December 2024 HTA ESIG meeting - minutes

· December 3, 2024

SIG meetings

Date/time

03-December-2024 14:00-15:00 CET

Agenda

  1. Admin updates (10min)
    • ESIG leaders meeting (Anders/Lara)
    • 2025 meetings (Lara)
  2. Member/subteam/guest driven topic (30min)
    • Report on October multistakeholder workshop - see page 14 here (Tina Wang)
    • Extrapolation topic for 2025 dissemination (conference/webinar) (Arthur)
  3. EU HTA – info sharing and updates (15min)
    • EU HTA Stakeholder Network 29-Nov meeting update (Anders)
    • New guidance documents (all)
  4. Events and conferences (5min)
    • EFSPI Regulatory Statistics Workshop 2025
    • PSI 2025 HTA townhall session outline (Anders/Lara)
    • Webinars 2025
  5. AOB

1. Admin updates (10min)

ESIG leaders meeting

  • SIG collaboration spaces
    • Distribution list management
    • SIG sharepoint site (for all/some? Unclear)
  • Webinars
    • 10-15 joint PSI/EFSPI webinar; input required by year-end (topic/rationale)
  • Quarterly joint ESIG meetings (proposal)
    • 8 SIGs per call (groupings TBD), ~7min status update
    • Bandwidth issue flagged - is it the best use of ESIG’s time?

2025 meetings (Lara)

  • ACTION: Lara to share new meeting dates/invites

2. Member/subteam/guest driven topic (1/2)

Report on October multistakeholder workshop (Tina Wang - 20min incl Q/A)

2. Member/subteam/guest driven topic (2/2)

Extrapolation topic for 2025 conference/webinar (Arthur - 10min)

  • Discussion that this topic would be relevant for both a webinar and potentially ISPOR collab
  • Arthur and Min Hua will investigate potential for ISPOR session 2025
  • ACTION: Arthur to share with Anders suggestion for title/topic/rationale to feed to PSI/EFSPI in webinar requests

Time-to-event extrapolations leveraging RWD

Potential speaker: Ash Bullement

Time-to-event extrapolations leveraging external CTs

E.g., in oncology setting, potential use of phase 2 data with longer follow-up, or leverage publisehd data

Potential speaker: TBD

Time-to-event extrapolations using SEE

Following-up on the great sessions on SEE at ISPOR-EU 2024, focus on statistical methods that use SEE outputs to improve long-term extrapolations

Potential speakers

  • Min-Hua
  • Kate Ren (with a focus on upcoming NICE guidance)
  • Christopher Jackson (author of the survextrap package)

Time-to-event extrapolations in “special circonstances

Other interesting topics that do not entirely fit into a session on the use of external data

  • Time-to-event extrapolations adjusting for treatment switching (potential speaker: Claire Watkins)
  • Time-to-event extrapolations in basket trials/ Tumor agnostic indications (Potential speaker: one author of https://pubmed.ncbi.nlm.nih.gov/34990339/, someone who submitted a tumor agnostic indication)
  • Time-to-event extrapolations in subgroups/subpopulations: Probably similar techniques than for basket trials could be used.

3. EU HTA – info sharing and updates (10min)

EU HTA Stakeholder Network Meeting 29-Nov (Anders)

Agenda key points

  • Update on implementation of HTAR
  • Breakout sessions (based on extensive guidance adopted 28-Nov, soon to be public)
    • Update on the work in the JSC subgroup
    • Update on the work in the JCA subgroup
    • Protection of commercially sensitive data and personal data in joint work
    • Identification of patient and clinical experts and other experts for the joint work
    • Joint work on medical devices
  • Horizon scanning
  • Stakeholder presentations
    • Including EFSPI: Open-source statistical code and its potential for EU HTA JCA

Many new stakeholder organizations

  • 37 applications for new call, 26 additional members accepted
  • EFSPI still only more statistical/technical learned society

Key input/learnings

  • Alignment JCA table templates vs methodology guidelines?
    • –> Templates meant as a help, deviations can be justified
  • Adjustments when and how? Encouraged transparency around “what works”, what is used in local decision making
    • –>On an ongoing basis, requirements are comprehensive to limit need for extra local work, need to understand if too comprehensive
  • Capacity + rolling calls JSC? JSC as an integral part of EU HTA.
    • –> Focus has been on JCA for now
    • –> Increasing capacity is a priority, hope that more frequent calls (quarterly?)
  • JCA advice from procedural/methods SG:
    • –> provide justification and rationale; consider HTA questions early

EFSPI presentation “Open-source statistical code and its potential for EU HTA JCA”

EFSPI key points:

  • Open-source statistical code for JCA work can support HTAR aspiration of reduced duplication, increased efficiency, and scientific excellence
  • Built-in transparency and accountability enables ‘safe’ utilization of expertise and resources across all stakeholders
  • A community-driven effort by construction – but the CG and national HTABs can catalyze and impact direction by engaging in dialogue and, in the future, pilots

Feedback from the CG

  • A “glimpse of the future”
  • Making open-source work at HTA bodies is indeed difficult
  • Curiosity around participating in R Consortium HTA WG efforts (observer mode)

Discussion SIG meeting

  • Ursula: important to have HTAB contact for the R Consortium HTA WG, need to align on what we are solving. Anders: agree, will see if we can leverage the first contact via SN more in 2025.

New EU HTA guidance and documents (~350 pages)

Shared w/Stakeholder Network 28-Nov (confidentially) - expect publication shortly

https://health.ec.europa.eu/health-technology-assessment_en

  • Guidance on scoping process
  • Guidance on procedural steps and timeframe for joint clinical assessments of medicinal products
  • Guidance on filling in the joint clinical assessment (JCA) dossier template – Medicinal products
  • Table template collection for guidance on filling in the joint clinical assessment (JCA) dossier template – Medicinal Products
  • Guidance for the appointment of assessors and co-assessors for joint clinical assessments and joint scientific consultations

  • Procedural guidance for joint scientific consultation on medicinal products

  • Format and template of requests from health technology developers for joint scientific consultation – medicinal products
  • Format and template for the dossier submitted by the health technology developer for joint scientific consultation - medicinal products
  • Format and template for the joint scientific consultation outcome document medicinal products
  • Guidance for the selection of joint scientific consultations for medicinal products
  • Annual Work Programme 2025

ACTION: Anders/Lara revisit topic at next meeting when guidelines have been published

4. Events and conferences (10min)

  • EFSPI Regulatory Statistics Workshop 2025 (10-year anniversary workshop)
    • 2½ days but no dedicated ½d HTA (HTA integrated into main workshop)
    • One scientific subcommittee (no separate HTA Scientific Subcomittee)
    • Deadline for applying 18-Dechttps://www.linkedin.com/posts/efspi_do-you-want-to-contribute-to-the-scientific-activity-7267839774026047489-h3Fm
  • PSI 2025 HTA townhall: communicating statistics and uncertainty in HTA
    • Science journalist (Maricarmen Climent/Sense About Science); assessor/HTA perspective (Nick Lattimer/USHEFF); patient perspective (Valentina Strammiello/EPF)
  • Webinars
    • Topics needed during December to maximize chances of getting a slot!
    • Discussion at meeting: Arthur extrapolation topic

5. AOB

  • Anders reminded everybody that at the January meeting, we will be discussing 2025 targets for the SIG - please revisit the 2024 targets and think about what would be relevant for the new year
  • Thanks for a great 2024 and looking forward to more great exchanges and cross-company collaboration next year!