Cost-effectiveness of catheter-based radiofrequency renal denervation for the treatment of uncontrolled hypertension: an analysis for the UK based on recent clinical evidence.

AIMS: Catheter-based radiofrequency renal denervation (RF RDN) has recently been approved for clinical use in the European Society of Hypertension guidelines and by the US FDA. This study evaluated the lifetime cost-effectiveness of RF RDN using contemporary evidence. METHODS AND RESULTS: A decision-analytic model based on multivariate risk equations projected clinical events, quality-adjusted life years (QALYs) and costs. The model consisted of seven health states: hypertension alone, myocardial infarction (MI), other symptomatic coronary artery disease, stroke, heart failure (HF), end-stage renal disease, and death. Risk reduction associated with changes in office systolic blood pressure (oSBP) was estimated based on a published meta-regression of hypertension trials. The base case effect size of -4.9 mmHg oSBP (observed vs. sham control) was taken from the SPYRAL HTN-ON MED trial of 337 patients. Costs were based on NHS England data. The incremental cost-effectiveness ratio (ICER) was evaluated against the NICE cost-effectiveness threshold of £20 000-30 000 per QALY gained. Extensive scenario and sensitivity analyses were conducted, including the ON-MED subgroup on three medications and pooled effect sizes. RF RDN resulted in a relative risk reduction in clinical events over 10 years (0.80 for stroke, 0.88 for MI, 0.72 for HF), with an increase in health benefit over a patient's lifetime, adding 0.35 QALYs at a cost of £4 763, giving an ICER of £13 482 per QALY gained. Findings were robust across tested scenarios. CONCLUSION: Catheter-based radiofrequency RDN can be a cost-effective strategy for uncontrolled hypertension in the UK, with an ICER substantially below the NICE cost-effectiveness threshold. Funding: Medtronic Inc.

Cost-Effectiveness of Tonic Motor Activation (TOMAC) Therapy for Patients with Restless Legs Syndrome: An Exploratory Analysis.

INTRODUCTION: Tonic motor activation (TOMAC) therapy is a novel non-pharmacologic treatment approach for patients suffering from medication-refractory restless legs syndrome (RLS). The objective of this study was to explore the potential cost-effectiveness of TOMAC in the US healthcare system. METHODS: A decision-analytic Markov model was constructed to project strategy-specific treatment costs and benefits over 3 years and lifetime. Cohort characteristics (mean age 57.4 years, 39.8% male) and treatment effects were derived from the sham-controlled RESTFUL study. Study-observed International RLS Study Group (IRLS) scores were used to estimate changes in healthcare resource utilization and quality of life based on mapping algorithms informed by published data. The incremental cost-effectiveness ratio (ICER) was evaluated against established willingness-to-pay thresholds of $50,000/$150,000 per QALY to determine cost-effectiveness. Extensive scenario analyses were performed, including longer-term extension study data. RESULTS:  TOMAC and sham reduced IRLS scores from baseline 25.3 to 18.10 and 21.60, respectively, at 4 weeks (treatment effect - 3.4 vs. sham), with an increase in utility from 0.80 to 0.84 (0.75-0.84 vs. baseline). Over 3 years and lifetime, the TOMAC vs. sham effect size corresponded to an added 0.10 and 0.49 QALYs (2.36 vs. 2.26; 12.59 vs. 12.10) at incremental costs of $8061 and $36,373 ($36,707 vs. $28,646; $224,040 vs.$187,667), resulting in ICER estimates of $83,822 and $73,600, respectively. Compared to baseline, TOMAC resulted in ICER estimates of $29,569 and $23,690 over 3 years and lifetime, respectively. TOMAC remained cost-effective or dominant across all scenarios, with ICERs ranging from $10,530-$83,822 and - $8061 to $29,569 vs. sham and baseline, respectively. Larger TOMAC effect sizes, achieved per extension study data, further increased cost-effectiveness. CONCLUSION:  Based on this exploratory analysis of published trial data, TOMAC therapy appears to offer meaningful improvements in patient health-related quality at net costs that render it a cost-effective intervention. Further analyses are warranted.

Cost associated with diverting ostomy after rectal cancer surgery: a transnational analysis.

BACKGROUND: Diverting ileostomy and colostomy after total mesorectal excision reduces the risk of complications related to anastomotic leakages but is associated with a reduction in health-related quality of life and long-term economic consequences that are unknown. Our objective was to estimate the lifetime costs of stoma placement after rectal cancer resection in the U.S., England, and Germany. METHODS: Input parameters were derived from quasi-systematic literature searches. Decision-analytic models with survival from colorectal cancer-adjusted life tables and country-specific stoma reversal proportions were created for the three countries to calculate lifetime costs. Main cost items were stoma maintenance costs and reimbursement for reversal procedures. Discounting was applied according to respective national guidelines. Sensitivity analysis was conducted to explore the impact of parameter uncertainty onto the results. RESULTS: The cohort starting ages and median survival were 63 and 11.5 years for the U.S., 69 years and 8.5 years for England, and 71 and 6.5 years for Germany. Lifetime discounted stoma-related costs were $26,311, £9512, and €10,021, respectively. All three models were most sensitive to the proportion of ostomy reversal, age at baseline, and discount rate applied. CONCLUSION: Conservative model-based projections suggest that stoma care leads to significant long-term costs. Efforts to reduce the number of patients who need to undergo a diverting ostomy could result in meaningful cost savings.

Cost-effectiveness of neuromuscular electrical stimulation for the treatment of mild obstructive sleep apnea: an exploratory analysis.

OBJECTIVES: To assess the potential cost-effectiveness of neuromuscular electrical stimulation (NMES) for treatment of mild obstructive sleep apnea (OSA). METHODS: A decision-analytic Markov model was developed to estimate health state progression, incremental cost, and quality-adjusted life year (QALY) gain of NMES compared to no treatment, continuous airway pressure (CPAP), or oral appliance (OA) treatment. The base case assumed no cardiovascular (CV) benefit for any of the interventions, while potential CV benefit was considered in scenario analyses. Therapy effectiveness was based on a recent multi-center trial for NMES, and on the TOMADO and MERGE studies for OA and CPAP. Costs, considered from a United States payer perspective, were projected over lifetime for a 48-year-old cohort, 68% of whom were male. An incremental cost-effectiveness ratio (ICER) threshold of USD150,000 per QALY gained was applied. RESULTS: From a baseline AHI of 10.2 events/hour, NMES, OA and CPAP reduced the AHI to 6.9, 7.0 and 1.4 events/hour respectively. Long-term therapy adherence was estimated at 65-75% for NMES and 55% for both OA and CPAP. Compared to no treatment, NMES added between 0.268 and 0.536 QALYs and between USD7,481 and USD17,445 in cost, resulting in ICERs between USD15,436 and USD57,844 per QALY gained. Depending on long-term adherence assumptions, either NMES or CPAP were found to be the preferred treatment option, with NMES becoming more attractive with younger age and assuming CPAP was not used for the full night in all patients. CONCLUSIONS: NMES might be a cost-effective treatment option for patients with mild OSA.

Clinical event reductions in high-risk patients after renal denervation projected from the global SYMPLICITY registry.

AIMS: Renal denervation has been shown to lower blood pressure in sham-controlled trials and represents a device-based treatment option for hypertension. We sought to project clinical event reductions after radiofrequency renal denervation using a novel modelling approach. METHODS AND RESULTS: The Global SYMPLICITY Registry is a global, prospective all-comer registry to evaluate safety and efficacy after renal denervation. For this analysis, change in office systolic blood pressure from baseline was calculated from reported follow-up in the Global SYMPLICITY Registry. Relative risks for death and other cardiovascular events as well as numbers needed to treat for event avoidance were obtained for the respective blood pressure reductions based on previously reported meta-regression analyses for the full cohort and high-risk subgroups including type 2 diabetes, chronic kidney disease, resistant hypertension, and high basal cardiovascular risk. Average baseline office systolic blood pressure and reduction estimates for the full cohort (N = 2651) were 166±25 and -14.8 ± 0.4 mmHg, respectively. Mean reductions in blood pressure ranged from -11.0--21.8 mmHg for the studied high-risk subgroups. Projected relative risks ranged from 0.57 for stroke in the resistant hypertension cohort to 0.92 for death in the diabetes cohort. Significant absolute reductions in major adverse cardiovascular events over 3 years compared with the projected control (8.6 ± 0.7% observed vs. 11.7 ± 0.9% for projected control; P < 0.01) were primarily due to reduced stroke incidence. The robustness of findings was confirmed in sensitivity and scenario analyses. CONCLUSION: Model-based projections suggest radiofrequency renal denervation for patients with uncontrolled hypertension adds considerable clinical benefit across a spectrum of different cohort characteristics.

Economics of drug-coated balloons for arteriovenous fistula stenosis in Japan and Korea based on the IN.PACT AV access trial.

AIM: The recent IN.PACT AV Access study found drug-coated balloon therapy to be associated with reduced reinterventions compared to percutaneous transluminal angioplasty using standard balloons in the management of arteriovenous fistula stenosis. The economic implications of drug-coated balloon use in Asia, including Japan and Korea, remain unknown. METHODS: A decision-analytic model was developed to calculate strategy-specific costs for Korea and Japan through 5-year follow-up. The analysis assumed maintained therapy benefit beyond current trial follow-up of 1 year in the base case, with several alternative scenarios explored in sensitivity analysis. Costs were derived from claims and reimbursement data, and projections were evaluated at 3 and 5 years post-index procedure. RESULTS: Model-projected access circuit reintervention events for drug-coated versus standard balloons were 1.70 versus 2.76 (-1.06) and 2.53 versus 4.10 (-1.57) at 3 and 5 years in the base case. Corresponding 3- and 5-year costs were ₩6 211 103 versus ₩7 605 553 (-₩1 394 451) and ₩7 766 051 versus ₩10 124 954 (-₩2 358 904) in Korea, and ¥1 469 824 versus ¥1 504 161 (-¥34 337) and ¥1 956 931 versus ¥2 106 632 (-¥149 701) in Japan. In scenario analyses, drug-coated balloons remained cost saving at 3- and 5-year follow-up in Korea, but required up to 5 years to reach cost-savings in Japan. Drug-coated balloon use in reinterventions increased projected savings, as did younger treatment age. CONCLUSION: Treatment of arteriovenous fistulas with the IN.PACT AV drug-coated balloon, based on preliminary data, may lead to meaningful reductions in reintervention costs that would render it cost-saving at timeframes of around 1 year in Korea and between 3 and 5 years in Japan.

Development of a Clinical Decision Support System for Living Kidney Donor Assessment Based on National Guidelines.

BACKGROUND: Live donor nephrectomy is an operation that places the donor at risk of complications without the possibility of medical benefit. Rigorous donor selection and assessment is therefore essential to ensure minimization of risk and for this reason robust national guidelines exist. Previous studies have demonstrated poor adherence to donor guidelines. METHODS: We developed a clinical decision support system (CDSS), based on national living donor guidelines, to facilitate the identification of contraindications, additional investigations, special considerations, and the decision as to nephrectomy side in potential living donors. The CDSS was then tested with patient data from 45 potential kidney donors. RESULTS: The CDSS comprises 17 core tasks completed by either patient or nurse, and 17 optional tasks that are triggered by certain patient demographics or conditions. Decision rules were able to identify contraindications, additional investigations, special considerations, and predicted operation side in our patient cohort. Seventeen of 45 patients went on to donate a kidney, of whom 7 had major contraindications defined in the national guidelines, many of which were not identified by the clinical team. Only 43% of additional investigations recommended by national guidelines were completed, with the most frequently missed investigations being oral glucose tolerance testing and routine cancer screening. CONCLUSIONS: We have demonstrated the feasibility of turning a complex set of national guidelines into an easy-to-use machine-readable CDSS. Comparison with real-world decisions suggests that use of this CDSS may improve compliance with guidelines and informed consent tailored to individual patient risks.