[Cost-utility analysis: Mechanical thrombectomy plus thrombolysis in ischemic stroke due to large vessel occlusion in the public sector in Chile]. / Análisis de costo utilidad: trombectomía mecánica más trombólisis en accidente vascular cerebral isquémico debido a oclusión de grandes vasos en el sector público en Chile.

INTRODUCTION: Several studies demonstrate the therapeutic superiority of thrombolysis plus mechanical thrombectomy versus thrombolysis alone to treat stroke. OBJECTIVE: To analyze the cost-utility of thrombolysis plus mechanical thrombectomy versus thrombolysis in patients with ischemic stroke due to large vessel occlusion. METHODS: Cost-utility analysis. The model used is blended: Decision Tree (first 90 days) and Markov in the long term, of seven health states based on a disease-specific scale, from the Chilean public insurance and societal perspective. Quality-Adjusted Life-Years and costs are evaluated. Deterministic (DSA) and probabilistic (PSA) analyses were carried out. RESULTS: From the public insurance perspective, in the base case, mechanical thrombectomy is associated with lower costs in a lifetime horizon, and with higher benefits (2.63 incremental QALYs, and 1.19 discounted incremental life years), at a Net Monetary Benefit (NMB) of CLP 37,289,874, and an Incremental Cost-Utility Ratio (ICUR) of CLP 3,807,413/QALY. For the scenario that incorporates access to rehabilitation, 2.54 incremental QALYs and 1.13 discounted life years were estimated, resulting in an NMB of CLP 35,670,319 and ICUR of CLP 3,960,624/QALY. In the scenario that incorporates access to long-term care from a societal perspective, the ICUR falls to CLP 951,911/QALY, and the NMB raises to CLP 43,318,072, improving the previous scenarios. In the DSA, health states, starting age, and relative risk of dying were the variables with the greatest influence. The PSA for the base case corroborated the estimates. CONCLUSIONS: Thrombolysis plus mechanical thrombectomy adds quality of life at costs acceptable for decision-makers versus thrombolysis alone. The results are consistent with international studies.

INTRODUCCIÓN: Diversos estudios demuestran la superioridad terapéutica de la trombólisis más trombectomía mecánica, versus trombólisis sola, en el tratamiento del accidente vascular cerebral. OBJETIVOS: Analizar el costo utilidad de la trombólisis más trombectomía versus trombólisis sola en pacientes con accidente vascular cerebral isquémico con oclusión de grandes vasos. MÉTODOS: Evaluación de costo utilidad. Se ha utilizado un modelo mixto: árbol de decisión (primeros 90 días) y Markov en el largo plazo, de siete estados de salud definidos en escala específica de enfermedad, desde la perspectiva del seguro público chileno y societal. Se evalúan costos y años de vida ajustados por calidad. Se realizó análisis de incertidumbre determinístico y probabilístico. RESULTADOS: Bajo la perspectiva de seguro público, en el caso base la trombectomía mecánica se relaciona con menores costos en un horizonte de por vida, con mayores beneficios (2,63 años de vida ajustados por calidad incrementales, y 1,19 años de vida incrementales descontados), a un beneficio monetario neto de $37 289 874 pesos chilenos, y una razón incremental de costo utilidad de $3 807 413 pesos por años de vida ajustados por calidad. Para el escenario que agrega acceso a rehabilitación se estimaron 2,54 años de vida ajustados por calidad incremental y 1,13 años de vida descontados, resultando en un beneficio monetario neto de $35 670 319 pesos y razón incremental de costo utilidad de $3 960 624 pesos por años de vida ajustados por calidad. En el escenario que agrega el efecto de acceso a cuidados de larga duración con perspectiva societal, la razón incremental de costo utilidad cae hasta $951 911 pesos por años de vida ajustados por calidad y el beneficio monetario neto se eleva a $43 318 072 pesos, superando las estimaciones anteriores. En el análisis de incertidumbre determinístico, los estados de salud, edad de inicio de la cohorte y riesgo relativo de morir, fueron las variables con mayor influencia. El análisis de incertidumbre probabilístico para el caso base, corroboró las estimaciones. CONCLUSIONES: La trombólisis más trombectomía mecánica agrega calidad de vida a costos aceptables por el tomador de decisión, versus trombólisis sola. Los resultados son consistentes con los estudios internacionales.

Implications of achieving TICI 2b vs TICI 3 reperfusion in patients with ischemic stroke: a cost-effectiveness analysis.

BACKGROUND: The benefit of endovascular thrombectomy (EVT) in stroke patients with large-vessel occlusion (LVO) depends on the degree of recanalization achieved. We aimed to determine the health outcomes and cost implications of achieving TICI 2b vs TICI 3 reperfusion in acute stroke patients with LVO. METHODS: A decision-analytic study was performed with Markov modeling to estimate the lifetime quality-adjusted life years (QALY) of EVT-treated patients, and costs based on the degree of reperfusion achieved. The study was performed with a societal perspective in the United States' setting. The base case calculations were performed in three age groups: 55-, 65-, and 75-year-old patients. RESULTS: Within 90 days, achieving TICI 3 resulted in a cost saving of $3676 per patient and health benefit of 11 days in perfect health as compared with TICI 2b. In the long term, for the three age groups, achieving TICI 3 resulted in cost savings of $46,498, $25,832, and $15 719 respectively, and health benefits of 2.14 QALYs, 1.71 QALYs, and 1.23 QALYs. Every 1% increase in TICI 3 in 55-year-old patients nationwide resulted in a cost saving of $3.4 million and a health benefit of 156 QALYs. Among 65-year-old patients, the corresponding cost savings and health benefit were $1.9 million and 125 QALYs. CONCLUSION: There are substantial cost and health implications in achieving complete vs incomplete reperfusion after EVT. Our study provides a framework to assess the cost-benefit analysis of emerging diagnostic and therapeutic techniques that might improve patient selection, and increase the chances of achieving complete reperfusion.

Economic challenges of using innovative medical devices in major public health pathologies: Example of acute ischemic stroke management by mechanical thrombectomy.

BACKGROUND: Activity-based Funding can induce financial imbalances for health institutions if innovative medical devices (MD) used to perform acts are included in Diagnosis Related Groups (DRG) tariff. To be reimbursed in addition to the DRG tariff, innovative MD must have received a favorable evaluation by the French National Authority for Health (Haute Autorité de Santé) and be registered on the positive list. The aim of this study was to evaluate the expenses and incomes generated by each scenario (before and after the reimbursement of MD), and the financial reports. This study concerned the management of ischemic stroke by mechanical thrombectomy devices, in high-volume French hospital. METHODS: All patients who have had an acute ischemic stroke and admitted to the interventional neuroradiology unit between January 2016 and December 2017 were included retrospectively in this monocentric study. They were divided into four subgroups based on the severity of the DRG. The cost study was carried out using the French National Cost Study Methodology adjusted for the duration of the stays and by micro-costing on MD. RESULTS: A total of 267 patients were included. Over the study period, the average cost of the hospital stay was €10,492±6364 for a refund of €9838±6749 per patient. The acts performed became profitable once the MD were registered on the positive list (€-1017±3551 vs. €560±2671; P<0.05). Despite this reimbursement, this activity remained in deficit for DRG lowest severity (level 1) patients (€-492±1244). Specific MD used for mechanical thrombectomy represented 37% of the total cost of stay. CONCLUSION: The time required to evaluate MD reimbursement files is too long compared to their development. As a result, practitioners are in difficulty to be able to carry out acts according to the consensual practices of their learned societies, without causing any financial deficit of their institutions.

Exploring the Cost-Effectiveness of Mechanical Thrombectomy Beyond 6 Hours Following Advanced Imaging in the United Kingdom.

Background and Purpose- In the United Kingdom, mechanical thrombectomy (MT) for acute ischemic stroke patients assessed beyond 6 hours from symptom onset will be commissioned up to 12 hours provided that advanced imaging (AdvImg) demonstrates salvageable brain tissue. While the accuracy of AdvImg differs across technologies, evidence is limited regarding the proportion of patients who would benefit from late MT. We compared the cost-effectiveness of 2 care pathways: (1) MT within and beyond 6 hours based on AdvImg selection versus (2) MT only within 6 hours based on conventional imaging selection. The impact of varying AdvImg accuracy and prior probability for acute ischemic stroke patients to benefit from late MT was assessed. Methods- A decision tree and a Markov trace were developed. A hypothetical United Kingdom cohort of suspected stroke patients aged 71 years with first event was modeled. Costs, health outcomes, and probabilities were obtained from the literature. Outcomes included costs, life years (LYs), quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios. Probabilistic sensitivity analyses were performed. Various scenarios with prior probabilities of 10%, 20%, and 30%, respectively, for acute ischemic stroke patients to benefit from late MT, and with perfect accuracy, 80% sensitivity, and 70% specificity of AdvImg were studied. Results- Incremental cost-effectiveness ratios resulting from our deterministic analyses varied from $8199 (£6164) to $49 515 (£37 229) per QALY gained. AdvImg accuracy impacted the incremental cost-effectiveness ratio only when its specificity decreased. Over lifetime horizons, all scenarios including late MT improved QALYs and LYs. Depending on the scenario, the probabilistic sensitivity analyses showed probabilities varying between 46% and 93% for the late MT pathway to be cost-effective at a willingness to pay threshold of $39 900 (£30 000) per QALY. Conclusions- Late MT based on AdvImg selection may be good value for money. However, additional data regarding the implementation of AdvImg and prior probability to benefit from late MT are needed before its cost-effectiveness can be fully assessed.

Cost-effectiveness of mechanical thrombectomy within 6 hours of acute ischaemic stroke in China.

OBJECTIVES: Endovascular mechanical thrombectomy is an effective but expensive therapy for acute ischaemic stroke with proximal anterior circulation occlusion. This study aimed to determine the cost-effectiveness of mechanical thrombectomy in China, which is the largest developing country. DESIGN: A combination of decision tree and Markov model was developed. Outcome and cost data were derived from the published literature and claims database. The efficacy data were derived from the meta-analyses of nine trials. One-way and probabilistic sensitivity analyses were performed in order to assess the uncertainty of the results. SETTING: Hospitals in China. PARTICIPANTS: The patients with acute ischaemic stroke caused by proximal anterior circulation occlusion within 6 hours. INTERVENTIONS: Mechanical thrombectomy within 6 hours with intravenous tissue plasminogen activator (tPA) treatment within 4.5 hours versus intravenous tPA treatment alone. OUTCOME MEASURES: The benefit conferred by the treatment was assessed by estimating the cost per quality-adjusted life-year (QALY) gained in the long term (30 years). RESULTS: The addition of mechanical thrombectomy to intravenous tPA treatment compared with standard treatment alone yielded a lifetime gain of 0.794 QALYs at an additional cost of CNY 50 000 (US$7700), resulting in a cost of CNY 63 010 (US$9690) per QALY gained. The probabilistic sensitivity analysis indicated that mechanical thrombectomy was cost-effective in 99.9% of the simulation runs at a willingness-to-pay threshold of CNY 125 700 (US$19 300) per QALY. CONCLUSIONS: Mechanical thrombectomy for acute ischaemic stroke caused by proximal anterior circulation occlusion within 6 hours was cost-effective in China. The data may be used as a reference with regard to medical resources allocation for stroke treatment in low-income and middle-income countries as well as in the remote areas in the developed countries.

Cost-Effectiveness of Thrombectomy in Patients With Acute Ischemic Stroke: The THRACE Randomized Controlled Trial.

BACKGROUND AND PURPOSE: The benefit of mechanical thrombectomy added to intravenous thrombolysis (IVT) in patients with acute ischemic stroke has been largely demonstrated. However, evidence of the economic incentive of this strategy is still limited, especially in the context of a randomized controlled trial. We aimed to analyze whether mechanical thrombectomy combined with IVT (IVMT) is cost-effective when compared with IVT alone. METHODS: Individual-level cost and outcome data were collected in the THRACE randomized controlled trial (Thrombectomie des Artères Cerébrales) including patients with acute ischemic stroke. Patients were assigned to receive IVT or IVMT. The primary outcomes were modified Rankin Scale score of functional independence at 90 days (score 0-2) and the EuroQol-5D quality-of-life score at 1 year. RESULTS: Treating acute ischemic stroke with IVMT (n=200) versus IVT (n=202) increased the rate of functional independence by 10.9% (53.0% versus 42.1%; P=0.028), at an increased cost of $2116 (€1909), with no significant difference in mortality (12% versus 13%; P=0.70) or symptomatic intracranial hemorrhage (2% versus 2%; P=0.71). The cost per one averted case of disability was estimated at $19 379 (€17 480). The incremental cost per one quality-adjusted life year gained was $14 881 (€13 423). On sensitivity analysis, the probability of cost-effectiveness with IVMT was 84.1% in terms of cases of averted disability and 92.2% in terms of quality-adjusted life years. CONCLUSIONS: Based on randomized trial data, this study demonstrates that IVMT used to treat acute ischemic stroke is cost-effective when compared with IVT alone. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01062698.

Mechanical Thrombectomy in Patients With Acute Ischemic Stroke: A Health Technology Assessment.

BACKGROUND: In Ontario, current treatment for eligible patients who have an acute ischemic stroke is intravenous thrombolysis (IVT). However, there are some limitations and contraindications to IVT, and outcomes may not be favourable for patients with stroke caused by a proximal intracranial occlusion. An alternative is mechanical thrombectomy with newer devices, and a number of recent studies have suggested that this treatment is more effective for improving functional independence and clinical outcomes. The objective of this health technology assessment was to evaluate the clinical effectiveness and cost-effectiveness of new-generation mechanical thrombectomy devices (with or without IVT) compared to IVT alone (if eligible) in patients with acute ischemic stroke. METHODS: We conducted a systematic review of the literature, limited to randomized controlled trials that examined the effectiveness of mechanical thrombectomy using stent retrievers and thromboaspiration devices for patients with acute ischemic stroke. We assessed the quality of the evidence using the GRADE approach. We developed a Markov decision-analytic model to assess the cost-effectiveness of mechanical thrombectomy (with or without IVT) versus IVT alone (if eligible), calculated incremental cost-effectiveness ratios using a 5-year time horizon, and conducted sensitivity analyses to examine the robustness of the estimates. RESULTS: There was a substantial, statistically significant difference in rate of functional independence (GRADE: high quality) between those who received mechanical thrombectomy (with or without IVT) and IVT alone (odds ratio [OR] 2.39, 95% confidence interval [CI] 1.88-3.04). We did not observe a difference in mortality (GRADE: moderate quality) (OR 0.80, 95% CI 0.60-1.07) or symptomatic intracerebral hemorrhage (GRADE: moderate quality) (OR 1.11, 95% CI 0.66-1.87). In the base-case cost-utility analysis, which had a 5 year time horizon, the costs and effectiveness for mechanical thrombectomy were $126,939 and 1.484 quality-adjusted life-years (QALYs) (2.969 life-years). The costs and effectiveness for IVT alone were $124,419 and 1.273 QALYs (2.861 life-years), respectively. Mechanical thrombectomy was associated with an incremental cost-effectiveness ratio of $11,990 per QALY gained. Probabilistic sensitivity analysis showed that the probability of mechanical thrombectomy being cost-effective was 57.5%, 89.7%, and 99.6%, at thresholds of $20,000, $50,000, and $100,000 per QALY gained, respectively. We estimated that adopting mechanical thrombectomy would lead to a cost increase of approximately $1 to 2 million. CONCLUSIONS: High quality evidence showed that mechanical thrombectomy significantly improved functional independence and appeared to be cost-effective compared to IVT alone for patients with acute ischemic stroke.

Comparison of endovascular treatment approaches for acute ischemic stroke: cost effectiveness, technical success, and clinical outcomes.

INTRODUCTION: The use of mechanical thrombectomy for the treatment of acute ischemic stroke has significantly advanced over the last 5 years. Few data are available comparing the cost and clinical and angiographic outcomes associated with available techniques. The aim of this study is to compare the cost and efficacy of current endovascular stroke therapies. METHODS: A single-center retrospective review was performed of the medical record and hospital financial database of all ischemic stroke cases admitted from 2009 to 2013. Three discrete treatment methodologies used during this time were compared: traditional Penumbra System (PS), stent retriever with local aspiration (SRLA) and A Direct Aspiration first Pass Technique (ADAPT). Statistical analyses of clinical and angiographic outcomes and costs for each group were performed. RESULTS: 222 patients (45% men) underwent mechanical thrombectomy. Successful revascularization was defined as Thrombolysis In Cerebral Infarction (TICI) 2b/3 flow, which was achieved in 79% of cases with PS, 83% of cases with SRLA, and 95% of cases with ADAPT. The average total cost of hospitalization for patients was $51,599 with PS, $54,700 with SRLA, and $33 ,11 with ADAPT (p<0.0001). Average times to recanalization were 88 min with PS, 47 min with SRLA, and 37 min with ADAPT (p<0.0001). Similar rates of good functional outcomes were seen in the three groups (PS 36% vs SRLA 43% vs ADAPT 47%; p=0.4). CONCLUSIONS: The ADAPT technique represents the most technically successful yet cost-effective approach to revascularization of large vessel intracranial occlusions.