HEMA opens consultation on framework for evaluating benefits in health technology assessment

HEMA group, the international collaboration between ICER, NICE, and Canada’s Drug Agency, has released its first draft report defining appropriate benefits for economic evaluation in HTA, inviting global stakeholder feedback ahead of final guidance expected in early 2026.

The Health Economics Methods Advisory (HEMA) group – a collaboration between the Institute for Clinical and Economic Review (ICER, USA), Canada’s Drug Agency (CDA-AMC), and the National Institute for Health and Care Excellence (NICE, England) – has released its inaugural draft report, “Defining Appropriate Benefits for Economic Evaluation of Health Care Technologies”. The consultation invites stakeholder feedback until October 30, 2025, marking the group’s first major step toward developing shared methodological guidance for health technology assessment (HTA).

Established earlier this year, HEMA was created to provide independent, evidence-based advice on evolving methods in economic evaluation. While supported by these leading HTA organizations, it operates autonomously, ensuring its analyses and recommendations remain objective. The group’s work aims to strengthen consistency, transparency, and methodological rigor in how HTA agencies assess treatment benefits.

In our recent interview with Sarah Edmond, President and Chief Executive Officer of ICER, she explained the HEMA initiative reflects a shared recognition among HTA agencies of the need for methodological clarity:

“With all of the research that's out there about how to do this, whether it's the ISPOR value flower or generalized cost-effectiveness analysis, we deserve to know what makes sense from a population health perspective to consider in an HTA. And I think it's fair to say that both NICE in the UK and CDA in Canada feel similarly, that there are these new methods that get proposed and talked about so we can have a principled approach to evaluating these new methods to see which are ready for prime time?”

This first report takes step to address this need by examining how HTA agencies might determine which treatment benefits are appropriate to include in economic evaluation, particularly as health systems increasingly look beyond traditional clinical outcomes. It sets out a clear framework and guiding principles to help organizations assess whether “novel value elements,” such as productivity impacts, equity considerations, or patient preferences toward health risks, should be incorporated into benefit assessments.

The report applies three key principles to guide these decisions:

• Relevance: Additional benefits must align with the core objectives and responsibilities of HTA organizations.
• Valuation: Benefits should be aggregated consistently with population-level preferences and avoid double counting.
• Opportunity cost: The inclusion of new benefits must consider the health gains that may be forgone elsewhere due to finite healthcare resources.

Applying these principles, HEMA outlines several recommendations for HTA organizations. These include evaluating any additional benefit measures against the guiding principles before adoption, ensuring new benefits are not incorporated without evidence to quantify opportunity costs, and maintaining deliberative processes that do not bypass such considerations. The report also advises that any use of patient preferences or “modifiers” be grounded in a clear normative framework and that broader benefits, such as productivity or cross-sector impacts, be considered only when consistent with decision makers’ remits and supported by robust evidence.