Pharmacoeconomic evaluation of apixaban use for the treatment and prevention of venous thromboembolism in the general population and patients with oncological diseases
https://doi.org/10.37489/2588-0519-2022-4-38-49
Abstract
Aim. To conduct a pharmacoeconomic analysis of the use of the drug Eliquis® (apixaban), belonging to direct oral anticoagulants (DOACs), for the treatment and prevention of deep vein thrombosis (DVT) and/or pulmonary embolism (PE), including in patients suffering from cancer disease compared with other anticoagulants. Materials and Methods. The economic assessment was made from the standpoint of the healthcare of the Russian Federation. Comparative evaluation of the effectiveness of DOACs was carried out on the basis of the combined rate of the incidence of VTE and death from VTE, as well as death from any cause. Safety assessment — based on the rate of major bleeding (MB) and clinically significant non-severe bleeding (CSNSB). The evaluation was performed on the basis of data obtained in the course of previously performed meta-analyses, the results of which were published. The total cost of patient management for each of the compared alternative treatment tactics was estimated by calculating the cost of a course of drug therapy, as well as the cost of managing adverse events in the study horizon, which was 12 months. The conclusion about the most preferred alternative was made on the basis of data on the relationship between the effectiveness and cost of treating the patient. Results. Apixaban compared with dabigatran and rivaroxaban was associated with a lower risk of developing MB and CSNSB. In addition, in patients taking apixaban, there was a trend towards a decrease in the risk of death from any cause compared with patients who used dabigatran and rivaroxaban, which did not reach statistical significance, which in turn led to the choice of the method of pharmacoeconomic analysis — “cost minimization”. It has been established that the use of apixaban is characterized by the lowest costs, the cost of managing one patient amounted to 59 271,89 rubles per year, which is 28,8 % and 27,2 % lower than similar costs for treatment regimens with the original drugs dabigatran and rivaroxaban, respectively. The difference in costs was due to both the cost of treating complications (1362.8 rubles vs. 2536.3 rubles vs. 3170.9 rubles for apixaban, rivaroxaban and dabigatran, respectively), and the cost of treatment and prophylaxis of DOACs (31 514,20 RUB vs 46 434,8 RUB vs 46 790,6 RUB, respectively). Similar results were achieved in the group of patients suffering from oncological diseases, as DOACs also allowed to reduce costs by 4–5 times compared with the use of LMWH. Conclusion. Among the original DOACs and traditional LMWH therapies, the apixaban regimen has the best cost-effectiveness ratio and is the most preferred alternative in terms of pharmacoeconomic analysis.
Keywords
About the Authors
A. S. KolbinRussian Federation
Kolbin Alexey S., Dr. Sci. (Med.), Professor, Head of the Department of Clinical Pharmacology and Evidence-Based Medicine
Saint-Petersburg
A. R. Kasimova
Russian Federation
Kasimova Alina R., PhD, Cand. Sci. (Med.), Assistant of the Department of Clinical Pharmacology and Evidence- based Medicine, FSBEI HE I. P. Pavlov SPbSMU MOH Russia; Clinical Pharmacologist, Vreden’ National Medical Research Centre fоr Traumatology and Orthopedics of the Ministry of Health of Russia
Saint-Petersburg
S. R. Gilyarevskiy
Russian Federation
Gilyarevskiy Sergey R., Dr. Sci. (Med.), Professor, Department of Clinical Pharmacology and Therapy
Moscow
References
1. Heit JA, Silverstein MD, Mohr DN, Petterson TM, O’Fallon WM, Melton LJ 3rd. Predictors of survival after deep vein thrombosis and pulmonary embolism: a population-based, cohort study. Arch Intern Med. 1999 Mar 8;159(5):445–53. doi:10.1001/archinte.159.5.445. PMID:10074952.
2. Russian clinical guidelines for the diagnosis, treatment and prevention of venous thromboembolic complications (VTEC), 2015. Phlebology. 2015;9(2):1–52. (In Russ). https://clck.ru/33G6wL.
3. Agnelli G, Buller HR, Cohen A, Curto M, Gallus AS, Johnson M, Porcari A, Raskob GE, Weitz JI; AMPLIFY-EXT Investigators. Apixaban for extended treatment of venous thromboembolism. N Engl J Med. 2013 Feb 21;368(8):699–708. doi:10.1056/NEJMoa1207541
4. Kudykin MN. Mechanical ways of thromboprophylaxis and therapy of chronic venous insufficiency: accent — compression therapy. Meditsinskiy sovet = Medical Council. 2017;(12):176–81. (In Russ). doi:10.21518/2079-701X-2017-12-176-181
5. van der Hulle T, Kooiman J, den Exter PL, Dekkers OM, Klok FA, Huisman MV. Effectiveness and safety of novel oral anticoagulants as compared with vitamin K antagonists in the treatment of acute symptomatic venous thromboembolism: a systematic review and meta-analysis. J Thromb Haemost. 2014;12(3):320–8. doi:10.1111/jth.12485
6. Mantha S, Ansell J. Indirect comparison of dabigatran, rivaroxaban, apixaban and edoxaban for the treatment of acute venous thromboembolism. J Thromb Thrombolysis. 2015 Feb;39(2):155–65. doi:10.1007/s11239-014-1102-5
7. Russian clinical guidelines for the prevention and treatment of venous thromboembolic complications (VTEC) in cancer patients, 2015. (In Russ). https://oncology.ru/specialist/treatment/symptomatic/thromboembolic_disorders/recommendations.pdf.
8. Blom JW, Vanderschoot JP, Oostindiër MJ, Osanto S, van der Meer FJ, Rosendaal FR. Incidence of venous thrombosis in a large cohort of 66,329 cancer patients: results of a record linkage study. J Thromb Haemost. 2006 Mar;4(3):529–35. doi:10.1111/j.1538-7836.2006.01804.x
9. Streiff MB, Holmstrom B, Angelini D, Ashrani A, Bockenstedt PL, Chesney C et al. NCCN Guidelines® insights cancer-associated venous thromboembolic disease, version 2.2018 featured updates to the NCCN guidelines. J Natl Compr Canc Netw. 2018 Nov 1;16(11):1289-303. doi:10.6004/jnccn.2018.0084
10. Farge D, Frere C, Connors JM, Ay C, Khorana AA, Munoz A, Brenner B, Kakkar A, Rafii H, Solymoss S, Brilhante D, Monreal M, Bounameaux H, Pabinger I, Douketis J; International Initiative on Thrombosis and Cancer (ITAC) advisory panel. 2019 international clinical practice guidelines for the treatment and prophylaxis of venous thromboembolism in patients with cancer. Lancet Oncol. 2019 Oct;20(10):e566-e581. doi:10.1016/S1470-2045(19)30336-5
11. Shimabukuro-Vornhagen A, Böll B, Kochanek M, Azoulay É, von Bergwelt-Baildon MS. Critical care of patients with cancer. CA Cancer J Clin. 2016 Nov 12;66(6):496–517. doi:10.3322/caac.21351
12. Akl EA, Kahale LA, Ballout RA, Barba M, Yosuico VE, van Doormaal FF, Middeldorp S, Bryant A, Schünemann H. Parenteral anticoagulation in ambulatory patients with cancer. Cochrane Database Syst Rev. 2014 Dec 10;(12):CD006652. doi:10.1002/14651858.CD006652.pub4. Update in: Cochrane Database Syst Rev. 2017 Sep 11;9: CD006652. doi:10.1002/14651858.CD006652.pub5
13. Omelyanovskiy VV, Avksentyeva MV, Sura MV et al. Guidelines for comparative clinical-economic drug evaluation (new edition). — Moscow: FGBU, 2018. (In Russ). https://rosmedex.ru/wpcontent/uploads/2019/06/MR-KE%60I_novaya-redaktsiya_2018-g..pdf
14. Cohen AT, Hamilton M, Mitchell SA, Phatak H, Liu X, Bird A, Tushabe D, Batson S. Comparison of the Novel Oral Anticoagulants Apixaban, Dabigatran, Edoxaban, and Rivaroxaban in the Initial and Long-Term Treatment and Prevention of Venous Thromboembolism: Systematic Review and Network Meta-Analysis. PLoS One. 2015 Dec 30;10(12):e0144856. doi:10.1371/journal.pone.0144856
15. Ryan ES, Havrilesky LJ, Salinaro JR, Davidson BA. Cost-Effectiveness of Venous Thromboembolism Prophylaxis During Neoadjuvant Chemotherapy for Ovarian Cancer. JCO Oncol Pract. 2021 Aug;17(8):e1075-e1084. doi:10.1200/OP.20.00783
16. Zhou Q, Gao X, Gao J, Feng Z, Wang M. Pharmacoeconomic Systematic Review of Anticoagulants for the Prevention and Therapy of Venous Thrombo-embolism in Cancer Patients. China Pharmacy, 2021:850–9.
17. Lanitis T, Leipold R, Hamilton M, Rublee D, Quon P, Browne C, Cohen AT. Cost-effectiveness of Apixaban Versus Other Oral Anticoagulants for the Initial Treatment of Venous Thromboembolism and Prevention of Recurrence. Clin Ther. 2016 Mar;38(3):478–93.e1–16. doi:10.1016/j.clinthera.2016.01.020
18. Glickman A, Brennecke A, Tayebnejad A, Matsuo K, Guntupalli SR, Sheeder J. Cost-effectiveness of apixaban for prevention of venous thromboembolic events in patients after gynecologic cancer surgery. Gynecol Oncol. 2020 Nov;159(2):476–82. doi:10.1016/j.ygyno.2020.07.096
19. Li A, Carlson JJ, Kuderer NM, Schaefer JK, Li S, Garcia DA, Khorana AA, Carrier M, Lyman GH. Cost-eff ectiveness analysis of low-dose direct oral anticoagulant (DOAC) for the prevention of cancer-associated thrombosis in the United States. Cancer. 2020 Apr 15;126(8):1736–48. doi:10.1002/cncr.32724
20. de Jong LA, van der Velden AWG, Hulst MV, Postma MJ. Cost-eff ectiveness analysis and budget impact of rivaroxaban compared with dalteparin in patients with cancer at risk of recurrent venous thromboembolism. BMJ Open. 2020 Nov 19;10(11): e039057. doi:10.1136/bmjopen-2020–039057
21. Ryan E, Salinaro J, Havrilesky LJ, Davidson BA. Venous thromboembolism prophylaxis in ambulatory cancer patients initiating chemotherapy: A cost-effectiveness analysis. Journal of Clinical Oncology. 2020;38(15):7074. doi:10.1200/JCO.2020.38.15_suppl.7074
22. State register of maximum selling prices (In Russ.) Доступно по: https://grls.rosminzdrav.ru/PriceLims.aspx.
23. Somonova OV, Antukh EA, Vardanyan AV, Gromova EG, Dolgushin BI, Elizarova AL, Sakaeva DD, Selchuk VYu, Tryakin AA, Cherkasov VA. Practical recommendations for the prevention and treatment of thromboembolic complications in cancer patients. Malignant tumors. 2021;11(3s2–2):145–55. (In Russ). doi:10.18027/2224-5057-2021-11-3s2-47
Review
For citations:
Kolbin A.S., Kasimova A.R., Gilyarevskiy S.R. Pharmacoeconomic evaluation of apixaban use for the treatment and prevention of venous thromboembolism in the general population and patients with oncological diseases. Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice. 2022;(4):38-49. (In Russ.) https://doi.org/10.37489/2588-0519-2022-4-38-49