January 2025 HTA ESIG meeting - minutes

· January 9, 2025

Date/time

09-January-2025 13:00-14:00 CET

Agenda

  1. Admin updates (5min)
  2. Member/subteam/guest driven topic (5min)
    • EU HTA training 2025 (Jonas Hägströmm)
  3. EU HTA – info sharing and updates (20min)
    • New EU HTA guidance documents (Martin Scott)
  4. 2025 HTA ESIG targets (20min) (all)
  5. Conferences/events (5min)
  6. AOB (5min)

1. Admin updates

  • 2 HTA ESIG PSI/EFSPI webinars requested 2025
    • Time-to-event extrapolation using external information (Arthur)
    • EU HTA Joint Clinical Assessment methodology (topic to be aligned in SIG)
  • Lara: question from training group, general introduction to HTA stats (virtual)
  • ITIT course: company to host session on reimbursement? Anders will share email with more details.

2. EU HTA training 2025

Jonas Hägströmm presentation postponed

Reason for Jonas’ visit

  • The EFSPI Scientific and Training Academy has discussed EU HTA training as a potentially relevant topic to target in 2025 (F2F or/and virtual)
  • I’ve talked briefly with Jonas that the ESIG has discussed something similar (with a broader focus than just EU HTA)
  • Volunteers to connect with Jonas?
    • Anna Wiksten + Ash volunteer (what will be the audience?). Lara: historically, there has been more of an interest in training for non-HTA.
    • Michael S: echoes. Hands-on + connection with methodological training for non-HTA.
    • Antonia Brozek: Ecker & Ecker might be interested as well

3. EU HTA - info sharing and updates

  • New EU HTA guidance documents (Martin Scott) European Commission Website
  • Click here to download Martin’s presentation
  • Claudia: JCA dossier template, no guidance on if/when comparative analyses needed for safety (number of events). Lara: can we propose criteria for analyzable PICOs?
  • VFA did a comparison AMNOG/JCA templates. Lena: will look into whether VFA AMNOG/JCA comparison slides can be shared with SIG (Lara: alternatively, ask your German colleagues)

4. 2025 HTA ESIG targets

  • Topic postponed to February meeting

SIG objectives

  1. Empower HTA statisticians, through a platform for sharing and co-developing best practices.
    Shape a platform where HTA statisticians can exchange insights, share experiences, and collaboratively develop best practices, enhancing their role and fostering leadership
  2. Foster interdisciplinary and intradisciplinary scientific dialogue on HTA statistical matters.
    Foster discussions within the statistician community and across other disciplines to deepen the understanding of HTA statistical matters and foster collaboration.
  3. Utilize our collective HTA statistical expertise to provide influential input to policy-making.
    Harness our collective skills and experience to deliver expert advice to influence HTA and regulatory policy-making.
  4. Promote education and awareness about the importance and applications of HTA statistics.
    Broaden awareness of HTA statistics by leading educational initiatives such as webinars or short courses, highlighting the role and significance of HTA statistics.

2024 HTA ESIG targets

  • Related to SIG objective #1:
    • ✔ Deepen SIG dialogue around EU HTA readiness & strategic role of statisticians
  • Related to SIG objective #2:
    • ✔ Review and comment on methods and procedural guidelines for HTA
    • (✔) Strengthen Social Media communication on HTA statistics/role of HTA statisticians
    • ✔ Successful ½d HTA addition to the EFSPI Regulatory Workshop 2024
  • Related to objective #3
    • ✔ High SIG visibility at PSI 2024 and ISPOR EU
    • ✘ Publish 3 position papers pertaining to EU HTA
    • ✘ Strengthen relationship with ISPOR Statistical Methods SIG (Martin) & visibility of technical subgroups
    • ✔ Update HTA handbook
  • Related to objective #4
    • (✘) Training course to be delivered 2025
    • ✔ ITC webinar + PICOs follow-up webinar

2025 targets?

5. Conferences/events

PSI 2025 update (Lara)

  • HTA townhall session confirmed
    • “Communicating statistics and uncertainty in HTA”
    • Speaker lineup: Maricarmen Climent/Sense About Science); Nick Lattimer/USHEFF; Valentina Strammiello/EPF
  • 1 SIG session (Min-Hua + historical data SIG, “SEE-ing the Future: Empowering Health Decisions through Structured Expert Elicitation”)
    • Not every SIG that asked got a session
  • A lot of HTA-related topics submitted
    • Still room for HTA poster submissions

6. AOB

EU HTA CG webinar

  • EU HTA Regulation for health technology developers of medicinal products. Featuring Chairs and Co-chairs of the Member State Coordination Group on Health Technology Assessment (HTACG) explaining the process for joint clinical assessments and joint scientific consultations, with a focus on guidance documents adopted by the HTACG on 28 November 2024.
  • Targeted at representatives of health technology developers of medicinal products.
  • Link

HTA ESIG meeting dates 2025 (may change during 2025)

Month Date Time
Jan Thu, Jan 9th 13:00-14:00 CET
Feb Tue, Feb 4th 13:00-14:00 CET
Mar Tue, Mar 4th 13:00-14:00 CET
Apr Thu, Apr 8th 13:00-14:00 CET
May Tue, May 6th 13:00-14:00 CET
Jun Thu, Jun 26th 13:00-14:00 CET
Jul Thu, Jul 17th 13:00-14:00 CET
Aug Tue, Aug 19th 13:00-14:00 CET
Sep Thu, Sep 18th 13:00-14:00 CET
Oct Tue, Oct 14th 13:00-14:00 CET
Nov Thu, Nov 13th 13:00-14:00 CET
Dec Tue, Dec 9th 13:00-14:00 CET

Events/conferences 2025