In recognition of Rare Disease Day 2022, we thought we’d share some insights on the impact of regulatory orphan drug designation on the time to HTA recommendation. Regulatory orphan designation [...]
Digitisation and digital health technologies are transforming clinical development; companies, regulators and Health Technology Assessment (HTA) agencies are looking to derive actionable insights from the data being generated. This [...]
Over the last five years, regulatory and HTA interactions, as well multi-HTA and multi-regulatory interactions and collaborations, have evolved in thinking and mutual activities both at a product level [...]
There is a growing trend for pharmaceutical companies to seek scientific advice on drug development from a Health Technology Assessment (HTA) perspective, to improve the efficiency of their studies, [...]
For a new medicine to reach patients, it must achieve both regulatory marketing authorisation and reimbursement from the payer. Because regulators assess the benefits and risks of a medicine [...]
This Briefing presents data from HTADock, an ongoing metrics study that collects data on new active substances (NASs) appraised by eight HTA agencies and analyses synchronisation between the regulatory [...]
Background: Health technology assessment (HTA) has increased in importance in supporting payer decision making by assessing the relative effectiveness and cost effectiveness of new medicines. Thus, pharmaceutical companies need to [...]
This workshop was a follow-on from a collaborative forum held in Utrecht in 2018 entitled What new research can enable a joint approach by regulatory and HTA agencies to [...]
Objectives: The objectives of the study were to establish a benchmarking tool to collect metrics to enable increased clarity regarding the differences and similarities across health technology assessment (HTA) [...]
This Briefing presents data from HTADock, an ongoing metrics study that collects data on new active substances (NASs) appraised by eight HTA agencies and analyses synchronisation between the regulatory [...]
