PSI VisSIG Wonderful Wednesday Webinar Series
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If you would like to join the HTA eSIG please complete this membership request form.
You will then be invited to our future meetings (every 2 months), and be included in any relevant eSIG emails.
The purpose of the Healthcare Technology Assessment European Special Interest Group (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:
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)
For all EUnetHTA 21 deliverables the future EU HTA Regulation will serve as a basis.
Public Consultation of EUnetHTA 21 draft deliverables is planned from 7th March 2022 until 31 August 2023.
EUnetHTA21 has 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.
As part of the Public Consultation period, the HTA eSIG will be submitting comments on behalf of EFSPI in relation (primarily) to the Methodological Deliverables detailed below, as well as selected Process Deliverables that have high statistical content/impact.
We invite all EFSPI members who are interested to participate. We are aware many of you may already be contributing via your own companies but we welcome any comments you have that you would like to include in the EFSPI response.
On the "Public Consultation of draft deliverable" date detailed in the table below, you will be able to view the released deliverable on the EUnetHTA website.
EFSPI members can then submit their comments for consideration to the HTA SIG by the due date below here.
The HTA eSIG will then host a comments review meeting, which all EFSPI members are invited to attend. Meeting date and dial-in details can be found in the table below.
If required, the HTA eSIG will then submit comments on behalf of EFSPI by the documented due date.
|Deliverable ID||Sub-Deliverable||Title||Public consultation of draft deliverable||EFSPI Members to submit comments to HTA eSIG by||HTA eSIG Comments Review Meeting - Open to all EFSPI Members|
Public consultation until
(HTA eSIG submit final comments on behalf of EFSPI)
|D4.5||Applicability of evidence||04/07/2022||13/07/2022|
|D4.6||Validity of clinical studies||04/07/2022||13/07/2022|
|D5.1||JCA/CA Submission Dossier Template||04/07/2022||02/08/2022|
|D7.1||Guidance for the interaction between HTD and HTA (for JCA and JSC)||20/7/2022||19/8/2022|
|D4.3||D4.3.1||Compartors and comparisons||01/08/2022||11/08/2022|
Join on your computer or mobile app
Join with a video conferencing device
Video Conference ID: 114 874 547 8
Or call in (audio only)
+1 929-229-5981,,253265936# United States, New York City
Phone Conference ID: 253 265 936#
|D5.2||JCA/CA Assessment Report Template||01/08/2022||30/08/2022|
|D7.2/3||Guidance and template for the interaction with patient representative, healthcare professional and other experts||01/08/2022||30/08/2022|
|D6.2/3||Template Briefing Book||01/08/2023||31/08/2023|
|D6.4||Procedural Guidance JSC||01/08/2023||31/08/2023|
Whilst the HTA eSIG won't be facilitating collecting wider EFSPI comments on the other EUnetHTA 21 deliverables, you can find the details of these in the table above and on the EUnetHTA website. If any prove to contain content of high statistical interest we may allow time for discussion at the comments review meeting so we encourage everyone to familiarize themselves with all available deliverables when they are made available.
If you have any questions about this process please get in touch with Emma Crawford.
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.