Preview

FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology

Advanced search

Pharmacoepidemiology and pharmacoeconomics of multidrug- and extensively drug-resistant tuberculosis

https://doi.org/10.17749/2070-4909/farmakoekonomika.2021.089

Abstract

Treatment of multidrug-resistant (MDR) and extensively drug-resistant (XDR) tuberculosis (TB) is a current problem worldwide. Currently, special attention is paid to the possibility of using new high-cost chemotherapy regimens in the treatment of MDR/XDR-TB. Numerous studies have shown that, from a clinical point of view, the effectiveness of MDR/XDR-TB therapy increases with the inclusion of bedaquiline, delamanid, linezolid, fluoroquinolones (moxifloxacin, levofloxacin), and pretomanid. At the same time, there is an assumption that the use of new and repurposed anti-tuberculosis drugs (ATDs) may be associated with an increase in overall costs. This paper demonstrates the potential of pharmacoepidemiology and pharmacoeconomics to evaluate the widespread introduction of new anti-tuberculosis drugs (ATDs), taking into account all the typical features of MDR/XDR-TB therapy. The authors analyzed studies of pharmacoeconomic feasibility of using expensive drugs in treatment regimens of pulmonary tuberculosis patients with MDR/XDR pathogen. It was shown that the use of chemotherapy regimens containing new high-cost and highly effective drugs (moxifloxacin, linizolid, and bedaquiline) in rational combinations with other drugs of the basic and reserve series, selected concerning drug resistance of the pathogen, is associated with a significant economic effect. From the applicability of pharmacoeconomic analysis point of view, the introduction of short-term MDR-TB treatment regimens is also a promising direction in phthisiology. The key link to achieve effective MDR/XDR-TB treatment is the use of new drugs. Considering the specificity of pharmacoeconomic analysis in phthisiology and results of existing clinical and economic studies, the authors have formed recommendations aimed at a more complete realization of pharmacoeconomic analysis potential in MDR- and XDR-TB treatment.

About the Authors

N. Yu. Nikolenko
Moscow Scientific and Practical Center for Tuberculosis Control
Russian Federation

Nikolay Yu. Nikolenko – Researcher, Scientific and Clinical Department. RSCI SPIN-code: 5011-4166

10 Stromynka Str., Moscow 107014, Russia



D. А. Kudlay
Sechenov University; State Research Center “Institute of Immunology”; Federal Medical and Biological Agency of Russia
Russian Federation

Dmitry A. Kudlay – Dr. Med. Sc., Professor, Chair of Pharmacology, Nelyubin Institute of Pharmacy; Leading Researcher, Laboratory of Personalized Medicine and Molecular Immunology No. 71.  Scopus Author ID: 57201653374; RSCI SPIN-code: 4129-7880

8/2 Trubetskaya Str., Moscow 119991, Russia
24 Kashirskoye Shosse, Moscow 115522, Russia



N. P. Doktorova
National Research Medical Center for Phthisiopulmonology and Infectious Diseases
Russian Federation

Natalia P. Doktorova – PhD (Med.), Researcher, Department of Differential Diagnosis and Treatment of Tuberculosis and Combined Infections. Scopus Author ID: 21733662400; RSCI SPIN-code: 5791-6542

4 corp. 2 Dostoyevskiy Str., Moscow 127473, Russia



References

1. Global tuberculosis report 2020. Geneva, Switzerland: World Health Organization; 2020. Available at: https://www.who.int/publications/i/item/9789240013131 (accessed 19.05.2021).

2. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990–2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018; 392 (10159): 1789–858. https://doi.org/10.1016/S0140-6736(18)32279-7.

3. The End TB Strategy. Global strategy and targets for tuberculosis, prevention, care and control after 2015. Geneva, Switzerland: World Health Organization, 2014. Available at: https://www.who.int/tb/strategy/End_TB_Strategy.pdf (accessed 19.05.2021).

4. Tuberculosis in adults. Clinical guidelines. All-Russian Public Organization “Russian Society of Phthisiologists”. 2020. Available at: http://obltub.ru/assets/files/2020/01.20/kr-tuberkulez-uvzroslyh-2020.pdf (in Russ.) (accessed 19.05.2021).

5. WHO consolidated guidelines on drug-resistant tuberculosis treatment. Geneva, Switzerland: World Health Organization; 2019. Available at: https://www.who.int/tb/publications/2019/consolidatedguidelines-drug-resistant-TB-treatment/en/ (accessed 19.05.2021).

6. Sterlikov S.А. (Ed.) Industry and economic indicators of antituberculosis work in 2018–2019. Analytical overview of the main indicators and statistical materials. Moscow; 2020. Available at: https://mednet.ru/images/materials/CMT/otraslevye_i_ekonomicheskie_2018_2019_final.pdf (in Russ.) (accessed 19.05.2021).

7. Federal Service for Supervision of Consumer Rights Protection and Human Welfare. State Report “The state of sanitary and epidemiological well-being of the population in the Russian Federation in 2019”. Available at: https://www.rospotrebnadzor.ru/documents/details.php?ELEMENT_ID=14933 (in Russ.) (accessed 19.05.2021).

8. Parolina L.Е., Morozova Т.I., Doktorova N.P. Pharmacoeconomics in phthisiology: opportunities and prospects. Tuberculosis and Lung Diseases. 2012; 89 (2): 8–14 (in Russ.).

9. Yagudina R.I., Sorokovikov I.V. Pharmacoeconomics of tuberculosis: methodological features of research. Pharmacoeconomics: Theory and Practice. 2014; 2 (4): 10–3 (in Russ.).

10. INAHTA, HTAi, Organizations P. HTA Glossary. Available at: http://htaglossary.net/Доказательная-медицина (in Russ.) (accessed 19.05.2021).

11. Rachina S.A., Kozlov R.S., Belkova Yu.A. Pharmacoepidemiology: from theory to practice. FARMAKOEKONOMIKA. Sovremennaya farmakoekonomika i farmakoepidemiologiya / FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology. 2014;7 (1): 33–9 (in Russ.).

12. Yagudina R.I., Kulikov A.Yu., Metelkin I.A. Methodology of costeffectiveness analysis in pharmacoeconomics. FARMAKOEKONOMIKA. Sovremennaya farmakoekonomika i farmakoepidemiologiya / FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology. 2012; 5 (4): 3–8 (in Russ.).

13. Strachunskaya Е.Ya. Pharmacoeconomics of chronic pathologic process. Clinical Microbiology and Antimicrobial Chemotherapy. 2007; 9 (2): 176–86 (in Russ.).

14. Reshet'ko O.V., Lutsevich K.A. Pharmacoeconomics as an instrument of clinical pharmacology for optimization of pharmacotherapy (review). The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. 2015; 4: 54–7 (in Russ.).

15. Morozova T.I., Parolina L.E., Doktorova N.P. Use of АВС/VENanalysis pharmacotherapy in a tuberculosis hospital. FARMAKOEKONOMIKA. Sovremennaya farmakoekonomika i farmakoepidemiologiya / FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology. 2011; 4 (1): 51–2 (in Russ.).

16. Diel R., Vandeputte J., de Vries G., et al. Costs of tuberculosis disease in the European Union: a systematic analysis and cost calculation. Eur Respir J. 2014; 43 (2): 554–65. https://doi.org/10.1183/09031936.00079413.

17. Pooran A., Pieterson E., Davids M., et al. What is the cost of diagnosis and management of drug resistant tuberculosis in South Africa? PLoS One. 2013; 8 (1): e54587. https://doi.org/10.1371/journal.pone.0054587.

18. Laurence Y.V., Griffiths U.K., Vassall A. Costs to health services and the patient of treating tuberculosis: a systematic literature review. Pharmacoeconomics. 2015; 33 (9): 939–55. https://doi.org/10.1007/s40273-015-0279-6.

19. Markelov Yu.M., Lesonen А.S. Clinical and economic aspects of enhanced treatment efficacy of multiple drug resistant tuberculosis. Tuberculosis and Lung Diseases. 2020; 98 (9): 50–4 (in Russ.). http://doi.org/10.21292/2075-1230-2020-98-9-50-54.

20. McNaughton A., Blackmore T., McNaughton H. Comprehensive cost of treating one patient with MDR/pre-XDR-TB in Wellington, New Zealand. Eur Respir J. 2016; 48 (4): 1256–9. http://doi.org/10.1183/13993003.00876-2016.

21. Kendall E.A., Malhotra S., Cook-Scalise S., et al. Estimating the impact of a novel drug regimen for treatment of tuberculosis: a modeling analysis of projected patient outcomes and epidemiological considerations. BMC Infect Dis. 2019; 19: 794. https://doi.org/10.1186/s12879-019-4429-x.

22. Wirth D., Dass R., Hettle R. Cost-effectiveness of adding novel or group 5 interventions to a background regimen for the treatment of multidrug-resistant tuberculosis in Germany. BMC Health Serv Res. 2017; 17: 182. https://doi.org/10.1186/s12913-017-2118-2.

23. Golubchikov P.N., Kruk E.A., Mishustin S.P., et al. Experience of treating extensive drug resistant tuberculosis patients including continuous use of bedaquiline, in Tomsk Region: immediate and postponed results. Tuberculosis and Lung Diseases. 2019; 97 (8): 38–45 (in Russ.). https://doi.org/10.21292/2075-1230-2019-97-8-38-45.

24. Stavitskaya N., Smerdin S., Kudlay D., et al. Multivariate analysis of the effectiveness of bedaquiline-containing chemotherapy regimens in previously treated XDR TB patients. Eur Respir J. 2020; 56 (S64): 1597.

25. Stavitskaya N.V., Felker I.G., Zhukova E.M., et al. The multivariate analysis of results of bedaquiline use in the therapy of MDR/XDR pulmonary tuberculosis. Tuberculosis and Lung Diseases. 2020; 98 (7): 56–62 (in Russ.). https://doi.org/10.21292/2075-1230-2020-98-7-56-62.

26. Bot’ko D.V., Korovina А.V. Efficacy of treatment of extensively drugresistant pulmonary tuberculosis. In: Sikorskiy А.V., Khryshchanovich V.Ya. (Eds.) Actual problems of modern medicine and pharmacy 2020: collection of materials of the LXXIII International Scientific and Practical Conference of Students and Young Scientists, April 15–17. Minsk; 2020: 1809–12 (in Russ.).

27. Danilova T. I., Korneev Yu. V., Kudlay D. А., Nikolenko N. Yu. Results of treatment with bedaquiline containing regimens of MDR/XDR tuberculosis patients including those with concurrent HIV infection (the experience of Leningrad Region). Tuberculosis and Lung Diseases. 2020; 98 (9): 56–62 (in Russ.). http://doi.org/10.21292/2075-1230-2020-98-9-56-62.

28. Vasilyeva I.A., Samoylova A.G., Rudakova A.V., et al. Economic feasibility of new chemotherapy regimens for treatment of tuberculosis patients with extensive drug resistance. Tuberculosis and Lung Diseases. 2018; 96 (6): 7–14 (in Russ.). https://doi.org/10.21292/2075-1230-2018-96-6-7-14.

29. Wolfson L.J., Walker A., Hettle R., et al. Cost-effectiveness of adding bedaquiline to drug regimens for the treatment of multidrug-resistant tuberculosis in the UK. PLoS One. 2015; 10 (3): e0120763. https://doi.org/10.1371/journal.pone.0120763.

30. Byun J.H., Park J.A., Kang H.R., et al. Comparison of effectiveness between delamanid and bedaquiline among patients with multidrugresistant tuberculosis: a Markov model simulation study. Clin Drug Investig. 2016; 36 (11): 957–68. https://doi.org/10.1007/s40261-016-0443-6.

31. Kudlay D.A. Development and implementation of new pharmacological agent of the diarylquinoline class in clinical practice. Experimental and Clinical Pharmacology. 2021; 84 (3): 41–7 (in Russ.). https://doi.org/10.30906/0869-2092-2021-84-3-41-47.

32. Shabanov P.D. Linezolid in treatment of multidrug-resistant forms of tuberculosis. Reviews on Clinical Pharmacology and Drug Therapy. 2018; 16 (3): 36–46 (in Russ.). https://doi.org/10.17816/RCF16336-46.

33. Filinyuk O.V., Alliluev A.S., Аmichba D.E., et al. HIV infection and multiple drug resistant tuberculosis: the frequency of co-infection and treatment efficacy. Tuberculosis and Lung Diseases. 2021; 99 (2): 45–51 (in Russ.). https://doi.org/10.21292/2075-1230-2021-99-2-45-51.

34. Codecasa L.R., Toumi M., D’Ausilio A., et al. Cost-effectiveness of bedaquiline in MDR and XDR tuberculosis in Italy. J Mark Access Heal Policy. 2017; 5 (1): 1283105. https://doi.org/10.1080/20016689.2017.1283105.

35. Ionescu A.M., Agnarson A.M., Kambili C., et al. Bedaquiline-versus injectable-containing drug-resistant tuberculosis regimens: a costeffectiveness analysis. Expert Rev Pharmacoecon Outcomes Res. 2018; 18 (6): 677–89. https://doi.org/10.1080/14737167.2018.1507821.

36. Fan Q., Ming W.K., Yip W.Y., You J.H. Cost-effectiveness of bedaquiline or delamanid plus background regimen for multidrugresistant tuberculosis in a high-income intermediate burden city of China. Int J Infect Dis. 2019; 78: 44–9. https://doi.org/10.1016/j.ijid.2018.10.007.

37. Schnippel K., Firnhaber C., Conradie F., et al. Incremental cost effectiveness of bedaquiline for the treatment of rifampicin-resistant tuberculosis in South Africa: model-based analysis. Appl Health Econ Health Policy. 2018; 16 (1): 43–54. https://doi.org/10.1007/s40258-017-0352-8.

38. Ivanova D.A., Borisov S.E., Rodina O.V., et al. Safety of treatment regimens in multiple drug resistant tuberculosis patients compiled as per the new WHO recommendations as of 2019. Tuberculosis and Lung Diseases. 2020; 98 (1): 5–15 (in Russ.). https://doi.org/10.21292/2075-1230-2020-98-1-5-15.

39. Kononets A.S., Safonova S.G., Sidorova S.V., et al. Clinical features and therapeutic efficacy in patients with pulmonary multidrug-resistant cavitary tuberculosis at Russian penitentiary system. Pulmonologiya. 2020; 3: 67–72 (in Russ.). https://doi.org/10.18093/0869-0189-2008-0-3-67-72.

40. Loveday M., Wallengren K., Reddy T., et al. MDR-TB patients in KwaZulu-Natal, South Africa: cost-effectiveness of 5 models of care. PLoS One. 2018; 13 (4): e0196003. https://doi.org/10.1371/journal.pone.0196003.

41. Fitzpatrick C., Hui Z., Lixia W., et al. Cost-effectiveness of a comprehensive programme for drug-resistant tuberculosis in China. Bull World Health Organ. 2015; 93: 775–84. http://dx.doi.org/10.2471/BLT.14.146274.

42. Tupasi T.E., Gupta R., Quelapio M.I., et al. Feasibility and costeffectiveness of treating multidrug-resistant tuberculosis: a cohort study in the Philippines. PLoS Med. 2006; 3 (9): e352. http://dx.doi.org/10.1371/journal.pmed.0030352.

43. Russkikh A.E., Kutuzova D.M., Lovacheva O.V., et al. Short course treatment of pulmonary tuberculosis patients suffering from multiple drug resistance. The current situation and future perspectives. Tuberculosis and Lung Diseases. 2021; 98 (12): 57–66 (in Russ.). https://doi.org/10.21292/2075-1230-2020-98-12-57-66.


Review

For citations:


Nikolenko N.Yu., Kudlay D.А., Doktorova N.P. Pharmacoepidemiology and pharmacoeconomics of multidrug- and extensively drug-resistant tuberculosis. FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology. 2021;14(2):235–248. (In Russ.) https://doi.org/10.17749/2070-4909/farmakoekonomika.2021.089

Views: 1358


ISSN 2070-4909 (Print)
ISSN 2070-4933 (Online)