TOCILIZUMAB

Organisation: ROCHE SLOVENSKO s.r.o.

Created at: 31.03.2025

Processed at: 07.04.2026

Question

Tocilizumab (according to the SPC) is a drug indicated for the treatment of severe or life-threatening cytokine release syndrome (CRS) induced by chimeric antigen receptor-expressing T-lymphocytes (CAR-T cell therapy) in patients with hematologic malignancies. Treatment with bispecific antibodies, such as glofitamab, in patients with diffuse large B-cell lymphoma (DLBCL) or, for example, talcetamab, in patients with multiple myeloma, can also induce severe infusion-related reactions (CRS). Therefore, according to the SPC, at least one dose of tocilizumab should be available for use in the event of CRS prior to the initial administration of bispecific antibodies. Access to the next dose of tocilizumab must also be ensured, to be administered according to the clinical condition of the patient within 8 hours of the previous dose of tocilizumab. Uncontrolled cytokine release syndrome is a serious side effect of treatment that can lead to life-threatening complications such as high fever, hypoxia, hypotension, organ failure and multi-organ dysfunction. Without the availability of tocilizumab, it is very difficult to effectively manage these symptoms. Without its administration, a very serious deterioration in the patient's condition could occur. In addition, the lack of tocilizumab could lead to the need to suspend or delay the planned continuation of bispecific antibody therapy, which could subsequently reduce the effectiveness of treatment and worsen the patient's prognosis. Continuous administration of treatment is important to achieve optimal treatment outcomes. Treatment of untreated CRS can be costly, as high-grade CRS requires the patient to be admitted to the intensive care unit (ICU), invasive monitoring and other expensive interventions. The lack of tocilizumab can thus lead to higher healthcare costs, which can be avoided by its administration. Treatment with tocilizumab in the case of outpatient administration requires approval by the Ministry of Health (MoH) and the insurance company, which causes time delays and puts the patient's life at risk (it is an emergency treatment)

The inclusion of tocilizumab in the DRG system in the context of CAR T cell and bispecific antibody therapy (hereafter innovative immunotherapy) is essential for several reasons: - Primarily, it is important to ensure that patients have immediate access to standardised, high-quality care, which is key to achieving the best possible treatment outcomes. - Rapid treatment availability: inclusion of tocilizumab in the DRG system will ensure that patients have access to this important drug without delay, which is critical for the effective management of CRS as a complication of the innovative immunotherapy administered. - Promoting innovative immunotherapy: integrating tocilizumab into the DRG system will facilitate the introduction of new and innovative medicines into clinical practice. This allows patients to benefit more quickly from the latest and most effective treatment options. - Cost control: the DRG system helps to predict and manage the costs associated with treatment. The inclusion of tocilizumab in this system contributes to a more transparent and efficient use of resources in healthcare. These steps will result in an increase in the quality of care provided to patients with haemato-oncological malignancies, a faster and more efficient introduction of innovative treatments, and an overall improvement in cost management and efficiency in the health system.

Tocilizumab should be included as an inpatient case for several important reasons: - Acuteness and severity of CRS. Tocilizumab, which is used for the management of CRS induced by innovative immunotherapy, is important to stabilize the patient in the event of its occurrence. - Monitoring and safety: The administration of tocilizumab for the management of CRS requires careful monitoring of the patient for various severe manifestations of CRS. Hospitalization allows for continuous surveillance by medical staff, rapid intervention and real-time optimization of treatment. - Rapid access to additional doses: If CRS persists it is necessary to ensure tocilizumab administration within 8 hours of the first dose; a maximum of 3 doses of tocilizumab are administered. Hospitalization allows immediate access to the necessary drugs and rapid response to a change in the patient's condition. - Comprehensive care: Patients with haemato-oncological malignancies often need comprehensive care that includes multimodal treatment approaches, including the administration of supportive care drugs. Hospitalization ensures that all aspects of treatment are carefully coordinated and the patient receives the best possible care. - Minimising risks: treating CRS and administering tocilizumab in a hospital setting minimises the risks associated with unexpected complications. The healthcare facility is equipped to deal with emergencies and provides specialised care that may be critical to the patient's survival. Note: A single dose of tocilizumab is 8mg/kg, a maximum of 3 doses of tocilizumab are administered in the management of CRS.

Answer

Tocilizumab has been in the KPP as an attributable item for a long time, until the end of 2025 it was reported under medical procedure code group: 64210-, from 1.1.2026 all drugs have been recoded and its new code is 6a5b0.