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Clinical, pharmacokinetic and economic analysis of the first switch to an extended half-life factor IX (albutrepenonacog alfa, rFIX-FP) in Spain
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Clinical, pharmacokinetic and economic analysis of the first switch to an extended half-life factor IX (albutrepenonacog alfa, rFIX-FP) in Spain
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Clinical, pharmacokinetic and economic analysis of the first switch to an extended half-life factor IX (albutrepenonacog alfa, rFIX-FP) in Spain
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Journal Article
Clinical, pharmacokinetic and economic analysis of the first switch to an extended half-life factor IX (albutrepenonacog alfa, rFIX-FP) in Spain
2020
Overview
Extended half-life of factor IX (FIX) demonstrated clinical benefit and lower treatment burden than standard half-life FIX products in clinical trials. We analysed the impact in efficacy, pharmacokinetics (PKs) and costs of the switch from nonacog alfa (rFIX) to albutrepenonacog alfa (rFIX-FP) in the first patient with haemophilia B (HB) treated in Spain outside clinical trials. A 7-year-old boy presented with HB with poor venous access and repetition infections using rFIX, which was switched to rFIX-FP. Prophylaxis was adjusted by PKs using WAPPS-Hemo tailoring from 100 IU/kg/week of rFIX to 80 IU/kg/3 weeks of rFIX-FP. Comparing 6 months before, rFIX-FP reduced 68.5% FIX consumption/kg and 58.3% infusion frequency, but total costs/weight showed a slight increase. Ratio of half-life between rFIX and rFIX-FP was 3.4–3.7. This case report revealed that switch to rFIX-FP decreased frequency and FIX consumption, without adverse events and bleeds.
Publisher
BMJ Publishing Group Ltd,BMJ,BMJ Publishing Group LTD,BMJ Publishing Group
Subject
/ Child
/ congenital disorders, haematology (incl blood transfusion), health economics, pharmacokinetics
/ Costs
/ Drug Substitution - economics
/ Factor IX - administration & dosage
/ Factor IX - pharmacokinetics
/ haematology (incl blood transfusion)
/ Hemophilia B - complications
/ Hemorrhage - prevention & control
/ Humans
/ Male
/ Novel treatment (new drug/intervention; established drug/procedure in new situation)
/ Recombinant Fusion Proteins - administration & dosage
/ Recombinant Fusion Proteins - economics
/ Recombinant Fusion Proteins - pharmacokinetics
/ Serum Albumin - administration & dosage
