PILOT Parallel Procedure Marketing Authorisation and HTA in the Netherlands

Author(s)

Liebrand K1, Pasman P2
1CBG-MEB, Utrecht, UT, Netherlands, 2National Healthcare Institute, Diemen, Netherlands

In the Netherlands the Medicines Evaluation Board (MEB) assesses the quality, efficacy and safety of a medicine before issuing a marketing authorisation and the National Health Care Institute (ZIN) then assesses whether the registered medicine is eligible for reimbursement via the standard health care package. In the Netherlands the MEB and ZIN have joined forces to shorten the time from registration up to the moment that medicines are reimbursed in the "pilot Parallel Procedures MEB-ZIN." As indicated by the name: a more parallel procedure for authorisation and reimbursement trajectories, instead of the current sequential process. This entails that the procedure for reimbursement starts before the marketing authorization has been granted.

In order to facilitate such an approach, the MEB provides context and background information on the assessment and shares information and gained knowledge with ZIN. Furthermore, in the pilot procedure pharmaceutical companies are able to discuss reimbursement in early pre-meetings. The overarching goal is to develop a new method for parallel assessment to increase patient access to new medicine.

In this project pharmaceutical companies have dedicated their products to be used in this parallel procedure. In November 2019, the first procedure in the project was started. Normally, the procedure for reimbursement could have started, after publication of the European Assessment Report (May 27th, 2020). However, in this pilot procedure, the procedure for reimbursement was finalized one week later (early June), demonstrating that the parallel approach for registration and reimbursement is feasible and greatly enhances patient’s access to new medicines by shortening the time from registration to reimbursement. In the pilot the parallel assessment method is tested by more products to come to national recommendations, which could be internationally integrated.

Conference/Value in Health Info

2020-11, ISPOR Europe 2020, Milan, Italy

Value in Health, Volume 23, Issue S2 (December 2020)

Code

PNS12

Disease

No Specific Disease

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