If you would like to join the Healthcare Technology Assessment European Special Interest Group (HTA ESIG) please complete this membership request form.
You will then be invited to our future meetings (monthly - see calendar below), and be included in any relevant ESIG emails.
The purpose of the HTA ESIG is to provide statisticians working in the Pharmaceutical Industry engaged in Health Technology Assessments, and others in related fields of research, an opportunity to:
The HTA ESIG is sponsored by PSI (Statisticians in the Pharmaceutical Industry) and EFSPI (European Federation of Statisticians in the Pharmaceutical Industry).
In Autumn 2021, the European Commission passed legislation
to create a legal framework for HTA collaboration in the EU. Starting in 2025, with gradual entry
into force for different types of products, there will be a binding obligation on both
manufacturers and member states to have a joint clinical
assessment based on a dossier submitted by the manufacturer. The assessment will be non-binding for member states, but to be given “due consideration” in the national
HTA. As part of the objective to formalise and implement the
legal framework for HTA collaboration in the EU, EunetHTA21 is a collaboration
both to conduct joint HTA/EMA scientific advice and clinical assessments in the
“interim period”, as well as support the future EU HTA system.
EU HTA regulation implementation (2022 – 2030)
Objective: Formalise and implement the legal framework for HTA collaboration in EU
EUnetHTA21 (2021 -2023)
Objective: Build on achievement of EUnetHTA and support future EU HTA system under the HTA regulation.
Members: HTA agencies, lead by ZIN (the Netherlands)
Public Consultation of EUnetHTA 21 draft deliverables is planned from 7th March 2022 until 31 August 2023.
EUnetHTA21 formally launched a series of public consultations until August 2023 to collect feedback on draft guidelines for the methods and processes that will be used during the "interim period" and, importantly, inform the subsequent implementation of the legislation. During 2022, the HTA ESIG was actively involved in this consultation and submitted comments on important methodological deliverables on behalf of EFSPI. You can view the comments submitted here. Many of the final deliverables have now been published by EUnetHTA and can be viewed on their website.
On 14th September 2022, we presented 2 posters at the 7th EFSPI workshop on Regulatory Statistics 2022. You can view the posters presented here --> EFSPI Regulatory HTA Workshop September 2022 - HTA SIG EU HTA Posters.
On 14th November 2022, we hosted a webinar "Statistics in EU HTA - PICOs, Estimands & More!". If you missed it, watch the recording on Video on Demand!
We have recorded a series of 4 podcast episodes with The Effective Statistician:
The HTA ESIG continues to be heavily involved in external engagement relating to the future EU HTA regulation. As such we have split ourselves into several sub-teams that are working on various deliverables throughout 2023 such as white papers, webinars, PSI conference sessions, EFSPI Regulatory Workshop, etc. You can view our full list of sub-teams and their membership here.
If you are interested in joining one of the sub-teams please send an email to htasig@psiweb.org stating which sub-team you are keen to join and we will put you in touch with the lead.
Please note, you must first be a member of the HTA ESIG to join one of the sub-teams. If you would like to join the HTA ESIG please complete this membership request form.
For an introduction to HTA please read the HTA handbook which you can access on the PSI website under Resources (go to the HTA SIG/HTA handbook folder). The handbook contains useful links to a variety of HTA related resources including HTA agency websites, HTA guidelines, recommended books and reference materials. Key statistical challenges relating to HTA are also discussed.
For 1-day HTA scientific meetings please view past Scientific meetings on the PSI Website and the Basel Biometrics Section (BBS) website.
For HTA related conference sessions, please view past PSI Conferences on the PSI Website, the International Society of Pharmacoeconomics and Outcomes Research (ISPOR) website and the HTAi website.
If you have any questions relating to HTA or need further information please contact Lara Wolfson and Anders Gorst-Rasmussen (Co-Chairs).
If you wish to join the HTA ESIG, please complete this membership request form.
