Vitry Agnes I, Shin Ng Huah, Vitre Pauline
Quality Use of Medicines and Pharmacy Research Centre, Sansom Institute for Health Sciences, School of Pharmacy and Medical Sciences, University of South Australia, Adelaide, Australia.
J Pharm Policy Pract. 2013 Jun 13;6:2. doi: 10.1186/2052-3211-6-2. eCollection 2013.
The belief that all new medicines bring a therapeutic innovation and better health outcomes is widely shared among the public, health professionals and policy makers.
To examine the therapeutic value of new medicines marketed in Australia using two classification systems.
The therapeutic value of new medicines was categorised using the Motola's s and the Ahlqvist-Rastad's systems for all approvals made by the Australian Therapeutics Goods Administration (TGA) between 2005 and 2007. Scores were assigned independently by the three authors on the basis of the Public Summary Documents and Prescrire' review articles.
Overall, 217 approval recommendations were made including 81 (37.3%) for new indications and 69 (31.8%) for new medicines. In Motola's rating system, 31 (52.5%) of the 59 drugs were rated as pharmacological or technological innovations and 28 (47.5%) were rated as therapeutic innovations. Only seven of the 59 drugs (11.9%) were rated as important innovations. In Ahlqvist-Rastad's system, only a third of the new drugs were rated as "added therapeutic value".
Only a minority of the new medicines marketed in Australia provide added therapeutic value compared to existing treatments. Stricter regulatory approval criteria would ensure better safety of the public and simplify the reimbursement processes.
公众、医疗专业人员和政策制定者普遍认为，所有新药都能带来治疗创新并改善健康结果。
使用两种分类系统研究在澳大利亚上市的新药的治疗价值。
采用莫托拉（Motola）和阿尔奎斯特 - 拉斯塔德（Ahlqvist-Rastad）的系统，对澳大利亚治疗用品管理局（TGA）在2005年至2007年期间批准的所有新药的治疗价值进行分类。三位作者根据公开摘要文件和《Prescrire》评论文章独立打分。
总体而言，共提出了217项批准建议，其中81项（37.3%）用于新适应症，69项（31.8%）用于新药。在莫托拉的评级系统中，59种药物中有31种（52.5%）被评为药理学或技术创新，28种（47.5%）被评为治疗创新。59种药物中只有7种（11.9%）被评为重要创新。在阿尔奎斯特 - 拉斯塔德的系统中，只有三分之一的新药被评为“增加治疗价值”。
与现有治疗方法相比，在澳大利亚上市的新药中只有少数具有增加的治疗价值。更严格的监管批准标准将确保公众有更好的安全性，并简化报销流程。
