Hill S R, Mitchell A S, Henry D A
Discipline of Clinical Pharmacology, School of Population Health Sciences, Faculty of Medicine and Health Sciences, The University of Newcastle, New South Wales, Australia.
JAMA. 2000 Apr 26;283(16):2116-21. doi: 10.1001/jama.283.16.2116.
Pharmacoeconomic analyses are being used increasingly as the basis for reimbursement of the costs of new drugs. Reports of these analyses are often published in peer-reviewed journals. However, the analyses are complex and difficult to evaluate.
To describe the nature of problems encountered in the evaluation and interpretation of pharmacoeconomic analyses used as a basis for reimbursement decisions.
All major submissions to the Department of Health and Aged Care (DHAC) by the pharmaceutical industry for funding made under the Australian Pharmaceutical Benefits Scheme. Specifically, the DHAC's database of submissions that were received between January 1994 and December 1997 were reviewed.
Of a total of 326 submissions, 218 had serious problems of interpretation and were included in the analysis. The nature of the serious problems reviewed were classified as estimates of comparative clinical efficacy, comparator issues, modeling issues, and calculation errors.
All submissions in the DHAC's database were reviewed and data were extracted if both the DHAC evaluators and technical subcommittee considered problems to have a significant bearing on the decisions of the parent committee.
Of a total of 326 submissions, 218 (67%) had significant problems and 31 had more than 1 problem. Of the 249 problems identified, 154 (62%) related to uncertainty in the estimates of comparative clinical efficacy, and 71 (28.5%) related to modeling issues, which included clinical assumptions or cost estimates, used in the construction of the economic models. There were 15 instances of disagreement over the choice of comparator, and serious calculation errors were found on 9 occasions. Overall, 159 problems (64%) were considered to be avoidable.
Significant problems were identified in these pharmacoeconomic analyses. The intensive evaluation process used in the Australian Pharmaceutical Benefits Scheme allowed for identification and correction of pharmacoecomomic analysis problems, but the resources that are required may be beyond the capacity of many organizations, including peer-reviewed journals.
药物经济学分析越来越多地被用作新药成本报销的依据。这些分析报告经常发表在同行评审期刊上。然而，这些分析很复杂，难以评估。
描述在将药物经济学分析用作报销决策依据时，评估和解读过程中遇到的问题的性质。
制药行业根据澳大利亚药品福利计划向卫生与老年护理部（DHAC）提交的所有主要资助申请。具体而言，对1994年1月至1997年12月期间收到的DHAC申请数据库进行了审查。
在总共326份申请中，218份存在严重的解读问题，并被纳入分析。审查的严重问题的性质被分类为比较临床疗效的估计、对照品问题、建模问题和计算错误。
对DHAC数据库中的所有申请进行了审查，如果DHAC评估人员和技术小组委员会都认为问题对上级委员会的决策有重大影响，则提取数据。
在总共326份申请中，218份（67%）存在重大问题，31份有不止一个问题。在识别出的249个问题中，154个（62%）与比较临床疗效估计的不确定性有关，71个（28.5%）与建模问题有关，其中包括经济模型构建中使用的临床假设或成本估计。在对照品选择上存在15次分歧，9次发现严重计算错误。总体而言，159个问题（64%）被认为是可以避免的。
在这些药物经济学分析中发现了重大问题。澳大利亚药品福利计划中使用的密集评估过程有助于识别和纠正药物经济学分析问题，但所需资源可能超出包括同行评审期刊在内的许多组织的能力范围。
