Mohammadnezhad Ghader, Sattarpour Melika, Moradi Najmeh
School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Health Management and Economics Research Center, Health Management Research Institute, Iran University of Medical Sciences, Tehran, Iran.
J Pharm Policy Pract. 2022 Dec 29;15(1):105. doi: 10.1186/s40545-022-00493-1.
Breast cancer (BC) is the most common cancer globally among women, with 2,261,419 new cases in 2020; systemic treatment may be neo-adjuvant, adjuvant, or both. BC subtype guides the standard systemic therapy administered, which consists of endocrine therapy for all HR + tumors, trastuzumab-based HER2-directed antibody therapy plus chemotherapy for all HER2 + tumors (with endocrine therapy given in addition, if concurrent HR positivity), and chemotherapy alone for the triple-negative subtype. This study aimed to identify, evaluate, and systematically review all budget impact analyses (BIAs) of BC medications worldwide.
PubMed, Scopus, and Web of Science Core Collection databases were thoroughly searched up to 26th March 2022 to identify original published studies which evaluate BIA of BC medications. ISPOR Task Force guidelines were used to assess the quality of included studies. This study was conducted and reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.
In total, 17 BIAs were included in the study. About half of the studies were conducted in Europe. The results of the BIAs showed that most of the included BIAs are conducted from the payer's perspective; they have different methodological frameworks for recommended chemotherapy, targeted therapy, and immunotherapy agents to treat BC. For the same medications, the results of budgetary effects are not consistent in diverse countries. Nine out of the 17 studies were focused on trastuzumab, in which the biosimilar form reduced costs, but the brand form increased costs, especially in a 52-week treatment period.
Researchers should conduct the budget impact analysis of high-value medications such as anti-tumor drugs more objectively, and the accuracy of parameters needs to be more strictly guaranteed. Furthermore, it is worthy of declaring that the budgetary impact of the same drug is not always consistent over time, so the researchers should measure access to medication in the long run.
乳腺癌(BC)是全球女性中最常见的癌症,2020年有2261419例新发病例;全身治疗可能是新辅助治疗、辅助治疗或两者皆有。BC亚型指导所采用的标准全身治疗,其中所有HR+肿瘤采用内分泌治疗,所有HER2+肿瘤采用以曲妥珠单抗为基础的HER2靶向抗体治疗加化疗(如果同时存在HR阳性,则加用内分泌治疗),三阴性亚型则单独采用化疗。本研究旨在识别、评估并系统综述全球范围内所有关于BC药物的预算影响分析(BIA)。
截至2022年3月26日,对PubMed、Scopus和科学引文索引核心合集数据库进行全面检索,以识别评估BC药物BIA的原始发表研究。采用国际药物经济学与结果研究协会(ISPOR)工作组指南评估纳入研究的质量。本研究按照系统评价和Meta分析的首选报告项目(PRISMA)指南进行实施和报告。
本研究共纳入17项BIA。约一半的研究在欧洲开展。BIA的结果显示,大多数纳入的BIA是从支付方的角度进行的;它们在推荐用于治疗BC的化疗、靶向治疗和免疫治疗药物方面有不同的方法框架。对于相同的药物,不同国家的预算影响结果并不一致。17项研究中有9项聚焦于曲妥珠单抗,其中生物类似药形式降低了成本,但原研药形式增加了成本,尤其是在52周的治疗期内。
研究人员应更客观地进行抗肿瘤药物等高价值药物的预算影响分析,参数的准确性需要更严格地保证。此外,值得声明的是,同一药物的预算影响并非始终随时间保持一致,因此研究人员应从长远角度衡量药物的可及性。