Cost and cost effectiveness of vaginal progesterone gel in reducing preterm birth: an economic analysis of the PREGNANT trial.
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.


CONCLUSIONS
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.
Thomas Jefferson University, 901 Walnut Street, Suite 911, Philadelphia, PA, 19107, USA, laura.pizzi@jefferson.edu.
Laura T
LT
Pizzi
Neil S
NS
Seligman
Jason K
JK
Baxter
Eric
E
Jutkowitz
Vincenzo
V
Berghella
D003362:Cost-Benefit Analysis; D016527:Drug Costs; D005260:Female; D017048:Health Care Costs; D006801:Humans; D018803:Models, Economic; D011247:Pregnancy; D047928:Premature Birth / Q000191:economics / Q000453:epidemiology / Q000517:prevention & control*; D011336:Probability; D011374:Progesterone / Q000008:administration & dosage / Q000191:economics* / Q000627:therapeutic use; D011372:Progestins / Q000008:administration & dosage / Q000009:adverse effects / Q000191:economics* / Q000627:therapeutic use; D016032:Randomized Controlled Trials as Topic / Q000191:economics; D014622:Vaginal Creams, Foams, and Jellies
D011372:Progestins; D014622:Vaginal Creams, Foams, and Jellies; D011374:Progesterone