Evaluation of the Cost of a High-Dose Intravenous Iron Protocol in a Regional Hemodialysis Program: Research Letter.

Background: Intravenous (IV) iron and erythropoietin stimulating agents (ESAs) are standard treatments for anemia in patients receiving maintenance hemodialysis. These medications are associated with significant costs to hemodialysis programs and patients. Recent trial evidence demonstrated that a high-dose IV iron protocol reduces ESA usage and improves cardiovascular outcomes. The cost of implementing a high-dose iron protocol within the Canadian public healthcare context remains unknown.

Objective: Our primary aim was to estimate the costs of a high-dose IV iron protocol in a large Canadian hemodialysis program that currently uses a low-dose and reactive IV iron strategy. Our secondary aim was to estimate the reduction in ESA use required to maintain cost neutrality with a high-dose IV iron protocol.

Design: In this modeling study of IV iron and ESA utilization from a regional hemodialysis program, changes in medication utilization were calculated based on observed effects from published trial data. Using data from a quality improvement audit of regional anemia management and medication utilization, we estimated potential cost differences under various modeling conditions.

Setting: Four adult hospital-based and 9 community in-center hemodialysis units in the Alberta Kidney Care-South renal program during the observation period of September 1, 2018, to November 30, 2018.

Patients: In total, data from 826 patients were included.

Measurements: Mean monthly IV iron and ESA doses were obtained from routine audit data captured within an electronic medical record. Costs were determined from provincially negotiated medication prices.

Methods: Current IV iron and erythropoietin dosages were aggregated at the hemodialysis unit level. We used the results from the PIVOTAL trial to estimate the expected increase in IV iron dose and reduction in ESA dose with a high-dose IV iron protocol. We assumed the split between various manufactures of IV iron and ESA were maintained in our cost model. Total medication costs were aggregated by hemodialysis unit, and the mean costs in each unit were used to estimate per-patient costs. Sensitivity analyses included models that assumed 100% IV iron sucrose usage, as well as models where community hemodialysis units and hospital-based hemodialysis units were examined separately. Finally, we calculated a break-even point for ESA dose reduction required to maintain cost neutrality.

Results: Actual baseline IV iron and ESA dose utilization across 13 adult HD units were 118 mg/patient/month (95% confidence interval [CI]: 102-134 mg) and 20,764 IU/pt./mo. (95% CI: 18,104-23,424 IU), respectively. The mean combined cost of ESA and IV iron was $315/pt./mo. (95% CI: $274-$355). In comparison, using the results of the PIVOTAL trial and assuming a high-dose IV iron scenario, we estimated mean IV iron use of 215 mg/pt./mo. (95% CI: 187-243 mg/pt./mo.) and a reduction in mean ESA use to 15,923 IU/pt./mo. (95% CI: 13,883-17,962 IU/pt./mo.). This resulted in an estimated cost savings of $38/pt./mo. (95% CI: $33-$42/pt./mo.) and a total program savings of $370,000 per year (95% CI: $325,000-$420,000). Sensitivity analyses under various alternate conditions also showed potential cost savings. We estimated that a dose reduction of ESA of 10% would be required for cost neutrality with a high-dose IV iron protocol.

Limitations: Our study is limited in its use of data from a single randomized controlled trial (RCT) to estimate cost savings rather than actualized utilization. Our models do not take into consideration anticipated reductions in transfusions and hospitalizations that could be realized from a high-dose IV iron protocol.

Conclusions: Based on cost modeling, a high-dose IV iron protocol could be integrated in large Canadian regional hemodialysis program in a cost saving manner. Programs implementing such a protocol should monitor IV iron and EPO use prospectively to determine if the trial protocol as applied in a real-world setting translates into cost savings.