Tay-Teo Kiu, Trapani Dario, Sengar Manju, Aziz Zeba, Meheus Filip, Ilbawi André, de Vries Elisabeth G E, Moja Lorenzo
World Health Organization, Geneva, Switzerland.
European Institute of Oncology, IRCCS, Milan, Italy.
EClinicalMedicine. 2025 May 24;84:103261. doi: 10.1016/j.eclinm.2025.103261. eCollection 2025 Jun.
Access to immune checkpoint inhibitors remains limited due to cost-effectiveness and affordability concerns. This study evaluates the financial impacts of expanding global access to PD1/PD-L1 inhibitors as first-line monotherapy for patients aged 40-74 years with advanced unresectable non-small cell lung cancer (NSCLC), with wildtype EGFR and ≥50% of tumour cells with PD-L1 expression.
The potential usage and associated costs were assessed from 2024 to 2040 through repeated cross-sectional assessments. The base case assumed treatment rates in countries with access to PD1/PD-L1 inhibitors in 2023, while expanded-access scenarios projected coverage increases to 30% in low-income, 50% in lower-middle-income, 80% in upper-middle-income (UMICs), and 95% in high-income countries over 10 years.
The model estimated that 200,000-250,000 individuals are treatment-eligible, with only about one-fifth receiving PD1/PD-L1 inhibitors in the base case. Expanding access would increase global treatment coverage to 75% by 2040, particularly in middle-income countries. The largest increases would be in UMICs (+100,700) and the Western Pacific region (+82,400). At an estimated per-patient lifetime cost of US$37,600-US$75,100, total costs could reach US$14,087 million with fixed dosing, or US$9080 million with weight-based dosing. PD-L1 testing costs would add <1% to the total.
Expanding access to PD1/PD-L1 inhibitors for advanced NSCLC over 10 years demands significant funding, making equitable access in lower-income countries doubtful without a significant price reduction. Policymakers should negotiate lower prices to ensure cost-effectiveness and affordability, improve spending efficiency by optimised dosing and treatment duration, and enhance health system capacity, including ensuring appropriate use and introducing biosimilars.
This publication was made available as open access through WHO funding provided by two projects: the Universal Health Coverage Partnership (Award 74812, the European Union, the Grand Duchy of Luxembourg, Irish Aid, the Government of Japan, the French Ministry for Europe and Foreign Affairs, the United Kingdom's Foreign, Commonwealth & Development Office, the Government of Belgium, the Government of Canada, and the Government of Germany) and the Increasing Global Equitable Access to Health Products & Health Technologies project (Award 72913, the Government of Belgium).
由于对成本效益和可负担性的担忧,免疫检查点抑制剂的可及性仍然有限。本研究评估了扩大全球对PD1/PD-L1抑制剂的可及性作为40-74岁晚期不可切除非小细胞肺癌(NSCLC)患者一线单药治疗的财务影响,这些患者具有野生型表皮生长因子受体(EGFR)且≥50%的肿瘤细胞有PD-L1表达。
通过重复横断面评估对2024年至2040年的潜在使用情况和相关成本进行评估。基础病例假设2023年可获得PD1/PD-L1抑制剂的国家的治疗率,而扩大可及性情景预计在10年内低收入国家的覆盖率提高到30%,中低收入国家提高到50%,中高收入国家(UMICs)提高到80%,高收入国家提高到95%。
该模型估计有20万至25万人符合治疗条件,在基础病例中只有约五分之一的人接受PD1/PD-L1抑制剂治疗。扩大可及性将使到2040年全球治疗覆盖率提高到75%,特别是在中等收入国家。增加最多的将是中高收入国家(增加100,700人)和西太平洋地区(增加82,400人)。估计每位患者的终身成本为37,600美元至75,100美元,固定剂量时总成本可能达到140.87亿美元,基于体重给药时为90.80亿美元。PD-L1检测成本占总成本的比例不到1%。
在10年内扩大晚期NSCLC患者对PD1/PD-L1抑制剂的可及性需要大量资金,在没有大幅降价的情况下,低收入国家的公平可及性令人怀疑。政策制定者应协商降低价格以确保成本效益和可负担性,通过优化给药和治疗持续时间提高支出效率,并加强卫生系统能力,包括确保合理使用和引入生物类似药。
本出版物通过世界卫生组织由两个项目提供的资金以开放获取的形式提供:全民健康覆盖伙伴关系(赠款74812,欧盟、卢森堡大公国、爱尔兰援助署、日本政府、法国欧洲和外交部、英国外交、联邦和发展办公室、比利时政府、加拿大政府和德国政府)以及增加全球卫生产品和卫生技术公平可及性项目(赠款72913,比利时政府)。