Montefiore Medical Center Department of Medicine, United States.
Montefiore Medical Center Department of Medicine, United States.
Res Social Adm Pharm. 2022 Dec;18(12):4038-4047. doi: 10.1016/j.sapharm.2022.07.047. Epub 2022 Aug 2.
The number of biologics among new medication approvals is increasing. Social, political, and economic factors influence access to these expensive medications. Disparities in access to new medications can exacerbate health disparities. The notion of "structural determinants" provides a theoretical framework for broadly evaluating the integration of upstream social, political, and economic determinants in the clinical study of access.
To review the literature on access to FDA approved biologic medications with particular focus on the integration of social, political, and economic determinants into study design and interpretation.
We used PRISMA guidelines to review studies on racial and socioeconomic disparities in biologic access through August 2020. We assessed whether the design or interpretation of studies considered key economic determinants of access: the biologics supply chain, trade agreements, patents, drug research and development, insurance reimbursement, and non-insurance drug policies.
100 studies met our inclusion criteria. Sixty-six studies considered insurance reimbursement, but trade law, patents, and other key economic determinants were rarely considered. The literature focuses on a small number of older biologics.
A small number of studies model the integration of structural determinants into clinical research on access to biologics, but overall this literature has many limitations and lacks integration of structural determinants. Increased interdisciplinary collaboration, availability of manufacturer data, and use of disease registries can help create structurally grounded understandings of the relationship between the political economy of expensive medications and clinical disparities.
新批准的药物中生物制剂的数量正在增加。社会、政治和经济因素影响这些昂贵药物的可及性。获得新药物的机会不平等会加剧健康不平等。“结构决定因素”的概念为广泛评估将社会、政治和经济上游决定因素纳入药物获取的临床研究提供了一个理论框架。
回顾 FDA 批准的生物药物可及性的文献，特别关注将社会、政治和经济决定因素纳入研究设计和解释的情况。
我们使用 PRISMA 指南，通过 2020 年 8 月审查了关于生物制剂获取方面的种族和社会经济差异的研究。我们评估了研究设计或解释是否考虑了药物获取的关键经济决定因素：生物制剂供应链、贸易协议、专利、药物研发、保险报销和非保险药物政策。
100 项研究符合我们的纳入标准。66 项研究考虑了保险报销，但很少考虑贸易法、专利和其他关键经济决定因素。该文献主要关注少数几种较老的生物制剂。
少数研究将结构决定因素纳入生物制剂获取的临床研究中，但总体而言，该文献存在许多局限性，并且缺乏结构决定因素的整合。增加跨学科合作、制造商数据的可用性以及使用疾病登记处可以帮助建立关于昂贵药物的政治经济与临床差异之间关系的具有结构性基础的理解。
