Presentation (CTI)

OBJECTIVES: As healthcare systems face increasing pressure to contain pharmaceutical expenditure, therapeutically comparable lower-cost medicines may offer direct cost savings without compromising patient outcomes. However, it is unclear how health technology assessment (HTA) systems and payers recognise therapeutic comparability. This study assessed how HTA archetypes evaluate these medicines and the availability of formal cost-advantage pathways across markets.
METHODS: A targeted review was conducted across 11 markets representing four HTA archetypes: cost-effectiveness systems (UK, SE, CA, NL), clinical-benefit systems (FR, DE), budget-impact systems (IT, ES, BE), and Nordic systems (DK, NO). Public HTA and P&R guidance, process descriptions, and published timelines were reviewed. Data were extracted on pathway availability, evidence requirements, reimbursement timelines, and pricing implications. Cost-advantage pathways were defined as routes enabling assessment based on comparable clinical outcomes and lower treatment costs versus alternatives.
RESULTS: Formal cost-advantage pathways were identified in 6/11 markets and were most common in cost-effectiveness systems. These pathways generally replaced full cost-effectiveness modelling with comparative clinical evidence, cost-minimisation approaches, and/or budget-impact analyses. Published timelines suggested potential acceleration in 6/11 markets, including reductions from approximately 52 to 32 weeks in the UK, ≤180 to 100-120 days in CA, and approximately 70 to 15 working days in FR. Clinical-benefit systems diverged: FR offered expedited pricing, while DE applied standard AMNOG assessment. Budget-impact systems were mixed, with BE offering a streamlined reimbursement route, while IT and ES relied primarily on standard HTA. Nordic systems offered alternative routes, including a 16-week pathway in DK and simplified assessment in NO.
CONCLUSIONS: HTA systems vary in how they reward therapeutic comparability. Cost-effectiveness systems offered the clearest opportunities for reduced evidence burden and potentially faster P&R. Budget-impact systems relied more on standard HTA, with fewer acceleration opportunities. Whether these pathways deliver real-world efficiency gains, and the extent of manufacturer uptake, remain uncertain and require further investigation.