Presentation (CTI)

OBJECTIVES: Non-small cell lung cancer (NSCLC) remains a major cause of cancer mortality globally. While targeted and immunotherapies offer significant clinical advances, access to these therapies varies across Europe due to heterogeneity in health technology assessments (HTA). This study compares reimbursement decisions for NSCLC therapies across European HTA bodies.
METHODS: Reports for EMA-approved targeted therapies and immunotherapies for NSCLC since 2000 were identified across six European HTA bodies, including the NICE (UK), IQWiG (Germany), HAS (France), SMC (Scotland), ZIN (Netherlands), and NCPE (Ireland). Publicly available HTA reports were reviewed to extract data on reimbursement processes, incremental cost-effectiveness ratios (ICERs) and decision rationales.
RESULTS: A total of 262 HTA reports were retrieved from NICE (90), IQWiG (30), HAS (22), SMC (62), ZIN (19), and NCPE (22), assessing 22 targeted therapies and 7 immunotherapies used either as monotherapy or in combination for the treatment of NSCLC. The positive decisions across HTA bodies were driven by robust clinical evidence, acceptable ICERs within country-specific WTP thresholds, and acceptable safety profiles. Therapies with immature survival data, improper trial design, lack of added clinical benefits, were more likely to receive negative or conditional decisions, particularly from IQWiG and HAS. NICE and SMC showed the highest alignment, recommending several therapies via flexible mechanisms like managed access. ICERs for NICE-recommended therapies ranged from £19,512-£38,831 per QALY, versus £55,043-£72,710 for non-recommended therapies. The considerations by other HTA bodies varied, with emphasis on direct comparative evidence or unmet medical needs for favorable decisions, and decisions being withheld due to uncertainties in economic model or linked to confidential pricing.
CONCLUSIONS: Although some consistency exists in reimbursement decisions, notable differences remain. Despite EMA approval, national decisions vary due to differing evidence standards and healthcare priorities, leading to uneven patient access. Ongoing evaluation will offer deeper insights into HTA reimbursement decisions across Europe.