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.

Cost profiles and budget impact of rechargeable versus non-rechargeable sacral neuromodulation devices in the treatment of overactive bladder syndrome.

OBJECTIVES: Sacral neuromodulation (SNM) is a guideline-recommended third-line treatment option for managing overactive bladder. Current SNM devices are not rechargeable, and require neurostimulator replacement every 3-6 years. Our study objective was to assess potential cost effects to payers of adopting a rechargeable SNM neurostimulator device. METHODS: We constructed a cost-consequence model to estimate the costs of long-term SNM-treatment with a rechargeable versus non-rechargeable device. Costs were considered from the payer perspective at 2015 reimbursement levels. Adverse events, therapy discontinuation, and programming rates were based on the latest published data. Neurostimulator longevity was assumed to be 4.4 and 10.0 years for non-rechargeable and rechargeable devices, respectively. A 15-year horizon was modeled, with costs discounted at 3% per year. Total budget impact to the United States healthcare system was estimated based on the computed per-patient cost findings. RESULTS: Over the 15-year horizon, per-patient cost of treatment with a non-rechargeable device was $64,111 versus $36,990 with a rechargeable device, resulting in estimated payer cost savings of $27,121. These cost savings were found to be robust across a wide range of scenarios. Longer analysis horizon, younger patient age, and longer rechargeable neurostimulator lifetime were associated with increased cost savings. Over a 15-year horizon, adoption of a rechargeable device strategy was projected to save the United States healthcare system up to $12 billion. CONCLUSIONS: At current reimbursement rates, our analysis suggests that rechargeable neurostimulator SNM technology for managing overactive bladder syndrome may deliver significant cost savings to payers over the course of treatment. Neurourol. Urodynam. 36:727-733, 2017. © 2016 Wiley Periodicals, Inc.

Cost-Effectiveness of Deep Brain Stimulation for Advanced Parkinson's Disease in the United States.

OBJECTIVES: Deep brain stimulation (DBS), which uses an implantable device to modulate brain activity, is clinically superior to medical therapy for treating advanced Parkinson's disease (PD). We studied the cost-effectiveness of DBS in conjunction with medical therapy compared to best medical therapy (BMT) alone, using the latest clinical and cost data for the U.S. healthcare system. MATERIALS AND METHODS: We used a decision-analytic state-transition (Markov) model to project PD progression and associated costs for the two treatment strategies. We estimated the discounted incremental cost-effectiveness ratio (ICER) in U.S. dollars per quality-adjusted life-year (QALY) from the Medicare payer perspective, considering a ten-year horizon, and evaluated the robustness of our projections through extensive deterministic sensitivity analyses. RESULTS: Over ten years, DBS treatment led to discounted total costs of $130,510 compared to $91,026 for BMT and added 1.69 QALYs more than BMT, resulting in an ICER of $23,404 per QALY. This ICER was relatively insensitive to variations in input parameters, with neurostimulator replacement, costs for DBS implantation, and costs for treatment of disease-related falls having the greatest effects. Across all investigated scenarios, including a five-year horizon, ICERs remained under $50,000 per QALY. Longer follow-up periods and younger treatment age were associated with greater cost-effectiveness. CONCLUSIONS: DBS is a cost-effective treatment strategy for advanced PD in the U.S. healthcare system across a wide range of assumptions. DBS yields substantial improvements in health-related quality of life at a value profile that compares favorably to other well-accepted therapies.

Cost-effectiveness of stimulation of the sphenopalatine ganglion (SPG) for the treatment of chronic cluster headache: a model-based analysis based on the Pathway CH-1 study.

BACKGROUND: In the recent Pathway CH-1 study, on-demand stimulation of the sphenopalatine ganglion (SPG) by means of an implantable neurostimulation system was proven to be a safe and effective therapy for the treatment of chronic cluster headache. Our objective was to assess the cost-effectiveness of SPG stimulation in the German healthcare system when compared to medical management. METHODS: Clinical data from the Pathway CH-1 study were used as input for a model-based projection of the cost-effectiveness of SPG stimulation through 5 years. Medical management as the comparator treatment was modeled on the basis of clinical events observed during the baseline period of CH-1. The costs of treatment were derived from a previously published cluster headache costing study and 2014 medication, neurostimulator, and procedure costs. We computed the 5-year incremental cost-effectiveness ratio (ICER) in euros per quality-adjusted life year (QALY), with costs and effects discounted at 3 % per year. RESULTS: SPG stimulation was projected to add 0.325 QALYs over the study period, while adding €889 in cost, resulting in a 5-year ICER of €2,736 per QALY gained. Longer follow-up periods, higher baseline attack frequency, and higher utilization of attack-aborting medications led to overall cost savings. SPG stimulation was found either cost-effective or cost-saving across all scenarios investigated in sensitivity analyses. CONCLUSIONS: Our model-based analysis suggests that SPG stimulation for the treatment of chronic cluster headache, under the assumption of sustained therapy effectiveness, leads to meaningful gains in health-related quality of life and is a cost-effective treatment strategy in the German healthcare system.

Economic analysis of endovascular interventions for femoropopliteal arterial disease: a systematic review and budget impact model for the United States and Germany.

OBJECTIVES: To study the economic impact on payers and providers of the four main endovascular strategies for the treatment of infrainguinal peripheral artery disease. BACKGROUND: Bare metal stents (BMS), drug-eluting stents (DES), and drug-coated balloons (DCB) are associated with lower target lesion revascularization (TLR) probabilities than percutaneous transluminal angioplasty (PTA), but the economic impact is unknown. METHODS: In December 2012, PubMed and Embase were systematically searched for studies with TLR as an endpoint. The 24-month probability of TLR for each treatment was weighted by sample size. A decision-analytic Markov model was used to assess the budget impact from payers' and facility-providers' perspectives of the four index procedure strategies (BMS, DES, DCB, and PTA). Base cases were developed for U.S. Medicare and the German statutory sickness fund perspectives using current 2013 reimbursement rates. RESULTS: Thirteen studies with 2,406 subjects were included. The reported probability of TLR in the identified studies varied widely, particularly following treatment with PTA or BMS. The pooled 24-month probabilities were 14.3%, 19.3%, 28.1%, and 40.3% for DCB, DES, BMS, and PTA, respectively. The drug-eluting strategies had a lower projected budget impact over 24 months compared to BMS and PTA in both the U.S. Medicare (DCB: $10,214; DES: $12,904; uncoated balloons $13,114; BMS $13,802) and German public health care systems (DCB €3,619; DES €3,632; BMS €4,026; PTA €4,290). CONCLUSIONS: DCB and DES, compared to BMS and PTA, are associated with lower probabilities of target lesion revascularization and cost savings for U.S. and German payers.

Cost-effectiveness of endobronchial valve therapy for severe emphysema: a model-based projection based on the VENT study.

BACKGROUND: Endobronchial valve (EBV) therapy is an innovative treatment that has been shown to be safe and effective in selected subgroups of patients with severe emphysema. OBJECTIVES: The objective of our study was to assess the cost-effectiveness of EBV therapy compared to the medical management of patients with high heterogeneity, complete fissures and lobar exclusion in the context of the German health-care system. METHODS: Clinical data from a subset of VENT (Endobronchial Valve for Emphysema Palliation Trial) provided information about clinical events, health-related quality of life, and disease staging for 12 months. This information was subsequently used to project long-term disease progression, mortality, and health resource utilization. We computed the 5- and 10-year incremental cost-effectiveness ratio (ICER) in euros per quality-adjusted life year (QALY). Costs and effects were discounted at 3% per year. RESULTS: EBV therapy led to clinically meaningful disease restaging at 12 months (37.8% of the cohort improved staging, compared to 0% in the controls). Over 5 years, EBV therapy was projected to increase survival from 66.4 to 70.7%, and to add 0.22 QALYs. Costs were estimated to increase by EUR 10,299, resulting in an ICER of EUR 46,322 per QALY. Over 10 years, 0.41 QALYs were gained at an additional cost of EUR 10,425, yielding an ICER of EUR 25,142 per QALY. CONCLUSIONS: Our model-based analysis suggests that EBV therapy leads to clinically meaningful changes in disease staging and progression when compared to medical management, with resulting gains in unadjusted and quality-adjusted life expectancy. Our results indicate that EBV therapy is cost-effective in the German health-care system.

Meniscus Root Repair vs Meniscectomy or Nonoperative Management to Prevent Knee Osteoarthritis After Medial Meniscus Root Tears: Clinical and Economic Effectiveness.

BACKGROUND: Medial meniscus root tears are a common knee injury and can lead to accelerated osteoarthritis, which might ultimately result in a total knee replacement. PURPOSE: To compare meniscus repair, meniscectomy, and nonoperative treatment approaches among middle-aged patients in terms of osteoarthritis development, total knee replacement rates (clinical effectiveness), and cost-effectiveness. STUDY DESIGN: Meta-analysis and cost-effectiveness analysis. METHODS: A systematic literature search was conducted. Progression to osteoarthritis was pooled and meta-analyzed. A Markov model projected strategy-specific costs and disutilities in a cohort of 55-year-old patients presenting with a meniscus root tear without osteoarthritis at baseline. Failure rates of repair and meniscectomy procedures and disutilities associated with osteoarthritis, total knee replacement, and revision total knee replacement were accounted for. Utilities, costs, and event rates were based on literature and public databases. Analyses considered a time frame between 5 years and lifetime and explored the effects of parameter uncertainty. RESULTS: Over 10 years, meniscus repair, meniscectomy, and nonoperative treatment led to 53.0%, 99.3%, and 95.1% rates of osteoarthritis and 33.5%, 51.5%, and 45.5% rates of total knee replacement, respectively. Meta-analysis confirmed lower osteoarthritis and total knee replacement rates for meniscus repair versus meniscectomy and nonoperative treatment. Discounted 10-year costs were $22,590 for meniscus repair, as opposed to $31,528 and $25,006 for meniscectomy and nonoperative treatment, respectively; projected quality-adjusted life years were 6.892, 6.533, and 6.693, respectively, yielding meniscus repair to be an economically dominant strategy. Repair was either cost-effective or dominant when compared with meniscectomy and nonoperative treatment across a broad range of assumptions starting from 5 years after surgery. CONCLUSION: Repair of medial meniscus root tears, as compared with total meniscectomy and nonsurgical treatment, leads to less osteoarthritis and is a cost-saving intervention. While small confirmatory randomized clinical head-to-head trials are warranted, the presented evidence seems to point relatively clearly toward adopting meniscus repair as the preferred initial intervention for medial meniscus root tears.

The cost-effectiveness of meniscal repair versus partial meniscectomy: A model-based projection for the United States.

BACKGROUND: Meniscal tears are the most common knee condition requiring surgery, and represent a substantial disease burden with clinical and cost implications. The success rates partial meniscectomy and meniscal repair have been studied, but limited information is available investigating their long-term costs and effects. Our objective was to assess the long-term cost-effectiveness of meniscal repair compared to meniscectomy. METHODS: We constructed a decision-analytic Markov disease progression model, using strategy-specific failure rates and treatment-specific probabilities for the development of osteoarthritis (OA) and subsequent knee replacement (TKR). Failure rates and OA incidence were derived from controlled and uncontrolled studies as well as meta-analyses. Costs were derived from 2014U.S. reimbursement amounts and published literature. RESULTS: Meniscal repair was associated with an increased failure rate (RR of 4.37), but meaningful reductions in OA and TKR incidence (29.7% vs. 39.4% and 19.6% vs. 27.9%, respectively) in our model-based analysis. Over the 30-year horizon, meniscal repair was associated with an increase in discounted QALYs to 16.52 (compared to 16.37 QALYs for meniscectomy), at overall discounted savings of $2384, making it the dominant index procedure strategy. Using age-specific per-patient cost and QALYs projected for the 30-year horizon, our computations suggest that payers could save approximately $43 million annually if 10% of current meniscectomies could be performed as meniscal repairs. CONCLUSIONS: Our projection suggests that meniscal repair, despite substantially higher failure rates, is associated with improved long-term outcomes and cost savings relative to meniscectomy in the majority of patients, making it the dominant treatment strategy.

Economic analysis of endovascular drug-eluting treatments for femoropopliteal artery disease in the UK.

OBJECTIVES: To estimate the clinical and economic impact of drug-eluting endovascular treatment strategies for femoropopliteal artery disease compared with current standard of care. DESIGN: Systematic literature search to pool target lesion revascularisations (TLR). Model-based per-patient cost impact and quasi-cost-effectiveness projection over 24 months based on pooled TLRs and current reimbursement. SETTING: The UK's National Health Service (NHS). PARTICIPANTS: Patients presenting with symptomatic femoropopliteal disease eligible for endovascular treatment. INTERVENTIONS: Current National Institute for Health and Care Excellence (NICE) guideline-recommended treatment with percutaneous transluminal balloon angioplasty (PTA) and bailout bare metal stenting (BMS) versus primary BMS placement, or drug-coated balloon (DCB), or drug-eluting stent (DES) treatment. PRIMARY AND SECONDARY OUTCOME MEASURES: 24-month per-patient cost impact to NHS (primary outcome). SECONDARY OUTCOMES: pooled 24-month TLR rates; numbers needed to treat (NNTs); cost per TLR avoided and estimated incremental cost-effectiveness ratio (ICER) in £ per quality-adjusted life year (QALY). RESULTS: N=28 studies were identified, reporting on 5167 femoropopliteal lesions. Over 24 months, DCB, DES and BMS reduced TLRs of de novo lesions from 36.2% to 17.6%, 19.4% and 26.9%, respectively, at an increased cost of £43, £44 and £112. NNTs to avoid 1 TLR in 24 months were 5.4, 6.0 and 10.8, resulting in cost per TLR avoided of £231, £264 and £1204. DCB was estimated to add 0.011 QALYs, DES 0.010 QALYs and BMS 0.005 QALYs, resulting in estimated ICERs of £3983, £4534 and £20 719 per QALY gained. A subset analysis revealed more favourable clinical and economic outcomes for a 3.5 µg/mm(2) DCB with urea excipient, compared with the rest of DCBs. A modest reduction of 10% in DCB and DES prices made drug-eluting treatments dominant. CONCLUSIONS: Widespread adoption of drug-eluting endovascular therapies for femoropopliteal disease would add meaningful clinical benefit at reasonable additional costs to the NHS. Based on currently available data, DCBs offer the highest clinical and economic value.

Economic Impact of Changes in Neonatal Intensive Care Unit Ventilation Strategies with the Advent of New Noninvasive Ventilation Techniques: A Review and Proposed Assessment Framework for High Flow Therapy as a Routine Respiratory Support Paradigm.

Background: High flow therapy (HFT) has been demonstrated to be a safe and effective noninvasive respiratory support technique for the treatment of pre-term infants in neonatal intensive care. Objectives: Our objective was to develop a quantitative framework based on available evidence to estimate the economic impact of adoption of a HFT respiratory support strategy compared to current standard of care. Methods: Model parameters were derived from a recent study comparing respiratory modality utilization between five US-based neonatal intensive care units (NICUs) adopting a HFT strategy and a larger pool of NICUs in the Vermont-Oxford Network (VON), and from single center experience. We computed the total cost difference between the respiratory support strategies based on published cost data. Parameter uncertainty was tested in sensitivity analyses. Results: The constructed model projected expected cost savings of $2,317 for the HFT strategy for the base case. Results were sensitive to length of HFT use, length of CMV, cost of HFT, and length of nCPAP support. Conclusions: Adoption of a HFT strategy appears to be associated with meaningful savings in total NICU episode of care costs, primarily because of reductions in the time of conventional mechanical ventilation. Further research is warranted to substantiate these findings.

Long-Term Cost-Effectiveness of Upper Airway Stimulation for the Treatment of Obstructive Sleep Apnea: A Model-Based Projection Based on the STAR Trial.

STUDY OBJECTIVES: Upper airway stimulation (UAS) is a new approach to treat moderate-to-severe obstructive sleep apnea. Recently, 12-month data from the Stimulation Treatment for Apnea Reduction (STAR) trial were reported, evaluating the effectiveness of UAS in patients intolerant or non-adherent to continuous positive airway pressure therapy. Our objective was to assess the cost-effectiveness of UAS from a U.S. payer perspective. DESIGN: A 5-state Markov model was used to predict cardiovascular endpoints (myocardial infarction [MI], stroke, hypertension), motor vehicle collisions (MVC), mortality, quality-adjusted life years (QALYs), and costs. We computed 10-year relative event risks and the lifetime incremental cost-effectiveness ratio (ICER) in $/QALY, comparing UAS therapy to no treatment under the assumption that the STAR trial-observed reduction in mean apnea-hypopnea index from 32.0 to 15.3 events/h was maintained. Costs and effects were discounted at 3% per year. SETTING: U.S. healthcare system; third-party payer perspective. PARTICIPANTS: 83% male cohort with mean age of 54.5 years. INTERVENTIONS: UAS vs. no treatment. MEASUREMENTS AND RESULTS: UAS substantially reduced event probabilities over 10 years (relative risks: MI 0.63; stroke 0.75; MVC 0.34), and was projected to add 1.09 QALYs over the patient's lifetime. Costs were estimated to increase by $42,953, resulting in a lifetime ICER of $39,471/QALY. CONCLUSIONS: Relative to the acknowledged willingness-to-pay threshold of $50,000-$100,000/QALY, our results indicate upper airway stimulation is a cost-effective therapy in the U.S. healthcare system.

Cost-effectiveness and clinical effectiveness of catheter-based renal denervation for resistant hypertension.

OBJECTIVES: The purpose of this study was to assess cost-effectiveness and long-term clinical benefits of renal denervation in resistant hypertensive patients. BACKGROUND: Resistant hypertension affects 12% of hypertensive persons. In the Symplicity HTN-2 randomized controlled trial, catheter-based renal denervation (RDN) lowered systolic blood pressure by 32 ± 23 mm Hg from 178 ± 18 mm Hg at baseline. METHODS: A state-transition model was used to predict the effect of RDN and standard of care on 10-year and lifetime probabilities of stroke, myocardial infarction, all coronary heart disease, heart failure, end-stage renal disease, and median survival. We adopted a societal perspective and estimated an incremental cost-effectiveness ratio in U.S. dollars per quality-adjusted life-year, both discounted at 3% per year. Robustness and uncertainty were evaluated using deterministic and probabilistic sensitivity analyses. RESULTS: Renal denervation substantially reduced event probabilities (10-year/lifetime relative risks: stroke 0.70/0.83; myocardial infarction 0.68/0.85; all coronary heart disease 0.78/0.90; heart failure 0.79/0.92; end-stage renal disease 0.72/0.81). Median survival was 18.4 years for RDN versus 17.1 years for standard of care. The discounted lifetime incremental cost-effectiveness ratio was $3,071 per quality-adjusted life-year. Findings were relatively insensitive to variations in input parameters except for systolic blood pressure reduction, baseline systolic blood pressure, and effect duration. The 95% credible interval for incremental cost-effectiveness ratio was cost-saving to $31,460 per quality-adjusted life-year. CONCLUSIONS: The model suggests that catheter-based renal denervation, over a wide range of assumptions, is a cost-effective strategy for resistant hypertension that might result in lower cardiovascular morbidity and mortality.

An integrated health-economic analysis of diagnostic and therapeutic strategies in the treatment of moderate-to-severe obstructive sleep apnea.

STUDY OBJECTIVES: Obstructive sleep apnea (OSA) is a common disorder associated with substantially increased cardiovascular risks, reduced quality of life, and increased risk of motor vehicle collisions due to daytime sleepiness. This study evaluates the cost-effectiveness of three commonly used diagnostic strategies (full-night polysomnography, split-night polysomnography, unattended portable home-monitoring) in conjunction with continuous positive airway pressure (CPAP) therapy in patients with moderate-to-severe OSA. DESIGN: A Markov model was created to compare costs and effectiveness of different diagnostic and therapeutic strategies over a 10-year interval and the expected lifetime of the patient. The primary measure of cost-effectiveness was incremental cost per quality-adjusted life year (QALY) gained. PATIENTS OR PARTICIPANTS: Baseline computations were performed for a hypothetical average cohort of 50-year-old males with a 50% pretest probability of having moderate-to-severe OSA (apnea-hypopnea index [AHI] ≥ 15 events per hour). MEASUREMENTS AND RESULTS: For a patient with moderate-to-severe OSA, CPAP therapy has an incremental cost-effectiveness ratio (ICER) of $15,915 per QALY gained for the lifetime horizon. Over the lifetime horizon in a population with 50% prevalence of OSA, full-night polysomnography in conjunction with CPAP therapy is the most economically efficient strategy at any willingness-to-pay greater than $17,131 per-QALY gained because it dominates all other strategies in comparative analysis. CONCLUSIONS: Full-night polysomnography (PSG) is cost-effective and is the preferred diagnostic strategy for adults suspected to have moderate-to-severe OSA when all diagnostic options are available. Split-night PSG and unattended home monitoring can be considered cost-effective alternatives when full-night PSG is not available.