Research Department of Primary Care and Population Health, University College London, London, United Kingdom.
Department of Methodology and Statistics, Faculty of Health Medicine and Life Sciences, Maastricht University, Maastricht, Netherlands.
PLoS One. 2022 Jun 2;17(6):e0269192. doi: 10.1371/journal.pone.0269192. eCollection 2022.
Adding abiraterone acetate (AA) plus prednisolone (P) to standard of care (SOC) improves survival in newly diagnosed advanced prostate cancer (PC) patients starting hormone therapy. Our objective was to determine the value for money to the English National Health Service (NHS) of adding AAP to SOC. We used a decision analytic model to evaluate cost-effectiveness of providing AAP in the English NHS. Between 2011-2014, the STAMPEDE trial recruited 1917 men with high-risk localised, locally advanced, recurrent or metastatic PC starting first-line androgen-deprivation therapy (ADT), and they were randomised to receive SOC plus AAP, or SOC alone. Lifetime costs and quality-adjusted life-years (QALYs) were estimated using STAMPEDE trial data supplemented with literature data where necessary, adjusting for baseline patient and disease characteristics. British National Formulary (BNF) prices (£98/day) were applied for AAP. Costs and outcomes were discounted at 3.5%/year. AAP was not cost-effective. The incremental cost-effectiveness ratio (ICER) was £149,748/QALY gained in the non-metastatic (M0) subgroup, with 2.4% probability of being cost-effective at NICE's £30,000/QALY threshold; and the metastatic (M1) subgroup had an ICER of £47,503/QALY gained, with 12.0% probability of being cost-effective. Scenario analysis suggested AAP could be cost-effective in M1 patients if priced below £62/day, or below £28/day in the M0 subgroup. AAP could dominate SOC in the M0 subgroup with price below £11/day. AAP is effective for non-metastatic and metastatic disease but is not cost-effective when using the BNF price. AAP currently only has UK approval for use in a subset of M1 patients. The actual price currently paid by the English NHS for abiraterone acetate is unknown. Broadening AAP's indication and having a daily cost below the thresholds described above is recommended, given AAP improves survival in both subgroups and its cost-saving potential in M0 subgroup.
在开始激素治疗的新诊断晚期前列腺癌 (PC) 患者中，添加醋酸阿比特龙 (AA) 加泼尼松 (P) 联合标准治疗 (SOC) 可改善生存。我们的目标是确定为英国国家医疗服务体系 (NHS) 添加 AAP 联合 SOC 的经济效益。我们使用决策分析模型评估在英国 NHS 中提供 AAP 的成本效益。在 2011-2014 年间，STAMPEDE 试验招募了 1917 名接受一线雄激素剥夺治疗 (ADT) 的高危局限性、局部晚期、复发性或转移性 PC 患者，他们被随机分配接受 SOC 加 AAP 或 SOC 单独治疗。使用 STAMPEDE 试验数据和必要时的文献数据估计终生成本和质量调整生命年 (QALY)，并根据基线患者和疾病特征进行调整。采用英国国家处方集 (BNF) 价格 (£98/天) 计算 AAP 价格。成本和结果按 3.5%/年贴现。在非转移性 (M0) 亚组中，AAP 的增量成本效益比 (ICER) 为每增加 1 个质量调整生命年 (£149748)，在 NICE 的 £30000/QALY 阈值下，有 2.4%的可能性具有成本效益；在转移性 (M1) 亚组中，ICER 为每增加 1 个质量调整生命年 (£47503)，有 12.0%的可能性具有成本效益。情景分析表明，如果 AAP 的价格低于 £62/天，或者在 M0 亚组中低于 £28/天，那么它在 M1 患者中可能具有成本效益。在 M0 亚组中，AAP 的价格低于 £11/天，则 AAP 可以优于 SOC。AAP 对非转移性和转移性疾病有效，但使用 BNF 价格则不具有成本效益。AAP 目前仅在英国获得批准用于 M1 患者的一部分。英国国民保健系统目前实际支付的醋酸阿比特龙价格尚不清楚。鉴于 AAP 可改善两组患者的生存且在 M0 亚组具有节省成本的潜力，建议扩大 AAP 的适应证并使其每日费用低于上述阈值。
