CytoSorb ® - Preliminary information report available in Italy

Emilia Romagna Region published a preliminary information report on the CytoSorb® device, an extracorporeal cytokine adsorber for the reduction of circulating cytokines in the blood stream.

Technology and indications

The CytoSorb® device (Cytosorbents Corporation) is a non-pyrogenic, sterile, single-use device that, placed in a blood pump circuit, is designed to remove cytokines using adsorbent polymer beads that adsorb cytokines as blood passes through the device.

The hospital that requested the technology intends to use it for the treatment of sepsis, septic shock, systemic inflammatory response syndrome (SIRS), rhabdomyolysis, and hyperbilirubinemia (in patients with hepatic insufficiency).

The device is currently indicated for use in conditions where excessive cytokine levels exist (CE mark). The manufacturer has requested approval for other indications (adsorption of myoglobin, bilirubin, and free hemoglobin). 

Diffusion of the technology in Italy

During 2016, 230 units of the device have been purchased across 12 Regions. A total of 33 units have been purchased in Emilia Romagna with price ranging from EUR 1,865 to EUR 1,952.

Comparators

The device is proposed as an additional treatment to the standard therapy (antibiotic therapy in case of sepsis, septic shock, and SIRS). Other available systems operate on plasma, and not on the whole blood, and this makes their use more complex compared to the CytoSorb® device.

Preliminary evidence summary

Searches of secondary studies identified 2 relevant documents:

• NICE (2016) concluded that: “Key uncertainties are that there is little evidence on key outcomes for CytoSorb therapy compared with standard care. Also, the generalisability of the available evidence to NHS clinical practice is unclear. The main resource impact on the NHS would be the costs of the technology in addition to standard care.”
• Hawlik et al. (2017) concluded that: “The current evidence does not suffice to prove that extracorporeal cytokine haemadsorption therapy (ECAT) in patients with sepsis, septic shock and SIRS is effective and safe. Clinical benefits in terms of patient-relevant outcomes in both indications need to be demonstrated in order to introduce ECAT into practice. A re-evaluation is recommended in 2019, if results from RCTs or CT including more than 100 patients are available.”

Searches of primary studies identified 62 relevant studies: 33 (53%) studies were on sepsis while the others were on different conditions.

Searches of ongoing studies identified 20 studies (12 were RCT; 11 were aimed to assess the device during cardiac surgery with cardio-pulmonary bypass.)

See the full report in Italian here.

Subscribe to our newsletter delivered every second week not to miss important reimbursement information.