D4.1 – Methodological description of the forecasting model and the model of decision

By the time a new health technology reaches the market, most of the decisions that shape its price, its uptake and its fit with the health system have already been taken. Payers and policymakers are then left reacting to something they had little part in guiding, while developers discover only late whether their innovation answers a real system priority. This deliverable addresses that timing problem by setting out a method for assessing health technologies while they are still under development, when there is still room to influence both the technology and the decisions around it.

The document opens with desk research on the financing pressures now facing European health systems, on how healthcare budgets are allocated across EU member states, drawing on Eurostat and MedTech Europe data (roughly 11% of GDP spent on health across Europe, of which about 7.6% goes to medical technologies), and on existing approaches to early health economic modelling, including the classification of early assessment methods by Grutters and colleagues and the five step early cost effectiveness approach described by Buisman and colleagues. It then presents the FLASH early assessment methodology, built in four stages: a technology radar to map innovations in the pipeline, consultation of expert focus groups, the definition of a list of indicators aligned with Health Technology Assessment practice, and a decision matrix based on multicriteria decision analysis. The methodology deliberately combines quantitative evidence, such as the incremental cost effectiveness ratio against the gold standard, the degree of uncertainty and organisational efficiencies, with qualitative dimensions, such as health system priority, preparedness and resilience attributes, smart procurement practices and social or environmental need. It is being validated through a case study in Catalonia, involving fifteen stakeholder organisations from HTA agencies, hospitals, academia, industry, government, payers and patient organisations, and its outputs are designed to feed into the budget impact analysis tool developed elsewhere in the same work package.

What the deliverable contains:

  • Background research on healthcare budget allocation in the EU and on the financing challenges left by the pandemic, ageing populations and workforce shortages
  • A review of early Health Technology Assessment and early cost effectiveness analysis, including established step by step frameworks
  • The four stage FLASH early assessment methodology: technology radar, expert focus groups, indicator definition and decision matrix
  • The design of the decision matrix, using multicriteria decision analysis with weighted scoring of clinical, economic, organisational, social and environmental criteria
  • The Catalan case study set up for validation, with the stakeholder groups and expert profiles involved

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