October 2024 HTA ESIG meeting - minutes

· October 2, 2024

SIG meetings

Date/time

01-October-2024 12:30-13:30 CET

Agenda

  1. Admin updates
    • 2024 EFSPI Regulatory Statistics Workshop recap + looking towards 2025
  2. Member/subteam/guest driven topic
    • HTA handbook status (Ash) + HTA training course 2025
  3. EU HTA – info sharing and updates
    • EU HTA Stakeholder Network – new survey, 2025 annual programme, next meeting
    • New EU HTA methodology guideline
  4. Events and conferences
    • PSI 2025 brainstorm subteam update (Arthur) + townhall options
  5. AOB

1. Admin updates

  • New PSI SIG director - collated SIG overview
    • Start connecting more “officially” with other SIGs (joint meetings)? Which SIGs?
    • Cornelia: work together with L&L SIG? Lara: RWE SIG; regulatory SIG; PFDD SIG
  • Topic next SIG leaders meeting: PSI sharepoint + SIG email addresses/Distribution list
  • EFSPI Council: new EFSPI website on its’ way, will have SIG space (blog/board), too

2024 EFSPI Regulatory Statistics Workshop (Anders/Sandro/Katrin/Lilla/Antonia)

  • 13-Sep morning session on HTA following a lot of work by HTA Scientific Subcomm
    • Lara/Antonio/Wim Goettsch speakers (David McConnell/NCPE unfortunately ill)
    • Well received, lively panel discussion
  • Looking ahead 2025 (local organizing committee currently evaluating on ‘experiments’)
    • Topics/speakers?
    • Format: integrated into main workshop? Separate HTA part? Separate workshop?
      • Katrin: good that we had it integrated, regulators liked
      • Lilla: probably better that it was a separate half day
      • Ursula: having them together -> having more HTAB reps, to have discussions with regulators

2. Member/subteam/guest driven topic

  • HTA handbook status (Ash)
  • HTA training course 2025

HTA Handbook status (Ash)

  • Reference doc for new HTA statisticians/those with ltd HTA background
    • What is HTA? What to be aware of? Link to guidance docs etc.
  • Original handbook ~10y old
  • Nearly there!
  • First formal draft: google drive
    • ACTION: HTA handbook team to share draft for review/feedback hope 2nd half Oct
    • 2 weeks window (urgent comments)
  • EU HTA not covered (yet)
  • Anders: wiki/bookdown/website format? TBC later

HTA (half-day) training course 2025

  • Have discussed several times (venue/scope; vendor involvement)
    • Declined PSI 2025 short course (low expected participation/long weekend Ascension day)
    • Lara: virtual vs F2F
  • Possible EFSPI anchoring (new training committee to help facilitate)
  • Alexander Schacht has expressed an interest in running an HTA course
    • Commercial vs open considerations
  • Ursula: content of course, how to differentiate? Maybe PSI could be good “pilot”.
  • Ash: great if handbook could have “further life” through this. Who is target audience? Could do HTA only - or mix in stats methods relevant for HTA?
  • Lilla: BBS as support, clear focus on HTA, has an audience. Format can be e.g. hybrid. Not keen on more commercial focus.
  • Lara: do companies have own training material? Ursula: Roche youtube videos about stats methods HTA
  • ACTION: Lara/Anders revisit discussion following release of HTA Handbook draft (November or December SIG meeting)
  • ACTION: Anders check with EFSPI training committee format of support

3. EU HTA – info sharing and updates

  • EU HTA Stakeholder Network – new survey, 2025 annual programme, next meeting
  • New methodology guideline (Guidance on Validity of Clinical Studies)
  • Lara: IA for JSC just published - open for consultation until 29-Oct
    • https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13759-Health-technology-assessment-Joint-scientific-consultations-on-medicinal-products-for-human-use_en
    • ACTION: all, volunteer for SIG review of IA (write to Lara/Anders)

EU HTA Stakeholder Network

  • New survey: submission request template medical devices/outcome document template medical devices (deadline: 11-Oct)
  • Work programme 2025
    • Strategic direction: prioritize JCA and JSC work
    • CG may increase meeting frequency to depending on number of JSCs/JCAs
      • Expected 17 JCAs, 5-7 JSCs/medicinal products, 1-3 JSCs/medical devices
    • JSC subgroup/JCA subgroup (higher meeting frequency); emerging HT subgroup
  • Next stakeholder network meeting
    • 29-Nov Brussels
    • Topics TBD (deadline for input 16-Oct)
      • Open source?
      • Call for tenders for assessors. How will this play out in practice, representativeness?

Guidance on Validity of Clinical Studies

  • Limited updates vs EUnetHTA21 D4.6 (primarily wording tweaks)
    • “Applicability” concept now rolled back to “external validity”
    • ROB-1 instead of ROB-2 (ROB-2 too time-consuming)
    • Considerations on cross-over vs treatment switching confusion
    • More(?) nuance on SAT:
      • “Data from a single-arm trial can (at least theoretically) be used coupled with an external source of data as a control to allow for a comparative statistical analysis. When this is done, internal and external validity of the resulting indirect comparison, rather than of the uncontrolled study in its’ own right, determines certainty of evidence for the assessment of relative effectiveness.”
  • Other reflections?
    • Lara: unfortunate that no consultation for these docs

Events and conferences

  • PSI 2025 brainstorm subteam update (Arthur) + including townhall options (Lara)

Some additional Calendar events:

  • Oct 23 15:00-16:30 CET RWE4Decisions webinar on “HTA/Payer Collaboration in the Nordics: The Role of Real World Evidence”. https://lnkd.in/dZUThNG8

  • Oct 23 - Denmark “Implementation of the EU HTA Regulation JCA”, (with Anders as a speaker!) https://lnkd.in/d-YSuZJw (F2F only)

  • Oct 24/25th - European Access Academy “EU HTA: Transitioning from Preparation to Implementation: Approaching the Pain Points”. https://www.euaac.org/conventions

PSI Conference 2025

  • London, Wembley, Sunday 1st - Wednesday 4th June 2025
  • Contributed oral abstracts deadline: 22nd November; posters 25th February
  • SIG session details by 23rd November 2024
    • Need: preferred duration of the session, the content of the session i.e. an abstract and the speakers
    • Alternatives to having multiple presentations, such as workshops or discussion groups are also welcome.
    • Given the number of SIGs and the amount of other interest we have in the PSI conference we are unable to guarantee all SIGs a slot

PSI 2025: brainstorm subteam update (Arthur)

  • Subteam: Arthur, Milana, Claudia, Katrin, Martin, Claire, Michael, Lena
  • Topics discussed in subteam
      1. Update on EU HTA
        • Update on JSC implementing acts, remaining guidelines, etc.
        • Operational considerations on preparing for EU JCA, set up, process, etc. (potentially difficult to get someone to share experiences at this early stage though),
        • Folding our prespecification for HTA topic more, and potentially also how to shape trials (in theory, more than in practice).
      1. Use of non-RCT data in HTA
        • History of HTA acceptability
        • EU HTA guidance on validity of clinical evidence
        • Use cases (maybe going beyond ECA, and into e.g. observational evidence, long-term linkage, etc)
        • Could also have an angle on clinical advice/elicitation when directly used in evidence generation, as updates in guidance. We could have EAG speaker, like Dawn Lee, on HTA’s considerations, and Min-Hua’s worked with this a lot.
      1. Estimands in HTA
        • Angle regulatory vs HTA estimands, and which questions are behind them. New guidance on trt. switching from NICE very clearly references estimand framework.
        • Estimands in ITCs – overview on how often aligned/reported approach for intercurrent events, impact
        • PICO scoping in JCA process vs estimands, suitable choice on e.g. intercurrent events left to drug developer? JCA guidance overview.
        • Estimands and COAs – use in CEMs vs typical modeling, lack of analytical guidance.
      1. ITC advanced topics?
  • Discussion around topics - Update on EU HTA may lack “news” by summer next year, Estimands in HTA very interesting but hardest to pull off - agreement to with Use of non-RCT data in HTA
  • Min-Hua also offered to help shape a session
  • ACTION: subteam/Min-Hua to continue elaborating on idea #3 ahead of 06-Nov ESIG meeting

PSI 2025: townhall [postmeeting note: we didn’t get to this one]

  • We will be offered a townhall session again
    • EU HTA topic may be exhausted for broad audience (for now)
  • Go for a less EU HTA focused topic like ‘patient perspective in HTA’?
    • Less-than-usual suspect speaker (patient organization?)

AOB

  • Ursula will share a survey among SIG members to understand how companies are setting up operations to deal with HTA analytics work
    • Results to be shared back with the SIG at an upcoming meeting, including discussion on perceived opportunities/pain points
    • ACTION: Ursula to share draft survey with Lara/Anders first