ORGANIZATION: State Institute for Drug Control (SUKL)  PROBLEM OR ISSUE ADDRESSED: Regular reimbursement revision – an obligation in the Czech reimbursement system The case of newly fixed “second” reimbursement level for specific product from group of medicines with similar clinical use (mesalazine, sulfasalazine) GOALS: System of two levels of reimbursement embodied in Czech law was applied also in a regular revision procedure. OUTCOMES ITEMS USED IN THE DECISION: The system of reimbursement allows to reimburse medicines in two levels. So-called “first” reimbursement is used for the majority of patients, for the main indication of the in principle therapeutically interchangeable drug or group of medicines with similar clinical use, the other, so-called “second” reimbursement is used for the specific group of patients, where justified. It is given by law that the system of reimbursement should be reviewed regularly. IMPLEMENTATION STRATEGY: Applicant in single administrative procedure could apply for a “second” reimbursement level with given proof of clinical and cost effectiveness evidence. During reimbursement revision procedure, its participants could also file an application for the “second” reimbursement level with the same kind of evidence needed as well. Assessment of the specific group of medicines (an anti-inflammatory drugs used to treat inflammation of the digestive tract, mesalazine, sulfasalazine) showed the clinical potential for the additional reimbursement. Participants to the administrative procedure (market authorization holders, MAHs) during the process came with the proof of clinical improvement and effectiveness of the treatment with mesalazine, which was clustered in a reference group with sulfasalazine by ministerial regulation. Budget impact analysis was also involved. RESULTS: The final decision of SUKL was to reimburse that active substance higher than other in the group. MAHs appealed against the decision because of the “second” reimbursement level and because of procedural steps. The appeal was administered by appellate authority – the Ministry of Health of the Czech Republic. Ministry of Health confirmed the SUKL´s decision to arrange for two levels of reimbursement with different conditions. LESSONS LEARNED: Principle of two levels of reimbursement could also be used in other reassessed groups of drugs, not only on demand of applicant in single procedure but also in reviewing process of reimbursement.