Colmenero Fernando, Sullivan Sean D, Palmer Jennifer A, Brauer Carmen A, Bungay Kathleen, Watkins John, Neumann Peter J
Harvard School of Public Health, Boston, MA, USA.
Am J Manag Care. 2007 Jul;13(7):401-7.
To investigate the quality and completeness of clinical and economic data in dossiers submitted by drug companies to a health plan using Academy of Managed Care Pharmacy guidelines (the Format) for formulary submissions.
We reviewed the quality of economic analyses in dossiers submitted to Premera Blue Cross Health Plan (Mountlake Terrace, Washington; enrollment 1.6 million) between January 2002 and September 2005. For dossiers submitted in 2003, we examined the clinical studies included.
Dossiers were audited with a data collection form to judge the types of clinical studies used to support labeled and off-label indications, and the quality and transparency of economic analyses. We compared economic analyses for high-cost (30-day treatment cost > $1000) versus low-cost products, and for "innovative" versus "me-too" drugs.
Evidence to support off-label indications often was included in 2003 dossiers, but the information was less extensive and of poorer quality than data for labeled indications. Of 115 dossiers submitted between 2002 and 2005, 53 (46%) included economic analyses. The economic analyses had low levels of compliance with standards: only 43% performed sensitivity analysis; 38% stated the study perspective; 37% discussed relevant treatment alternatives; 20% stated assumptions clearly; and 18% mentioned caveats to conclusions. Economic analyses of high-cost products and innovative products had higher compliance with recommended practices.
Drug companies are submitting dossiers of evidence to formulary committees. Dossiers often included clinical data to support off-label indications, but concerns persist about their quality. About half of dossiers included economic analyses, but these analyses had relatively low levels of compliance with recommended practices.
利用管理式护理药房学会的处方集提交指南（格式），调查制药公司提交给健康计划的档案中临床和经济数据的质量与完整性。
我们回顾了2002年1月至2005年9月期间提交给Premera Blue Cross健康计划（华盛顿州蒙特莱克台地；参保人数160万）的档案中经济分析的质量。对于2003年提交的档案，我们检查了其中包含的临床研究。
使用数据收集表对档案进行审核，以判断用于支持标签注明和未标明的适应症的临床研究类型，以及经济分析的质量和透明度。我们比较了高成本（30天治疗成本>1000美元）与低成本产品，以及“创新”药物与“仿制药”的经济分析。
支持未标明适应症的证据在2003年的档案中经常出现，但与标签注明适应症的数据相比，这些信息不够全面且质量较差。在2002年至2005年期间提交的115份档案中，53份（46%）包含经济分析。经济分析的标准合规水平较低：只有43%进行了敏感性分析；38%说明了研究视角；37%讨论了相关治疗替代方案；20%明确陈述了假设；18%提到了结论的注意事项。高成本产品和创新产品的经济分析对推荐做法的合规性更高。
制药公司正在向处方集委员会提交证据档案。档案中经常包含支持未标明适应症的临床数据，但对其质量的担忧依然存在。约一半的档案包含经济分析，但这些分析对推荐做法的合规水平相对较低。
