Principles for evidence-based drug formulary policy
Principles for evidence-based drug formulary policy
复制标题
DOI：
10.1111/j.1525-1497.2005.0232.x
复制
发表时间：
2005-10-01
影响因子：
5.7
通讯作者：
Mora, M
中科院分区：
文献类型：
--
作者：
Simon, GE;Psaty, BM;Mora, M
处方药的支出继续增加，促使保险公司和卫生系统采取限制使用更昂贵药物的处方集或覆盖政策。那些制定处方药政策的人面临着一系列复杂的关于疗效、安全性、治疗成本或成本效益差异的索赔。我们描述并说明了将研究证据应用于处方决策的5个具体原则：（1）实验数据应优先于模型或模拟，应仔细检查此类模型的假设。(2)发病率或死亡率结果应优先于替代或中间结果。(3)关于新处理方法优点的主张应考虑到所有替代品，而不是工业界选定的替代品。(4)个体或亚组之间的效应差异反对一线治疗的限制，但前提是这些差异是可预测的。(5)效果的差异反对改变正在进行的治疗。我们还讨论了经济激励可能如何影响研究问题的选择，特别是与药物-基因相互作用和确定现有药物的新适应症相关的研究。
Expenditures for prescription drugs continue to increase, prompting insurers and health systems to adopt formulary or coverage policies restricting the use of more expensive drugs. Those establishing formulary policies face a complex array of claims regarding differences in efficacy, safety, treatment cost, or cost-effectiveness. We describe and illustrate 5 specific principles for applying research evidence to formulary decisions: (1) Experimental data should take precedence over models or simulations, and assumptions of such models should be carefully examined. (2) Morbidity or mortality outcomes should take precedence over surrogate or intermediate outcomes. (3) Claims for advantages of new treatments should consider the full range of alternatives rather than those selected by industry. (4) Variation in effects across individuals or subgroups argue against restrictions on first-line treatment, but only if those differences are predictable. (5) Variation in effects argues against requiring changes in ongoing treatment. We also discuss how economic incentives are likely to influence selection of research questions, especially research related to drug-gene interactions and to identifying new indications for existing drugs.