The HEMA Draft Report: Is it Enough?

Building on discussions at ISPOR Europe 2024, summarised in our previous commentary, The Bigger Picture: Considering Broader Value Drivers and Perspectives in HEOR, HEOR value elements that extend beyond the healthcare perspective to broader well-being and societal benefits remained a key focus at ISPOR Europe 2025.

The 2024 Health Economics Methods Advisory (HEMA) Draft Report defines a broad, principled approach to expanding the benefit function used in economic evaluations for health technologies. It argues that health technology assessment (HTA) bodies should consider broader value elements beyond core costs and QALYs, including productivity effects, process benefits, equity considerations, and the wider societal impact of health interventions. The report articulates three guiding principles, Relevance, Valuation, and Opportunity Costs, to determine which additional benefits are appropriate for inclusion, how they should be measured, and how they should be weighted. It distinguishes between in-scope elements (those that can be formally incorporated into the benefit function) and out-of-scope elements (those outside the immediate scope of economic evaluation, potentially suitable for future exploration). Notably, the report addresses the challenges of incorporating risk attitudes, equity, and productivity, highlighting methodological complexities, data limitations, and the risk of double-counting. It emphasises transparency, consistency, and stakeholder engagement, and suggests approaches such as distributional cost-effectiveness analysis (DCEA) and cross-sectoral evaluation to capture broader benefits without compromising comparability.

In a panel session Defining Appropriate Benefits for Economic Evaluation: Do Recommendations from HEMA Help (110)¹, panellists and attendees discussed the proposals from HEMA. It was echoed that we shouldn’t aim to merely maximise the QALY; there are other goals, such as maximising social welfare. An illustrative example cited the Netherlands, where police advocated increased investment in mental health to alleviate pressures on the police service. The discussions underscored that HTA decisions on resource allocation are not isolated health decisions; they reverberate across society. While organisations like NICE and ZIN are open to quantifying certain broader value elements, such as applying severity modifiers and recognising productivity impacts, the majority of HTA bodies remain hesitant. The message to industry is clear: incentives should align with delivering technologies that best address patient, public, and healthcare needs.

A further point was that adopting novel analyses should avoid “cherry-picking,” which could bias benefits toward some interventions but not others. Any use of novel analyses must be applied consistently across both new and existing therapies that would be displaced. Generally there is a lack of standardisation to similar approaches. For example, a research podium presentation, Measuring the Broader Impact of Health on Quality of Life and Productivity: Advances in Patient-Reported Outcomes and Economic Evaluation (044),² highlighted inconsistent use of societal perspectives within HTA and the need for standardisation. Additionally, Avşar et al. (2023) note that 70% of guidelines published by well-established agencies and 56% by newer agencies explicitly consider the societal perspective, though substantial definitional variation remains. Societal perspectives are not new in principle, yet there is still a paucity of guidance on how to apply them. With the HEMA draft’s recommendations advocating novel analyses, how should HTA bodies proceed when consensus on societal perspectives is still evolving? We see a benefit for for explicit, harmonised guidance from HTA bodies on when these analyses should be used and how to safeguard against misapplication.

Taken together, the panel conveyed that while HEMA can advance the discourse, but it is not sufficient on its own to drive real change in HTA practice.