← 返回

西班牙黑色素瘤药物可及性:一项横断面调查

英文原题:Access to melanoma drugs in Spain: a cross-sectional survey.

查看英文原题

Access to melanoma drugs in Spain: a cross-sectional survey.

PubMed 2024/05/16(内容时间) Clin Transl Oncol Q3 · IF 2.7(JCR 2025)

分数与星级只用于站内排序 —— 不代表疗效、安全性或个人适用性。

研究概要

对于多数在 EMA 适应症之外报销受限的适应症,西班牙不同医院之间的可及性存在很大差异,包括 AACC 内部的异质性。

中文摘要

高活性药物改善了黑色素瘤患者生存,但药品价格高昂,给卫生系统带来沉重负担。在西班牙,公共卫生系统下放至 17 个自治区(AACC)。本研究旨在描述西班牙黑色素瘤患者的药物可及性现状,以及这种分权体系对公平性的影响。

2023 年 7 月至 9 月,向西班牙多学科黑色素瘤组(GEM Group)成员发送横断面调查,询问各医院患者实际获得新药的情况。匿名收集并按自治区等变量分析答复。

共 15 个自治区的 50 名医生答复。对于西班牙卫生系统已报销的适应证(IIIC–IIID 期和切除后 IV 期黑色素瘤辅助免疫治疗),不同自治区之间药物可及性未见明显差异。对于多数欧洲药品管理局(EMA)批准但未报销的适应证(IIB–IIC–IIIA–IIIB 期辅助免疫治疗)或未完全报销的适应证(晚期 ipilimumab 联合 nivolumab),不同自治区之间及同一自治区内不同治疗中心之间的药物可及性存在显著差异。各自治区辅助靶向药物、TIL 疗法和 T-VEC 的可及性普遍极低或不存在。

对于多数报销范围受限于 EMA 适应证之外的治疗,不同西班牙医院之间的可及性差异很大,同一自治区内也存在异质性。

展开英文摘要原文

The development of highly active drugs has improved the survival of melanoma patients, but elevated drug prices place a significant burden on health care systems. In Spain, the public health care system is transferred to the 17 autonomous communities (AACC). The objective of this study is to describe the situation of drug access for melanoma patients in Spain and how this decentralized system is affecting equity.

From July to September 2023, a cross-sectional survey was sent to members of the Spanish Multidisciplinary Melanoma Group (GEM Group). The questionnaire consulted about the real access to new drugs in each hospital. The responses were collected anonymously and analyzed according to several variables, including the AACC.

The survey was answered by 50 physicians in 15 AACC. No major differences on access between AACC were observed for indications that are reimbursed by the Spanish Health Care System (adjuvant immunotherapy for stage IIIC-IIID and resected stage IV melanoma). Important differences in drug access were observed among AACC and among centers within the same AACC, for most of the EMA indications that are not reimbursed (adjuvant immunotherapy for stages IIB-IIC-IIIA-IIIB) or that are not fully reimbursed (ipilimumab plus nivolumab in advanced stage). Homogeneously, access to adjuvant targeted drugs, TIL therapy and T-VEC, is extremely low or non-existing in all AACC.

For most indications that reimbursement is restricted out of the EMA indication, a great diversity on access was found throughout the different hospitals in Spain, including heterogeneity intra-AACC.

论文信息

作者
Gonzalez-Cao M、Puertolas T、Manzano JL、Maldonado C、Yelamos O、Berciano-Guerrero MÁ、Cerezuela P、Martin-Liberal J
第一作者单位
Translational Cancer Research Unit, Instituto Oncologico Dr Rosell, Dexeus University Hospital, C/Sabino Arana, 5, 080028, Barcelona, Spain. mgonzalezcao@oncorosell.com.Spain
通讯作者单位
CIBERER, Barcelona, Spain. spuig@clinic.cat.Spain
期刊
Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico2024 Oct
原文标识
PubMed 38750345 · DOI 10.1007/s12094-024-03501-9