Cost and Cost Effectiveness of Vaginal Progesterone Gel in Reducing Preterm Birth: An Economic Analysis of the PREGNANT Trial
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Preterm birth (PTB) is a costly public health problem in the USA. The PREGNANT trial tested the efficacy of vaginal progesterone (VP) 8 % gel in reducing the likelihood of PTB among women with a short cervix.
We calculated the costs and cost effectiveness of VP gel versus placebo using decision analytic models informed by PREGNANT patient-level data.
PREGNANT enrolled 459 pregnant women with a cervical length of 10–20 mm and randomized them to either VP 8 % gel or placebo. We used a cost model to estimate the total cost of treatment per mother and a cost-effectiveness model to estimate the cost per PTB averted with VP gel versus placebo. Patient-level trial data informed model inputs and included PTB rates in low- and high-risk women in each study group at <28 weeks gestation, 28–31, 32–36, and ≥37 weeks. Cost assumptions were based on 2010 US healthcare services reimbursements. The cost model was validated against patient-level data. Sensitivity analyses were used to test the robustness of the cost-effectiveness model.
The estimated cost per mother was $US23,079 for VP gel and $US36,436 for placebo. The cost-effectiveness model showed savings of $US24,071 per PTB averted with VP gel. VP gel realized cost savings and cost effectiveness in 79 % of simulations.
Based on findings from PREGNANT, VP gel was associated with cost savings and cost effectiveness compared with placebo. Future trials designed to include cost metrics are needed to better understand the value of VP.
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- 1. Thomas Jefferson University, 901 Walnut Street, Suite 911, Philadelphia, PA, 19107, USA
- 5. Department of Pharmacy Practice, Jefferson School of Pharmacy, 901 Walnut Street, Suite 901, Philadelphia, PA, 19107, USA
- 2. Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Rochester Medical Center, School of Medicine and Dentistry, 601 Elmwood Ave, Box 668, Rochester, NY, 14642, USA
- 3. Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Jefferson Medical College of Thomas Jefferson University, 834 Chestnut Street, Suite 400, Philadelphia, PA, 19107, USA
- 4. Division of Health Policy and Management, University of Minnesota, 420 Delaware Street SE, MMC 729, Minneapolis, MN, 55455, USA