Kandolf Sekulovic L, Peris K, Hauschild A, Stratigos A, Grob J-J, Nathan P, Dummer R, Forsea A-M, Hoeller C, Gogas H, Demidov L, Lebbe C, Blank C, Olah J, Bastholt L, Herceg D, Neyns B, Vieira R, Hansson J, Rutkowski P, Krajsova I, Bylaite-Bucinskiene M, Zalaudek I, Maric-Brozic J, Babovic N, Banjin M, Putnik K, Weinlich G, Todorovic V, Kirov K, Ocvirk J, Zhukavets A, Kukushkina M, De La Cruz Merino L, Ymeri A, Risteski M, Garbe C
Department of Dermatology, Medical Faculty, Military Medical Academy, Belgrade, Serbia.
Institute of Dermatology, Catholic University of the Sacred Heart, Rome, Italy.
Eur J Cancer. 2017 Apr;75:313-322. doi: 10.1016/j.ejca.2017.01.012. Epub 2017 Mar 4.
Despite the efficacy of innovative treatments for metastatic melanoma, their high costs has led to disparities in cancer care among different European countries. We analysed the availability of these innovative therapies in Europe and estimated the number of patients without access to first-line recommended treatment per current guidelines of professional entities such as the European Society for Medical Oncology (ESMO), the European Organisation for Research and Treatment of Cancer (EORTC), the European Association of Dermato-Oncology (EADO), and European Dermatology Forum (EDF).
Web-based online survey was conducted in 30 European countries with questions about the treatment schedules from 1st May 2015 to 1st May 2016: number of metastatic melanoma patients, registration and reimbursement of innovative medicines (updated data, as of 1st October 2016), percentage of patients treated and availability of clinical studies and compassionate-use programmes.
The recommended BRAF inhibitor (BRAFi) + MEK inhibitor (MEKi) combination was both registered and fully reimbursed in 9/30 (30%) countries, and in 13/30 (43%) (all from Eastern Europe) not reimbursed. First-line immunotherapy with anti-PD1 antibodies was registered and fully reimbursed in 14/30 (47%) countries, while in 13/30 (43%) (all from Eastern Europe) not reimbursed. It was estimated that in Europe 19,600 patients with metastatic melanoma are treated, and 5238 (27%) do not have access to recommended first-line therapy. Significant correlation was found between human development index (HDI, UNDP report 2015), (r = 0.662; p < 0.001), health expenditure per capita (r = 0.695; p < 0.001) and the Mackenbach score of health policy performance (r = 0.765; p < 0.001) with the percentage of patients treated with innovative medicines and a number of reimbursed medicines.
Great discrepancy exists in metastatic melanoma treatment across Europe. It is crucial to increase the awareness of national and European policymakers, oncological societies, melanoma patients' associations and pharma industry.
尽管转移性黑色素瘤的创新疗法疗效显著，但其高昂的成本导致欧洲不同国家在癌症治疗方面存在差异。我们分析了这些创新疗法在欧洲的可及性，并根据欧洲医学肿瘤学会（ESMO）、欧洲癌症研究与治疗组织（EORTC）、欧洲皮肤肿瘤学协会（EADO）和欧洲皮肤病学论坛（EDF）等专业机构的现行指南，估算了无法获得一线推荐治疗的患者数量。
在30个欧洲国家开展了基于网络的在线调查，问题涉及2015年5月1日至2016年5月1日的治疗方案：转移性黑色素瘤患者数量、创新药物的注册和报销情况（截至2016年10月1日的最新数据）、接受治疗的患者百分比以及临床研究和同情用药项目的可及性。
推荐的BRAF抑制剂（BRAFi）+MEK抑制剂（MEKi）联合疗法在9/30（30%）的国家已注册并全额报销，在13/30（43%）（均来自东欧）的国家未报销。抗PD1抗体一线免疫疗法在14/30（47%）的国家已注册并全额报销，而在13/30（43%）（均来自东欧）的国家未报销。据估计，欧洲有19,600例转移性黑色素瘤患者接受了治疗，5238例（27%）无法获得推荐的一线治疗。人类发展指数（HDI，联合国开发计划署2015年报告）（r = 0.662；p < 0.001）、人均卫生支出（r = 0.695；p < 0.001）与健康政策绩效的麦肯巴赫评分（r = 0.765；p < 0.001）与接受创新药物治疗的患者百分比和报销药物数量之间存在显著相关性。
欧洲各地转移性黑色素瘤治疗存在巨大差异。提高国家和欧洲政策制定者、肿瘤学会、黑色素瘤患者协会和制药行业的认识至关重要。
