Pharmacoeconomic evaluation of dual antiplatelet therapy in acute minor ischemic stroke
DOI:
https://doi.org/10.24959/uekj.19.3Keywords:
pharmacoeconomics, ischemic stroke, dual antiplatelet therapyAbstract
Aim. To make a pharmacoeconomic assessment of dual antiplatelet therapy (DAPT) in acute minor ischemic stroke by cost-effectiveness analysis.
Materials and methods. The results were obtained using systemic, analytical and comparative, logical and pharmacoeconomic methods and data on therapeutic equivalence or bioequivalence of pharmaceuticals from three sources: the Orange Book (USA), protocols of the Committee for Medicinal Products for Human Use of the European Medicines Agency and the Rx index, the Directory of Equivalence of Pharmaceuticals (Ukraine), the results of systematic review and meta-analysis of DAPT to prevent early recurrent ischemic stroke as well as information on the minimum purchase prices of pharmaceuticals.
Results. According to data obtained from the Orange Book (USA), protocols of the Committee for Medicinal Products for Human Use of the European Medicines Agency and the Rx index, the Directory of Equivalence of Pharmaceuticals (Ukraine), a cost-effectiveness index and an incremental indicator of cost-effectiveness were calculated for those antiplatelet pharmaceuticals for which there was information available on therapeutic equivalence and bioequivalence, since otherwise the extrapolation of the results of the clinical effectiveness of the original pharmaceuticals for generic drugs would not have been appropriate.
Conclusions. Based on data from the Orange Book (USA), protocols of the Committee for Medicinal Products for Human Use of the European Medicines Agency and the Rx index, the Directory of Equivalence of Pharmaceuticals (Ukraine), information on the equivalence of registered pharmaceuticals inUkraine such as Clopidogrel and Acetylsalicylic Acid (ASA) was systematized. Through pharmacoeconomic analysis it was established that as of July 2018: Clinical and economical advantage was observed for application of monotherapy in acute minor ischemic stroke with a use of a generic (Acecor Cardio, 100 mg, Intestine Soluble Tablets, Pharmaceutical company Microkhim Ltd., Ukraine) compared to the original pharmaceutical (Aspirin Cardio, 100 mg, Film-coated Intestine Soluble Tablets, Bayer AG, Germany); the need for additional involvement of small funds is inherent in 10 out of 11 combinations of more effective and more expensive DAPT of acute minor ischemic stroke (Clopidogrel + ASA). It ranges from 14.49 UAH per unit of effectiveness (Trombonet, 75 mg, Film-coated Tablets № 60, Farmak JSC, Ukraine + ASA ) to 29.91 UAH per unit of effectiveness (Clopidogrel Zentiva, 75 mg, Film-coated Tablets № 30, Zentiva, Czech Republic + ASA); for CoPlavix, a combination pharmaceutical (Intestinal Soluble Tablets, 75 mg/75 mg, № 28, Sanofi Winthrop Industrie, France) compared with four ASA pharmaceuticals the incremental cost-effectiveness ratio is the lowest, although still significant (185.77 UAH per unit of effectiveness); this is typical in comparison to Aspirin Cardio (100 mg, Film-coated Intestinal Soluble Tablets № 28, Bayer AG, Germany).
References
Guidelines for Management of Ischaemic Stroke. European Stroke Organisation (ESO). (2008). Available at: http://www.eso-stroke.org/recommendations.php
Nakaz MOZ Ukrainy № 602 vid 03.08.2012. (2012). «Pro zatverdzhennia ta vprovadzhennia medyko-tekhnolohichnykh dokumentiv zi standartyzatsii medychnoi dopomohy pry ishemichnomu insulti». Available at: http://www.moz.gov.ua/ua/portal/dn_20120803_602.html
Nakaz MOZ Ukrainy № 602 vid 03.08.2012 r. (2012).»Pro zatverdzhennia ta vprovadzhennia medyko-tekhnolohichnykh dokumentiv, rozroblenykh na zasadakh dokazovoi medytsyny» (insult). Available at: https://www.moz.gov.ua/ua/portal/dn_20120127_p.html
AHA/ASA Guideline. 2018 Guidelines for the Early Management of Patients With Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association (2018). Available at: https://stroke.ahajournals.org/content/early/2018/01/23/STR.0000000000000158
Vinichuk, S. M., Prokopiv, M. M. (2006). Hostryy ishemichnyy insul‘t. Kyiv, Naukova dumka. 286.
Geeganage, C. M., Diener, H.-C., Algra, A., Chen, C., Topol, E. J., … Dengler, R. (2012). Dual or Mono Antiplatelet Therapy for Patients With Acute Ischemic Stroke or Transient Ischemic Attack. Stroke, 43(4), 1058–1066. https://doi.org/10.1161/strokeaha.111.637686
Palacio, S., Hart, R. G., Pearce, L. A., & Benavente, O. R. (2012). Effect of Addition of Clopidogrel to Aspirin on Mortality. Stroke, 43(8), 2157–2162. https://doi.org/10.1161/strokeaha.112.656173
Zhou, X., Tian, J., Zhu, M. Z., & He, C. K. (2017). A systematic review and meta-analysis of published randomized controlled trials of combination of clopidogrel and aspirin in transient ischemic attack or minor stroke. Experimental and Therapeutic Medicine, 14(1), 324–332. https://doi.org/10.3892/etm.2017.4459
Adonkina, V. Yu., Mishchenko, O. Ya. (2013). Klìnìčna farmacìâ, 17(1), 8–11.
Mishchenko, O. Ya, Adonkina, V. Yu, Terentyeva, Yu. K. (2014). Klìnìčna farmacìâ, 18(1), 39–44. https://doi.org/10.24959/cphj.14.1290
Redkina, Ye. A., Tkachenko, N. A., Gladyshev, V. V., Pukhalskaya, I. A. (2017). Aktualni pytannia farmatsevtychnoi ta medychnoi nauky ta praktyky, 10 (2), 207–213. https://doi.org/10.14739/2409-2932.2017.2.103779
Levytska, O. R., Hromovyk, B. P. (2018). Pharmaceutical Review 3, 85–93. https://doi.org/10.11603/2312-0967.2018.3.9324
Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (2018). Available at: http://www.accessdata.fda.gov/scripts/cder/ob/
Syvolap, V. V., Franskyavichene, L. V. (2011). Zaporiz’kyy medychnyy zhurnal, 13 (6), 65–67.
Yavelov, I. S. (2012). Klinicheskaja farmakologija i terapija, 21(1), 48–53.
Grizodub, A., Leontyev, D., Dmitrieva, M., Baula O. (2006). Visnyk farmakolohiyi ta farmatsiyi, 2, 18–24.
European Medicines Agency. (2018). Available at: http://www.ema.europa.eu/en/search/search
Zupants, I. A., Chernykh, V. P. (Eds). (2016). Rx index – Dovidnyk ekvivalentnosti likarskykh zasobiv. Kyiv: Farmatsevt Praktyk, 848.
Yakovlieva, L. V. (Ed). (2009). Farmakoekonomika: posibnyk dlia studentiv vuziv. Vinnytsia: Nova Knyha, 208.
Programmnyj kompleks «Apteka». (n.d.). Available at: https://pharmbase.com.ua/ru/optovye-predlozheniya
Downloads
Published
Issue
Section
License
Copyright (c) 2019 National University of Pharmacy
This work is licensed under a Creative Commons Attribution 4.0 International License.
Authors who publish with this journal agree to the following terms:- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution License that allows others to share the work with an acknowledgement of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgement of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).
