Are Global Health Technology Assessment (HTA) Processes Inclusive and Equitable? A Scoping Review

OBJECTIVES: Regulatory agencies around the world have recently released diversity, equity, and inclusion (DEI) guidance to improve the representativeness of clinical trials. However, it is unknown if, and to what extent, Health Technology Assessment (HTA) bodies have undertaken similar DEI initiatives. This scoping review aimed to map the landscape of DEI considerations in leading HTA bodies worldwide.

METHODS: A targeted search was conducted to identify English-language submission guidance from leading HTA bodies in the largest pharmaceutical markets, as well as multi-country HTA collaborations. Information was extracted on processes for identifying relevant subpopulations; prioritized subpopulations; recommended health value metrics; and equity considerations, including recommendations for equity informative health economic analyses.

RESULTS: We identified one HTA body specific to the European Union (the Member State Coordination Group on HTA (HTACG)) and six HTA bodies covering 13 specific countries in North America and Europe: Beneluxa (Austria/Belgium/Ireland/Luxembourg/Netherlands); Canada’s Drug Agency (CDA; Canada); IQWiG (Germany); ICER (USA); the Joint Nordic HTA-Bodies (Denmark/Finland/Norway/Sweden); and NICE (UK). All institutions acknowledged that value and cost-effectiveness can differ by subpopulations, and the majority (n=5/7) provided guidance on how to identify relevant subpopulations. Only ICER and CDA specified prioritized subpopulations (e.g., sex, race/ethnicity), primarily historically underrepresented groups. Except for HTACG which did not specify health value metrics, other HTA bodies used the QALY as a key health value metric. ICER and NICE both included equity considerations in HTA guidance, but ICER was the only HTA body to include a quantitative equity impact assessment via the Health Improvement Distribution Index.

CONCLUSIONS: Leading HTA bodies have not undertaken significant DEI initiatives. Only ICER both identified priority subgroups and included a quantitative equity impact assessment. While there have been meaningful advancements in methods to integrate equity considerations into cost-effectiveness and other value assessments, these have not been adopted into HTA processes.