September 2024 HTA ESIG meeting - minutes

· September 5, 2024

SIG meetings

Date/time

03-Sep-2024 11:00-12:00 CET

Agenda

  1. Admin updates
  2. Member/subteam/guest driven topic
  3. EU HTA – info sharing and updates
  4. Events and conferences
  5. AOB

1. Admin updates

  • Any new members on the call today? Approaching member no. 100!

  • Join ESIG open-source subteam? (Anders)
    • Focus: thought leadership, link to HTA statisticians, complementing new initiatives including the R Consortium HTA working group (that will do a landscape/opportunity mapping)
    • Current members: Rossella, Cedric, Nermina, Amelie, Ian, Iain, Anders
    • Lara mentioned: connection/opportunities with SUSTAIN HTA
  • HTA ESIG private LinkedIn group (Anders)
    • For sharing ‘nice-to-have’ information/ideas asynchronously (instead of email)
    • Will still use email for meeting invites and core SIG info
  • We will stop doing video recordings from the meeting to simplify (minutes instead)

2. Member/subteam/guest driven topic

  • Strengthen focus on this
  • “Idea catalogue” (format pending)
    • Including both things that you want to talk about/hear about
    • Need SIG member help to populate the catalogue!
  • Michael S: update about the German subteam
    • 14 members working on update, also framing in context of EU HTA
    • Hope to complete work by end of year

3. EU HTA – info sharing and updates

  • EFSPI response EU HTA Stakeholder Network Survey (Anders)
    • For review (during August):
      • Template of requests from health technology developers (HTD) for joint scientific consultations (JSC)
      • JSC request template for medicinal products
    • Review by Katrin, Christof/Thomas, Milana, Anders
    • Limitation on review character count, key aspects:
      • Structure of templates artificually disaggregates PICO into P, I, C, O
      • ‘Area of advice’ section lacks an ‘Evidence synthesis’ item (very trial-focused)
        • Will also be taken up at EFSPI Regulatory Stats Workshop

  • Lara: actual IA not yet published, an issue for reviewing this

  • Outreach
    • DIA GCP-QA group 12-Sep-2024 presentation (Arthur)
      • GCP-QA: good clinical practices and quality assurance, including ICH, EMA, and FDA guidelines.
      • Recent presentations highlighted simultaneous planning and submission of HTA/HEOR alongside efficacy/safety dossiers in Europe.
      • The Community is now exploring how to adapt to new guidelines by integrating HTA/HEOR considerations into trial protocols.
      • Milana: public nature of the dossier, small subgroups, data privacy etc
      • Lara: multiplicity. Fewer rules than for AMNOG dossiers (minimum thresholds etc) - “responsible” way to define a PICO?
      • Michael S, GCP update H2 2024: investigator should have access to data collected
      • Lara, relation to EU CTR guidelines, how can we align?
      • Lara, also quality in relation to SLRs + data extracts, what role does QA play?
    • EU HTA 2025 in the Nordics 23-Oct-2024 presentation/Copenhagen Centre for Regulatory Science (Anders)
      • Pertinent statistical issues EU HTA JCA
  • 19-Sep-2024 CIRS: HTA Strategic Forum (not open), Lara (or Tina) may be able to provide an update/report
  • EAA https://www.euaac.org/conventions
  • Other EU HTA news/insights?
    • Methodology whitepaper
    • Expecting IA on JSC soon, will want to review as SIG
    • EFPIA HTA WG: metrics for JCA implementation

4. Events and conferences

  • EFSPI Reg Stats Workshop 09SEP-13SEP. Status and HTA ESIG attendees (Anders)
    • Who will join from the SIG?
    • Friday morning 13SEP HTA program
      • Antonio Remiro-Azócar, PhD (Novo Nordisk): Considerations for Methodological Innovation for Indirect Treatment Comparisons in EU HTA.
      • David McConnell (National Centre for Pharmacoeconomics, Ireland): What innovations in ITC methodology do HTA bodies want to encourage?
      • Wim Goettsch (Utrecht University): SUSTAIN-HTA, an EU-wide initiative to build a supporting infrastructure to ensure the ongoing implementation of the latest and fit-for-purpose HTA methodologies and tools in practice.
      • Lara J Wolfson (MSD): Proper Prior Planning for Pre-specified Post-hoc (Analysis of ) PICOs: How Statisticians can address the opportunities and challenges of EU HTA.
      • Panel discussion
    • HTA ESIG Poster Claudia, Michael S (thanks!!)
      • Improving Patient Access during Phase 2-3 Design – Things to Consider
  • PSI 2025 (London, 01JUN-04JUN) – HTA topics + planning
    • May be harder to get parallel SIG session next year - need to up our efforts
    • Planning/brainstorming subteam needed
      • Milana, Michael S, Claudia, Arthur, Claire
  • ISPOR EU 2024 (Barcelona, 17NOV-20NOV)
    • SIG contributions? Who will go?
    • Michael S - can we meet with ISPOR stats SIG and talk collab? Min-Hua (WS on elicitation, collab Martin), Antonio, Arthur, Fred (give course), Claire might be there, Sandro (panel/equity - methods WG in EFPIA also considering how to make noise, blog posts methods guideline leading up to ISPOR EU?)
  • HTAi 15JUN-18JUN Buenos Aires

5. AOB

  • Lara: is anyone involved in structured expert elicitation? There’s openness with NICE and ZIN for sth like this. Would like to hear more.
    • Min-Hua: ISPOR EU workshop (includes Kate Ren)

Post-meeting note Min-Hua

With regard to Structured Expert Elicitation (SEE), Kate Ren and I are currently engaged in a methodological study focused on long-term survival projections using SEE. We plan to extend this research to various scenarios. Additionally, NICE has recently approved Kate’s proposal to draft guidance on elicitation. The findings from our study are expected to make a significant contribution to this effort. Should you require further details about the study, please let me know.

I am keen to learn more about the level of interest in SEE from ZIN (or TLV?) and NICE. and volunteering to assist you on leading this initiative from our SIG. Furthermore, I am interested in understanding whether there is overlap among participants with an interest in this topic, as it might be beneficial to consolidate discussions. Please let me know your thoughts.

As mentioned during our call today, We have 3 abstracts accepted, including one workshop and two forums, for the EU ISPOR 2024.

Structured expert elicitation (SEE)

Workshop Title - Beyond “Guesstimates” in Long-Term Survival Extrapolation: Introducing a Comprehensive Step-By-Step Elicitation Framework Discussion Leader: Jessica Forsyth, PhD, University of Sheffield, Sheffield, South Yorkshire, UK; Discussants: Min-Hua Jen, PhD, Eli Lilly and Company, Bracknell, UK; Jacoline Bouvy, PhD, National Institute for Health and Care Excellence, London, LON, UK; Kate Ren, PhD, University of Sheffield, Sheffield, South Yorkshire, UK

Forum Title – Current Landscape and Future Directions of Structured Expert Elicitation in Healthcare Decision Making Moderator: Min-Hua Jen, PhD, Eli Lilly and the company. UK Speakers: Salah Ghabri, MSc, PhD, HDR, Department of Medical Evaluation - French National Authority for Health (HAS), Saint-Denis, France Dawn Lee, MSc, University of Exeter, England, UK Kate Ren, PhD, University of Sheffield|ConnectHEOR, Sheffield|London, England, UK

Forum Title - The Future of Single-Arm Trials and External Controls in Health Technology Assessment Moderator: Martin Scott, MSc, Numerus, Reutlingen, Germany Speakers: Min-Hua Jen, PhD, Eli Lilly and Company, Uxbridge, England, UK; David McConnell, PhD, St James’s Hospital, National Centre for Pharmacoeconomics, Dublin, Ireland, Dublin, Ireland; Kate Ren, PhD, University of Sheffield, Sheffield, South Yorkshire, UK