Presentation (CTI)

OBJECTIVES: Although England and Japan share similar economic scales and universal health systems, they follow distinct reimbursement pathways, leading to differences in patient access. In England, MHRA grants market authorisation, followed by HTAs by NICE, which emphasise cost-effectiveness. In contrast, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) grants market authorisation based on safety and efficacy, typically linking directly to reimbursement without formal HTA. These process variations potentially result in gaps in approval timing and reimbursed indication ranges, particularly for advanced oncology combination therapies, which often face cost-effectiveness challenges in England. This study examines how differences in reimbursement processes affect access to combination therapies.
METHODS: Regulatory and HTA reports (2015-2024) from NICE, MHRA, PMDA, and EMA were reviewed for oncology combination therapies involving two or more molecular targeted agents and/or immune checkpoint inhibitors for solid tumours. Data were extracted on regulatory/appraisal outcomes, timelines and indications.
RESULTS: Of 28 combination therapies appraised by NICE, 82% (23/28) were recommended (Recommended/Optimised), including 4 therapies initially approved through the Cancer Drug Fund. Most NICE recommendations involved commercial agreements; non-recommendations were largely due to poor cost-effectiveness. Among 35 therapies reimbursed in either England or Japan, 91% (32/35) were reimbursed in Japan with fewer indication restrictions (none involving HTA), while 66% (23/35) were recommended in England, with 43% (10/23) having restricted indications. Although England's market authorisations were faster in 70% of shared therapies (median: 3.3 months), Japan achieved faster reimbursement in 90% (median: 6.45 months), due to its direct linkage between authorisation and reimbursement without HTA.
CONCLUSIONS: Japan provides faster and broader access to combination therapies without cost-effectiveness review, whereas England ensures economic scrutiny through HTA, delaying access. This trade-off between faster access (Japan) and economic efficiency (England) suggests that Japan may require HTA for sustainability as use of expensive combination therapies increases, while England should streamline appraisals to improve access.