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Economic expertise of alirocumab in standard lipid lowering therapy insusceptibility

Abstract

Usage of PCSK9 inhibitors is a new approach of lipid lowering therapy allowing overcomes as well insusceptibility of standard statins’ therapy as their intolerance. In last case PCSK9 inhibitors can substitute statins in the treatment program. Introduction to the Russian clinical practice the new PCSK9 inhibitor alirocumab (INN) requires it’s economic evaluation. Aim: To evaluate of alirocumab reasonability from pharmacoeconomic point of view to the Governmental program of free medical aid and others programs of reimbursement for the treatment of high cardiac risks patients also. Materials and methods. Retrospective comparative economic analysis of published data on efficacy and safety of new technology with alirocumab using and standard statin therapy. Budget impact analysis has been performed in according to Methodological guidelines for evaluation of influence on the Governmental program of free medical aid and coat of illness of the Russian Ministry of Health with Markov’s model usage with direct medical costs calculation. Costs were calculated on 1 000 pts and then recalculated on one patient. For stability results checking the sensitivity analysis has been performed. Cost of illness has been calculated as sum of direct costs (remedies, cost of one case of cardiac event etc.) and indirect cost (GDP loss due to temporary and permanent disability or premature death due to cardiac events). Results. Alirocumab during two years could save at least 6,635 bln RUR of budget’s funds and decrease on 45,52% of Governmental budget impact in a treatment of high cardiac risks patients in case of it’s inclusion into the Governmental program of free medical aid. This result was stable in sensitive analysis on 25%. Cost of illness analysis with evaluation of indirect costs has shown that alirocumab could lead to burden of illness decreasing on 9,04 bln RUR in the frames of targeted group of patients (or 58,92% vs current methodology of the treatment) during two years. Conclusion. Alirocumab has pharmacoeconomics evidences to be included into the Governmental program of free medical aid, Essential Drug List and different reimbursement programs.

About the Authors

S. K. Zyryanov
Peoples' Friendship University of Russia, Moscow, Russia
Russian Federation


I. N. Dyakov
Federal State Budgetary Scientific Institution «I.I. Mechnikov Research Institute of Vaccines and Sera»; Autonomous Nonprofit Organization «Research and Practical Centre for Rational Pharmacotherapy and Pharmacoeconomics»
Russian Federation


References

1. Allender S., Scarborough P., Peto V. et al. European cardiovascular disease statistics, 2008 ed. European Heart Network. 2008.

2. Austin M.A., Hutter C.M., Zimmern R.L., Humphries S.E. Genetic causes of monogenic heterozygous familial hypercholesterolemia: a HuGE prevalence review. Am J Epidemiol. 2004; 160: 407-420.

3. Cholesterol Treatment Trialists’ (CTT) Collaboration, Baigent C., Blackwell L. et al. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomized trials. Lancet. 2010; 376: 1670-1681.

4. Piepoli M.F., Hoes A.W., Agewall S. et al.: The Sixth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice. European Heart Journal. 2016; 37: 2315-2381.

5. Ridker P.M., Danielson E., Fonseca F.A.H. et al. Rosuvastatin to Prevent Vascular Events in Men and Women with Elevated C-Reactive Protein. N Engl J Med. 2008; 359: 2195-2207.

6. Farnier M., Gaudet D., Valcheva V. et al. Efficacy of alirocumab in high cardiovascular risk populations with or without heterozygous familial hypercholesterolemia: Pooled analysis of eight ODYSSEY Phase 3 clinical program trials International Journal of Cardiology. 2016; 223: 750-757. doi: 10.1016/j.ijcard.2016.08.273

7. Клинические рекомендации «Стабильная ишемическая болезнь сердца» http://cr.rosminzdrav.ru/schema.html?id=133#/part/7 дата обращения к ресурсу 17.02.2017

8. Сафарова М.С., Афанасьева О.И. Применение афереза липопротеидов при атеросклерозе и его осложнениях. Атеросклероз и дислипидемии. 2014; 2: 5-16.

9. Nanchen D., Gencer B., Auer R. et al. Prevalence and management of familial hypercholesterolaemia in patients with acute coronary syndromes. European Heart Journal. 2015; 36: 2438-2445.

10. Khan I., Cannon C.P., Klimchak A. et al. Simulation of impact on Cardiovascular Events with Lipid-Lowering Treatment Intensification 2016in patients with Atherosclerotic Cardiovascular Disease in the US. Poster presented at American Heart Association’s Scientific Sessions 2016, New Orleans, LA, November 12-16, 2016.

11. Методические рекомендации по оценке влияния на бюджет в рамках реализации программы государственных гарантий бесплатного оказания гражданам медицинской помощи. М.: ФГБУ «Центр экспертизы и контроля качества медицинской помощи» МЗ РФ, 2016: 27.

12. Landmesser U., Chapman M.J., Farnier M. et al. on behalf of the European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS). European Society of Cardiology/European Atherosclerosis Society Task Force consensus statement on proprotein convertase subtilisin/kexin type 9 inhibitors: practical guidance for use in patients at very high cardiovascular risk. Eur Heart J. 2016; 0, 1 -11. doi:10.1093/eurheartj/ehw480

13. Инструкция по медицинскому применению лекарственного препарата Пралуэнт. Сайт государственного реестра лекарственных средств http:// grls.rosminzdrav.ru/grls.aspx?s=%D0%BF%D1%80%D0%B0%D0%BB%D1%83%D1%8D%D0%BD%D1%82. Дата обращения к ресурсу 11.02.2017

14. Распоряжения Правительства РФ №2724-р от 26.12.2015 и №2885-р от 28.12.2016.

15. http://grls.rosminzdrav.ru, дата обращения к ресурсу 17.02.2017

16. http;//pharmindex.ru, дата обращения 10.02.2017

17. Moriarty P.M., Parhofer K.G., Babirak S.P. Alirocumab in patients with heterozygous familial hypercholesterolaemia undergoing lipoprotein apheresis: the ODYSSEY ESCAPE trial European Heart Journal. 2016; 37: 3588-3595.

18. Silverman M.G., Ference B.A., Im K. Association Between Lowering LDL-C and Cardiovascular Risk Reduction Among Different Therapeutic Interventions. A Systematic Review and Meta-analysis. JAMA. 2016; 316 (12): 1289-1297.

19. Тарифное соглашение на оплату медицинской помощи, оказываемой по территориальной программе обязательного медицинского страхования города Москвы на 2016 г. от 25 декабря 2015 г.

20. Приказ Минэкономразвития России № 192, Минздравсоцразвития России № 323н, Минфина России № 45н, Росстата № 113 от 10.04.2012 «Об утверждении методологии расчета экономических потерь от смертности, заболеваемости и инвалидизации населения» (зарегистрировано в Минюсте России 28.04.2012 № 23983).


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For citations:


Zyryanov S.K., Dyakov I.N. Economic expertise of alirocumab in standard lipid lowering therapy insusceptibility. Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice. 2016;(4):4-13. (In Russ.)

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ISSN 2588-0519 (Print)
ISSN 2618-8473 (Online)

  

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