The Categorisation Commission for Medicinal Products at the June meeting approved the extension of the indication criteria for several medicinal products and also included the payment of another diabetes medicine. Medicinal products included in the list of categorised medicinal products are covered by a health insurance undertaking.
The Ministry of Health recalls that, if the medicinal product is to be categorised, the holder of the marketing authorisation must apply to the Ministry of Health for inclusion of the medicinal product in the list of categorised medicinal products. The decision to apply for a categorization of a medicinal product and a particular indication is entirely the responsibility of the marketing authorisation holder. The Health Department shall assess the application and subsequently be the subject of a hearing by the CEC. If the statutory conditions are met, the Minister may then decide to include the medicinal product in the list of categorised medicinal products. Categorisation of all medicines is carried out in Slovakia with respect to the financial stability of the system.
News in the list of categorised medicines from 1.9.2021
- Inclusion of Rydelsus It contains the active substance semaglutide. Treatment of type 2 diabetes mellitus has been approved for Rykelsus. These are oral tablets.
- Extension of Jardiance indication It contains the active substance empagliflozin. Treatment of chronic kidney disease has been approved for Jardiance. These are oral tablets.
- Extension of Jakavi indication It contains the active substance ruxolitinib. For Jakavi, the indication GvHD (Graft versus host disease) was approved. These are oral tablets.
- Extension of Rinvoq indication – contains the active substance padacitinib. Treatment of Crohn's disease and ulcerative colitis has been approved for Rinvoq. These are prolonged-release oral tablets.