Extracorporeal cytokine adsorption therapy is currently not recommended for inclusion into the benefit catalogue in Austria for patients with sepsis and SIRS

The Ludwig Boltzmann Institute – Health Technology Assessment (LBI-HTA) has published report with results of systematic literature review of application extracorporeal cytokine adsorption therapy (ECAT) for treatment and prevention of sepsis or systemic inflammatory response syndrome (SIRS).

Currently, only one ECAT device (CytoSorb®) received CE-mark for authorization on the European market. For now, ECAT is not reimbursed by Austrian health care system for treatment of sepsis, septic shock of SIRS.

Systematic literature search identified one randomized controlled trial (RCT) and one retrospective case series study for evaluation of clinical effectiveness. Both studies included small sample size and were aimed to assess efficacy of ECAT as preventative intervention during cardiopulmonary bypass surgery. Studies for assessment of ECAT as treatment option was not identified. Additionally, one small case series study was included for safety analysis.

Considered evidence was assessed as insufficient to prove that ECAT is effective and safe procedure in patients with sepsis, septic shock and SIRS.  Therefore, ECAT is currently not recommended for inclusion into the benefit catalogue.

However, LBI-HTA noted that there is a potential evidence for further evaluation:

• One International Registry on the Use of the CytoSorb Adsorber (n=3,000 patients; completion date – December 2020, NCT02312024)

• Two ongoing studies dedicated to assess efficacy of CytoSorb in patients with sepsis
  • Efficacy Study of CytoSorb Hemoperfusion Device on IL-6 Removal in ARDS/ALI Patients With Sepsis (n=100, study completed, no results are available, NCT00559130)
  • Cytokine Adsorption in Sepsis and Acute Kidney Injury (CASAKI) (n=124; completion date – December 2017, NCT02588794)
• Five studies focused on preventative use of ECAT during cardiopulmonary bypass surgery
  • CytoSorb Reduction of Free Hemoglobin During Cardiac Surgery (REFRESH) (n=52, study is completed, NCT02566525)
  • Cytokine Clearance With Cytoabsorbant Device During Cardiac Bypass (CCCC) (n=30; date of completion – December 2017; NCT02775123)
  • Use of Extracorporeal Treatment With the Cytosorb-Adsorber for the Reduction of SIRS in Heart Surgery Patients (CASHSP) (n=10; completion date – March 2018; NCT02265419)
  • Removal of Cytokines During Extracorporeal Circulation in Cardiac Surgery (n=40; completion date – February 2017, NCT02297334)
  • Removal of cytokines during cardiac surgery (RECCAS) (n=40; completion date – not known; German Clinical Trials Register number DRKS00007928)

LBI-HTA recommended to perform re-evaluation in 2019 for inclusion in the benefit catalogue for 2020 year. A minimum level of evidence from at least one larger RCT (n > 100 patients) and several prospective case-series studied (n > 20) for each indication should be available at the time of re-evaluation.

See full report in English here.

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