473: Cost-effectiveness of compounded versus commercially manufactured 17-alpha hydroxyprogesterone caproate (17P) for the prevention of recurrent preterm birth

Abstract

To estimate the costs and outcomes of commercially manufactured 17P compared to compounded 17P or no treatment in women with a history of prior preterm birth (PTB). Using a Markov model, we estimated the costs and outcomes of weekly treatment with 17P to prevent recurrent PTB (HR for delivery 0.7, 95% CI 0.56, 0.84) in two populations. The National Center for Health Statistics (NCHS) was used to obtain data on racial distribution and gestational age at first prenatal visit and delivery among women with a history of prior PTB. Racial distribution and risk of PTB was then modified to approximate the placebo arm of the MFMU trial. Compounded 17P differed from commercial 17P in cost ($30 vs. $695/dose), likelihood of receiving an ineffective dose, and risk of sepsis from contaminated drug. All outcomes, including long-term disabilities, and first-year costs were based on gestational age at delivery, and derived from NCHS data and/or the literature. Costs were in 2012 US dollars, and future costs and quality-adjusted life years (QALYs) were discounted at 3% annually. The model was run as a microsimulation (500,000 iterations), with the values for each parameter drawn from probability distributions. Compounded 17P was cost-saving (lower costs and better outcomes) compared to no treatment in the majority of simulations in both populations (Table). Commercial 17P was cost-effective compared to no treatment, but expensive relative to compounded 17P, with considerable uncertainty around estimates, primarily driven by variability in the baseline risk of PTB and the risk of ineffective dosing with compounded 17P. At current prices, commercial 17P is cost-effective compared to no treatment. Cost-effectiveness of compounded 17P relative to commercial 17P is dependent on the effect of variability in drug potency on overall efficacy of prevention of PTB.Tabled 1*Negative numbers indicate cost-savings. Open table in a new tab