CIRS RD Briefing 89 – Review of HTA outcomes and timelines in Australia, Canada, Europe and the UK 2018-2022

This R&D Briefing presents data from HTADock, an ongoing metrics study that collects publicly available data on new active substances (NASs) appraised by key international HTA agencies, each with [...]

2023-09-28T15:51:28+00:00September 28th, 2023|Tags: , , |

Evolution of HTA practice and approaches from the perspectives of HTA agencies and pharmaceutical industry

Health technology assessment (HTA) has emerged as an important tool to support healthcare decision-makers to make rational reimbursement decisions, with the ultimate purpose of promoting an efficient healthcare system. [...]

Kühler et al 2019 – To what degree are review outcomes aligned for new active substances between the EMA and the US FDA?

Objective To compare review outcome alignment between European Medicines Agency (EMA) and US Food and Drug Administration (FDA) for medicines approved by both agencies in the time period 2014–2016. Design [...]

2021-01-18T17:13:15+00:00November 15th, 2019|Tags: , |

CIRS RD Briefing 68: Regulatory and HTA decision making and access to medicines – the consequences of sequence

Historically, every jurisdiction with some form of regulatory agency capacity has undertaken the review of medicines as a first step in the market access process. This step is intended [...]