Cost-effectiveness of CT perfusion for patients with acute ischemic stroke (CLEOPATRA)-Study protocol for a healthcare evaluation study

Abstract

Introduction: Computed tomography perfusion (CTP) is variably considered to assess eligibility for endovascular thrombectomy (EVT) in acute ischemic (AIS) stroke patients. Although CTP is recommended for patient selection in later (6–24 h) time window, it is currently not recommended in the earlier (0–6 h) time window and the costs and health effects of including CTP for EVT selection remain unknown. We aim to estimate the costs and health effects of using CTP for EVT selection in AIS patients compared to conventional selection. Patients and methods: CLEOPATRA is a healthcare evaluation study using clinical and imaging data from multiple, prospective EVT trials and registries in both the earlier and later time windows. To study the long-term health and cost effects, we will construct a (“Markov”) health state transition model simulating the clinical outcome over a 5-year follow-up period for CTP-based and conventional selection for EVT. Clinical data acquired within the current study and estimates from the literature will be used as input for probabilities of events, costs, and Quality-Adjusted Life Years (QALYs) per modified Rankin Scale (mRS) subscore. Primary outcome for the cost-effectiveness analysis will be the Incremental Cost-Effectiveness Ratio (ICER) in terms of costs per QALY gained over the simulated follow-up period. Study outcomes: Outcome measures will be reported as cumulative values over a 5-year follow-up period. Discussion: This study will provide preliminary insight into costs and health effects of including CTP in the selection for EVT for AIS patients, presenting between 0 and 24 h after time last known well. The results may be used to develop recommendations and inform further implementation projects and studies.

Cost-effectiveness of CT perfusion for the detection of large vessel occlusion acute ischemic stroke followed by endovascular treatment: A model-based health economic evaluation study

“…We included patients from the Cost-effectiveness of CT perfusion for Patients with Acute Ischemic Stroke (CLEOPATRA) healthcare evaluation study. CLEOPATRA is a healthcare evaluation study using clinical and imaging data from multiple, prospective EVT trials and registries in both the earlier and later time windows (January 2018 – March 2022; trialregister.nl:NL7974) in the Netherlands (11). We only included data from EVT-treated patients with available CTP imaging who presented within six hours after stroke symptom onset.…”

“…We simulated 5- and 10-year follow-up using a Markov model with patient-level microsimulations. The Markov model was previously described and validated and consisted of a short-term 90-day post-AIS model followed by a long-term yearly model to simulate functional outcome using the modified Rankin Scale (mRS) ( Figure 1 ) (11,12). In the short-term model, we simulated the 90-day mRS of patients that received EVT and those who did not based on NCCT+CTA+CTP or NCCT+CTA based LVO detection.…”

“…Follow-up costs for the first, second, and third year onward per mRS sub-score included: acute setting treatment cost, in-hospital costs, outpatient clinic visits, rehabilitation, formal homecare, and long-term institutionalized costs (7). Acute care costs included NCCT, CTA, CTP, EVT, and IVT if applicable based on reference prices from the institute of Medical Technological Assessment, Rotterdam, the Netherlands (11,16). Acute care costs were increased by 42% to account for hospital overhead costs according to Dutch cost-pricing standards (17).…”

“…We pre-defined costs per CTP of € 251.40 based on the following assumptions and data: € 129 for the CTP acquisition (17), costs for acute care personnel (€ 94) (17), € 20 for the CTP software license based on expert opinion. EVT costs were € 9,924.50 consisting of material costs and 1.5 hours of personnel costs for (neuro-) interventionist, 1 anesthesiologist, 2 radiology assistants, and 2 anesthesia assistants (11,16). IVT costs of € 950.82 were extracted from m edicijnkosten.nl.…”

Costs and health effects of CT perfusion-based selection for endovascular treatment of patients with a large vessel occlusion presenting within six hours after symptom onset A model-based health economic evaluation

“…Costs in euros (€) from a healthcare payer perspective and QALYs over the simulated period were derived per mRS sub-score in a previous study 21 and predefined in our protocol. 12 Online supplement D describes the acute care and long-term follow-up costs. Acute care costs included personnel cost, radiological imaging, EVT procedure, and thrombolysis costs.…”