Zaradenie novej pripočítateľnej položky - lieky a liečivá

Organisation: Národný onkologický ústav, Bratislava

Created at: 11.07.2025

Processed at: 07.04.2026

Question

Glucarpidase, a Voraxaze drug, code 9442D, is registered with the European Medicines Agency (EMA). The therapeutic indication is the reduction of toxic plasma concentrations of methotrexate in patients with delayed elimination or at risk of developing methotrexate-induced toxicity. The latter condition arises particularly in patients receiving methotrexate at high doses as part of single chemotherapy regimens. High-dose methotrexate regimens with monitoring of serum levels and elimination rates are administered exclusively during hospitalisation. Glucocarpidase is the only antidote against the toxic effects of methotrexate. Because methotrexate toxicity is rare, the drug Voraxaze is recognized as a so-called orphan. The administration of glucarpidase is not currently included in the List of Medical Procedures; administration during hospitalization cannot be reported .

The medicinal product Voraxaze [plv ino 1x1000 units (medicinal injection glass)] is included in the List of medicinal products with an officially determined price, Part A (medicinal products not included in the list of categorised medicinal products). The officially determined price of one pack of 1000 units is € 23 375,01, the price in an institutional pharmacy is € 24 988,52. Dosage of the medicine according to the SPC: 50 units/kg of weight; i.e. for an average patient weight of 65-75 kg, the required dose is 3 250-3 750 units, which is 4 packs of the medicine at a total cost of 99 954,08 €. Considering the financial complexity of the medicine, we propose to include it in the list of items attributable to the hospitalisation case, section Medicines_medicines.

The cost of providing the medicine for one patient is € 99 954,08. We assume that 3, max. 4 patients/year will require glucarpidase administration at the National Cancer Institute in Bratislava. The cost of the mentioned medicine for this number of patients is 299 862,24 € - 399 816,30 €. The cost of this medicine cannot be included in the prospective budget agreed with the individual health insurance companies for the reimbursement of hospitalisation cases. For this reason, in order to provide a particularly costly medicine for our healthcare facility, we propose that it be included in the list of eligible items.

Answer

That request has been reassessed in accordance with Chapter 8 of the Methodology for Updating Attributable Items for SK-DRG 2026, available here: https://www.cksdrg.sk/sk/dokumenty/568/Metodika%20aktualizácie%20pripočítateľných%20položiek%20pre%20SK-DRG%202026.pdf

Given that the criteria were met, the Medical Review Panel proceeded to a vote, which is recorded in the minutes available here: https://www.cksdrg.sk/sk/dokumenty/571/Zápisy%20z%20rokovaní%20medicínsko-analytickej%20pracovnej%20skupiny%20s%20hlasovaniami.pdf

The proposed PP has been approved and incorporated into the KPP with reimbursement type B in accordance with the above methodology.