Background and ObjectiveHyperkalaemia can be a life-threatening condition, particularly in patients with advanced chronic kidney disease with and without heart failure. Renin-angiotensin-aldosterone system inhibitor therapy offers cardiorenal protection in chronic kidney disease and heart failure; however, it may also cause hyperkalaemia subsequently resulting in down-titration or discontinuation of treatment. Hence, there is an unmet need for hyperkalaemia treatment in patients with chronic kidney disease with and without heart failure to enable renin-angiotensin-aldosterone system inhibitor use in this patient population. In this study, we develop a de novo disease progression and cost-effectiveness model to evaluate the clinical and economic outcomes associated with the use of patiromer for the treatment of hyperkalaemia in patients with chronic kidney disease with and without heart failure. Methods A Markov model was developed using data from the OPAL-HK trial to assess the health economic impact of patiromer therapy in comparison to standard of care in controlling hyperkalaemia in patients with advanced chronic kidney disease with and without heart failure in the Irish setting. The model was designed to predict the natural history of chronic kidney disease and heart failure and quantify the costs and benefits associated with the use of patiromer for hyperkalaemia management over a lifetime horizon from a payer perspective. Results Treatment with patiromer was associated with an increase in discounted life-years (8.62 vs 8.37) and an increase in discounted quality-adjusted life-years (6.15 vs 5.95). Incremental discounted costs were predicted at €4979 per patient, with an incremental cost-effectiveness ratio of €25,719 per quality-adjusted life-year gained. Patients remained taking patiromer treatment for an average of 7.7 months, with treatment associated with reductions in the overall clinical event incidence and a delay in chronic kidney disease progression. Furthermore, patiromer was associated with lower overall rates of hospitalisation, major adverse cardiovascular events, dialysis, renin-angiotensin-aldosterone system inhibitor discontinuation episodes and renin-angiotensin-aldosterone system inhibitor down-titration episodes. At a willingness-to-pay threshold of €45,000 per quality-adjusted life-year in Ireland, treatment with patiromer was estimated to have a 100% chance of cost effectiveness compared with standard of care. Conclusions This study has demonstrated an economic case for the reimbursement of patiromer for the treatment of hyperkalaemia in patients with chronic kidney disease with and without heart failure in Ireland. Patiromer was estimated to improve life expectancy and quality-adjusted life expectancy, whilst incurring marginal additional costs when compared with current standard of care. Results are predominantly attributed to the ability of patiromer to enable the continuation of renin-angiotensin-aldosterone system inhibitor treatment whilst also reducing potassium levels.
Background Chronic kidney disease (CKD) patients with and without heart failure (HF) often present with hyperkalaemia (HK) leading to increased risk of hospitalisations, cardiovascular related events and cardiovascular-related mortality. Renin–angiotensin–aldosterone system inhibitor (RAASi) therapy, the mainstay treatment in CKD management, provides significant cardiovascular and renal protection. Nevertheless, its use in the clinic is often suboptimal and treatment is frequently discontinued due to its association with HK. We evaluated the cost-effectiveness of patiromer, a treatment known to reduce potassium levels and increase cardiorenal protection in patients receiving RAASi, in the UK healthcare setting. Methods A Markov cohort model was generated to assess the pharmacoeconomic impact of patiromer treatment in regulating HK in patients with advanced CKD with and without HF. The model was generated to predict the natural history of both CKD and HF and quantify the costs and clinical benefits associated with the use of patiromer for HK management from a healthcare payer’s perspective in the UK. Results Economic evaluation of patiromer use compared to standard of care (SoC) resulted in increased discounted life years (8.93 versus 8.67) and increased discounted quality-adjusted life years (QALYs) (6.36 versus 6.16). Furthermore, patiromer use resulted in incremental discounted cost of £2,973 per patient and an incremental cost-effectiveness ratio (ICER) of £14,816 per QALY gained. On average, patients remained on patiromer therapy for 7.7 months, and treatment associated with a decrease in overall clinical event incidence and delayed CKD progression. Compared to SoC, patiromer use resulted in 218 fewer HK events per 1,000 patients, when evaluating potassium levels at the 5.5–6 mmol/l; 165 fewer RAASi discontinuation episodes; and 64 fewer RAASi down-titration episodes. In the UK, patiromer treatment was predicted to have a 94.5% and 100% chance of cost-effectiveness at willingness-to-pay thresholds (WTP) of £20,000/QALY and £30,000/QALY, respectively. Conclusion This study highlights the value of both HK normalisation and RAASi maintenance in CKD patients with and without HF. Results support the guidelines which recommend HK treatment, e.g., patiromer, as a strategy to enable the continuation of RAASi therapy and improve clinical outcomes in CKD patients with and without HF.
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