Join the HTA ESIG!

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:

  • Collaborate and discuss strategies and methodology being applied in this area of research
  • Exchange information and share case studies and statistical/analytical challenges faced in HTA research
  • Keep abreast of new statistical research and methodological developments
  • Promote and highlight opportunities for statisticians to make a positive impact in HTAs
  • Interact with key opinion leaders in HTA statistical research
  • Organise and/or participate in workshops both statistical and process/strategy related to HTAs

The HTA ESIG is sponsored by PSI (Statisticians in the Pharmaceutical Industry) and EFSPI (European Federation of Statisticians in the Pharmaceutical Industry).

Objectives 2023

  • Foster collaboration, share case studies, discuss and debate statistical issues pertaining to HTA in ESIG. Priority areas include: EU common assessment/ EUnetHTA 21, national HTA agency hot topics, evidence synthesis including generalisability of real world evidence, patient perspectives in HTA and estimands in HTA.
  • Contribute to scientific meetings e.g.
    1. World EPA Congress (March 2023)
    2. DIA Europe (March 2023)
    3. EEA Convention (April 2023)
    4. EUnetHTA stakeholder meetings (May 2023 Virtual, September 2023 F2F)
    5. PSI Conference (June 2023)
    6. HTAi (June 2023)
    7. EFSPI Regulatory Workshop (September 2023)
    8. ISPOR EU (Nov 2023)
  • Publish papers on topics of interest e.g. advances in evidence synthesis and combining RCT with RWE, estimands in HTA, generalisability of RCT in HTA, and patient perspectives in HTA
  • Review and provide comments on Industry and/or regulatory guidelines or changes in processes relating to HTA, e.g. country-specific methods guidelines, EUnetHTA methods guidelines, ISPOR etc.
  • Meet with external experts in the HTA field, for example statisticians in HTA agencies, EUnetHTA, health economic leaders, ISPOR and EFPIA HTA Expert Group.
  • Update and reformat HTA handbook and develop other HTA educational materials e.g. write articles for EFSPI and local statistical association newsletters keeping members abreast of HTA developments and raise awareness of training materials relating to HTA.
  • Keep abreast of the IMI initiatives (e.g GetReal) and seek opportunities to provide input and/or comment on proposals/recommendations.

EU Common HTA Assessment

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

  • 2022-2024: Transition period
  • 2025: Implementation for new cancer and ATMP products
  • 2028: Implementation for new Orphan products
  • 2030: Implementation for remaining centrally authorised products and license extensions.

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.


EU HTA external engagement

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:

  • Episode 1: What is EU HTA and why should statisticians care?
  • Episode 2: What is the role of estimands in the EU HTA?
  • Episode 3: Future implications of EU HTA and how Next Gen get involved
  • Episode 4: What will be the role of health economics in the future EU HTA?

Our Sub-teams

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 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.

HTA ESIG calendar



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.

How to get in touch

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.

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