Cost effectiveness of paricalcitol versus cinacalcet with low-dose vitamin D for management of secondary hyperparathyroidism in haemodialysis patients in the USA.

BACKGROUND: The IMPACT SHPT [Improved Management of Intact Parathyroid Hormone (iPTH) with Paricalcitol-Centered Therapy Versus Cinacalcet Therapy with Low-Dose Vitamin D in Hemodialysis Patients with Secondary Hyperparathyroidism] study compared the effectiveness of paricalcitol and cinacalcet in the management of secondary hyperparathyroidism in haemodialysis patients but did not report the costs or cost effectiveness of these treatments. AIM: The aim of this study was to compare the cost effectiveness of a paricalcitol-based regimen versus cinacalcet with low-dose vitamin D for management of secondary hyperparathyroidism in haemodialysis patients from a US payer perspective, using a 1-year time horizon. METHODS: This was a post hoc cost-effectiveness analysis of data collected for US patients enrolled in the IMPACT SHPT study-a 28-week, randomized, open-label, phase 4, multinational study (ClinicalTrials.gov identifier: NCT00977080). Patients eligible for the IMPACT SHPT study were aged≥18 years with stage 5 chronic kidney disease, had been receiving maintenance haemodialysis three times weekly for at least 3 months before screening and were to continue haemodialysis during the study. Only US patients who reached the evaluation period (weeks 21-28) were included in this secondary analysis. US subjects in the IMPACT SHPT study were randomly assigned to receive intravenous paricalcitol, or oral cinacalcet plus fixed-dose intravenous doxercalciferol, for 28 weeks. Patients in the paricalcitol group could also receive supplemental cinacalcet for hypercalcaemia. The primary effectiveness endpoint in the IMPACT SHPT study was the proportion of subjects who achieved a mean intact parathyroid hormone (iPTH) level of 150-300 pg/mL during the evaluation period. In this secondary analysis, we estimated the incremental cost-effectiveness ratio (ICER), comparing paricalcitol-treated patients with cinacalcet-treated patients on the basis of this primary endpoint and several secondary endpoints. Costs were estimated by examining the dosage of the study drug (paricalcitol or cinacalcet) and phosphate binders used by each participant during the trial. Nonparametric bootstrap analysis was used to examine the accuracy of the ICER point estimates. RESULTS: The percentages of patients achieving the treatment goal of a mean iPTH level between 150-300 pg/mL during weeks 21-28 of therapy were 56.9% in the paricalcitol group and 34.0% in the cinacalcet group (a difference of 23%, p=0.0235). Paricalcitol was also more effective for each of the secondary endpoints. When annualized, the total drug costs were US$10,153 in the paricalcitol group and US$15,967 in the cinacalcet group, a difference of US$5,814 (57.3%, p=0.0053). Because the paricalcitol-based treatment was less expensive and more effective, it was 'dominant', compared with cinacalcet, in this cost-effectiveness analyses. In our bootstrap analysis, 99.1% of bootstrap replicates for the ICER of the primary endpoint fell within the lower right quadrant of the cost-effectiveness plane-where paricalcitol is considered dominant. For all of the other endpoints, paricalcitol was dominant in 100% of replicates. CONCLUSION: On the basis of dosing and effectiveness data from US patients in the IMPACT SHPT study, we found that a regimen of intravenous paricalcitol was more cost effective than cinacalcet plus low-dose vitamin D in the management of iPTH in patients with SHPT requiring haemodialysis.

Comparative cost analysis of management of secondary hyperparathyroidism with paricalcitol or cinacalcet with low-dose vitamin D in hemodialysis patients.

OBJECTIVE: The objective of this analysis was to compare costs of paricalcitol or cinacalcet plus low dose vitamin D, and of phosphate binders, in patients in the IMPACT SHPT study; and to extrapolate those to estimate expected annual maintenance costs. METHODS: IMPACT SHPT was a 28-week, randomized, open-label trial. Subjects from 12 countries received intravenous (IV) or oral paricalcitol, or oral cinacalcet plus fixed IV doxercalciferol or oral alfacalcidol. The primary end-point was the proportion of subjects who achieved a mean intact parathyroid hormone (iPTH) value of 150-300 pg/mL during weeks 21-28 (evaluation period). This study compares the costs of study drugs and phosphate binders among participants during the study and annualized. This analysis includes only those subjects that reached the evaluation period (134 in each group). RESULTS: The mean total drug costs over the study period were €2606 (SD = €2000) in the paricalcitol group and €3034 (SD = €3006) in the cinacalcet group (difference €428, p = 0.1712). The estimated annualized costs were €5387 (SD = €4139) in the paricalcitol group and €6870 (SD = €6256) in the cinacalcet group (difference €1492, p = 0.0395). In addition, a significantly greater proportion (p = 0.010) of subjects in the paricalcitol arm (56.0%) achieved an iPTH of 150-300 pg/mL during the evaluation period compared to the cinacalcet arm (38.2%). LIMITATIONS: This was a secondary analysis of the IMPACT SHPT study which was not designed or powered for costs as an outcome. The dosing of study drugs and phosphate binders in the IMPACT study may not reflect actual practice, and patients were followed for 28 weeks, while the treatment of SHPT is long-term. CONCLUSION: Patients with SHPT requiring hemodialysis who were treated with a paricalcitol-based regimen for iPTH control had lower estimated annual drug costs compared to those treated with cinacalcet plus low-dose vitamin D.

Does predialysis nephrology care influence patient survival after initiation of dialysis?

BACKGROUND: Early nephrology referral of patients with chronic kidney disease (CKD) has been suggested to reduce mortality after initiation of dialysis. This retrospective cohort study of incident dialysis patients between 1995 and 1998 was performed to address the association between frequency of nephrology care during the 24 months before initiation of dialysis and first-year mortality after initiation of dialysis. METHODS: Patient data were obtained from the Centers for Medicare & Medicaid Services. Patients who started dialysis between 1995 and 1998, and were Medicare-eligible for at least 24 months before initiation of dialysis, were included. One or more nephrology visits during a month was considered a month of nephrology care (MNC). RESULTS: Of the total 109,321 patients, only 50% had received nephrology care during the 24 months before initiation of dialysis. Overall, first-year mortality after initiation of dialysis was 36%. Cardiac disease was the major cause of mortality (46%). After adjusting for comorbidity, higher mortality was associated with increasing age (HR, 1.04 per year increase; 95% CI, 1.03 to 1.04) and more frequent visits to generalists (HR, 1.009 per visit increase; 95% CI, 1.003 to 1.014) and specialists (HR, 1.012 per visit increase; 95% CI, 1.011 to 1.013). Compared to patients with >/=3 MNC in the six months before initiation of dialysis, higher mortality was observed among those with no MNC during the 24 months before initiation of dialysis (HR, 1.51; 95% CI, 1.45 to 1.58), no MNC during the six months before initiation of dialysis (HR, 1.28; 95% CI, 1.20 to 1.36), and one or two MNC during the six months before initiation of dialysis (HR, 1.23; 95% CI, 1.18 to 1.29). CONCLUSION: Nephrology care before dialysis is important, and consistency of care in the immediate six months before dialysis is a predictor of mortality. Consistent nephrology care may be more important than previously thought, particularly because the frequency and severity of CKD complications increase as patients approach dialysis.

Chronic kidney disease: the distribution of health care dollars.

BACKGROUND: The cost of care for end-stage renal disease (ESRD) is known to be high. The factors responsible for higher ESRD cost develop during chronic kidney disease (CKD), where the data on distribution of cost are limited. METHODS: This retrospective cohort study of 1995 through 1998 incident dialysis patients was performed to study the distribution of costs during the 24 months prior to initiation of dialysis. Patient data were obtained from the Centers for Medicare and Medicaid Services (CMS). Patients who were Medicare eligible for at least 2 years prior to initiation of dialysis were included in the study. Financial data were obtained from Medicare Part A and Part B claims and inflationary adjustments were made. The study period was divided into four segments based on overall distribution of cost. RESULTS: The mean age was 75 years, 51% were males, 73% were white, and 22% were black. Overall, patient comorbidity increased significantly during the study years. Cost showed a sharp increase in the last 6 months prior to initiation of dialysis. Hospitalization was the major component of cost throughout study period. Patients who initiated hemodialysis incurred a higher cost compared to patients who initiated other modes of kidney replacement therapy. Patients with diabetes or cardiovascular disease incurred higher cost compared to those who had no diabetes or cardiovascular disease, respectively. CONCLUSION: These data showed that hospitalization was the major component of the sharp increase in cost around the initiation of dialysis. Increased comorbidity was associated with higher cost. A focus on timely management of CKD may prevent future morbidity and costs.

Late nephrology referral and mortality among patients with end-stage renal disease: a propensity score analysis.

BACKGROUND: Late nephrology referral has been associated with adverse outcomes among patients with end-stage renal disease; however, its relationship to mortality is unclear. We examined the impact of timing of nephrology care relative to initiation of dialysis on mortality after initiation of dialysis. METHODS: Data from the Dialysis Morbidity and Mortality Study - Wave II, a prospective study of incident dialysis patients, were used. Late referral (LR) was defined as first nephrology visit <4 months and early referral (ER) as first nephrology visit >or=4 months prior to initiation of dialysis. Propensity scores (PS) were estimated using logistic regression to predict the probability that a given patient was LR. A Cox proportional hazards model was built to examine the association between timing of nephrology referral and mortality. RESULTS: The cohort was comprised of 2195 patients: 54% were males, 66% were Caucasians, 26% were African-Americans and 33% were referred late. A Cox proportional hazards analysis demonstrated that compared with ER patients, LR patients had a 44% higher risk of death at 1 year after initiation of dialysis [hazards ratio (HR) = 1.44; 95% confidence interval (CI): 1.15-1.80], which remained significant after adjusting for quintiles of PS (HR = 1.42; 95% CI: 1.12-1.80). CONCLUSIONS: Among patients with chronic kidney disease (CKD) who initiated dialysis, LR was associated with higher risk of death at 1 year after initiation of dialysis compared with ER.

Health care utilization among patients with chronic kidney disease.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Management of patients with chronic renal insufficiency in the Northeastern United States.

Comorbid conditions that develop during chronic renal insufficiency (CRI) contribute to the high morbidity and mortality among patients with end-stage renal disease (ESRD). Thus, appropriate management during CRI may lead to improved ESRD outcomes. A retrospective cohort study was performed to describe the management of patients with CRI. A total of 602 patients with CRI (creatinine > or =1.5 mg/dl for women and > or =2.0 mg/dl for men) were seen between October 1994 and September 1998 at five nephrology outpatient clinics in the Boston area. The mean (SD) age of the patients was 63 (15.5) yr, and 53% were male. At the first nephrology visit, mean (SD) serum creatinine was 3.2 (1.6) mg/dl, and mean (SD) predicted GFR was 22.3 (8.9) ml/min per 1.73 m(2). Laboratory tests for iron levels were performed in only 18% of patients, serum parathyroid hormone levels were obtained in only 15%, lipid studies were obtained in fewer than half, and among patients with diabetes, only 28% had a glycosylated hemoglobin level measured. A hematocrit <30% was present in 38%, and abnormal calcium-phosphorus metabolism was noted in 55%. Only 59% of patients who had hematocrit <30% received recombinant human erythropoietin. Among patients who received recombinant human erythropoietin, only 47% received iron. Angiotensin-converting enzyme inhibitor use was recorded for only 65% of patients with diabetes (49% of patients overall). Among patients who were known to have progressed to ESRD, only 41% had permanent access placed before initiation of dialysis. There seems to be room for improvement in the management of patients with CRI, which could result in a slower rate of progression of CRI and reduced severity of comorbid conditions.