Announcement of an RSNN expert meeting ´The interface between authorisation and reimbursement/HTA’

The marketing authorisation of a medicine, national or European, is a requirement for entering the Dutch market. Whether or not the medicine will ultimately be accessible to patients in The Netherlands depends on, among other things, advice from the Dutch National Health Care Institute (ZIN). Many questions and societal debates play a role at the interface between registration and reimbursement, two separate administrative processes and responsibilities. From the perspective of regulatory science, questions arise about the (development of) methods used to establish evidence of (relative) efficacy, the operationalisation of the benefit-risk balance and the added value of a new therapy compared to usual practice. The contribution of regulatory science to Health Technology Assessment (HTA) and joint scientific advice, learnings from each other's experiences and improving dialogue and knowledge sharing can help addressing these questions.

In light of this, the RSNN organises an expert meeting with various stakeholders and key opinion leaders. The goal of the meeting is to identify knowledge gaps and to investigate to what extent addressing knowledge gaps can play a role creating stronger links between authorisation and HTA/reimbursement decision-making in the Netherlands.

This Expert meeting is invitation only but outcomes of the meeting will be presented in a meeting report published on the RSNN website.