Budget impact of secondary hyperparathyroidism treatment in chronic kidney disease in an Ecuadorian social security hospital.

BACKGROUND: Chronic kidney disease (CKD) is a disorder with high morbidity and mortality worldwide whose complications generate multiple costs. In Ecuador, only a few healthcare institutions have implemented management protocols aimed to reduce costs and to improve the quality of life of patients. The aim of this study is to evaluate the short-term (1-year) and long-term (5-year) costs and savings in the management of secondary hyperparathyroidism (SHPT) of hemodialyzed CKD patients by comparing calcitriol and paricalcitol in a large social security hospital in Quito, Ecuador. METHODS: The estimation model assessed the resources used in the management of SHPT by comparing prospectively the cost savings within 1-year and 5-year time horizon with calcitriol and paricalcitol. Hospitalization, erythropoietin (EPO), treatment doses, intravenous iron consumption, and medical supplies were estimated according international references, based on the initial parathormone level (iPTH) of patients. The Ecuadorian National Reference costs (2014-2015) and institutional costs were used to calculate treatment costs. A statistical sensitivity analysis was also performed. RESULTS: The study was based on data from 354 patients of whom 147 (41.4 %) had a value of iPTH in the range 300-600 pg/ml, 45 (12.8 %) in the range 601-800 pg/ml, and 162 (45.7 %) over 800 pg/ml. The 1-year estimated costs per patient for calcitriol and paricalcitol, respectively, were: medication, 63.88 USD and 1,123.44 USD; EPO, 19,522.95 USD and 16,478 USD; intravenous iron 143.21 USD and 187.76 USD. Yearly hospitalization costs per patient were 11,647.99 USD with calcitriol and 8,019.41 USD with paricalcitol. Total yearly costs per patient amounted to 31,378.02 USD with calcitriol and 25,809.50 USD with paricalcitol. Total savings using paricalcitol were 5,568.52 USD per patient compared with calcitriol. The 5-year cumulative medication costs were 319 USD for calcitriol and 2,403 USD for paricalcitol; EPO with calcitriol was 97,615 USD and with paricalcitol 82,394 USD; intravenous iron with calcitriol was 716 USD and paricalcitol 939 USD. Hospitalization costs for patients with calcitriol and paricalcitol were 43,095 USD and 62,595 USD, respectively. Total savings using paricalcitol amounted 32,414 USD per patient compared with calcitriol. CONCLUSIONS: Paricalcitol use generated more cost savings than calcitriol after 1 and 5 years.

Comparison of oral and intravenous alfacalcidol in chronic hemodialysis patients.

BACKGROUND: Activated vitamin D is the mainstay of treatment for secondary hyperparathyroidism (SHPT) in chronic hemodialysis patients. However, the optimal route of administration is still debated. The aim of our study was to compare efficacy of oral vs intravenous (IV) administration of alfacalcidol in hemodialysis. A secondary objective was to determine the cost-effectiveness advantage of oral administration. METHODS: Eighty-eight chronic hemodialysis patients receiving IV alfacalcidol three times a week were included in the study. All were switched to the same dose of alfacalcidol given orally three times a week during the hemodialysis session. A budget impact analysis was performed. RESULTS: Mean patient age was 64 years old and 43% were males. The mean alfacalcidol dose administered was 2.1 µg three times a week. After three months, serum parathormone (PTH) levels decreased from 80 to 59 pmol/L (p = 0.001) and total serum calcium levels increased from 2.34 to 2.40 mmol/L (p = 0.002). After six months, total serum calcium levels were still significantly higher. Alfacalcidol dosage was significantly decreased during study period; the mean reduction was 0.44 µg per dose. Finally, oral administration was associated with an annual cost reduction of 197 678$CAN and an annual nursing time reduction of 25 days. CONCLUSION: Our findings support that switching IV to oral administration of alfacalcidol during hemodialysis sessions may lead to a similar control of SHPT with lower doses of activated vitamin D. This is a good strategy for optimizing compliance and may allow a dose reduction because of a greater efficacy to suppress PTH. Oral administration also has significant cost-effectiveness advantages.

Parathyroidectomy reduces the costs of medication in patients with secondary hyperparathyroidism.

INTRODUCTION: Subtotal Parathyroidectomy (S-PTx) and total Parathyroidectomy with immediate Autograft (PTx-AG) are well-established techniques for the treatment of refractory Secondary Hyperparathyroidism (SHPT), with comparable improvements in patients' quality of life and survival. However, the long-term costs after these operations may impact the choice of surgical technique. The objective of the study is to analyze the impact of surgical treatment on medication costs and whether there is any difference between medication use after each procedure, considering impacts on the health system. MATERIAL AND METHODS: Prospective and randomized study in patients with severe SHPT undergoing S-PTx and PTx-AG. Analysis of prescribed medication costs in the month before the postoperative period at 1-, 3-, 6-, 12-, and 18 months. Costs were estimated according to government payment system values. The medications of 65 patients after PTx-AG were compared with those of 24 patients after S-PTx. A comparison of the total costs of the period between 38 men and 51 women was also made. RESULTS: There were 89 evaluable cases. Surgery reduced medication costs after 12 months. The median of total drug costs in the analyzed period was R$ 8,375.00 per patient. There was no difference in costs per patient in the S-PTx group compared to the PTx-AG group. The median total costs were R$ 11,063.0 for men and R$ 7,651.0 for women (p = 0.0078). CONCLUSIONS: The type of parathyroidectomy did not impact costs after surgery. In the first year after surgery, the use of calcium and calcitriol was more significant than the use of other medications. In the following months, the use of sevelamer is responsible for the highest costs. Men have higher costs in outpatient follow-up after surgery.

Cost-effectiveness of cinacalcet hydrochloride for hemodialysis patients with severe secondary hyperparathyroidism in Japan.

BACKGROUND: Cinacalcet effectively reduces elevated levels of parathyroid hormone (PTH) in patients with secondary hyperparathyroidism (SHPT), even those with severe disease for whom parathyroidectomy can be the treatment of choice. The objective of this study was to estimate the cost-effectiveness of cinacalcet treatment in hemodialysis patients with severe SHPT in Japan. STUDY DESIGN: Cost-effectiveness analysis. SETTING & POPULATION: Patients with severe SHPT (intact PTH >500 pg/mL) who were receiving hemodialysis in Japan. MODEL, PERSPECTIVE, & TIMEFRAME: A Markov model was constructed from the health care system perspective in Japan. Patients were followed up over their lifetime. Dialysis costs were not included in the base case. INTERVENTION: Cinacalcet as an addition to conventional treatment compared to conventional treatment alone. In both arms, patients underwent parathyroidectomy if intact PTH level was >500 pg/mL for 6 months and they were eligible for surgery. OUTCOMES: Costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs). RESULTS: ICERs for cinacalcet for those who were eligible for surgery and those who were not were $352,631/QALY gained and $21,613/QALY gained, respectively. Sensitivity and scenario analyses showed that results were fairly robust to variations in model parameters and assumptions. In the probabilistic sensitivity analysis, cinacalcet was cost-effective in only 0.9% of simulations for those eligible for surgery, but in more than 99.9% of simulations for those ineligible for surgery, if society would be willing to pay $50,000 per additional QALY. LIMITATIONS: Data for the long-term effect of cinacalcet on patient-level outcomes are limited. The model predicted rates for clinical events using data for the surrogate biochemical end points. CONCLUSIONS: The use of cinacalcet to treat severe SHPT is likely to be cost-effective for only those who cannot undergo parathyroid surgery for medical or personal reasons.

Cinacalcet - clinical and laboratory effectiveness, concomitant treatment patterns and treatment cost: could we do better and how?

BACKGROUND: The cost and effectiveness patterns in the treatment of secondary hyperparathyroidism (SHPT) in dialysis patients in the Czech Republic are unknown. METHODS: 52 dialysis patients from 17 centers were followed up in a multicenter prospective study of laboratory and clinical (hospitalization rate, clinical complaints questionnaire) responses to 12-month cinacalcet treatment. Treatment patterns and cost (including phosphate binders, vitamin D, and cinacalcet) were evaluated. RESULTS: The mean s-Ca dropped significantly from 2.36 ± 0.24 to 2.21 ± 0.20 mmol/l, s-P from 2.45 ± 0.54 to 2.01 ± 0.53 mmol/l, Ca×P from 5.79 ± 1.25 to 4.42 ± 1.13 mmol²/l², and iPTH dropped from 919.0 ± 465.6 to 372.1 ± 294.6 pg/ml. The mean cinacalcet dose reached 44.1 ± 23.0 mg/day after 12 months. Itching intensity decreased significantly. No change in hospitalization rate was observed. The direct cost of daily SHPT treatment rose significantly from EUR 8.77 ± 9.59 to 20.62 ± 9.22. CONCLUSIONS: Cinacalcet decreased elevated s-Ca, s-P, Ca×P, and iPTH, alleviated itching, and significantly raised the SHPT treatment cost. A minority of patients reached K/DOQI targets, especially due to poor phosphate control caused by insufficient phosphate binder treatment, cinacalcet underdosing, and advanced SHPT.

Association of secondary hyperparathyroidism with CKD progression, health care costs and survival in diabetic predialysis CKD patients.

BACKGROUND/AIMS: The objective of this study was to examine health care costs and utilization and the risks of dialysis or mortality among diabetic predialysis chronic kidney disease (CKD) patients with and without secondary hyperparathyroidism (SHPT). METHODS: This retrospective, matched cohort study examined insurance claims from 703 adult diabetic predialysis CKD patients with and without SHPT during a 72-month follow-up period. Annualized estimates of health care service utilization, costs and disease progression to dialysis or death following index CKD diagnosis were compared. RESULTS: Preindex (baseline) characteristics were similar between the cohorts. Postindex numbers of prescription utilization, outpatient service utilization and hospitalizations were all higher (p < 0.0001) in diabetic CKD patients with SHPT compared to those without SPHT in both unadjusted and adjusted analyses even after multivariate adjustment for known confounders. The rate of progression to dialysis or death was higher for diabetic CKD patients with SHPT compared to those without SPHT. Those with SHPT were at higher risk of requiring dialysis treatment [hazard ratio (HR) = 6.7; 95% confidence interval (CI) = 4.3-10.6] and death (HR = 2.3; 95% CI = 1.1-4.9) compared to those without SHPT. CONCLUSION: In diabetic predialysis CKD patients, the presence of SHPT is associated with significantly greater health care resource utilization and costs, and a faster rate of disease progression.

[Chronic kidney disease (CKD) and bone. Control of CKD-MBD from the viewpoint of the medical cost].

Pharmacoeconomics (PE) , which contribute to the decisions on the population rather than the patient level such as policy making, provides us with the cost and value of a given drug. In the midst of terrible economic climate, medications for CKD-MBD are reviewed from the viewpoint of PE in this manuscript. DCOR trial is the only study in maintenance hemodialysis patients with mortality as a primary endpoint, which compared expensive sevelamer hydrochloride and economical calcium containing phosphate binders, showing no difference in mortality between these drugs. This means that calcium containing phosphate binders are more cost-effective. Cost utility analysis from the United States revealed that parathyroidectomy became more cost-effective at 16 months than cinacalcet hydrochloride, which theoretically have to be continued throughout life. The effect of active vitamin D on mortality is controversial, since there has not been any prospective randomized controlled trial. Taking these findings into account, cinacalcet should be indicated only in those patients who have secondary hyperparathyroidism refractory to conventional therapy and for whom parathyroidectomy is not a good indication. Furthermore, when cinacalcet have to be used, we should give priority to calcium containing phosphate binders rather than expensive sevelamer from the viewpoint of the medical cost. Moreover, the doses of cinacalcet should be minimized by administering inexpensive vitamin D concomitantly.

Cost-effectiveness of early versus late cinacalcet treatment in addition to standard care for secondary renal hyperparathyroidism in the USA.

OBJECTIVES: The objective of this research was to estimate lifetime cost-effectiveness of treating patients with cinacalcet early (when parathyroid hormone [PTH] levels are in the range of 300-500 pg/ml) versus delaying treatment with cinacalcet (cinacalcet initiated when PTH levels are > 800 pg/ml) in patients with secondary hyperparathyroidism (SHPT) in the US setting. METHODS: A Markov model was developed to simulate the effects of early versus delayed use of cinacalcet (plus standard of care). Four different PTH ranges (< or = 300 pg/ml; 301-500 pg/ml; 501-800 pg/ml; > 800 pg/ml) were used to represent four different health states within the Markov model. Associated with each Markov state (PTH range) were varying risks of major SHPT complications, including cardiovascular disease (CVD), fracture (Fx), and parathyroidectomy (PTx). Baseline cohort characteristics and risks of CVD, Fx, and PTx by PTH category were derived from a large US renal database and published sources. Costs were estimated from the US Renal Data System database and reported in 2006 US Dollars ($). Clinical and economic outcomes were discounted at 3.0% per annum. RESULTS: Early treatment was projected to improve quality-adjusted life years (QALYs) by 0.337 years compared to delaying treatment. The incremental cost-effectiveness ratio was $17,275 per QALY gained. CONCLUSIONS: Early treatment with cinacalcet was associated with improvements in QALYs and would represent good value for money compared to delaying treatment with cinacalcet.

[Is Cinacalcet a cost-effective treatment in severe secondary hyperparathyroidism in patients on hemodialysis?]. / Es el cinacalcet un tratamiento coste-efectivo en el hiperparatiroidismo secundario severo en pacientes en hemodiálisis?

BACKGROUND: A previous study using cinacalcet, as compared to vitamin D alone, showed a better reduction response of PTH levels and a significant diminution of secondary effects. The objective of present study was to evaluate the additional cost of adding cinacalcet to the standard treatment of patients with severe secondary hyperparathyroidism (SHPT) taking into account the treatment goals achieved. METHODS: 12 month prospective study of 23 patients with severe SHPT. Two treatment regimens were considered: standard treatment (m 0) and standard treatment plus cinacalcet (m 12). Four consequences of inadequate control of SHPT were registered: parathiroid hormone (PTH), Calcium (Ca), Phosphorus (P) and the Ca x P product serum levels. Treatment effectiveness was measured as percentage of patients who achieved treatment goal according to each indicator: PTH < 800 pg/mL, PTH between 150 and 300 pg/mL, Calcium < 9.5 mg/dL, Phosphorus < 5.5 mg/dL, and Ca x P product < 55. Annual and monthly costs were calculated for both treatment regimens using Spanish 2007 tariffs, and taking into account the dose reduction in some other treatments. Results are presented as incremental costs and cost per patient who achieved treatment goal. RESULTS: At 12 month it was observed a higher percentage of patients who achieved simultaneously the 4 therapeutic goals with respect to basal moment, from 0% to 52.1%. Cinacalcet allowed to save costs in concomitant drugs, achieving a total saving of 149 euros per patient and month. At 12 month, Cinacalcet achieved a reduction of percentage of patients with PTH > 800 pgr/mL with half of costs than standard treatment (651.35 euros vs 1363.68 euros). It was not possible to calculate the cost for PTH indicator since at the study onset, there was no patient who achieved a level between 150 and 300 pg/mL. Cinacalcet allowed reaching treatment goals in Calcium, Phosphorus and Ca x P product in a more cost-effective way (2164.2 euros vs 2684.8 euros). CONCLUSIONS: Although Cinacalcet is expensive,p atients treated with Cinacalcet showed a minor cost per patient who achieved treatment goal than patients without Cinacalcet. The ability of cinacalcet to reduce PTH secretion, along with the reductions in the serum Ca, P, and Ca x P product, provides an alternative to the traditional treatment paradigm, and should be a welcomed addition in the management of SHPT.

[Basic and clinical aspects of calcimimetics. Calcimimetics from the viewpoint of medical cost].

Cinacalcet hydrochrolide has now become available in Japan after a three-year interval from its introduction to Western countries. The clinical use of this drug should certainly bring benefit to the treatment of secondary hyperparathyroidism among dialysis patients. But, at the same time, it should increase the medical cost, as shown in the cost utility analyses reported previously in Western countries. Moreover, the longevity of Japanese hemodialysis patients might increase the difference between the cost of parathyroidectomy (PTX) and that of cinacalcet treatment which theoretically should be continued throughout their life. From the viewpoint of the cost, the intervention techniques, such as PTX and percutaneous ethanol injection therapy, should be encouraged. When sevelamer hydrochloride was first introduced in Japan, the abrupt and complete transition from calcium containing phosphate binder to large amount of sevelamer brought about severe constipation among Japanese dialysis patients, resulting in unwillingness or reluctance to take this agent and low compliance. Looking back on this bitter experience and again from the viewpoint of the cost, it is reasonable in Japan to administer small dose of cinacalcet with concomitant vitamin D therapy.

Etelcalcetide for Treating Secondary Hyperparathyroidism: An Evidence Review Group Evaluation of a NICE Single Technology Appraisal.

The manufacturer of the calcimimetic drug etelcalcetide was invited to make an evidence submission as part of the National Institute for Health and Care Excellence (NICE) Single Technology Appraisal (STA) programme. Within this submission, they reported evidence on the clinical and cost effectiveness of etelcalcetide for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) on haemodialysis. The Southampton Health Technology Assessments Centre (SHTAC), part of the Wessex Institute at the University of Southampton, was the independent Evidence Review Group (ERG) commissioned to appraise the company's submission. This article describes the ERG's review and critique of the company's submission and summarises the NICE Appraisal Committee's subsequent guidance (issued in June 2017). The clinical-effectiveness evidence submitted by the company consisted of two double-blind, randomised controlled trials (RCTs) comparing etelcalcetide with placebo, one RCT comparing etelcalcetide with cinacalcet, two single-arm extension studies of the above trials, and one single-arm study evaluating the effect of switching from cinacalcet to etelcalcetide. No study specifically examined the population specified in the NICE appraisal scope: patients refractory to standard therapy with phosphate binders and vitamin D (PBVD). None of these trials were designed to collect long-term efficacy data for outcomes such as mortality, bone fractures, cardiovascular events, or parathyroidectomies. Instead, biomarker data from the trials were mapped to long-term outcomes by an assumed linear relationship between the trial outcome, reduction of parathyroid hormone (PTH) by > 30%, and the log-hazard ratios for the occurrence of clinical events derived from a large, long-term RCT of cinacalcet (the EVOLVE trial). After submission of a confidential Patient Access Scheme (PAS) discount reducing etelcalcetide drug costs, the incremental cost-effectiveness ratio (ICER) for etelcalcetide versus cinacalcet was £14,778 per quality-adjusted life-year (QALY) gained in the company's base case. While this value is lower than the NICE threshold range of £20,000 and £30,000 per QALY gained, it was the opinion of the ERG that the ICER was highly uncertain due to efficacy data limitations for etelcalcetide, inadequate synthesis of clinical-effectiveness evidence, and strong assumptions connecting short-term biomarker data with long-term clinical outcomes. The ERG produced an alternative base case for etelcalcetide versus cinacalcet, with an ICER of £22,400 per QALY gained, also subject to uncertainty. The NICE Appraisal Committee recommended etelcalcetide as an option for the treatment of SHPT in adults with CKD only if treatment with a calcimimetic is indicated and cinacalcet is not suitable, subject to the company's provision of the agreed PAS discount.

A Decision-Analytic Model to Assess the Cost-Effectiveness of Etelcalcetide vs. Cinacalcet.

INTRODUCTION: Etelcalcetide is a novel intravenous calcimimetic for the treatment of secondary hyperparathyroidism (SHPT) in haemodialysis patients. The clinical efficacy and safety of etelcalcetide (in addition to phosphate binders and vitamin D and/or analogues [PB/VD]) was evaluated in three phase III studies, including two placebo-controlled trials and a head-to-head study versus the oral calcimimetic cinacalcet. OBJECTIVE: The objective of this study was to develop a decision-analytic model for economic evaluation of etelcalcetide compared with cinacalcet. METHODS: We developed a life-time Markov model including potential treatment effects on mortality, cardiovascular events, fractures, and subjects' persistence. Long-term efficacy of etelcalcetide was extrapolated from the reduction in parathyroid hormone (PTH) in the phase III trials and the available data from the outcomes study in cinacalcet (EVOLVE trial). Etelcalcetide was compared with cinacalcet, both in addition to PB/VD. We applied unit costs averaged from five European countries and a range of potential etelcalcetide pricing options assuming parity price to weekly use of cinacalcet and varying it by a 15 or 30% increase. RESULTS: Compared with cinacalcet, the incremental cost-effectiveness ratio of etelcalcetide was €1,355 per QALY, €24,521 per QALY, and €47,687 per QALY for the three prices explored. The results were robust across the probabilistic and deterministic sensitivity analyses. CONCLUSIONS: Our modelling approach enabled cost-utility assessment of the novel therapy for SHPT based on the observed and extrapolated data. This model can be used for local adaptations in the context of reimbursement assessment.

The effectiveness and cost-effectiveness of cinacalcet for secondary hyperparathyroidism in end-stage renal disease patients on dialysis: a systematic review and economic evaluation.

OBJECTIVES: To establish the effectiveness and cost-effectiveness of cinacalcet for the treatment of secondary hyperparathyroidism (SHPT) for people on dialysis due to end-stage renal disease (ESRD). DATA SOURCES: Electronic databases were searched up to February 2006. REVIEW METHODS: Included randomised controlled trials (RCTs) on the clinical effectiveness of cinacalcet for SHPT in ESRD were critically appraised, had relevant data extracted and were summarised narratively. A Markov (state transition) model was developed that compared cinacalcet in addition to current standard treatment with phosphate binders and vitamin D to standard treatment alone. A simulated cohort of 1000 people aged 55 with SHPT was modelled until the whole cohort was dead. Incremental costs and quality-adjusted life-years (QALYs) were calculated. Extensive one-way sensitivity analysis was undertaken as well as probabilistic sensitivity analysis. RESULTS: Seven trials comparing cinacalcet plus standard treatment with placebo plus standard treatment were included in the systematic review. A total of 846 people were randomised to receive cinacalcet. Cinacalcet was more effective at meeting parathyroid hormone (PTH) target levels (40% vs 5% in placebo, p < 0.001). In those patients meeting PTH targets, 90% also experienced a reduction in calcium-phosphate product levels, compared with 1% in placebo. Significantly fewer people treated with cinacalcet were hospitalised for cardiovascular events, although no difference was seen in all-cause hospitalisation or mortality. Significantly fewer fractures and parathyroidectomies were also seen with cinacalcet. Findings on all patient-based clinical outcomes were based on small numbers. The authors' economic model estimated that, compared to standard treatment alone, cinacalcet in addition to standard care costs an additional 21,167 pounds and confers 0.34 QALYs (or 18 quality-adjusted weeks) per person. The incremental cost-effectiveness ratio (ICER) was 61,890 pounds/QALY. In most cases, even extreme adjustments to individual parameters did not result in an ICER below a willingness-to-pay threshold of 30,000 pounds/QALY with probabilistic analysis showing only 0.5% of simulations to be cost-effective at this threshold. Altering the assumptions in the model through using different data sources for the inputs produced a range of ICERs from 39,000 pounds to 92,000 pounds/QALY. CONCLUSIONS: Cinacalcet in addition to standard care is more effective than placebo plus standard care at reducing PTH levels without compromising calcium levels. However, there is limited information about the impact of this reduction on patient-relevant clinical outcomes. Given the short follow-up in the trials, it is unclear how data should be extrapolated to the long term. Together with the high drug cost, this leads to cinacalcet being unlikely to be considered cost-effective. Recommendations for future research include obtaining accurate estimates of the multivariate relationship between biochemical disruption in SHPT and long-term clinical outcomes.

Secondary hyperparathyroidism is associated with higher cost of care among chronic kidney disease patients with cardiovascular comorbidities.

BACKGROUND: Chronic kidney disease (CKD) is associated with high morbidity and mortality, and incurs a substantial cost. Secondary hyperparathyroidism (SHPT) is a major complication associated with CKD and has been linked with cardiovascular disease, leading to poor outcomes. METHODS: We analyzed retrospective studies for the prevalence of congestive heart failure (CHF) and acute myocardial infarction/ischemic heart disease (AMI/IHD) in pre-dialysis CKD patients to estimate the additional hospitalization cost incurred secondary to high parathyroid hormone (PTH) levels. Two models were developed to estimate the contribution of elevated PTH levels towards hospitalization costs in CKD patients with CHF and AMI/IHD. RESULTS: Cost contributions were estimated for the time intervals relative to initiation of dialysis, with the largest contributions estimated for the 3- to 1-month period prior to initiation of dialysis, $205.24 per patient-month at risk for CHF and $69.44-111.75 per patient-month at risk for AMI/IHD, without and with major complications, respectively. CONCLUSION: Higher PTH levels are associated with a high prevalence of CHF and AMI/IHD. Our cost analyses show that elevated PTH levels contribute significantly toward the overall cost of care among CKD patients with CHF and AMI/IHD. The contribution of elevated PTH levels toward hospitalization cost is highest during the months directly leading up to initiation of dialysis. Further studies are required to evaluate the relationship between hyperparathyroidism and cardiovascular disease, and its impact on economic outcomes.

Outcomes of secondary hyperparathyroidism in chronic kidney disease and the direct costs of treatment.

BACKGROUND: There has been an emphasis over the last several years to identify and treat chronic kidney disease (CKD) and its complications as they evolve rather than waiting until the patient reaches end-stage renal disease (ESRD), also known as CKD stage 5. The number of patients who will be identified and prescribed therapies for complications such as secondary hyperparathyroidism (SHPT) is greater than initially proposed. OBJECTIVE: To review the pathways, complications, management, and estimated treatment costs of CKD-related SHPT. METHODS: An electronic literature search of MEDLINE (January 1980 through January 2007) was conducted for English-language publications using the base search term secondary hyperparathyroidism. To refine subsequent searches, the authors added Boolean operators to the following secondary and tertiary search terms: parathyroid hormone, chronic kidney disease, renal osteodystrophy, adynamic bone disease, vascular calcification, cardiovascular disease, vitamin D, vitamin D analogs, hypercalcemia, hyperphosphatemia, calcimimetics, costs, prevalence, and economics. RESULTS: The initial MEDLINE search produced 278 relevant articles. After refining the search terms, the authors triaged the results for English-language publications relevant to the discussion of SHPT and its complications in CKD, eliminating 149 publications. The remaining 129 publications were accepted for review. These articles represent a growing body of primarily observational evidence that demonstrates that elevated intact parathyroid hormone (PTH) levels cause deleterious physiological results across a variety of organ systems, including the cardiovascular and skeletal systems. Specific complications associated with SHPT are left ventricular hypertrophy (LVH), renal osteodystrophy (ROD), and extraskeletal calcification. Medical management of the PTH/vitamin D/calcium and phosphorus imbalances in SHPT focus on regulating PTH levels via vitamin D therapy. The class of calcimimetics is a newer treatment modality that has favorable effects on biochemical laboratory values, such as serum calcium and phosphorus levels, but current data do not show differences on hard endpoint patient-oriented outcomes compared with standard generic agents. The direct drug costs in April 2007 U.S. dollars of treating CKD-associated elevations in PTH in predialysis patients range from $8.40 per patient per week ($437 per year) for oral generic calcitriol to $88.90 per patient per week ($4,623 per year) for oral paricalcitol (expressed as 85% of average wholesale price [AWP] for brand drugs or 70% of AWP for generic drugs). The direct drug costs of treating SHPT in hemodialysis patients range from $80.20 per patient per week ($4,170 per year) for generic calcitriol (IV) to $278.46 per patient per week ($14,480 per year) for oral cinacalcet. CONCLUSIONS: SHPT causes skeletal and cardiovascular complications in CKD patients. Calcitriol therapy is effective in managing PTH levels, but efforts to reduce the associated hypercalcemia and hyperphosphatemia have led to the development of newer, yet more expensive, vitamin D analogs. With the lack of evidence to support comparative superior outcomes in end-organ disease among SHPT therapy alternatives, future research is still needed to clearly identify which newer agents are most competitive with the historical gold standard of calcitriol therapy.

Cost-effectiveness analysis of paricalcitol versus calcitriol for the treatment of SHPT in dialytic patients from the SUS perspective.

Introduction: Secondary hyperparathyroidism (SHPT) is a consequence of chronic kidney disease. The treatment at the Brazilian Unified Heath System (SUS) is performed with calcitriol, a drug which favors hypercalcemia and/or hyperphosphatemia, hindering the control of SHPT. Another option is paricalcitol, which causes parathormone (PTH) suppression faster than calcitriol, with minor changes in calcium-phosphorus product and calcium and phosphorus serum levels. Objective: This study aims to develop a cost-effectiveness analysis of paricalcitol versus calcitriol for patients in dialytic treatment with SHPT, from the SUS perspective. Methods: A Markov decision model was developed for patients ≥ 50 years old with end stage renal disease in dialytic treatment and SHPT. Quarterly cycles and a lifetime time horizon were considered. Life years (LY) gained were assessed as clinical outcome. Clinical and economic inputs were obtained from systematic literature review and official databases. Costs are presented in Brazilian real (BRL), for the year 2014. Results: In the base case: paricalcitol generated a clinical benefit of 16.28 LY gained versus 14.11 LY gained with calcitriol, total costs of BRL 131,064 and BRL 114,262, respectively, determining an incremental cost-effectiveness ratio of BRL 7,740 per LY gained. The data robustness was confirmed by the sensitivity analysis. Conclusions: According to cost-effectiveness threshold recommended by the World Health Organization for 2013, the treatment of SHPT in patients on dialysis with paricalcitol is cost-effective when compared to calcitriol, from the public healthcare system perspective, in Brazil.

Introdução: O hiperparatireoidismo secundário (HPTS) é uma consequência da doença renal crônica. O tratamento no SUS é realizado com calcitriol, que favorece a hipercalcemia e/ou hiperfosfatemia, dificultando o controle do HPTS. Uma opção clinicamente relevante é o paricalcitol, que ocasiona a supressão do paratormônio (PTH) de forma mais rápida que o calcitriol e com menores alterações nas taxas séricas de cálcio, fósforo e do produto cálcio-fósforo. Objetivo: Este trabalho tem como objetivo desenvolver uma análise de custo-efetividade de paricalcitol versus calcitriol para pacientes em diálise com HPTS, perspectiva do SUS. Métodos: Foi desenvolvido um modelo de decisão de Markov para a população ≥ 50 anos, com DRC em diálise e HPTS. Foram considerados ciclos trimestrais e um horizonte temporal lifetime. O desfecho clínico avaliado foram os anos de vida ganhos. Dados foram obtidos a partir de revisão sistemática da literatura e bases de dados oficiais. Custos em reais (R$), ano de 2014. Resultados: No caso base: paricalcitol gerou benefício clínico de 16,28 anos de vida ganhos versus 14,11 anos de vida ganhos com calcitriol, custos totais de R$ 131.064 e R$ 114.262, respectivamente. A razão de custo-efetividade incremental de R$ 7.740 por ano de vida salvo. Dados robustos confirmados pela análise de sensibilidade. Conclusão: De acordo com o limiar de custo-efetividade recomendado pela Organização Mundial de Saúde para o ano de 2013, o tratamento de pacientes com HPTS em diálise com paricalcitol é custo-efetivo, comparado ao calcitriol, perspectiva SUS.

Early hospital readmission was less likely for hemodialysis patients from facilities with longer median length of stay in the DOPPS study.

The length of hospital stay is considered to influence hospital readmission in general. The Dialysis Outcomes and Practice Patterns Study (DOPPS), an international prospective observational study undertaken to establish a relationship between facility practices and dialysis outcomes, started in 1996. Results suggest that the duration of hospital stay is significantly correlated with the probability of early readmission in dialysis patients. Thus, early hospital readmission was observed to be less likely for hemodialysis patients from facilities with longer median length of stay. The lengths of hospital stay for hemodialysis patients differed in the three continents studied. Although socioeconomic pressures may drive the lengths of hospital stay, the duration of hospitalization should be determined keeping in mind the safety of clinical course for each disease. In this forum, a 47-year-old female hemodialysis patient with severe secondary hyperparathyroidism, who had been treated with hemodialysis for 21 years, was hospitalized with severe clinical symptoms. Although the clinical symptoms disappeared 10 days after total parathyroidectomy with autotransplantation, severe hypocalcemia persisted despite large amounts of intravenous calcium gluconate. This patient was hospitalized for a long duration owing to the large calcium deficit in her body. Had the length of her hospital stay been shortened, either she could have needed rehospitalization or her condition could have worsened.

The cost-effectiveness of drug therapies to treat secondary hyperparathyroidism in renal failure: a focus on evidence regarding paricalcitol and cinacalcet.

The present review aims to assess the state-of-the-art regarding cost-effectiveness of therapy for secondary hyperparathyroidism in order to identify the best treatment and review methodological issues. PubMed and the Cochrane Library were searched to identify papers performing comparative analysis of costs and effects of treatment for secondary hyperparathyroidism in adult patients. Among the 66 papers identified, only 10 were included in the analysis. Treatment strategies evaluated in the selected papers were: cinacalcet in addition to vitamin D and phosphate binders versus vitamin D and phosphate binders only (seven papers), paricalcitol versus non-selective vitamin D (two papers), early and late introduction of cinacalcet in addition to vitamin D and phosphate binders (one paper) and paricalcitol versus cinacalcet (one paper). The high degree of heterogeneity among alternative treatments and methodological limits related to cost items considered, resource valuation methods and so on, make it unfeasible to reach a definite conclusion regarding cost-effectiveness but allow for future research opportunities.

Reforming medicare's dialysis payment policies: implications for patients with secondary hyperparathyroidism.

OBJECTIVE: To demonstrate how expanding services covered by a "bundled payment" can also expand variation in the costs of treating patients under the bundle, using the Medicare dialysis program as an example. DATA SOURCES/STUDY SETTING: Observational claims-based study of 197,332 Medicare hemodialysis beneficiaries enrolled for at least one quarter during 2006-2008. STUDY DESIGN: We estimated how resource utilization (all health services, dialysis-related services, and medications) changes with intensity of secondary hyperparathyroidism (sHPT) treatment. DATA EXTRACTION METHODS: Using Medicare claims, a patient-quarter level dataset was constructed, including a measure of sHPT treatment intensity. PRINCIPAL FINDINGS: Under the existing, narrow dialysis bundle, utilization of covered services is relatively constant across treatment intensity groups; under a broader bundle, it rises more rapidly with treatment intensity. CONCLUSIONS: The broader Medicare dialysis bundle reimburses providers uniformly, even though patients treated more intensively for sHPT cost more to treat. Absent any payment adjustments or efforts to ensure quality, this flat payment schedule may encourage providers to avoid high-intensity patients or reduce their treatment intensity. The first incentive harms efficiency. The second may improve or worsen efficiency, depending on whether it reduces appropriate or inappropriate treatment.