PharmacoEconomics

, Volume 32, Issue 5, pp 467–478

Cost and Cost Effectiveness of Vaginal Progesterone Gel in Reducing Preterm Birth: An Economic Analysis of the PREGNANT Trial

Authors

    • Thomas Jefferson University
    • Department of Pharmacy PracticeJefferson School of Pharmacy
  • Neil S. Seligman
    • Division of Maternal-Fetal Medicine, Department of Obstetrics and GynecologyUniversity of Rochester Medical Center, School of Medicine and Dentistry
  • Jason K. Baxter
    • Division of Maternal-Fetal Medicine, Department of Obstetrics and GynecologyJefferson Medical College of Thomas Jefferson University
  • Eric Jutkowitz
    • Division of Health Policy and ManagementUniversity of Minnesota
  • Vincenzo Berghella
    • Division of Maternal-Fetal Medicine, Department of Obstetrics and GynecologyJefferson Medical College of Thomas Jefferson University
Original Research Article

DOI: 10.1007/s40273-014-0133-2

Cite this article as:
Pizzi, L.T., Seligman, N.S., Baxter, J.K. et al. PharmacoEconomics (2014) 32: 467. doi:10.1007/s40273-014-0133-2

Abstract

Background

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.

Objective

We calculated the costs and cost effectiveness of VP gel versus placebo using decision analytic models informed by PREGNANT patient-level data.

Methods

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.

Results

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.

Conclusion

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.

Copyright information

© Springer International Publishing Switzerland 2014