Presentation (CTI)

OBJECTIVES: To compare health technology assessment (HTA) outcomes for selected high-cost therapies evaluated by the National Institute for Health and Care Excellence (NICE) in England and the Institute for Clinical and Economic Review (ICER) in the United States, and to assess how differences in institutional authority influence value assessment and pricing outcomes.
METHODS: A targeted review of publicly available NICE and ICER assessments published between 2015 and 2025 was conducted. Three case studies across distinct therapeutic areas were selected: tisagenlecleucel for paediatric B-cell acute lymphoblastic leukaemia (B-ALL), lumacaftor/ivacaftor for cystic fibrosis, and nivolumab for second-line treatment of non-small cell lung cancer (NSCLC). Data were compared qualitatively, focusing on clinical benefit, cost-effectiveness, and pricing considerations.
RESULTS: For tisagenlecleucel in paediatric B-ALL, NICE recommended managed access via the Cancer Drugs Fund, followed by routine commissioning conditional on a confidential discount. ICER concluded that price premiums could be justified to achieve cost-effectiveness within their $100,000-$150,000 per QALY threshold range. For lumacaftor/ivacaftor, both organisations recognised clinical benefit but identified substantial cost-effectiveness concerns. NICE supported access through a commercial agreement beyond simple discounting, while ICER determined that prices exceeded value-based benchmarks and estimated that a 54-58% simple discount would be required to meet a $500,000 per QALY threshold. For nivolumab in advanced NSCLC, NICE recommended use via the Cancer Drugs Fund with a confidential discount, whereas ICER found it not cost-effective at list price and estimated that a 57-68% discount would be required.
CONCLUSIONS: While NICE and ICER apply similar evidence-based frameworks, differences in decision-making authority and pricing transparency lead to divergent outcomes. Higher ICER willingness-to-pay thresholds and the absence of mandated price concessions in the US contribute to variation, but also faster routine access. Further research is needed to understand how ICER assessments influence pricing dynamics in less transparent markets.