COST EFFECTIVENESS ANALYSIS OF UNIVERSAL SCREENING FOR SICKLE-CELL TRAIT PRIOR TO IVF IN STATES WITH AND WITHOUT AN IVF INSURANCE MANDATE.

To evaluate the cost-effectiveness of universal screening for sickle-cell trait (SCT) prior to in-vitro fertilization (IVF). Preliminary studies have shown that in couples known to both carry SCT, IVF with preimplantation genetic testing (IVF-PGT) for selection of embryos unaffected by sickle cell disease (SCD) is a cost-effective strategy1. However, it is unknown whether universal SCT screening to identify these dual-carrier couples is cost-effective, or if the value of a specific screening strategy is impacted by the greater number of IVF cycles and resulting higher conception rate afforded by IVF insurance mandates. Cost-effectiveness analysis A simple decision model was designed from a societal perspective with a 1 year horizon, to compare SCT screening to no screening. The primary outcome was cost-effectiveness in US dollars per quality-adjusted life year (QALY) gained. QALY totals were assigned to cases of live offspring based on prior published studies (33 QALYs for HbSS offspring and 67 QALYs for unaffected offspring). We assumed that 50% of dual-positive couples (patient and partner with SCT) would choose IVF-PGT. In states with no insurance mandate, we assumed and that an average of 1.3 cycles of IVF-PGT were employed during the time horizon, with a 70% IVF conception rate. In states with an IVF insurance mandate, we assumed an average of 3 cycles of IVF-PGT were employed due to lower cost constraints on patients, with an 85% IVF conception rate. Rates of natural conception, IVF-PGT, early and late pregnancy loss, amniocentesis, therapeutic abortion, SCD lifetime costs and productivity, and prenatal care were derived from the literature, CPT and APC codes, and our experience at a single suburban academic IVF center. Multiple one-way sensitivity analyses were performed to test model assumptions. In the base case primary analysis, the mean cost of the SCT screening strategy was lower than for no SCT screening ($322,548 vs. $322,580). No screening resulted in 0.00039 more QALYs than SCT screening, and was cost-effective with an ICER of $83,096/QALY. In the case of an IVF insurance mandate, the mean cost of the SCT screening strategy remained $14 lower than for no SCT screening and also resulted in 0.00048 more QALYS, making SCT screening a dominant strategy. In sensitivity analysis of the base case model, when the IVF conception rate exceeds 76%, SCT screening becomes a dominant strategy. Universal SCT screening is cost-effective when compared with no screening if the IVF conception rate exceeds 76%. These conditions would be met if every dual-carrier couple with SCT had the financial resources to pursue the recommended follow-up treatment with maximization of pregnancy rates through multiple IVF-PGT cycles. Ultimately, the cost-effectiveness of this intervention is contingent upon disease prevalence and the cumulative IVF conception rate. Therefore, in states where patients have insurance coverage to undergo multiple IVF-PGT cycles, SCT screening could be considered a value-based strategy.