Cost effectiveness of sodium zirconium cyclosilicate for the treatment of hyperkalaemia in patients with CKD in Norway and Sweden.

BACKGROUND: Hyperkalaemia is common in patients with chronic kidney disease (CKD) and is associated with a range of adverse outcomes. Historically, options for management of chronic hyperkalaemia in the outpatient setting have been limited. Novel oral potassium binders provide a safe, effective therapy for maintenance of normokalaemia in patients with CKD, but despite being approved for reimbursement in many countries, prescription data indicate uptake has been slower than anticipated. This analysis aimed to demonstrate the value to patients and the healthcare system of the potassium binder sodium zirconium cyclosilicate (SZC) for treatment of hyperkalaemia in patients with CKD in Norway and Sweden. METHODS: A published simulation model reflecting the natural history of CKD was adapted to the Norwegian and Swedish settings and used to predict long-term health economic outcomes of treating hyperkalaemia with SZC versus usual care. RESULTS: SZC was highly cost effective compared to usual care in Norway and Sweden, with incremental cost-effectiveness ratios of €14,838/QALY in Norway and €14,352/QALY in Sweden, over a lifetime horizon. The acquisition cost of SZC was largely offset by cost savings associated with reductions in hyperkalaemia events and hospitalisations; a modest overall increase in costs was predominantly attributable to costs associated with gains in life years compared with usual care. SZC remained cost effective in all scenarios examined. CONCLUSIONS: SZC was estimated to be cost effective for treating hyperkalaemia. Consequently, improving access to a clinically effective, safe and cost-effective therapy, such as SZC, may result in considerable benefits for CKD patients with hyperkalaemia.

Systematic Fluid Assessment in Haemodialysis: Development and Validation of A Decision Aid.

BACKGROUND: About a third of patients undergoing haemodialysis have poorly controlled fluid status, which may affect survival. Clinical assessment is subjective and imprecise, which has led to the increasing use of devices based on bioimpedance spectroscopy (BIS). However, BIS cannot provide a simple target applicable to all patients. Our aim was to develop and validate a decision aid combining clinical assessment of fluid status with information from BIS in target weight determination. METHODS: The decision aid was based on empirical experience and a literature review identifying physiological parameters already used in the clinical assessment of fluid status. Content validity was established by patient representatives, interdisciplinary stakeholders and external experts, who assessed item relevance and comprehensiveness. Reliability was assessed by inter-rater agreement analysis between nurses assessing typical patient cases. RESULTS: The decision aid for Recognition and Correction of Volume Alterations (RECOVA) consists of three parts (1) a scoring system; (2) thresholds and triggers; (3) a decision aid algorithm. Agreement between raters in the assessment of symptoms was almost perfect, with Intraclass Correlation Coefficient > 0.90. Agreement in clinical response was only fair, but increased to moderate, with training and self-reported confidence. CONCLUSION: RECOVA may enable systematic clinical assessment of fluid status, facilitating early recognition of fluid alterations, and incorporation of bioimpedance into target weight management. However, implementation into clinical practice will require training of staff. Clinical intervention studies are required to evaluate if RECOVA facilitates response to and correction of recognised fluid alterations.

The value of maintaining normokalaemia and enabling RAASi therapy in chronic kidney disease.

BACKGROUND: People with chronic kidney disease (CKD) are at an increased risk of developing hyperkalaemia due to their declining kidney function. In addition, these patients are often required to reduce or discontinue guideline-recommended renin-angiotensin-aldosterone system inhibitor (RAASi) therapy due to increased risk of hyperkalaemia. This original research developed a model to quantify the health and economic benefits of maintaining normokalaemia and enabling optimal RAASi therapy in patients with CKD. METHODS: A patient-level simulation model was designed to fully characterise the natural history of CKD over a lifetime horizon, and predict the associations between serum potassium levels, RAASi use and long-term outcomes based on published literature. The clinical and economic benefits of maintaining sustained potassium levels and therefore avoiding RAASi discontinuation in CKD patients were demonstrated using illustrative, sensitivity and scenario analyses. RESULTS: Internal and external validation exercises confirmed the predictive capability of the model. Sustained potassium management and ongoing RAASi therapy were associated with longer life expectancy (+ 2.36 years), delayed onset of end stage renal disease (+ 5.4 years), quality-adjusted life-year gains (+ 1.02 QALYs), cost savings (£3135) and associated net monetary benefit (£23,446 at £20,000 per QALY gained) compared to an absence of RAASi to prevent hyperkalaemia. CONCLUSION: This model represents a novel approach to predicting the long-term benefits of maintaining normokalaemia and enabling optimal RAASi therapy in patients with CKD, irrespective of the strategy used to achieve this target, which may support decision making in healthcare.

Development of a health economic model to evaluate the potential benefits of optimal serum potassium management in patients with heart failure.

AIMS: Patients with heart failure are at increased risk of hyperkalemia, particularly when treated with renin-angiotensin-aldosterone system inhibitor (RAASi) agents. This study developed a model to quantify the potential health and economic value associated with sustained potassium management and optimal RAASi therapy in heart failure patients. MATERIALS AND METHODS: A patient-level, fixed-time increment stochastic simulation model was designed to characterize the progression of heart failure through New York Heart Association functional classes, and predict associations between serum potassium levels, RAASi use, and consequent long-term outcomes. Following internal and external validation exercises, model analyses sought to quantify the health and economic benefits of optimizing both serum potassium levels and RAASi therapy in heart failure patients. Analyses were conducted using a UK payer perspective, independent of costs and utilities related to pharmacological potassium management. RESULTS: Validation against multiple datasets demonstrated the predictive capability of the model. Compared to those who discontinued RAASi to manage serum potassium, patients with normokalemia and ongoing RAASi therapy benefited from longer life expectancy (+1.38 years), per-patient quality-adjusted life year gains (+0.53 QALYs), cost savings (£110), and associated net monetary benefit (£10,679 at £20,000 per QALY gained) over a lifetime horizon. The predicted value of sustained potassium management and ongoing RAASi treatment was largely driven by reduced mortality and hospitalization risks associated with optimal RAASi therapy. LIMITATIONS: Several modeling assumptions were made to account for a current paucity of published literature; however, ongoing refinement and validation of the model will ensure its continued accuracy as the clinical landscape of hyperkalemia evolves. CONCLUSIONS: Predictions generated by this novel modeling approach highlight the value of sustained potassium management to avoid hyperkalemia, enable RAASi therapy, and improve long-term health economic outcomes in patients with heart failure.

Clinical praxis for assessment of dry weight in Sweden and Denmark: A mixed-methods study.

Overhydration is an independent predictor of mortality in hemodialysis (HD) patients. More than 30% of HD patients are overhydrated, motivating the development of new methods for assessing hydration status. This study surveyed clinical praxis and local guidelines for dry weight (DW) assessment in Swedish and Danish HD units, and examined if differences in routines and utilization of bioimpedance spectroscopy (BIS) and other assistive technology affected frequency of DW adjustments and blood pressure (BP) levels. Cross-sectional information on praxis, guidelines and routines, plus treatment-related data from 99 stratified patients were collected. Qualitative data were analyzed with content analysis and interpreted in convergence with statistical analysis of quantitative data in a mixed-methods design. Local guidelines concerning DW existed in 54% of the units. A BIS device was present in 52%, but only half of those units used it regularly, and no correlations to frequency of DW adjustments or BP were found. HD nurses were authorized to adjust DW in 60% of the units; in these units, the frequency of DW adjustments was 1.6 times higher and systolic BP pre-HD 8 mmHg lower. There is a wide variation in routines for DW determination, and there are indications that authorization of HD nurses to adjust DW may improve DW assessment. BIS is sparsely used; its implementation may have been delayed by uncertainty over how to manage the device and interpret measurements. Hence, better methods and guidelines for assessing DW and using BIS need to be developed.