Purpose

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:

• 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

Objectives 2022

• 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. PSI Conference (June 2022)
  2. EFSPI/BBS HTA scientific meeting (June 2022) 
  3. HTAi (June 2022)
  4. EFSPI Regulatory Workshop (Sept 2022)
  5. EU ISPOR conference (Nov 2022)
• 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.

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.

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.

Resources

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 (Chair). 

If you wish to join the HTA eSIG, please complete this membership request form.