HTA SIG

Purpose

The purpose of the Healthcare Technology Assessment SIG 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. 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.

HTA SIG at PSI Conference 2022

Monday 13 June – Benefit-Risk Assessment (BRA) in Practice (15:15 - 16:30), Plenary Room (F4+F5)

Many advances have been made in BRA in recent years. Pharmaceutical industry statisticians are among the key drivers contributing to these developments and welcome these advances positively. Cross-functional initiatives and future trends, as well as the recent FDA guidance on BRA and the BRA implications of the new EU HTA (Health Technology Assessment) regulation are examined and discussed. The session concludes with an open dialogue.

HTA SIG Chair Lara Wolfson and HTA SIG member Shahrul Mt-Isa will be presenting during this session.

 

Tuesday 14 June – HTA SIG informal meet-up (12:00 - 13:00), open area by F1

We invite all delegates to join the HTA SIG members for an informal meet-up during Tuesday Lunch break outside F1. Not sure what HTA is but want to know more? Want to understand further about our involvement in the EUnetHTA21 public consultation? Then come chat with us to find out!

(NB: We advise delegates to collect their lunch first and then bring it to the meet-up)

 

You can view the full conference agenda here.

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)

 

    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.

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    As part of the Public Consultation period, the HTA SIG will be submitting comments on behalf of PSI in relation (primarily) to the Methodological Deliverables detailed below, as well as selected Process Deliverables that have high statistical content/impact.

    We invite all PSI 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 PSI 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.

    PSI members can then submit their comments for consideration to the HTA SIG by the due date below here.

    The HTA SIG will then host a comments review meeting, which all PSI members are invited to attend. Meeting date and dial-in details can be found in the table below.

    If required, the HTA SIG will then submit comments on behalf of PSI by the documented due date.

    Deliverable IDSub-DeliverableTitlePublic consultation of draft deliverablePSI Members to submit comments to HTA SIG byHTA SIG Comments Review Meeting - Open to all PSI Members

    Public consultation until

    (HTA SIG submit comments on behalf of PSI)

    D4.2
    Scoping Process02/05/202213/05/2022

    16/05/2022

    31/05/2022
    D4.3D4.3.2Methodological Guideline on Direct and indirect comparisons02/05/202213/05/2022

    16/05/2022

    31/05/2022
    D4.7D.4.7.1/2Assessment of High-Risk Medical Devices02/05/202213/05/2022

    16/05/2022

     

    31/05/2022
    D4.7D4.7.3/4EUDAMED data reporting template / Guidance for EUDAMED based TISP process06/06/2022N/A  - PSI will not be submitting comments for this deliverable

    N/A  - PSI will not be submitting comments for this deliverable

    05/07/2022 - PSI will not be submitting comments for this deliverable
    D4.5 Applicability of evidence04/07/202215/07/2022

    18/07/2022

     

    12-2pm GMT

     

    Join on your computer or mobile app

    Click here to join the meeting

     

    Or call in (audio only)

    +1 929-229-5981,,623974466#   United States, New York City

    Phone Conference ID: 623 974 466#

    Find a local number

    02/08/2022
    D4.6 Validity of clinical studies04/07/202215/07/2022

    18/07/2022

    (see above)

    02/08/2022
    D4.3D4.3.1Compartors and comparisons01/08/202212/08/2022

    16/08/2022

     

    11-1pm GMT

     

    Details TBC

    30/08/2022
    D4.4 Endpoints03/10/202214/10/2022

    17/10/2022

     

    2-4pm GMT

     

    Details TBC

    01/11/2022


    Whilst the HTA SIG won't be facilitating collecting wider PSI comments on the other EUnetHTA 21 deliverables, you can find the details of these on the EUnetHTA website

    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, need further information or wish to join the HTA ESIG please contact Lara Wolfson (Chair). 

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