title: Ferric Citrate, an Iron-Based Phosphate Binder, Reduces Health Care Costs in Patients on Dialysis Based on Randomized Clinical Trial Data.
abstract: BACKGROUND
  Patients with end-stage renal disease (ESRD) require phosphate binders for hyperphosphatemia and erythropoiesis-stimulating agents (ESAs) and intravenous (i.v.) iron for anemia. Ferric citrate (FC) is a novel, iron-based phosphate binder that increases iron stores and decreases i.v. iron and ESA usage while maintaining hemoglobin levels, and may decrease the cost of ESRD care. The study objectives were to (1) quantify differences in ESA and i.v. iron usage among ESRD patients receiving FC compared with active control (AC) (sevelamer carbonate and/or calcium acetate) on the basis of data from a 52-week phase III clinical trial and (2) standardize trial data to the general United States (US) ESRD population and calculate the potential impact of FC on ESRD cost/patient/year in the USA.
  
  
  METHODS
  The study was a randomized, controlled clinical trial.
  
  
  METHODS
  A total of 441 adult subjects with ESRD who received FC or AC for 52 weeks were included.
  Differences in ESA and i.v. iron usage between the treatment groups were modeled over time using generalized linear mixed models and zero-inflated Poisson models. Trends were modeled via logarithmic curves, and utilization patterns were applied to the general dialysis population to estimate expected resource savings.
  
  
  RESULTS
  Study outcomes were costs saved/patient/year using FC versus AC (US dollars).
  
  
  RESULTS
  Our model suggests an annual decrease of 129,106 U of ESAs and 1960 mg of i.v. iron per patient in the second year after a switch from AC to FC. Applying 2013 Medicare pricing, this would save $1585 in ESAs and $516 in i.v. iron: a total of $2101/patient/year; these savings would be expected to double for managed care plans.
  
  
  CONCLUSIONS
  The projections were made on 1 year of trial data.
  
  
  CONCLUSIONS
  Phosphate binding with FC reduces i.v. iron and ESA usage. Given the high cost burden of ESRD, our model demonstrates significant potential cost savings.
  
  
  BACKGROUND
  ClinicalTrials.gov (NCT01191255) http://clinicaltrials.gov/ct2/show/NCT01191255 .
authors.affiliation: Rush University Medical Center, Chicago, IL, USA, rogerrodby@mac.com.
authors.forename: Roger A
authors.initials: RA
authors.lastname: Rodby
authors.forename: Kausik
authors.initials: K
authors.lastname: Umanath
authors.forename: Robert
authors.initials: R
authors.lastname: Niecestro
authors.forename: T Christopher
authors.initials: TC
authors.lastname: Bond
authors.forename: Mohammed
authors.initials: M
authors.lastname: Sika
authors.forename: Julia
authors.initials: J
authors.lastname: Lewis
authors.forename: Jamie P
authors.initials: JP
authors.lastname: Dwyer
mesh_terms: D016527:Drug Costs; D005260:Female; D005290:Ferric Compounds / Q000191:economics* / Q000627:therapeutic use*; D006397:Hematinics / Q000191:economics / Q000627:therapeutic use; D006801:Humans; D007501:Iron / Q000191:economics / Q000627:therapeutic use; D007676:Kidney Failure, Chronic / Q000188:drug therapy / Q000191:economics* / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D006435:Renal Dialysis / Q000191:economics* / Q000379:methods*
chemical_list: D005290:Ferric Compounds; D006397:Hematinics; C025314:ferric citrate; D007501:Iron