Podnet na vytvorenie PP - liek elranatamab

Organisation: Klinika hematológie a transfuziológie LF UK, LF SZU a UN Bratislava

Created at: 31.03.2025

Processed at: 07.04.2026

Question

We propose the inclusion of elranatamab in the list of attributable items because of: - the indication of elranatamab for the treatment of heavily pre-treated adult patients with relapsed and refractory multiple myeloma, - the limited number of patients treated, - the financial complexity of the new drug (the reimbursement for the hospital case does not cover the cost of provision and purchase of the drug), - the need to administer initial doses of the medicine during hospitalisation due to the risk of serious side effects, - equal access to other medicines indicated for the treatment of multiple myeloma and already included in the list of eligible items (e.g., 'the new medicine', 'the new medicine', 'the new medicine', 'the new medicine', 'the new medicine', 'the new medicine', 'the new medicine', 'the new medicine', 'the new medicine daratumumab, lenalidomide, carfilzomib). We are proposing the inclusion of elranatamab administration in the List of Creditable Items in the same breakdown as the administration of the drug in the List of Medical Procedures: elranatamab administration, subcutaneous, in the indication limitation: 44 mg Administration of elranatamab, subcutaneous, within indication limitation: 76 mg Administration of elranatamab, subcutaneous, within indication limitation: 88 mg Administration of elranatamab, subcutaneous, within indication limitation: 164 mg Administration of elranatamab, subcutaneous, within indication limitation: 240 mg Administration of elranatamab, subcutaneous, within indication limitation: 150 mg Administration of elranatamab, subcutaneous, within indication limitation: 240 mg

Answer

The above request has been reconsidered 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 In view of the failure to meet the criteria, the Medical Analysis Working Group proceeded to a vote, which is recorded in the minutes, available here: https://www.cksdrg.sk/en/dokumenty/571/Records%20of%20the%20negotiations%20of%20the%20medical%20analytical%20working%20group%20with%20votes.pdf , whereby the Working Group rejected the proposed PP, as it is a medicinal product that can also be administered in an outpatient form and at the time of the evaluation of the submission - summer 2025, it had not gone through the legal process of categorisation of the medicinal product, so it does not meet the criteria of the methodology as mentioned above.