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

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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.

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References

  1. American College of Obstetricians and Gynecologists, Iams J, et al. Practice Bulletin No. 130: prediction and prevention of preterm birth. Obstet Gynecol. 2012;120:964–73.

    Article  Google Scholar 

  2. March of Dimes, PMNCH, Save the Children, WHO. In: Howson CP, Kinney MV, Lawn JE, editors. Born too soon: the global action report on preterm birth. Geneva: World Health Organization; 2012. http://www.who.int/pmnch/media/news/2012/201204_borntoosoon-report.pdf. Accessed 19 Nov 2012.

  3. Hamilton BE, Martin JA, Ventura SJ. Births: Preliminary data for 2010. National Vital Statistics Reports. 2011;60(2).

  4. Davidoff MJ, Dias T, Damus K, et al. Changes in the gestational age distribution among U.S. singleton births: impact of rates of late preterm birth 1992–2002. Semin Perinatol. 2006;30(1):8–15.

    Article  PubMed  Google Scholar 

  5. Institute of Medicine (US) Committee on Understanding Premature Birth and Assuring Healthy Outcomes. Societal costs of preterm birth. In: Behrman RE, Butler AS, editors. Preterm birth: causes, consequences, and prevention. Washington, DC: National Academic Press; 2007. p. 389–439.

  6. Preterm Birth: Causes, Consequences, and Prevention. Consensus Panel Report. Institute of Medicine; 2006. http://iom.edu/Reports/2006/Preterm-Birth-Causes-Consequences-and-Prevention.aspx; Chapter 12 (IHC data). Accessed 31 Jan 2012.

  7. Andersen HF, Nugent CE, Wanty SD, Hayashi RH. Prediction of risk for preterm delivery by ultrasonographic measurement of cervical length. Am J Obstet Gynecol. 1990;163:859–67.

    Article  CAS  PubMed  Google Scholar 

  8. Heath VC, Southall TR, Souka AP, et al. Cervical length at 23 weeks of gestation: prediction of spontaneous preterm delivery. Ultrasound Obstet Gynecol. 1998;12:312–7.

    Article  CAS  PubMed  Google Scholar 

  9. Hassan SS, Romero R, Berry SM, et al. Patients with an ultrasonographic cervical length < or = 15 mm have nearly a 50% risk of early spontaneous preterm delivery. Am J Obstet Gynecol. 2000;182:1458–67.

    Article  CAS  PubMed  Google Scholar 

  10. Iams JD, Goldenberg RL, Meis PJ, et al. The length of the cervix and the risk of spontaneous premature delivery. National Institute of Child Health and Human Development Maternal Fetal Medicine Unit Network. N Engl J Med. 1996;334:567–72.

    Article  CAS  PubMed  Google Scholar 

  11. Berghella V, Tolosa JE, Kuhlman K, et al. Cervical ultrasonography compared with manual examination as a predictor of preterm delivery. Am J Obstet Gynecol. 1997;177:723–30.

    Article  CAS  PubMed  Google Scholar 

  12. Owen J, Yost N, Berghella V, et al. Can shortened midtrimester cervical length predict very early spontaneous preterm birth? Am J Obstet Gynecol. 2004;191:298–303.

    Article  PubMed  Google Scholar 

  13. Society for Maternal-Fetal Medicine, Berghella V. Progesterone and preterm birth prevention: translating clinical trials data into clinical practice. Am J Obstet Gynecol. 2012;206:376–86.

    Article  Google Scholar 

  14. Fonseca EB, Bittar RE, Carvalho MHB, Zugaib M. Prophylactic administration of progesterone by vaginal suppository to reduce the incidence of spontaneous preterm birth in women at increased risk: a randomized placebo-controlled double-blind study. Am J Obstet Gynecol. 2003;188:419–24.

    Article  PubMed  Google Scholar 

  15. Fonseca EB, Celik E, Parra M, et al. Progesterone and the risk of preterm birth among women with a short cervix. N Engl J Med. 2007;357:462–9.

    Article  CAS  PubMed  Google Scholar 

  16. Hassan SS, Romero R, Vidyadhari D, et al. Vaginal progesterone reduces the rate of preterm birth in women with a sonographic short cervix: a multicenter, randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol. 2011;38:18–31.

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  17. U.S. Food and Drug Administration. Reproductive Health Drugs Advisory Committee. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ReproductiveHealthDrugsAdvisoryCommittee/UCM292006.pdf. Accessed 5 Mar 2012.

  18. International classification of diseases and related health problems. 10th revision. Geneva: World Health Organization; 1992.

  19. United States Department of Labor. Bureau of Labor Statistics. Consumer Price Index (Medical Services Component). Consumer Price Index Detailed Report: Data for December 2011; 2011. http://www.bls.gov/cpi/cpid1112.pdf. Accessed 13 Mar 2012.

  20. National Fee Analyzer. Ingenix; 2010.

  21. Crinone. RED BOOK™ Drug References. Horsham: Thomson Reuters; 2010.

  22. Expert DRG. A comprehensive guidebook to the DRG classification system. Salt Lake City: Ingenix; 2011.

    Google Scholar 

  23. Agency for Healthcare Research and Quality HCUPNet. DRG 775 Normal newborn, 2009HCUPNet database, Rockville. http://www.hcupnet.arhq.gov. Accessed 1 Jan 2013.

  24. Consumer Price Index Detailed Report, Table 1. December 2010, U.S. Bureau of Labor Statistics. http://www.bls.gov/cpi/#tables. Accessed 31 Jan 2012.

  25. Luke B, Bigger HR, Leurgans S, Sietsema D. The cost of prematurity: a case–control study of twins vs singletons. Am J Public Health. 1996;86:809–14.

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  26. St John EB, Nelson KG, Cliver SP, et al. Cost of neonatal care according to gestational age at birth and survival status. Am J Obstet Gynecol. 2000;182:170–5.

    Article  CAS  PubMed  Google Scholar 

  27. Husereau D, Drummond M, Petrou S, Carswell C, Moher D, Greenberg D, et al. Consolidated Health Economic Evaluation Reporting Standards (CHEERS) Statement. Pharmacoeconomics. 2013;31:361–7.

    Article  PubMed  Google Scholar 

  28. Centers for Disease Control and Prevention. Department of Health and Human Services. PRAMS and Preterm Delivery; 2006. http://www.cdc.gov/reproductivehealth/ProductsPubs/PDFs/Preterm%20Delivery%20FS.pdf. Accessed 10 Jan 2013.

  29. Progesterone Gel 8% NDA 22-139. Presentation to the Reproductive Health Drugs Advisory Committee of the U.S. Food and Drug Administration, Columbia Laboratories, Inc.; 2012.

  30. Cahill AG, Odibo AO, Caughey AB, et al. Universal cervical length screening and treatment with vaginal progesterone to prevent preterm birth: a decision and economic analysis. Am J Obstet Gynecol. 2010;202:548.e1–8.

    PubMed  Google Scholar 

  31. Werner EF, Han CS, Pettker CM, et al. Universal cervical-length screening to prevent preterm birth: a cost-effectiveness analysis. Ultrasound Obstet Gynecol. 2011;38:32–7.

    Article  CAS  PubMed  Google Scholar 

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Funding disclosure

Watson Pharmaceuticals (now Actavis) is the sponsor of this economic analysis. The NDA for Prochieve® was transferred to Watson Pharmaceuticals from Columbia Laboratories, Inc. during the course of this work.

Author disclosures

Pizzi, Seligman, Baxter, Jutkowitz, and Berghella have no conflicts of interest to disclose. Contributions of individual authors are as follows: Pizzi: conception, design, analysis, drafting and critical revision of the manuscript, manuscript approval, and guarantor of work; Seligman, Baxter, and Berghella: conception, design, critical revision of the manuscript, manuscript approval; Jutkowitz: conception, analysis, critical revision of manuscript, manuscript approval.

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Authors and Affiliations

  1. Thomas Jefferson University, 901 Walnut Street, Suite 911, Philadelphia, PA, 19107, USA

    Laura T. Pizzi

  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

    Neil S. Seligman

  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

    Jason K. Baxter & Vincenzo Berghella

  4. Division of Health Policy and Management, University of Minnesota, 420 Delaware Street SE, MMC 729, Minneapolis, MN, 55455, USA

    Eric Jutkowitz

  5. Department of Pharmacy Practice, Jefferson School of Pharmacy, 901 Walnut Street, Suite 901, Philadelphia, PA, 19107, USA

    Laura T. Pizzi

Authors
  1. Laura T. Pizzi
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  2. Neil S. Seligman
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  5. Vincenzo Berghella
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Correspondence to Laura T. Pizzi.

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Pizzi, L.T., Seligman, N.S., Baxter, J.K. et al. Cost and Cost Effectiveness of Vaginal Progesterone Gel in Reducing Preterm Birth: An Economic Analysis of the PREGNANT Trial. PharmacoEconomics 32, 467–478 (2014). https://doi.org/10.1007/s40273-014-0133-2

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  • DOI: https://doi.org/10.1007/s40273-014-0133-2

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