Posted by Michael Wonder on 10 Sep 2016
How aligned are the perspectives of EU regulators and HTA bodies? A comparative analysis of regulatory-HTA parallel scientific advice
9 September 2016 - In 2010, the EMA initiated a pilot project on parallel scientific advice with European health technology assessment (HTA) agencies that allows developers of new health care technologies to receive simultaneous feedback from both the EU regulators and HTA agencies on their development plans for new medicines.
The present retrospective qualitative analysis aimed to explore how the parallel scientific advice system is working and levels of commonality between the EU regulators and HTA agencies, and among HTA agencies, when applicants obtain parallel scientific advice from both a regulatory and a reimbursement/HTA perspective.
Tafuri et al. analysed the minutes of discussion meetings held at the EMA between 2010, when parallel advice was launched, and 1 May 2015, when the cut-off date for data extraction was set. The analysis was based on predefined criteria and conducted at two different levels of comparison: the answers of the HTA agencies versus those of the regulators, and between the answers of the participating HTA agencies.
The analysis was based on 31 procedures of parallel scientific advice. The level of full agreements was highest for questions on patient population (77%), while disagreements reached a peak for questions on the study comparator (30%). With regard to comparisons among HTA agencies, there was a high level of agreement for all domains.
There is evident commonality, in terms of evidence requirements between the EU regulators and participating HTA agencies, as well as among HTA agencies, on most aspects of clinical development. Indeed, regardless of the question content, the analysis showed that a high level of overall agreement was reached through the process of parallel scientific advice.
