English (United Kingdom)

https://curated-unify.zendy.io/wp-json/zendy-region/v1/featured_content/oa?rat=en

https://curated-unify.zendy.io/wp-json/zendy-region/v1/highlighted_journal/

Global: Zendy Plus annual

Presents the access of premium content as premium feature

Premium Content

Presents the keyphrase highlighting as premium feature

Keyphrase Highlighting

Presents the summarisation as premium feature

Summarisation

Insights

Presents the pdf analysis as premium feature

PDF Analysis

Presents the zaia usage as premium feature

ZAIA

Global: Zendy Plus monthly

Global: Zendy Tools annual

Global: Zendy Tools monthly

Global: Zendy Free Plan

In 2012, total treatment costs for end-stage renal disease (ESRD) [in-center dialysis and outpatient costs combined] were estimated to be about US$88,000 per person per year [1]. For payers, this represents over US$7000 per member per month (PMPM) in expenses, a substantial burden. Therefore, analyses of ESRD costs are vital. Brunelli et al. conducted a budget impact analysis of a new phosphate binder (PB), ferric citrate (FC), to estimate potential cost savings compared with current PBs [2]. The effectiveness of FC to manage phosphate levels has been shown to be similar to PBs currently on the market. Brunelli et al. indicate that a potential advantage of FC is that it also improves iron absorption, which may lead to decreased doses of erythropoiesis-stimulating agents (ESAs) and intravenous iron. The authors contend that it might also decrease the number of missed dialysis days because of fewer hospitalizations. It should be noted that FC is not approved by the US Food and Drug Administration for reducing iron and ESA, and the effects on iron indices are actually included in the ‘Warnings and Precautions’ in the approved labeling. Previous researchers have looked at potential cost savings of FC. Rodby et al. [3] developed a model using data from a randomized controlled trial, and estimated that the reduced ESA and intravenous iron would provide cost savings of about US$175 PMPM. They do address some limitations, including that (1) the population enrolled in the randomized controlled trial was a younger, and probably less severe, population (the patients had to have [1-year life expectancy to be included in the study) than the average patient with ESRD and (2) the costs of PBs was NOT accounted for in the model, and it is expected that new medications will be priced at a higher rate than current comparators. Mutell et al. [4] generated a cost-offset model comparing FC with current PBs. The researchers assumed that the effectiveness and costs for all PBs were equivalent, and estimated cost offsets to be about US$160 PMPM. For the Brunelli et al. model, shortcomings in the application of phase III data in the model should be noted. The application of the results of the phase III trial assumes perfect adherence to FC prescriptions. As previously reported by Chui et al., approximately 62% of patients are non-adherent to their PB prescriptions [5]. Next, estimates of reductions in ESA utilization may be overstated. The Brunelli et al. article includes a reduction in ESA dose of 36% based on ‘‘primary study data from a phase III trial’’ and references an article by Lewis et al. However, Table 3 in the Lewis article shows only a 23.7% ESA reduction in the 52-week median doses [6]. Additionally, confounding may have occurred because the FC phase III study was conducted between December 2010 and November 2012—about the same period when significant anemia management changes were implemented in response to the Center for Medicare and Medicaid Services new bundled reimbursement to dialysis facilities [7]. It has been estimated that bundling decreased the mean ESA dose by 35% during a similar time period. In addition, current ESA and intravenous iron utilization is lower than & Karen Rascati krascati@mail.utexas.edu

drugs in randd

Comment on: “Net Budgetary Impact of Ferric Citrate as a First-Line Phosphate Binder for the Treatment of Hyperphosphatemia: A Markov Microsimulation Mode”