A cost-effectiveness analysis of patiromer in the UK: evaluation of hyperkalaemia treatment and lifelong RAASi maintenance in chronic kidney disease patients with and without heart failure.

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.

Highly Purified Human Menopausal Gonadotropin (HP-hMG) Versus Recombinant Follicle-Stimulating Hormone (rFSH) for Controlled Ovarian Stimulation in US Predicted High-Responder Patients: A Cost-Comparison Analysis.

OBJECTIVES: Infertility imposes considerable clinical and economic burden, and the high costs of fertility care are a major barrier to payers. This study assessed the cost differences of highly purified human menopausal gonadotropin (HP-hMG) versus recombinant follicle stimulating hormone (rFSH) for controlled ovarian stimulation (COS) protocols in predicted high-responders from the US payer perspective. METHODS: A discrete event simulation model was built to perform a cost-comparison analysis of HP-hMG versus rFSH in a cohort of predicted high-responders undergoing up to three embryo transfer cycles, informed by efficacy data from the MEGASET-HR trial. The model considered an event-based treatment pathway and transition probabilities were derived from MEGASET-HR. A variable time horizon was employed, and deterministic and probabilistic sensitivity analyses conducted. RESULTS: Subjects undergoing COS with HP-hMG and rFSH demonstrated comparable live birth rates following three in vitro fertilization (IVF) cycles, with 161 live births with HP-hMG and 152 live births with rFSH, per 310 high-responders. The total cost saving per live birth in subjects receiving HP-hMG versus rFSH was US$3024. These cost savings were largely driven by the need for fewer embryo transfers to achieve similar efficacy outcomes and a reduced rate of ovarian hyperstimulation syndrome. Following deterministic sensitivity analysis, HP-hMG remained cost saving in all baseline parameter variations. No parameters led to rFSH providing cost savings when compared with HP-hMG. CONCLUSION: Comparable clinical outcomes can be achieved at a lower cost when using HP-hMG versus rFSH based COS protocols in a cohort of predicted high-responders. Such cost savings may reduce the economic burden infertility currently presents to US healthcare providers and those seeking fertility care.

The Cost Effectiveness of Patiromer for the Treatment of Hyperkalaemia in Patients with Chronic Kidney Disease with and without Heart Failure in Ireland.

BACKGROUND AND OBJECTIVE: Hyperkalaemia 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.

Cost-effectiveness and budget impact analysis of viscosupplementation with hylan G-F 20 for knee and hip osteoarthritis.

PURPOSE: To estimate the cost-effectiveness and budget impact of viscosupplementation with one intra-articular (IA) injection of 6 mL hylan G-F 20 (Synvisc-One®) and with three injections of 2 mL hylan G-F 20 (Synvisc®3×2) in knee osteoarthritis (OA) patients compared with conventional support therapy (CST - eg, NSAIDs and acetaminophen) and the cost-effectiveness of one IA injection of 2 mL hylan G-F 20 (Synvisc®1×2) in hip OA patients compared with CST from an Italian Health System perspective. METHODS: The model used was a Markov model with states for stages II-IV on the Kellgren-Lawrence scale and runs on 6-month cycles over a 5-year time horizon. A 3.5% discount was applied to both costs and utilities. Direct costs were determined from the perspective of the Italian National Health Service. A one-way and probabilistic sensitivity analysis was conducted for both comparisons. RESULTS: Hylan G-F 20 1×6 mL and hylan G-F 20 3×2 mL for knee OA were very likely to be cost-effective when compared to acetaminophen (ICER = €3,160.61 and €3,845.81 per QALY, respectively) and NSAIDs as both ICERs are below €25,000. The hip OA treatment by hylan G-F 20 1×2 mL was dominant compared to NSAIDs and very likely compared to acetaminophen. The results of the cost-effectiveness analysis were confirmed by one-way sensitivity analysis. The budget impact analysis for knee and hip OA showed a small increase in expenditure during 5 years. CONCLUSIONS: Hylan G-F 20 1×6 mL/hylan G-F 20 is a cost-effectiveness treatment compared to NSAIDs and acetaminophen in the treatment of knee/hip OA in Italy. The treatment of hip and knee OA resulted in cost-saving with hylan G-F 20 1×2 mL and economically sustainable with hylan G-F 20 1×6 mL. However, Real Word Evidence studies should be conducted in order to estimate costs associated with both prosthetics and to understand the reduction of physiotherapy and medication due to hylan G-F 20.