Clinical, pharmacokinetic and economic analysis of the first switch to an extended half-life factor IX (albutrepenonacog alfa, rFIX-FP) in Spain

BMJ Case Rep. 2020 Oct 13;13(10):e234142. doi: 10.1136/bcr-2019-234142.

Abstract

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.

Keywords: congenital disorders; haematology (incl blood transfusion); health economics; pharmacokinetics.

Publication types

  • Case Reports

MeSH terms

  • Blood Coagulation Tests
  • Child
  • Drug Costs
  • Drug Substitution / economics
  • Factor IX / administration & dosage*
  • Factor IX / economics
  • Factor IX / pharmacokinetics
  • Half-Life
  • Hemophilia B / complications
  • Hemophilia B / diagnosis
  • Hemophilia B / drug therapy*
  • Hemophilia B / economics
  • Hemorrhage / economics
  • Hemorrhage / etiology
  • Hemorrhage / prevention & control*
  • Humans
  • Male
  • Recombinant Fusion Proteins / administration & dosage*
  • Recombinant Fusion Proteins / economics
  • Recombinant Fusion Proteins / pharmacokinetics
  • Serum Albumin / administration & dosage*
  • Serum Albumin / economics
  • Serum Albumin / pharmacokinetics
  • Severity of Illness Index

Substances

  • Recombinant Fusion Proteins
  • Serum Albumin
  • Factor IX
  • albutrepenonacog alfa