Medicines available faster due to simultaneous assessment
The National Health Care Institute joined forces with the Medicines Evaluation Board to develop a method that would give patients faster access to innovative and other medicines. This is made possible by fully or partially assessing whether or not to reimburse a medicine while also simultaneously assessing whether or not to grant a marketing authorisation. Normally, these processes take place in succession. Armed with this new method, an assessment of whether or not to reimburse a medicine is just as thorough as the normal assessment but takes approximately three months less. This new method is called the parallel procedure. The National Health Care Institute and the MEB have been offering it as a standard option since February 2022.
The parallel procedure started as a pilot that the National Health Care Institute and the MEB launched in May 2019. The pilot focused on just seven medicines. One of these was Rybelsus, which is used to treat diabetes mellitus type 2. The European Medicines Agency published a positive assessment report about the efficacy, safety and quality of this medicine at the end of May 2020. Because the National Health Care Institute had almost completed its assessment of whether or not to reimburse this medicine at this time, it was possible to submit the reimbursement recommendation to the Minister of Health, Welfare and Sports very shortly afterwards, on 4 June 2020. The Minister adopted the recommendation, and so the use of Rybelsus has been reimbursed under the basic health insurance package since 1 August 2020. This made the Netherlands one of the first countries in the European Union to reimburse Rybelsus.
In the pilot, the National Health Care Institute and the MEB worked with the umbrella organisations for the pharmaceutical industry (VIG and HollandBIO) to ensure the development of the best procedure possible.
Information and registration
The National Health Care Institute and the MEB trust that this permanent collaboration will encourage more pharmaceutical companies to register for the parallel assessment procedure.
It should be observed that the success of parallel assessment depends on early contact between pharmaceutical companies on the one hand and the National Health Care Institute and the Medicines Evaluation Board on the other. Companies will also be required to submit their final reimbursement dossiers to the National Health Care Institute during the EMA registration procedure.
Read more about the parallel procedure and the registration for this procedure.