Managed Care - January 2008 - (Page 48) reduction in preterm labor and delivery for high-risk women with a history of spontaneous preterm delivery. In 19 clinical trial centers, the study enrolled 463 women with a confirmed history of preterm birth. Patients were enrolled at 16–21 weeks of gestation and randomly assigned to receive weekly injections of 17P or placebo until delivery or until 37 weeks of gestation. This may have amounted to as many as 20 or more injections of 17P for the 16–21 week group as opposed to the group receiving injections only after 21 weeks gestation. The initiation of the treatment injections is confounded with the total amount of 17P the participants in the study received. Therefore, it is possible that the amount of 17P received is more valuable than the timing of its initiation. In the study, treatment with 17P resulted in an overall reduction in the preterm birth rate of 34 percent and a reduction of 42 percent in the rate of preterm births before 32 weeks. In addition, infants born to women treated with 17P had significantly lower rates of serious complications such as necrotizing enterocolitis, intraventricular hemorrhage, use of supplemental oxygen, and mean number of days of post-delivery respiratory therapy. A longitudinal review of birth outcomes in 24 pregnant women with a confirmed history of preterm birth in a managed Medicaid health plan revealed a significant decrease in NICU admissions as well as NICU length of stay, resulting in cost savings related to treatment with 17P (Mason 2005). Obstetricians who treat women with high-risk pregnancy, such as those with a history of spontaneous preterm birth, will often initiate progesterone treatments. A 2005 survey found that 67 percent of these obstetricians use the progesterone treatments, compared to 38 percent in 2003 (March of Dimes 2006). The goal of this study is to determine whether delaying the initiation of weekly injections of 17P until 21 weeks gestation or later could affect the number of NICU admissions and premature births in a Medicaid population. What is 17P? The drug is a naturally occurring metabolite of progesterone, produced in large quantities during pregnancy. It is used to prevent recurrent miscarriages and for various menstrual disorders. This hormone has been indicated for amenorrhea, endometrial carcinoma, and uterine corpus adenocarcinoma. Use of 17P in women who have had a previous premature birth (fewer than 37 weeks) has been endorsed by the American College of Obstetrics and Gynecology (2003). In 2006, the Reproductive Health Drugs Advisory Committee of the Food and Drug Administration (FDA) recommended that the data presented by a particular biotech company in its new drug application (NDA) for a 17P-type product supports the efficacy of 17P treatments in preventing preterm birth prior to 35 weeks. This committee also agreed that overall safety data are adequate and sufficiently reassuring to support use of these treatments in women with a history of preterm delivery. How does 17P work? In animal models, progesterone appears to be primarily responsible for maintaining uterine quiescence during pregnancy. A drop in progesterone levels normally occurs at the initiation of labor at term. However, the mechanism is not the same for preterm labor and preterm rupture of the membranes; evidence suggests this is the result of an inappropriate, inflammatory response. Weekly injections of 17P starting at 16–21 weeks until 35 weeks gestation (totaling as many as 20 injections) may suppress this pathological labor (Mercer 1999). The quantities of 17P produced naturally during pregnancy, predominantly by the placenta, far exceed the recommended dose of 250 mg weekly by intramuscular injection during the last half of pregnancy. Based on the animal and clinical studies that support the safety of 17P in pregnancy, and on the fact that large quantities are produced naturally by the body during pregnancy, one would not expect any serious side effects from initiation of 17P. Indeed, Reprotox (1997), an online reproductive toxicology database, states that “there is no available evidence that the administration of this agent (17P) during pregnancy is harmful.” Based on this information, we hypothesized that an adequate number of injections of 17P, even after 21 weeks gestation, could help to reduce negative pregnancy outcomes associated with preterm delivery in a managed Medicaid environment. METHODS Environment Centene Corp. is a large company with many products, including insurance, nursing services, disease management, and behavioral health management, for people receiving benefits under state Medicaid programs, including Supplemental Security Income (SSI) and the State Children’s Health Insurance Program (SCHIP). Centene operates health plans in Georgia, Indiana, New Jersey, Ohio, South Carolina, Texas, and Wisconsin and manages over 1.1 million Medicaid members. These Centene health plans had 63,895 deliveries in the past 12 months. Approximately 12 percent of these deliveries resulted in NICU admissions. Because the majority of our members are from lower income 48 MANAGED CARE / JANUARY 2008
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