT, Beyer-Westendorf J, Albaladejo P, Lopez-Sendon J, Demchuk AM, Pallin DJ, Concha M, Goodman S, Leeds J, Souza S, Siegal DM, Zotova E, Meeks B, Ahmad S, Nakamya J, Milling TJ Jr, Investigators A- (2019) Full study report of andexanet alfa for bleeding associated with factor Xa inhibitors. N Engl J Med 380(14):1326–1335. https://doi.org/10.1056/NEJMoa1814051 CrossRefPubMedPubMedCentral Connolly SJ, Crowther M, Eikelboom JW, Gibson CM, Curnutte JT, Lawrence JH, Yue P, Bronson MD, Lu G, Conley PB, Verhamme P, Schmidt J, Middeldorp S, Cohen AT, Beyer-Westendorf J, Albaladejo P, Lopez-Sendon J, Demchuk AM, Pallin DJ, Concha M, Goodman S, Leeds J, Souza S, Siegal DM, Zotova E, Meeks B, Ahmad S, Nakamya J, Milling TJ Jr, Investigators A- (2019) Full study report of andexanet alfa for bleeding associated with factor Xa inhibitors. N Engl J Med 380(14):1326–1335. https://​doi.​org/​10.​1056/​NEJMoa1814051 CrossRefPubMedPubMedCentral
2.
Zurück zum Zitat Schulman S, Gross PL, Ritchie B, Nahirniak S, Lin Y, Lieberman L, Carrier M, Crowther MA, Ghosh I, Lazo-Langner A, Zondag M, Study Investigators (2018) Prothrombin complex concentrate for major bleeding on factor Xa inhibitors: a prospective cohort study. Thromb Haemost 118(5):842–851. https://doi.org/10.1055/s-0038-1636541 CrossRefPubMed Schulman S, Gross PL, Ritchie B, Nahirniak S, Lin Y, Lieberman L, Carrier M, Crowther MA, Ghosh I, Lazo-Langner A, Zondag M, Study Investigators (2018) Prothrombin complex concentrate for major bleeding on factor Xa inhibitors: a prospective cohort study. Thromb Haemost 118(5):842–851. https://​doi.​org/​10.​1055/​s-0038-1636541 CrossRefPubMed
7.
Zurück zum Zitat ATLS Subcommittee, American College of Surgeons’ Committee on Trauma, International ATLS Working Group (2012) Advanced trauma life support (ATLS®): the ninth edition. J Trauma Acute Care Surg 74(5):1363–1366 ATLS Subcommittee, American College of Surgeons’ Committee on Trauma, International ATLS Working Group (2012) Advanced trauma life support (ATLS®): the ninth edition. J Trauma Acute Care Surg 74(5):1363–1366
8.
9.
Zurück zum Zitat Frontera JA, Lewin JJ III, Rabinstein AA, Aisiku IP, Alexandrov AW, Cook AM, Del Zoppo GJ, Kumar M, Peerschke EI, Stiefel MF, Teitelbaum JS, Wartenberg KE, Zerfoss CL (2016) Guideline for reversal of antithrombotics in intracranial hemorrhage: executive Summary”. A statement for healthcare professionals from the Neurocritical Care Society and the Society of Critical Care Medicine. Crit Care Med 44(12):2251–2257. https://doi.org/10.1097/CCM.0000000000002057 CrossRefPubMed Frontera JA, Lewin JJ III, Rabinstein AA, Aisiku IP, Alexandrov AW, Cook AM, Del Zoppo GJ, Kumar M, Peerschke EI, Stiefel MF, Teitelbaum JS, Wartenberg KE, Zerfoss CL (2016) Guideline for reversal of antithrombotics in intracranial hemorrhage: executive Summary”. A statement for healthcare professionals from the Neurocritical Care Society and the Society of Critical Care Medicine. Crit Care Med 44(12):2251–2257. https://​doi.​org/​10.​1097/​CCM.​0000000000002057​ CrossRefPubMed
10.
Zurück zum Zitat Frontera JA, Lewin JJ 3rd, Rabinstein AA, Aisiku IP, Alexandrov AW, Cook AM, del Zoppo GJ, Kumar MA, Peerschke EI, Stiefel MF, Teitelbaum JS, Wartenberg KE, Zerfoss CL (2016) Guideline for reversal of antithrombotics in intracranial hemorrhage: a statement for healthcare professionals from the Neurocritical Care Society and Society of Critical Care Medicine. Neurocrit Care 24(1):6–46. https://doi.org/10.1007/s12028-015-0222-x CrossRefPubMed Frontera JA, Lewin JJ 3rd, Rabinstein AA, Aisiku IP, Alexandrov AW, Cook AM, del Zoppo GJ, Kumar MA, Peerschke EI, Stiefel MF, Teitelbaum JS, Wartenberg KE, Zerfoss CL (2016) Guideline for reversal of antithrombotics in intracranial hemorrhage: a statement for healthcare professionals from the Neurocritical Care Society and Society of Critical Care Medicine. Neurocrit Care 24(1):6–46. https://​doi.​org/​10.​1007/​s12028-015-0222-x CrossRefPubMed
13.
Zurück zum Zitat Services DoHaH (2018) Federal Register 83 (160):41355-41362 Services DoHaH (2018) Federal Register 83 (160):41355-41362
15.
Zurück zum Zitat Connolly SJ, Crowther M, Eikelboom JW, Gibson CM, Curnutte JT, Lawrence JH, Yue P, Bronson MD, Lu G, Conley PB, Verhamme P, Schmidt J, Middeldorp S, Cohen AT, Beyer-Westendorf J, Albaladejo P, Lopez-Sendon J, Demchuk AM, Pallin DJ, Concha M, Goodman S, Leeds J, Souza S, Siegal DM, Zotova E, Meeks B, Ahmad S, Nakamya J, Milling TJ Jr, ANNEXA-4 Investigators (2019) Full study report of andexanet alfa for bleeding associated with factor Xa inhibitors. N Engl J Med. https://doi.org/10.1056/NEJMoa1814051 CrossRefPubMedPubMedCentral Connolly SJ, Crowther M, Eikelboom JW, Gibson CM, Curnutte JT, Lawrence JH, Yue P, Bronson MD, Lu G, Conley PB, Verhamme P, Schmidt J, Middeldorp S, Cohen AT, Beyer-Westendorf J, Albaladejo P, Lopez-Sendon J, Demchuk AM, Pallin DJ, Concha M, Goodman S, Leeds J, Souza S, Siegal DM, Zotova E, Meeks B, Ahmad S, Nakamya J, Milling TJ Jr, ANNEXA-4 Investigators (2019) Full study report of andexanet alfa for bleeding associated with factor Xa inhibitors. N Engl J Med. https://​doi.​org/​10.​1056/​NEJMoa1814051 CrossRefPubMedPubMedCentral
17.
Zurück zum Zitat Kothari RU, Brott T, Broderick JP, Barsan WG, Sauerbeck LR, Zuccarello M, Khoury J (1996) The ABCs of measuring intracerebral hemorrhage volumes. Stroke 27(8):1304–1305CrossRefPubMed Kothari RU, Brott T, Broderick JP, Barsan WG, Sauerbeck LR, Zuccarello M, Khoury J (1996) The ABCs of measuring intracerebral hemorrhage volumes. Stroke 27(8):1304–1305CrossRefPubMed
18.
Zurück zum Zitat Gebel JM, Sila CA, Sloan MA, Granger CB, Weisenberger JP, Green CL, Topol EJ, Mahaffey KW (1998) Comparison of the ABC/2 estimation technique to computer-assisted volumetric analysis of intraparenchymal and subdural hematomas complicating the GUSTO-1 trial. Stroke 29(9):1799–1801CrossRefPubMed Gebel JM, Sila CA, Sloan MA, Granger CB, Weisenberger JP, Green CL, Topol EJ, Mahaffey KW (1998) Comparison of the ABC/2 estimation technique to computer-assisted volumetric analysis of intraparenchymal and subdural hematomas complicating the GUSTO-1 trial. Stroke 29(9):1799–1801CrossRefPubMed
20.
Zurück zum Zitat Tomaselli GF, Mahaffey KW, Cuker A, Dobesh PP, Doherty JU, Eikelboom JW, Florido R, Hucker W, Mehran R, Messe SR, Pollack CV Jr, Rodriguez F, Sarode R, Siegal D, Wiggins BS (2017) 2017 ACC Expert Consensus Decision Pathway on management of bleeding in patients on oral anticoagulants: a report of the American College of Cardiology Task Force on Expert Consensus Decision Pathways. J Am Coll Cardiol 70(24):3042–3067. https://doi.org/10.1016/j.jacc.2017.09.1085 CrossRefPubMed Tomaselli GF, Mahaffey KW, Cuker A, Dobesh PP, Doherty JU, Eikelboom JW, Florido R, Hucker W, Mehran R, Messe SR, Pollack CV Jr, Rodriguez F, Sarode R, Siegal D, Wiggins BS (2017) 2017 ACC Expert Consensus Decision Pathway on management of bleeding in patients on oral anticoagulants: a report of the American College of Cardiology Task Force on Expert Consensus Decision Pathways. J Am Coll Cardiol 70(24):3042–3067. https://​doi.​org/​10.​1016/​j.​jacc.​2017.​09.​1085 CrossRefPubMed
21.
Zurück zum Zitat Steffel J, Verhamme P, Potpara TS, Albaladejo P, Antz M, Desteghe L, Haeusler KG, Oldgren J, Reinecke H, Roldan-Schilling V, Rowell N, Sinnaeve P, Collins R, Camm AJ, Heidbuchel H, ESC Scientific Document Group (2018) The 2018 European Heart Rhythm Association Practical Guide on the use of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation. Eur Heart J 39(16):1330–1393. https://doi.org/10.1093/eurheartj/ehy136 CrossRefPubMed Steffel J, Verhamme P, Potpara TS, Albaladejo P, Antz M, Desteghe L, Haeusler KG, Oldgren J, Reinecke H, Roldan-Schilling V, Rowell N, Sinnaeve P, Collins R, Camm AJ, Heidbuchel H, ESC Scientific Document Group (2018) The 2018 European Heart Rhythm Association Practical Guide on the use of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation. Eur Heart J 39(16):1330–1393. https://​doi.​org/​10.​1093/​eurheartj/​ehy136 CrossRefPubMed
22.
Zurück zum Zitat Niessner A, Tamargo J, Morais J, Koller L, Wassmann S, Husted SE, Torp-Pedersen C, Kjeldsen K, Lewis BS, Drexel H, Kaski JC, Atar D, Storey RF, Lip GYH, Verheugt FWA, Agewall S (2017) Reversal strategies for non-vitamin K antagonist oral anticoagulants: a critical appraisal of available evidence and recommendations for clinical management—a joint position paper of the European Society of Cardiology Working Group on Cardiovascular Pharmacotherapy and European Society of Cardiology Working Group on Thrombosis. Eur Heart J 38(22):1710–1716. https://doi.org/10.1093/eurheartj/ehv676 CrossRefPubMed Niessner A, Tamargo J, Morais J, Koller L, Wassmann S, Husted SE, Torp-Pedersen C, Kjeldsen K, Lewis BS, Drexel H, Kaski JC, Atar D, Storey RF, Lip GYH, Verheugt FWA, Agewall S (2017) Reversal strategies for non-vitamin K antagonist oral anticoagulants: a critical appraisal of available evidence and recommendations for clinical management—a joint position paper of the European Society of Cardiology Working Group on Cardiovascular Pharmacotherapy and European Society of Cardiology Working Group on Thrombosis. Eur Heart J 38(22):1710–1716. https://​doi.​org/​10.​1093/​eurheartj/​ehv676 CrossRefPubMed
24.
25.
Zurück zum Zitat Pollack CV Jr, Reilly PA, van Ryn J, Eikelboom JW, Glund S, Bernstein RA, Dubiel R, Huisman MV, Hylek EM, Kam CW, Kamphuisen PW, Kreuzer J, Levy JH, Royle G, Sellke FW, Stangier J, Steiner T, Verhamme P, Wang B, Young L, Weitz JI (2017) Idarucizumab for dabigatran reversal—full cohort analysis. N Engl J Med 377(5):431–441. https://doi.org/10.1056/NEJMoa1707278 CrossRefPubMed Pollack CV Jr, Reilly PA, van Ryn J, Eikelboom JW, Glund S, Bernstein RA, Dubiel R, Huisman MV, Hylek EM, Kam CW, Kamphuisen PW, Kreuzer J, Levy JH, Royle G, Sellke FW, Stangier J, Steiner T, Verhamme P, Wang B, Young L, Weitz JI (2017) Idarucizumab for dabigatran reversal—full cohort analysis. N Engl J Med 377(5):431–441. https://​doi.​org/​10.​1056/​NEJMoa1707278 CrossRefPubMed
27.
Zurück zum Zitat NCT03661528 (2019) Trial of andexanet in ICH patients receiving an oral FXa inhibitor. clinicaltrials.gov. Accessed 15 Apr 2019 NCT03661528 (2019) Trial of andexanet in ICH patients receiving an oral FXa inhibitor. clinicaltrials.gov. Accessed 15 Apr 2019
Metadaten
Titel
Cost comparison of andexanet versus prothrombin complex concentrates for direct factor Xa inhibitor reversal after hemorrhage
verfasst von
Jennifer A. Frontera
Prachi Bhatt
Rebecca Lalchan
Shadi Yaghi
Tania Ahuja
John Papadopoulos
Danielle Joset
Publikationsdatum
29.10.2019
Verlag
Springer US
Erschienen in
Journal of Thrombosis and Thrombolysis / Ausgabe 1/2020
Print ISSN: 0929-5305
Elektronische ISSN: 1573-742X
DOI
https://doi.org/10.1007/s11239-019-01973-z

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