Keytruda (pembrolizumab) zaradenie indikácie IO1432_podľa klinického skúšania KN826 - ca cervixu

Organisation: Merck Sharp & Dohme, s.r.o.

Created at: 26.03.2025

Processed at: 02.04.2026

Question

The indication according to clinical trial KN826 in the following wording will be included in the ZKL by a final decision of the Ministry of Health as of 1.5.2025. Keytruda, in combination with or without chemotherapy and bevacizumab, is indicated for the first-line treatment of persistent, recurrent or metastatic cervical cancer in adults who have not been treated with chemotherapy (with the exception of its concomitant use as a radiosensitising agent) and whose tumours show PD-L1 expression with a CPS ≥ 1, for a maximum of 24 months. The combination of pembrolizumab with chemotherapy alone is covered only for patients unsuitable for treatment with bevacizumab.

Please include Keytruda (pembrolizumab) as a DRG creditable item from 1.1.2026.

Indication: patients with ca cervix requiring treatment during hospitalization according to the above IO.

Answer

The indication restrictions (IOs) in the DRG system are aligned with the IOs that are listed in the categorisation list of medicines. As the SK-DRG system is updated only once a year and new indications enter the categorisation list all year round, in order to avoid misalignment of the two systems, the reporting of indication restrictions has been transferred to marker reporting, which makes the DRG system more flexible and as soon as a medicine is categorised under a new indication, it can also be reported under the DRG system.