BACKGROUND: Two randomized clinical trials, the Study of Ascending Levels of Tolvaptan in Hyponatremia 1 and 2 (SALT-1 and SALT-2), showed that tolvaptan was an efficacious and safe therapy for the treatment of hyponatremic patients with the syndrome of inappropriate antidiuretic hormone secretion (SIADH).HYPOTHESIS: This study evaluated the potential cost savings associated with tolvaptan usage based on the SALT-1 and SALT-2 trials.METHODS: Hospital length of stay (LOS) reduction associated with tolvaptan versus placebo was evaluated among hyponatremic patients with the SIADH (serum sodium < 135 mEq/L) from the combined data of the SALT-1 and SALT-2 trials. The Healthcare Cost and Utilization Project 2009 Nationwide Inpatient Sample database was used to estimate hospital cost and LOS for hospitalizations of adult (age ? 18 years) patients with the SIADH. A cost-offset model was constructed to evaluate the impact of tolvaptan on hospital cost and LOS, with univariate and multivariate Monte Carlo sensitivity analyses.RESULTS: In the SALT-1 and SALT-2 trials, patients with the SIADH receiving tolvaptan had a shorter hospital LOS than patients receiving placebo (4.98 vs 6.19 days, respectively). There were 21 718 hospitalizations for the SIADH identified from the Healthcare Cost and Utilization Project Nationwide 2009 Inpatient Sample database, with a mean LOS of 5.7 days and mean total hospital costs of $8667. Using an inpatient tolvaptan treatment duration of 4 days, with a daily wholesale acquisition cost of $250, the cost-offset model estimated an LOS reduction among SIADH hospitalizations of 1.11 days. The total cost offset, including tolvaptan drug cost, was estimated to be $694 per admission. The cost-neutral break-even duration of tolvaptan therapy is 6.78 days. Univariate and multivariate sensitivity analyses demonstrated consistent cost reduction associated with tolvaptan usage. Ten thousand cycles of Monte Carlo simulation showed the 95% CI for cost offset to be $73 to $1405.CONCLUSION: Based on the SALT-1 and SALT-2 trials, tolvaptan usage is associated with a shorter hospital LOS than placebo among patients with the SIADH. Including the drug cost for 4 days of inpatient tolvaptan therapy, tolvaptan is associated with an estimated mean hospital cost reduction of $694 per admission in the United States.
Adolescent Adult