Incremental cost-utility of sevelamer relative to calcium carbonate for treatment of hyperphosphatemia among pre-dialysis chronic kidney disease patients

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Abstract

Background

Sevelamer is an alternative to calcium carbonate for the treatment of hyperphosphatemia among non-dialysis dependent patients with chronic kidney disease (CKD). Although some studies show that it may reduce mortality and delay the onset of dialysis when compared to calcium carbonate, it is also significantly more expensive. Prior studies looking at the incremental cost-effectiveness of sevelamer versus calcium carbonate in pre-dialysis patients are based on data from a single clinical trial. The goal of our study is to use a wider range of clinical data to achieve a more contemporary and robust cost-effectiveness analysis.

Methods

We used a Markov model to estimate the lifetime costs and quality-adjusted life years (QALYs) gained for treatment with sevelamer versus calcium carbonate. The model simulated transitions among three health states (CKD not requiring dialysis, end-stage renal disease, and death). Data on transition probabilities and utilities were obtained from the published literature. Costs were calculated from a third party payer perspective and included medication, hospitalization, and dialysis. Sensitivity analyses were also run to encompass a wide range of assumptions about the dose, costs, and effectiveness of sevelamer.

Results

Over a lifetime, the average cost per patient treated with sevelamer is S$180,724. The estimated cost for patients treated with calcium carbonate is S$152,988. A patient treated with sevelamer gains, on average, 6.34 QALYs relative to no treatment, whereas a patient taking calcium carbonate gains 5.81 QALYs. Therefore, sevelamer produces an incremental cost-effectiveness ratio (ICER) of S$51,756 per QALY gained relative to calcium carbonate.

Conclusion

Based on established benchmarks for cost-effectiveness, sevelamer is cost effective relative to calcium carbonate for the treatment of hyperphosphatemia among patients with chronic kidney disease initially not on dialysis.

Electronic supplementary material

The online version of this article (doi:10.1186/s12882-016-0256-0) contains supplementary material, which is available to authorized users.

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Most cited references 12

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Mortality in kidney disease patients treated with phosphate binders: a randomized study.

Antonio Bellasi, Biagio Di Iorio, Domenico Russo … (2012)

Dietary phosphorous overload and excessive calcium intake from calcium-containing phosphate binders promote coronary artery calcification (CAC) that may contribute to high mortality of dialysis patients. CAC has been found in patients in early stages of nondialysis-dependent CKD. In this population, no study has evaluated the potential role of phosphorus binders on mortality. This study aimed to evaluate all-cause mortality as the primary end point in nondialysis-dependent CKD patients randomized to different phosphate binders; secondary end points were dialysis inception and the composite end point of all-cause mortality and dialysis inception. This is a randomized, multicenter, nonblinded pilot study. Consecutive outpatients (n=212; stage 3-4 CKD) were randomized to either sevelamer (n=107) or calcium carbonate (n=105). Phosphorus concentration was maintained between 2.7 and 4.6 mg/dl for patients with stage 3-4 CKD and between 3.5 and 5.5 mg/dl for patients with stage 5 CKD. The CAC score was assessed by computed tomography at study entry and after 6, 12, 18, and 24 months. All-cause mortality, dialysis inception, and the composite end point were recorded for up to 36 months. In patients randomized to sevelamer, all-cause mortality and the composite end point were lower; a nonsignificant trend was noted for dialysis inception. Sevelamer provided benefits in all-cause mortality and in the composite end point of death or dialysis inception but not advantages in dialysis inception. Larger studies are needed to confirm these results.

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Health care utilization among patients with chronic kidney disease.

Rashid Kazmi, Annamaria Kausz, Brian J G Pereira … (2002)

Higher hospitalization rates among end-stage renal disease (ESRD) patients impose a substantial burden on the U.S. health care system. Early identification of patients with chronic kidney disease (CKD) and determination of factors associated with increased morbidity may lead to appropriate interventions to attenuate the complications of CKD and possibly reduce future resource utilization. This retrospective cohort study of CKD patients in an outpatient nephrology clinic was performed to identify risk factors for hospitalization. The study population consisted of adults with elevated serum creatinine (females > or =1.5 mg/dL, males > or =2.0 mg/dL). Hospitalizations, hospital days and outpatient nephrology visits were examined. Among the 259 patients, 123 (47%) were hospitalized during a median follow-up of 11.4 months. The number of hospitalizations and hospital days per patient-year at risk were 0.96 and 6.6, respectively. Cardiovascular disease/hypertension accounted for the majority of hospitalizations. In a multivariate regression analysis, older age (RR 1.01, 95% CI 1.00, 1.03) and presence of cardiac disease (RR 1.91, 95% CI 1.19, 3.07) were associated with higher risk of hospitalization while higher serum albumin (RR 0.58, 95% CI 0.35, 0.95) and higher hematocrit (RR 0.92, 95% CI 0.87, 0.97) were associated with lower risk of hospitalization. Higher serum albumin (RR 0.34, 95% CI 0.21, 0.55), higher hematocrit (RR 0.87, 95% CI 0.81, 0.93) and use of ACE-inhibitors (RR 0.63, 95% CI 0.47, 0.84) were associated with lower risk of subsequent hospital days. Erythropoietin (RR 1.47, 95% CI 1.11, 1.82) use was associated with higher risk of outpatient nephrology visits. Certain potentially modifiable factors appear to be associated with increased resource utilization. It is hypothesized that attention to these factors may lead to improved outcomes in this patient population, which could result in reduced utilization.

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A comparison of sevelamer and calcium-based phosphate binders on mortality, hospitalization, and morbidity in hemodialysis: a secondary analysis of the Dialysis Clinical Outcomes Revisited (DCOR) randomized trial using claims data.

Eric D Weinhandl, Qiao Fan, L Peter … (2008)

The Dialysis Clinical Outcomes Revisited (DCOR) trial, a large, randomized, multicenter, open-label study, compared effects of sevelamer with calcium-based phosphate binders on mortality and hospitalization in hemodialysis patients. Many patients were lost to follow-up, precluding intent-to-treat analysis by using prospective data collection. Preplanned secondary analysis, intent-to-treat design for all outcomes, using Centers for Medicare & Medicaid Services (CMS) data. Participants were 18 years or older and on hemodialysis therapy for more than 3 months, with Medicare as primary payor. The trial was completed at the end of 2004. Sevelamer, calcium-based phosphate binders. Mortality, morbidity, and hospitalization end points. DCOR subjects were linked to the CMS End-Stage Renal Disease database. Outcomes were evaluated through the CMS End-Stage Renal Disease enrollment and claims database; baseline characteristics and comorbid conditions were evaluated using CMS and case-report data. Groups were well balanced except for a greater percentage of calcium-group patients with atherosclerotic heart disease. Analyses were adjusted by using 10 baseline characteristics. All-cause (17.7 versus 17.4 deaths/100 patient-years; P = 0.8 unadjusted; P = 0.9 adjusted) and cardiovascular mortality (9.0 versus 8.2 deaths/100 patient-years; P = 0.3 unadjusted; P = 0.4 adjusted) did not differ significantly between treatment groups. First hospitalization, cause-specific multiple hospitalizations, first morbidity, and multiple morbidity rates also did not differ significantly. Multiple all-cause hospitalization rate (1.7 versus 1.9 admissions/patient-year; P = 0.03 unadjusted; P = 0.02 adjusted) and hospital days (12.3 versus 13.9 days/patient-year; P = 0.05 unadjusted; P = 0.03 adjusted) were lower in the sevelamer group. Outcome parameters and cardiovascular comorbidity assessments were derived from Medicare claims data; only subjects with Medicare-as-primary-payor status were included in hospitalization and morbidity analyses. In this secondary analysis, treatment with sevelamer versus calcium-based binders did not affect overall mortality (primary outcome), cause-specific mortality, morbidity, or first or cause-specific hospitalization (secondary outcomes), but there was evidence for a beneficial effect on multiple all-cause hospitalizations and hospital days (secondary outcomes).

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Author and article information

Contributors

Hai V. Nguyen: vanhai.nguyen@duke-nus.edu.sg

Journal

Journal ID (nlm-ta): BMC Nephrol

Journal ID (iso-abbrev): BMC Nephrol

Title: BMC Nephrology

Publisher: BioMed Central (London )

ISSN (Electronic): 1471-2369

Publication date (Electronic): 28 April 2016

Publication date PMC-release: 28 April 2016

Publication date Collection: 2016

Volume: 17

Electronic Location Identifier: 45

Affiliations

[ ]Program in Health Services and Systems Research, Duke-NUS Medical School, 8 College Road, Singapore, 169857 Singapore

[ ]Division of Cardiac, Thoracic, and Vascular Surgery, National University Hospital, 5 Lower Kent Ridge Road, Singapore, 119074 Singapore

Article

Publisher ID: 256

DOI: 10.1186/s12882-016-0256-0

PMC ID: 4848865

PubMed ID: 27121505

SO-VID: 14109053-6f06-4239-b65c-cb9b57c1a14d

License:

Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

History

Date received : 20 August 2015

Date accepted : 21 April 2016

Funding

Funded by: Sanofi-Aventis (Singapore)

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ScienceOpen disciplines: Nephrology

Keywords: sevelamer,calcium carbonate,dialysis,hyperphosphatemia,chronic kidney disease,cost-effectiveness

Data availability:

ScienceOpen disciplines: Nephrology

Keywords: sevelamer, calcium carbonate, dialysis, hyperphosphatemia, chronic kidney disease, cost-effectiveness

Incremental cost-utility of sevelamer relative to calcium carbonate for treatment of hyperphosphatemia among pre-dialysis chronic kidney disease patients

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Karger: Nephrology

Most cited references 12

Mortality in kidney disease patients treated with phosphate binders: a randomized study.

Health care utilization among patients with chronic kidney disease.

A comparison of sevelamer and calcium-based phosphate binders on mortality, hospitalization, and morbidity in hemodialysis: a secondary analysis of the Dialysis Clinical Outcomes Revisited (DCOR) randomized trial using claims data.

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