Sevelamer Dominates Calcium Carbonate in a Patient-Level Cost- Effectiveness Analysis of the Randomized, Open-Label INDEPENDENTHD Study

Background: In the randomized, open-label INDEPENDENT-HD study sevelamer (SV) significantly increased overall survival (OS) (p<0.001) versus calcium salts (CS) in incident dialysis patients. A patient-level cost-effectiveness analysis (CEA) was conducted to determine if improved OS with SV translates into good value for money from an NHS perspective. Methods: The CEA used OS and concomitant medication use data from 199 (SV) and 198 (CS) completer patients of the INDEPENDENT-HD study. Hospitalizations and length of stay (LOS) were collected retrospectively from medical charts. A clinician (BDI) estimated the frequency of use and dosage of concomitant medications. DRG tariffs and hospital acquisition costs informed hospitalization and drug costs, respectively. CEA outcomes were reported as incremental cost/life year gained (LYG) over 36 months. A probabilistic sensitivity analysis (PSA) was performed by bootstrapping. Results: SV patients lived 4.75 months (95% CI 3.27–6.23) longer on average than CS patients. SV patients also had 76% fewer hospital admissions and shorter LOS (-0.06 d, p>0.05) than CS patients, resulting in reduced total hospitalization costs (-€455,704 vs. CS). Considering drug acquisition and concomitant medication costs, both higher for SV, SV patients had higher total average costs (€35,280) vs. CS patients (€29,235), resulting in an incremental cost/LYG of €15,272 (without dialysis costs) and €44,078 (with dialysis costs). The PSA revealed that 1) SV provides more life years in 99.4% of simulations, 2) SV dominates CS (i.e., more effective and less costly) in 17% of simulations, and 3) SV is cost effective in >90% of remaining simulations at the €50,000 willingness-to-pay threshold. Conclusions: SV is cost effective versus CS for the treatment of hyperphosphatemia in incident dialysis patients.