From the Albert Einstein Medical Center, Philadelphia, Pennsylvania; the Yale University School of Medicine, New Haven, Connecticut; the Washington University School of Medicine, St. Louis, Missouri; the University of North Carolina School of Medicine, Chapel Hill, North Carolina; Massachusetts General Hospital, Boston, Massachusetts; and the University of Texas Medical Branch, Galveston, Texas.
Obstet Gynecol. 2011 Jun;117(6):1408-1412. doi: 10.1097/AOG.0b013e31821c2d75.
U.S. Food and Drug Administration (FDA) approval of 17α-hydroxyprogesterone caproate for the indication of decreasing the risk of preterm delivery in those high-risk patients who previously had spontaneous preterm birth has come at considerable cost to the health care system. Weekly injections provided by compounding pharmacies starting at 16-20 weeks of gestation and continuing until 36 weeks currently cost the health care system $200 to $300 per pregnancy. This cost is significantly less than the costs associated with delivering and caring for preterm children. Makena, by KV Pharmaceutical, the same 17α-hydroxyprogesterone caproate product, is priced at $1,500 per injection, or a projected cost of $30,000 per pregnancy. With approximately 132,000 pregnancies being eligible for treatment annually, this increase in cost of 75-150 times what previously had been paid far exceeds the benefits derived from the FDA-approved Makena when compared with previously available compounded versions of 17α-hydroxyprogesterone caproate. This increased health care cost is not justified at this time. The price barrier to access imposed by KV Pharmaceutical actually could result in an increase in preterm deliveries over current rates. Actions are needed by the FDA, national societies, and the manufacturer to ensure that all high-risk patients continue to get the needed therapy to reduce the number of preterm births.
美国食品和药物管理局（FDA）批准 17α-羟孕酮己酸酯用于降低有自发性早产史的高危患者早产风险的适应证，这给医疗保健系统带来了相当大的成本。从妊娠 16-20 周开始，由复方制药厂每周提供的注射剂，一直持续到 36 周，目前每个妊娠的成本为 200-300 美元。这一成本明显低于与早产儿分娩和护理相关的成本。由 KV 制药公司生产的 Makena（同样是 17α-羟孕酮己酸酯产品），每支注射剂的价格为 1500 美元，每个妊娠的预计成本为 30000 美元。每年约有 132000 例妊娠符合治疗条件，与之前可获得的 17α-羟孕酮己酸酯复方制剂相比，这种治疗成本增加了 75-150 倍，远远超过了 FDA 批准的 Makena 带来的益处。目前，这种增加的医疗保健成本是不合理的。KV 制药公司设定的准入价格壁垒实际上可能导致早产率高于当前水平。FDA、国家学会和制造商需要采取行动，确保所有高危患者继续获得所需的治疗，以减少早产的数量。
