Within the pilot "Parallel Procedures CBG-ZIN" the innovative drugs become available quicker because it allows obtaining reimbursement in parallel to the registration process. The first drug Rybelsus® (semaglutide tablets) used in type 2 diabetes has completed the pilot.
The Medicines Evaluation Board (MEB) and the Dutch Healthcare Institute (Zorginstituut Nederland, ZIN) have therefore joined forces to shorten the time from registration to reimbursement of drugs. In the pilot "Parallel Procedures CBG-ZIN," a method is being developed for more parallel processes for registration and reimbursement. This means that the reimbursement process (for admission to the basic package) has already started, while the registration process (for admission to the Dutch market) has not been completed.
The drug semaglutide (Rybelsus®) is used in the treatment of a defined group of patients with type 2 diabetes mellitus. After the European marketing authorization for the drug issued by the EMA, the assessment report was published on 27 May 2020. This is normally the time when a reimbursement file can be submitted by the manufacturer to the Healthcare Institute. Due to the parallel working method, the Healthcare Institute was able to start the reimbursement procedure earlier and can now make a decision about the reimbursement reasonably soon after registration. The Healthcare Institute advises the Minister for Medical Care to reimburse the drug semaglutide (Rybelsus®) for a subgroup of patients with type 2 diabetes from the basic package.
The MEB and the ZIN contribute ideas about this method and, where possible, will make drugs available for the pilot. A second parallel registration and reimbursement procedure will start in the summer of 2020.
The full details in Dutch can be found here
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