RSNN Expert Meeting - The interface between authorisation and reimbursement (HTA)

06 February 2020
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On November 28, 2019, the RSNN organized an Expert Meeting with the topic ‘The interface between authorisation and reimbursement (HTA)’. Sixteen experts from government, industry, clinical practice, universities and industry associations, discussed this theme in an informal setting.

The discussion made clear that there is a significant gap between authorisation and HTA, both in the formal sense and in practice. The gap between authorisation and HTA is sometimes context or country specific, with consequences for the predictability of the decision-making, and this gap appears to be widening, partly due to initiatives to gain earlier approval of medicines and with more limited or alternative types of evidence. A factor that also contributes to this gap is the variability in assessment capacity and expertise, which manifests in the activities of both authorisation and HTA authorities. 

Four main topics were further discussed in relation to the gap between authorisation and HTA: i) dialogue and transparency, ii) evidence and managing uncertainty, iii) questions that play a role later on in the life cycle of a drug, and iv) future uncertainties and challenges at the interface between authorisation and HTA. The discussions led to the identification of a number of relevant research questions from a regulatory science perspective within each of the main topics.

The results of this meeting, which can be read in the meeting report in Dutch or English, will be utilised by the RSNN in future research agendas that should contribute to informing policy discussions.