Cost of Applying the K/DOQI Guidelines for Bone Metabolism and Disease

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Cost of Applying the K/DOQI Guidelines for Bone Metabolism and Disease

Abstract and Introduction

Abstract


Hyperphosphatemia is a common feature of advanced chronic kidney disease (CKD) and is treated routinely with oral calcium-based phosphate binders. In 2003, the National Kidney Foundation Kidney Disease Outcomes and Quality Initiative (K/DOQI) published Clinical Practice Guidelines (CPGs) for the treatment of Bone Metabolism and Disease in CKD. These advocate broad usage of expensive non-calcium-based phosphate binders such as sevelamer. This study was designed to determine the cost of implementation of the K/DOQI CPGs as they pertain to phosphate binding in a large Canadian hemodialysis (HD) unit. Laboratory and medication data for all chronic HD patients at the Ottawa Hospital were reviewed (n=416). Patients meeting each of the relevant K/DOQI guidelines were identified. Where guidelines would recommend a switch to non-calcium binders, equivalent sevelamer doses were estimated. The cost of implementing each guideline was then calculated individually and an estimate total cost of implementing all the guidelines was derived. Overall, 53% (222) patients fulfilled at least one criterion for sevelamer use. The yearly cost of implementation of the K/DOQI guidelines at this center was estimated at $ 500 605 (American dollars). Given the significant cost, widespread adoption of the K/DOQI CPGs for Bone Metabolism and Disease should await the publication of compelling data demonstrating significant improved outcomes in patients treated with sevelamer.

Introduction


Advanced chronic kidney disease (CKD) is complicated by metabolic bone disease, hyperphosphatemia, and abnormalities of parathyroid hormone (PTH) secretion. The sequelae of these include bone pain and fracture, hypertension, and extra-osseous calcification, including vascular calcification that has been implicated in the excess cardiovascular mortality of CKD patients. Hyperphosphatemia itself is also associated with an increased risk of mortality.

Dietary phosphate (PO4) restriction and oral PO4 binders comprise the initial and principal steps in the management of hyperphosphatemia. Aluminum-based PO4 binders were once used extensively to treat hyperphosphatemia. These were largely abandoned when aluminum was found to contribute to anemia, myopathies, dementia, and low-turnover bone disease. Aluminum was replaced by the calcium-based PO4 binders, calcium acetate, and calcium carbonate (CaCO3). There is now growing concern that these may contribute to or accelerate the vascular calcification observed in hemodialysis (HD) patients. More recently, non-calcium and non-aluminum-based binders such as sevelamer have been developed. As yet, there are no published randomized controlled trials (RCTs) comparing sevelamer to calcium-based phosphate binders with clinical endpoints such as cardiovascular events and mortality.

In 2003, the US National Kidney Foundation (NKF) Kidney Disease Outcomes Quality Initiative (K-DOQI) published Clinical Practice Guidelines (CPGs) for Bone Metabolism and Disease in CKD. These CPGs advocate the use of sevelamer across a range of common clinical scenarios in CKD ( Table 1 ). Sevelamer is significantly more costly than the calcium-based salts. By analyzing patients in our large HD program, we have determined the economic impact of a 'common sense' application of the phosphate-binding recommendations of the NKF K/DOQI CPGs for Bone Metabolism and Disease in CKD.

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