RTI Health Solutions, Research Triangle Park, NC 27709, USA.
Int J Technol Assess Health Care. 2013 Jan;29(1):92-100. doi: 10.1017/S0266462312000724. Epub 2012 Dec 10.
The aim of this study was to estimate the relationship between the financial impact of a new drug and the recommendation for reimbursement by the Australian Pharmaceutical Benefits Advisory Committee (PBAC).
Data in the PBAC summary database were abstracted for decisions made between July 2005 and November 2009. Financial impact-the upper bound of the values presented in the PBAC summary database-was categorized as ≤A$0, >A$0 up to A$10 million, A$10 million up to A$30 million, and >A$30 million per year. Descriptive, logistic, survival, and recursive partitioning decision analyses were used to estimate the relationship between the financial impact of a new drug indication and the recommendation for reimbursement. Multivariable analyses controlled for other clinical and economic variables, including cost per quality-adjusted life-year gained.
Financial impact was a significant predictor of the recommendation for reimbursement. In the logistic analysis, the odds ratios of reimbursement for drug submissions with financial impacts ≥A$10 million to ≥A$30 million or >A$0 to <A$10 million compared with ≤A$0 were 0.12 (95 percent confidence interval [CI]: 0.03-0.51) and 0.16 (95 percent CI: 0.04-0.60), respectively. In the recursive partition decision analysis, the first split of the data was for submissions with a positive financial impact compared with those with a zero or negative financial impact.
In Australia, financial impact on the drug budget is an important determinant of whether a new drug is recommended for reimbursement when cost-effectiveness estimates and other clinical and economic variables are controlled.
本研究旨在评估新药对药物预算的财务影响与澳大利亚药品福利咨询委员会（PBAC）建议报销之间的关系。
从 2005 年 7 月至 2009 年 11 月 PBAC 总结数据库中提取决策数据。财务影响——PBAC 总结数据库中呈现的数值上限——分为≤澳元 0 元、＞澳元 0 元至 1000 万澳元、＞澳元 1000 万至 3000 万澳元以及＞澳元 3000 万澳元/年。采用描述性、逻辑、生存和递归分区决策分析来估计新药适应证的财务影响与报销建议之间的关系。多变量分析控制了其他临床和经济变量，包括每获得一个质量调整生命年的成本。
财务影响是报销建议的重要预测指标。在逻辑分析中，与澳元 0 元相比，财务影响≥澳元 1000 万至≥澳元 3000 万或≥澳元 0 元至＜澳元 1000 万的药物申请报销的比值比分别为 0.12（95%置信区间：0.03-0.51）和 0.16（95%置信区间：0.04-0.60）。在递归分区决策分析中，数据的第一次分割是针对财务影响为正的申请与财务影响为零或负的申请。
在澳大利亚，当控制成本效益估计和其他临床及经济变量时，药物预算的财务影响是决定新药物是否被推荐报销的一个重要因素。
