Novo Nordisk B.V. is the first MAH to have applied for the Dutch MEB-ZIN Parallel Procedures pilot. The procedure will start early in 2020.
The Dutch Medicines Evaluation Board (MEB) and the Dutch National Health Care Institute (ZIN) have developed the MEB-ZIN Parallel Procedure to shorten the time from authorization to the moment that innovative medicines are reimbursed. In this procedure, the authorization and reimbursement processes will be parallel processes, during which, the registration and reimbursement authorities will intensively collaborate and interact with each other. Having parallel authorization-reimbursement processes would place the Netherlands in the lead in Europe, since such procedures have barely taken off in other EU countries. In May 2019, the MEB and the ZIN started a two-year pilot to explore — together with the pharmaceutical industry — the possibilities of designing such parallel procedures. Only three to four products will be included in the pilot.
The products have to comply with certain inclusion criteria, for example acceptance of the marketing authorization application by EMA, commencement between August 2019 and April 2020, classification as a “regular” centralized marketing authorization application, and a reimbursement assessment should be required. Products that participate in the Beneluxa- or Eunetha project, “Subsidieregeling Veelbelovende Zorg” or “Nieuwe Regeling Weesgeneesmiddelen” cannot be included. Products for which there is a relatively high chance that a marketing authorization will not be granted — meaning that it is likely that a reimbursement procedure will not start — can, in principle, be excluded. If within the same period, two equivalent products are eligible for inclusion in the pilot (competing resources, overlapping indications), both products may be excluded from the Parallel Procedures pilot.
More information about the inclusion criteria and application form can be found on the following website: https://english.zorginstituutnederland.nl/publications/publications/2019/07/18/explanation-of-the-interest-form-cbg-zin-parallel-procedures-pilot