Background and objectives: A secondary analysis of the Dialysis Clinical Outcomes
Background and objectives: A secondary analysis of the Dialysis Clinical Outcomes Revisited (DCOR) trial suggested that sevelamer reduced hospitalizations relative to calcium-based phosphate binders. Sevelamer reduced inpatient Medicare costs compared with calcium binders. However, when binder costs were added, overall PMPM costs favored calcium-treated over sevelamer-treated participants. Phosphate-binding therapy is considered integral to the management of hyperphosphatemia in hemodialysis individuals. Current National Kidney Basis Kidney Disease Results Quality Initiative medical practice recommendations for bone rate of metabolism and disease in chronic kidney disease show that calcium-based and nonCcalcium-, nonCaluminum-, nonCmagnesium-containing phosphate binders (such as sevelamer) are effective and can be used as main therapy (1). However, issues about soft-tissue calcification with use of calcium-based binders and a small observational study suggesting that sevelamer may lead to reduced hospitalizations relative to calcium-based binders led to a large-scale randomized trial (Dialysis Clinical Results Revisited [DCOR]) comparing sevelamer with calcium-based binders in Medicare-covered hemodialysis individuals (2C4). Results showed no mortality difference in the overall population but significantly reduced hospitalization rates (10%) and days (12%) with sevelamer treatment (5,6). However, whether changed medical Rabbit polyclonal to POLDIP2 costs associated with reduced hospitalizations or additional medical solutions offset the higher cost of sevelamer compared with calcium binders is definitely unclear. A recent economic study concluded that hospitalization risk would have to be reduced by 30% to offset the additional costs of sevelamer, presuming no difference in mortality (7). However, many cost inputs were estimated because actual costs were unavailable. This study reports methods and secondary economic analysis of the DCOR trial in which Medicare costs for study participants could be directly evaluated. The objectives were to (calcium-treated individuals; (= 2103) were enrolled from March 2001 through January 2002 and randomly assigned to sevelamer (Renagel; Genzyme, Cambridge, MA; = 1053) or calcium-based phosphate binders (calcium acetate [PhosLo; Braintree Laboratories, Braintree, MA] or calcium carbonate [TUMS; GlaxoSmithKline, Philadelphia, PA]; = 1050). Included participants were adults receiving hemodialysis therapy with Medicare as the primary payer. The trial was 924416-43-3 IC50 completed at the end of 2004. Case report form data from 2101 of 2103 participants were linked to the Centers for Medicare & Medicaid Solutions ESRD database; of 2101 participants, 1947 (92.7%) met the Medicare-as-primary-payer criterion regarding dialysis statements (at least $675 in dialysis costs in a month for at least 90% of the follow-up weeks), so health care services info and costs could be collected. Of 1947 participants randomized, 1895 (97.3%) received a 924416-43-3 IC50 study medication. Detailed methodologic information about the DCOR medical trial and secondary analysis data sources, patient characteristics, and methods for mortality, morbidity, and hospitalization is definitely reported elsewhere (4C6). Follow-Up Dosed participants were adopted from the initial prescription day to the earliest date of death, kidney transplant, modality switch to peritoneal dialysis, early site closure, or early termination plus 90 d. In independent level of sensitivity analyses, we also evaluated randomized participants adopted from randomization day to these events and through the end of the study (intent-to-treat). Outcome The outcome was medical costs (Medicare health care costs plus phosphate binder costs). Medicare costs were defined by Medicare allowable amounts on submitted statements during the follow-up period. Per member per month (PMPM) costs were determined for total, inpatient, outpatient, experienced nursing facility, and additional medical claims. Each category of cost includes institutional and physician costs. An actuarial model was used to further categorize health care costs for a better understanding of which costs drove variations between organizations. To classify costs, institutional revenue codes, diagnosis-related 924416-43-3 IC50 groupings, Current Procedural Terminology codes, and Healthcare Common Process Coding System codes were used. Medicare allowable amounts were used to determine costs in each category. Phosphate binder costs were estimated because Medicare did not cover most outpatient oral medications before Medicare Part D went into effect in January 2006. A imply dose per day was determined for each participant.