1.
Health economics of inhibitor bypassing agents in haemophilia A-activated prothrombin complex concentrate (aPCC) and recombinant activated factor VIIa (rFVIIa) Polish
Szmurlo D, Derylo L, Rys P, Wladysiuk M
Polski Merkuriusz Lekarski. 2011;30((177):):202-7.
Abstract
Haemophilia A is a sex-linked recessive genetic disorder associated with haemorrhagic diathesis due to reduced plasma activity of coagulation factor VIII, i.e., below 50% of the normal value (< 0.5 IU/ ml). The treatment of haemophilia A-Inhibitor patients is bidirectional. Major issues with treatment are inhibitor eradication and control of haemorrhage. The aim of the analysis was to evaluate costs and effects of the use of aPCC and rFVIIa in haemophilia A-inhibitor patients in on-demand treatment, perioperative prophylaxis and long-term prophylaxis. MATERIALS AND METHODS The cost analysis was performed from the payer's perspective for all treatment schemes. Dosage and duration of treatment were obtained from a systematic review of clinical trials, Summary of Product Characteristics and clinical practice guidelines. Analysis was conducted in accordance with the AHTAPol (Agency for Health Technology Assessment in Poland) guidelines. RESULTS The use of aPCC in on-demand treatment of children and adults during one day or one episode of bleeding (irrespective of the intensity of bleeding: from mild to severe) reduced the payer's expenditures in comparison to the use of rFVIIa. The use of aPCC in perioperative prophylaxis of children and adults during minor and major surgical interventions and implantations of central venous access devices was associated with savings for the payer in comparison to the use of rFVIIa, irrespectively of dosage of both drugs. Break even point analysis showed that the use of aPCC in long-term prophylaxis may be less expensive than the use of aPCC in on-demand treatment if bleedings last for 2.5 days or more. Sensitivity analysis showed that assumptions concerning body weight of patients significantly influence expenses of the public payer. However, the use of aPCC was associated with lower costs than the use of rFVIIa, irrespectively of the patients' body weight. CONCLUSIONS In order to demonstrate the actual size of expenditures on treatment of haemophilia A-Inhibitor patients, collection of data concerning real clinical practice in Poland is required.
2.
Modeling the cost-effectiveness of prothrombin complex concentrate compared with fresh frozen plasma in emergency warfarin reversal in the United kingdom
Guest, J. F., Watson, H. G., Limaye, S.
Clinical Therapeutics. 2010;32((14):):2478-93.
Abstract
BACKGROUND Warfarin is the most commonly used oral anticoagulant in the United Kingdom. Indications for its long-term use include recurrent venous throm-bosis, prosthetic heart valves, stroke prevention in atrial fibrillation, valvular heart disease, and prosthetic heart valve replacement. OBJECTIVE The aim of this study was to estimate the cost-effectiveness of using prothrombin complex concentrate (PCC) compared with fresh frozen plasma (FFP) for emergency warfarin reversal in patients with a life-threatening intracranial, gastrointestinal, or retroperitoneal hemorrhage. METHODS Mortality estimates associated with managing an intracranial, gastrointestinal, or retroperitoneal hemorrhage were obtained from published studies after a systematic literature search. Estimates of health care resource use pertaining to managing warfarin-treated patients after a life-threatening hemorrhage were provided by 11 consultant physicians with experience in warfarin reversal. These published clinical outcomes and clinician-derived health care resource use estimates were used to construct a decision model depicting the treatment patterns and associated resource use attributable to current management of a hypothetical cohort of adults undergoing emergency warfarin reversal as a result of an intracranial, gastrointestinal, or retroperitoneal hemorrhage in the United Kingdom. The model only considered direct health care costs borne by the secondary care sector of the National Health Service, and not those borne in the community (with the exception of the cost of stroke rehabilitation) and estimated the cost effectiveness of using PCC compared with FFP to reverse the anticoagulant effects of warfarin, from the perspective of the National Health Service, at 2007-2008 prices. RESULTS The cost of warfarin reversal was estimated to be <=15% of the total cost of managing a patient after a life-threatening intracranial, gastrointestinal, or retroperitoneal hemorrhage. The cost per life-year gained with PCC was estimated to range from 1000 to 2000, depending on hemorrhage type (ie, intracranial, gastrointestinal, or retroperitoneal). The cost per quality-adjusted life-year gained with PCC was estimated at 3000 or less depending on hemorrhage type. CONCLUSION PCC appeared to be a more cost-effective treatment than FFP for the emergency reversal of warfarin, from the perspective of the UK National Health Service, in this model analysis. Copyright 2010 Elsevier HS Journals, Inc. All rights reserved.
3.
Cost minimization analysis to compare activated prothrombin complex concentrate (APCC) and recombinant factor VIIa for haemophilia patients with inhibitors undergoing major orthopaedic surgeries
Bonnet PO, Yoon BS, Wong WY, Boswell K, Ewenstein BM
Haemophilia. 2009;15((5):):1083-9.
Abstract
Benefits of bypassing agents for maintaining haemostasis in major surgeries have been described in the literature; however, their use has a substantial economic impact. This study assessed the cost of FEIBA, an activated prothrombin complex concentrate and recombinant factor VIIa (rFVIIa) when used in inhibitor patients undergoing major surgeries. After reviewing published literature, a cost minimization model was developed describing dosing regimens recommended and used during major surgeries for FEIBA (pre-operative: 75-100 U kg(-1); postoperative: 75-100 U kg(-1) q 8-12 h days 1-5 and 75-100 U kg(-1) q 12 h days 6-14) and rFVIIa (pre-operative: 90 microg kg(-1); intra-operative: 90 microg kg(-1) q 2 h; postoperative: 90 microg kg(-1) q 2-4 h days 1-5 and 90 microg kg(-1) q 6 h days 6-14). Using a 75 kg patient and US prices, total drug cost was calculated for three scenarios: use of FEIBA or rFVIIa alone and a third case combining rFVIIa pre- and intra-operative and FEIBA throughout a 14-day postoperative period. Dosage amounts of modelled bypassing agents were similar to cases in the literature. Using FEIBA instead of rFVIIa would decrease total drug cost by >50% and save over $400,000 per surgery. Sequential use of both bypassing agents would increase total drug cost by 9% when compared with FEIBA alone, but would remain >40% lower than rFVIIa alone. Univariate sensitivity analyses confirmed robustness of results. As large amounts of bypassing agents are necessary for patients with inhibitors to undergo major surgeries, cost is a major consideration. Use of FEIBA alone or in combination with rFVIIa has emerged as a cost-saving approach.