plenary themes


Fast-Tracking Clinical Innovation: The Balance of Speed and Rigour


Making HTA More Efficient: What Can we Learn about Harmonization, Work Sharing and Adaptation?


Feasibility of Aligning Technology Evaluation Processes and Decision in an Era of Sustainable Development


"Fast-Tracking Clinical Innovation: The Balance of Speed and Rigour"

While integrating clinical innovation involves risk at various stages, all stakeholders seem to agree with facilitating timely patient access to clinical innovation.

Plenary 1 will focus on the possible ways of fast-tracking clinical innovation while minimizing risks related to its introduction and management. Some crucial dilemmas will have to be discussed, and possibly solved, such as:

    • How to minimize health risks?
    • How to deal with medico-legal risks?
    • How to include financial risks in the overall balance?

To have a fruitful discussion, perspectives from different stakeholders such as policymakers, clinicians, and industry partners, will be included.

Such a debate will be extended to existing provisional registration pathways and a panoramic on them will be given. How successful have they been? What has been their impact on funding decisions? The role, current and future, of Real-World Evidence (RWE) will be integral part of the discussion. Is it the solution to the problem or just another flawed evidence source? 

Finally, the financial aspects of all this will be debated, trying to solve the decisive issue in this context: who should bear the financial risk related to fast-tracking clinical innovation? Industry or taxpayer? Argumentations from each perspective will be given.


"Making HTA More Efficient: What Can we Learn about Harmonization, Work Sharing and Adaptation?"

Effective integration is dependent on the sharing and harmonization of HTA across contexts. Plenary 2 will offer a panel discussion to explore and demonstrate local, regional, national, and international examples of harmonized HTA processes and rules. The most relevant initiatives at regional level (America, Asia, Europe) will be presented to highlight actual experiences and practical challenges related to the sharing of health technology evaluations (whether through adaptation or updating of existing HTA material), joint evaluations of technologies or joint submissions of evidence dossiers.

The discussion will move forward to discuss the benefits and risks of such approaches and provide guidance on how harmonization and/or work sharing might be achieved at different levels. A political perspective will be also included to highlight the benefits of harmonization in Europe and Asia.

International collaboration may be seen as the only way forward, but challenges are implicit and need to be explored a priori to build successful strategies. The experience shared in this panel will represent an effective learning experience for the audience.


"Feasibility of Aligning Technology Evaluation Processes and Decision in an Era of Sustainable Development" 

This Plenary builds on the discussion held at HTAi 2022 on facilitating collaboration between regulators, HTA bodies and clinicians. In HTAi 2023 we will consider how alignment of evaluation processes and decisions between different stakeholders might be achieved throughout the life cycle of a technology. We will explore how Early Feasibility studies developed in partnership can be used to guide Integrated Evidence Generation that is fit-for-purpose for a range of stakeholders. We will discuss how parallel decision making has been used to successfully drive more efficient HTA and evidence-based processes across the technology lifecycle. We will have a particular focus on how these alignments might be achieved in the era of technology sustainability, including through the use of in silico trials, digital twinning, and assessments of carbon footprint. In short, we will determine: 

    • How can we create better alignment between regulation, reimbursement, clinical guidelines, health service delivery and re-assessment of health technologies?
    • Is living HTA possible when health systems are siloed and often duplicative?
    • How can we work to achieve better alignment, given health system, environmental and resourcing constraints?

The aim is to develop a roadmap for integrated evidence generation and efficient decision-making that can inform decisions made by clinicians in consultation with patients, right through to public funding decisions made by a payer.


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