The drug 17-alpha hydroxyprogesterone caproate is an injectable synthetic progestin. It has been proven effective in preventing or delaying preterm birth in singleton pregnancies for women with a history of spontaneous preterm birth.¹ Once widely available as an inexpensive compounded drug, it now has a branded version (Makena; AMAG Pharmaceuticals) that costs approximately 100 times more than the original. On February 4, 2011, KV Pharmaceutical Company (later renamed Lumara) received approval from the US Food and Drug Administration to manufacture and market Makena, which is composed of the same active ingredients as found in the original compounded formulation. The approval included an orphan drug designation and gave KV Pharmaceutical Company the exclusive rights to manufacture Makena, which potentially contributed to its high listed price.² For this study, we used an insurance claims database to examine prescriptions for 17-alpha hydroxyprogesterone caproate among nearly 4000 commercially insured (not Medicaid) pregnant women. Our aim was to understand the use, costs, and outcomes of the branded and compounded versions of the drug.

己酸17-α羟孕酮是一种可注射的合成孕激素。已经证明，对于具有自发早产史的妇女，在单胎妊娠中预防或延迟早产有效。^1个曾经作为廉价的复合药物广泛使用，现在它有一个品牌版本（Makena； AMAG Pharmaceuticals），其价格是原始价格的约100倍。2011年2月4日，KV制药公司（后更名为Lumara）获得了美国食品和药物管理局的许可，可以生产和销售Makena，该产品由与原始配方相同的活性成分组成。该批准包括一个孤儿药的名称，并授予KV Pharmaceutical Company制造Makena的专有权利，这有可能导致其高昂的上市价格。^2个在本研究中，我们使用保险索赔数据库检查了近4000名商业保险（非医疗补助）孕妇中的己酸17-α羟孕酮处方。我们的目的是了解该商标品牌和复合版本的用途，成本和结果。