Prophylaxis therapy with bypassing agents in patients with haemophilia A and inhibitors undergoing surgery: A cost analysis in Spain

Eur J Haematol. 2020 Jul;105(1):94-100. doi: 10.1111/ejh.13414. Epub 2020 Apr 16.

Abstract

Objectives: This study estimated the cost of prophylaxis with activated prothrombin complex concentrate (aPCC) and recombinant activated factor VIIa (rFVIIa) in surgical patients with haemophilia A and inhibitors in Spain.

Methods: A decision-analytic model was developed to estimate the cost to the Spanish National Health System of providing haemostatic coverage in this haemophilia population, with age distribution and average weight derived from the literature, and the annual number of surgeries (0.33 per patient) from local data. Drug costs were calculated from official ex-factory prices with a 7.5% mandatory deduction and recommended dosing regimens.

Results: The estimated average costs per patient were €10 100.73 (aPCC) and €14 265.89 (rFVIIa) for dental extraction, €24 043.88 (aPCC) and €62 301.08 (rFVIIa) for minor surgery and €126 595.81 (aPCC) and €347 731.09 (rFVIIa) for major surgery. Assuming an estimated 23 annual surgeries in this population (N = 69), distributed as 19% dental extraction, 50% minor surgery and 31% major surgery, the total annual cost of prophylaxis was €1 209 682.35 with aPCC and €3 221 929.28 with rFVIIa.

Conclusions: aPCC costs were 62.5% lower than rFVIIa. Assuming potential clinical equivalence, aPCC is a potentially cost-saving option for surgical patients with haemophilia A and inhibitors.

Keywords: coagulation disorders.

MeSH terms

  • Blood Coagulation Factor Inhibitors / blood*
  • Clinical Decision-Making
  • Cost-Benefit Analysis
  • Disease Management
  • Drug Costs*
  • Factor VIIa / administration & dosage*
  • Factor VIIa / immunology
  • Health Care Surveys
  • Hemophilia A / complications*
  • Hemophilia A / drug therapy
  • Hemophilia A / epidemiology
  • Hemophilia A / surgery
  • Hemorrhage / epidemiology
  • Hemorrhage / etiology*
  • Hemorrhage / prevention & control*
  • Humans
  • Isoantibodies / blood*
  • Isoantibodies / immunology
  • Recombinant Proteins / administration & dosage
  • Recombinant Proteins / immunology
  • Spain / epidemiology
  • Surgical Procedures, Operative / adverse effects

Substances

  • Blood Coagulation Factor Inhibitors
  • Isoantibodies
  • Recombinant Proteins
  • recombinant FVIIa
  • Factor VIIa