Health technology assessment (HTA)
The 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: The target product profile (TPP) outlines the desired profile of a target product aimed at a particular disease and is used by companies to plan clinical development. Considering the [...]
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 [...]
