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45. WHO informal consultation on revision of guidelines on evaluation of similar biotherapeutic products, virtual meeting, 30 June – 2 July 2021

Author

Allam, M., Bahaa, H., Sayed, M., Al-Oballi, A., Alshahrani, A., Baek, D., Kim, J., Chua, H.M., Gangakhedkar, J., Jagtap, Mr P., Lyaskovsky, T., Okudaira, S., Ondee, W., Sotomayor, P.S., Ricra, J.I. Solis, Uviase, J., Ahmed, F., Rajendran, Y., Defendi, H.G. Tonioli, Cho, S.Yi O., Qu, A., Acha, V., Gencoglu, M., Ho, K., Baldrighi, M., Schiestl, M., Watson, K., Spitzer, E., Chong, S., Fukushima, A., Kang, H.-N., Knezevic, I., Pante, G., Simao, Mariangela, Wadhwa, Meenu, Kang, Hye-Na, Thorpe, Robin, Knezevic, Ivana, Aprea, P., Bielsky, M.-C., Ekman, N., Heim, H.-K., Joung, J., Kurki, P., Lacana, E., Njue, C., Nkansah, E., Savkina, M., Thorpe, R., Yamaguchi, T., Wadhwa, M., Wang, J., Weise, M., and Wolff-Holz, E.

Published
2022
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46. Mobile Cardiac Outpatient Telemetry Patch vs Implantable Loop Recorder in Cryptogenic Stroke Patients in the US – Cost-Minimization Model

Author

Medic G, Kotsopoulos N, Connolly MP, Lavelle J, Norlock V, Wadhwa M, Mohr BA, and Derkac WM

Subjects
outpatient cardiac monitoring, holter, atrial fibrillation, electrocardiography, economic evaluation, secondary prevention, Medical technology, R855-855.5
Abstract

Goran Medic,1,2 Nikos Kotsopoulos,3 Mark P Connolly,2,3 Jennifer Lavelle,4 Vincent Norlock,4 Manish Wadhwa,4 Belinda A Mohr,5 Wayne M Derkac4 1Chief Medical Office, Philips Healthcare, Eindhoven, Netherlands; 2Department of Pharmacy, University of Groningen, Groningen, Netherlands; 3Global Market Access Solutions LLC, Charlotte, NC, USA; 4BioTelemetry, Inc., A Philips Company, Malvern, PA, USA; 5Chief Medical Office, Philips, Cambridge, MA, USACorrespondence: Goran MedicChief Medical Office, Philips Healthcare, High Tech Campus 37-3.009, Eindhoven, 5656 AG, NetherlandsTel +31-61-819-3782Email goran.medic@philips.comPurpose: The aim of this study was to compare costs and outcomes of mobile cardiac outpatient telemetry (MCOT) patch followed by implantable loop recorder (ILR) compared to ILR alone in cryptogenic stroke patients from the US health-care payors’ perspective.Patients and Methods: A quantitative decision tree cost-minimization simulation model was developed. Eligible patients were 18 years of age or older and were diagnosed with having a cryptogenic stroke, without previously documented atrial fibrillation (AF). All patients were assigned first to one then to the alternative monitoring strategies. Following AF detection, patients were initiated on oral anticoagulants (OAC). The model assessed direct costs for one year attributed to MCOT patch followed by ILR or ILR alone using a monitoring duration of 30 days post-cryptogenic stroke.Results: In the base case modeling, the MCOT patch arm detected 4.6 more patients with AFs compared to the ILR alone arm in a cohort of 1000 patients (209 vs 45 patients with detected AFs, respectively). Using MCOT patch followed by ILR in half of the patients initially undiagnosed with AF leads to significant cost savings of US$4,083,214 compared to ILR alone in a cohort of 1000 patients. Cost per patient with detected AF was significantly lower in the MCOT patch arm $29,598 vs $228,507 in the ILR only arm.Conclusion: An initial strategy of 30-day electrocardiogram (ECG) monitoring with MCOT patch in diagnosis of AF in cryptogenic stroke patients realizes significant cost-savings compared to proceeding directly to ILR only. Almost 8 times lower costs were achieved with improved detection rates and reduction of secondary stroke risk due to new anticoagulant use in subjects with MCOT patch detected AF. These results strengthen emerging recommendations for prolonged ECG monitoring in secondary stroke prevention.Keywords: ambulatory cardiac monitoring, Holter, atrial fibrillation, electrocardiography, economic evaluation, secondary prevention

Published
2021

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