Module 1: What Is Health Technology Assessment and What Is It For?

Healthcare systems face a fundamental tension: the technologies available to them are expanding faster than the budgets available to pay for them. Health technology assessment (HTA) exists to resolve that tension — to provide a structured, evidence-based process for deciding which technologies represent sufficient value to justify public funding. This module introduces the core principles of HTA and explains why it has become the dominant framework for reimbursement decision-making worldwide.

• the economic logic of HTA — scarcity, opportunity cost and why healthcare systems cannot fund every technology that demonstrates clinical benefit
• the four pillars of HTA evidence — clinical effectiveness, cost-effectiveness, budget impact and wider considerations (equity, innovation, unmet need) — and how these interact in committee deliberations
• the historical development of HTA — from early technology assessment in the 1970s through to the establishment of NICE (England) and its international counterparts
• where HTA sits in the product lifecycle — the relationship between regulatory approval, HTA evaluation and actual patient access, and why the gap between approval and access is often wider than manufacturers expect

Module 2: How HTA Bodies Evaluate Evidence — The Decision-Making Architecture

HTA is not a single methodology — it is a family of approaches united by common principles but differing substantially in how evidence is evaluated, how committees deliberate and how decisions are framed. This module examines the architecture of HTA decision-making, covering the key stages from evidence submission through committee deliberation to final recommendation.

• the typical HTA process — scoping, evidence submission, independent critique, committee deliberation, draft recommendation and appeals
• how committees weigh evidence in practice — the interplay between quantitative analysis and qualitative judgment
• the role of independent review — how external review groups critique manufacturer submissions and why understanding this process is essential for preparing robust evidence packages
• the deliberative process — how committees handle uncertainty, conflicting evidence and the inevitable gaps between what manufacturers submit and what reviewers would ideally want to see

Module 3: The Global HTA Landscape — Classifying Jurisdictions by Approach

Rather than cataloguing every HTA agency in every country, this module provides participants with a practical framework for classifying jurisdictions by approach — enabling them to understand a new market’s HTA system quickly by identifying which archetype it most closely resembles.

• threshold-based single-payer systems — the NICE model and how willingness-to-pay thresholds influence decisions in England and similar jurisdictions
• multi-criteria and deliberative systems — how agencies like G-BA, HAS and AIFA evaluate comparative clinical benefit without applying explicit cost-effectiveness thresholds, and what this means for evidence strategy
• reference pricing and reimbursement-linked systems — how HTA intersects with pricing regulation in markets where reimbursement status and price are determined simultaneously
• emerging HTA systems — how countries establishing formal HTA processes (including through the EU HTA Regulation) adopt and adapt elements from established agencies, and the implications for companies preparing for newly formalised assessment requirements

Module 4: What Success Looks Like — Case Studies of Positive HTA Outcomes

The most effective way to understand what HTA bodies value is to study the submissions they have approved. This module examines a selection of case studies — drawn from across therapy areas and jurisdictions — in which manufacturers secured positive recommendations, and identifies the common factors that contributed to success.

• evidence strategy — how successful submissions aligned their clinical programme, economic modelling and outcomes evidence with the specific requirements of the target HTA body from the earliest stages of development
• stakeholder engagement — the role of scientific advice, early dialogue and patient engagement in shaping submissions that anticipated and addressed committee concerns before they were raised
• economic modelling choices — how the structure, assumptions and sensitivity analyses in successful submissions demonstrated transparency and robustness rather than optimism
• the value narrative — how manufacturers that secured positive outcomes framed their submissions around the decision-maker’s priorities rather than the product’s features, and what their value communication materials looked like in practice

Module 5: What Failure Looks Like — Case Studies of Negative HTA Outcomes

HTA failures are at least as instructive as successes — and many of the most consequential failures were avoidable. This module examines case studies in which submissions received negative or restricted recommendations, and draws out the recurring patterns that participants can learn to recognise and prevent.

• evidence gaps — submissions that failed because clinical trials measured the wrong endpoints, lacked an appropriate comparator or generated insufficient long-term follow-up data for credible economic modelling
• modelling weaknesses — cases where economic models were rejected for structural flaws, implausible assumptions, insufficient sensitivity analysis or failure to follow the reference case methodology
• poor engagement with the process — submissions that failed to use scientific advice, responded inadequately to critiques, or underestimated the importance of the deliberative process and stakeholder input
• the “avoidability index” — for each case study, identifying which failures could have been prevented with better evidence planning, earlier engagement or more rigorous quality assurance, and which reflected genuine structural challenges that no submission strategy could have overcome

Module 6: Navigating HTA Strategically — Lessons, Trends and the Evolving Landscape

This module brings together the conceptual foundations and case study lessons from the preceding modules and applies them to the HTA landscape as it is evolving today. It equips participants to think strategically about how HTA will shape market access over the coming years and what this means for their own evidence planning and submission strategies.

• the ten recurring lessons from HTA case studies — a synthesis of the success factors and failure modes that appear consistently across jurisdictions, therapy areas and technology types
• the EU HTA Regulation — what joint clinical assessments will mean in practice, how they will interact with national pricing and reimbursement decisions, and how companies should prepare
• the growing role of real-world evidence, patient-reported outcomes and outcomes-based agreements in HTA — and where HTA bodies remain sceptical
• how AI and advanced analytics are beginning to influence HTA processes — from automated literature surveillance and horizon scanning to AI-assisted evidence review — and what this means for the professionals who prepare and evaluate submissions