Preview

Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice

Advanced search

Principles of clinical and economic analysis of antimicrobial drugs

https://doi.org/10.24411/2588-0519-2019-10071

Abstract

In light of rising costs in the health care system and the introduction of innovative but expensive technologies, decision makers are looking for reliable methods to assess their cost-effectiveness. To this end, a comprehensive assessment of medical technology is carried out, including the analysis of information on its comparative clinical efficacy and safety, as well as an assessment of the economic consequences of its implementation. One of the most important features of clinical and economic studies of antimicrobials is the ability of infectious agents to acquire resistance to therapy, which fundamentally changes their effectiveness, and, consequently, the clinical and economic feasibility of use over time. Taking into account the risks of resistance as a criterion of effectiveness in pharmacoeconomical studies of antimicrobial drugs is an important factor affecting the feasibility of inclusion of drugs in the restrictive lists. At the same time, this criterion remains underutilized.

About the Authors

Y. M. Gomon
FSBEI HE I.P. Pavlov SPbSMU MOH Russia; St. George the Martyr city hospital
Russian Federation

Gomon Yulia - Candidate of Medical Sciences, physician-clinical pharmacologist, St. George the Martyr city hospital; professor assistant, Department of clinical pharmacology and evidence-based medicine, FSBEI HE I.P. Pavlov SPbSMU MOH Russia



A. S. Kolbin
FSBEI HE I.P. Pavlov SPbSMU MOH Russia; Federal State Budgetary Educational Institution of Higher Education Saint-Petersburg State University
Russian Federation

Kolbin Alexey - MD, DrSci, Professor, Head of the Department of Clinical Pharmacology and Evidence-Based Medicine, FSBEI HE I.P. Pavlov SPbSMU MOH Russia, St. Petersburg; professor of the Department of Pharmacology, Medical Faculty St. Petersburg SU



S. O. Mazurenko
St. George the Martyr city hospital; Federal State Budgetary Educational Institution of Higher Education Saint-Petersburg State University
Russian Federation

Mazurenko Sergey - MD, DrSci, Professor, Head of the Department of Propaedeutic of Internal Disease, Medical Faculty St. Petersburg SU



I. G. Ivanov
St. George the Martyr city hospital; Federal State Budgetary Educational Institution of Higher Education Saint-Petersburg State University
Russian Federation

Ivanov Igor - assistant of the Department of propaedeutic of internal diseases St. Petersburg SU, Deputy chief physician St. George the Martyr city hospital



References

1. Makady А, Ham R, Boer A, et al. Policies for Use of Real-World Data in Health Technology Assessment (HTA): A Comparative Study of Six HTA Agencies. Value in Health. 2017;20:520-532. DOI: 10.1016/j.jval.2016.12.003.

2. European Commission. Directive 2001/20/ec of the European Parliament and of the Council. 2015. URL: http://ec.europa.eu/health/?les/eudralex/vol-1/dir_2001_20/dir_2001_20_en.pdf.

3. Методические рекомендации по проведению сравнительной клинико-экономической оценки лекарственного препарата. Утверждено Приказом ФГБУ ЦЭККМП Минздрава России от 23.12.2016 №145-од. URL: https://rosmedex.ru/hta/recom/ [Metodicheskie recomendacii po sravnitel’noi kliniko-ekonomicheskoy ocenki lekarstvennogo preparata. Utverzhdeno prikazom FGBU CEEKMP ot 23.12.2016. #145-od. (In Russ).]

4. Avksent’eva M.A., Gerasimov B.V., Sura M.V. Kliniko-economicheskiy analis (ocenka I vibor medicinskih tehnologiy I upravleniya kachestvom medicinskoy pomoschi. Pod redakciey P.A. Vorobeva. Moscow: N’udiamed; 2004. (In Russ).

5. ГОСТ Р 56044. — 2014. Оценка медицинских технологий. Общие положения. Издание официальное. М.: Стандартинформ; 2014. [GOST P 56044. 2014. Ocenka medicinskih tehnologiy. Obschie polozheniya. Izdaniye oficial’noe. Moscow: Standartinform; 2014. (In Russ).]

6. Osnovniye ponyatiya v ocenke medicinskih tehnologiy: metodicheskoye posobie. Pod redakciey Kolbina AS, Zyryanova SK, Belousova DYu. Moscow: OKI; 2013. (In Russ).

7. Belousov YuB. Planirovanie I provedenie klinicheskih issledovaniy lekarstvennih sredstv. Moscow: OKI; 2000. (In Russ).

8. Gold MR. Cost-effectiveness in Health and Medicine. New York: Oxford University Press; 1996.

9. Walley T, Haycox А, Boland A. Pharmacoeconomics. Elsevier Health Sciences; 2004.

10. Drummond MF, O’Brien BJ, Stoddart GL, et al. (1997). Basic types of economic evaluation. In: Drummond MF, O’Brien BJ, Stod- dart GL, Torrance GW (eds). Methods for the Economic Evaluation of Health Care Programmes. Oxford University Press: New York, pp. 6-26.

11. Клинические рекомендации. URL: http://cr.rosminzdrav.ru/#!/ [Klinicheskie rekomendacii URL: http://cr.rosminzdrav.ru/#!/ (In Russ).]

12. Yagudina RI, Kulikov AYu, Nguen T. Opredelenie poroga gotovnosti obschestva platit v Rossii, Evropeiskih stranah I stranah SNG. Farmacoeconomica. 2011;4 (1):7-12. (In Russ).

13. Torrance GW. Measurement of health state utilities for economic appraisal. J Health Econ. 1986;5:1-30.

14. Yagudina RI, Sorokovikov IV. Metodologiya provedeniya analysa “zatrati-poleznost” pri provedenii farmacoeconomicheskih issledovaniy. Farmacoeconomica. 2012;5(2):9-12. (In Russ).

15. Angevine PD, Berven S. Health economic studies: an introduction to cost-benefit, cost-effectiveness, and cost-utility analyses. Spine. 2014;39(22 Suppl 1):S9-15. DOI: 10.1097/BRS.0000000000000576.

16. Shiroiwa T, Sung YK, Fukuda T, et al. International survey on willing-ness-to-pay (WTP) for one additional QALY gained: what is the threshold of cost effectiveness? Health Econ. 2010;19:422-437. DOI: 10.1002/hec.1481.

17. Yen ZS, Davis MA, Chen SC, et al. A cost-effectiveness analysis of treatment strategies for acute uncomplicated pyelonephritis in women. Acad EmergMed. 2003;10(4):309-14.

18. Bodrogi J, Kal? Z. Principles of pharmacoeconomics and their impact on strategic imperatives of pharmaceutical research and development. British Journal of Pharmacology. 2010;159:1367-1373. DOI: 10.1111/j.1476-5381.2009.00550.x.

19. O’Sullivan AK, Thompson D, Drummond MF. Collection of health-economic data alongside clinical trials: is there a future for piggyback evaluations? Value Health. 2005;8:67-79.

20. Hlatky MA, Owens DK, Sanders GD. Cost-effectiveness as an outcome in randomized clinical trials. Clin Trials. 2006;3:543-551.

21. Ramsey S, Willke R, Briggs A, et al. Good research practices for cost-effectiveness analysis alongside clinical trials: the ISPOR RCT-CEA Task Force report. Value Health. 2005;8:521-533.

22. Garrison LP, Neumann PJ, Erickson P, et al. Using real-world data for coverage and payment decisions: the ISPOR Real-World Data Task Force Report. Value Health. 2007;10:326-335.

23. Weinstein MC, O’Brien B, Hornberger J, et al. Principles of good practice for decision analytic modeling in health-care evaluation: report of the ISPOR Task Force on Good Research Practices — Modeling Studies. Value Health. 2003;6:9-17.

24. Sculpher MF, Drummond MJ. Analysis sans frontieres: can we ever make economic evaluations generalisable across jurisdictions? Pharmacoeconomics. 2006;24:1087-1099.

25. Gomon YuM, Kolbin AS, Sidorenko SV. Kliniko-ekonomicheskaya ocenka effectivnosti I bezopasnosti suschestvuyuschey praktiki provedeniya perioperacionnoy profilaktiki na osnove farmacoepidemiologicheskogo issledovaniya v mnogoprofilnikh stacionarak Sankt-Peterburga. Farmacoeconomika. Sovremennaya farmacoekonomica I farmacoepidemiologiya. 2017;10(2):3-11. (In Russ). DOI: 10.17749/2070-4909.2017.10.2.003-011

26. Nimmo WS, Tucker GT. Clinical Measurement in Drug Evaluation. 1995: Wiley & Sons Ltd. 344.

27. High level pharmaceutical forum 2005-2008. Conclusions and recommendations. http://bookshop.europa.eu/en/high-level-pharmaceutical-forum-2005-2008-pbND3008692/

28. Kleijnen S, George E, Goulden S, et al. Relative effectiveness assessment of pharmaceuticals: similarities and differences in 29 jurisdictions. Value Health. 2012;15(6):954-60. DOI: 10.1016/j.jval.2012.04.010.

29. Gomon YuM, Kolbin AS. Analis kriteriev effectivnosti pri provedenii farmacoeconomicheskih issledovaniy antimikrobnykh lekarstvennih sredstv. Dannie ogranichitelnih spiskov RF v 2014 — 2016 gg. Klinicheskaya microbiologiya I antimicrobnaya terapiya. 2017;19(3):260-264. (In Russ).

30. Schwaber M, Carmeli Y. Mortality and delay in effective therapy associated with extended-spectrum beta-lactamase production in Enterobacteriaceae bacteraemia: a systematic review and meta-analysis. J Antimicrob Chemother. 2007;60(5):913-920.

31. Macgowan A, BSAC Working Parties on Resistance Surveillance. Clinical implications of antimicrobial resistance for therapy. J. Antimicrob. Chemother. 2008;62(Suppl. 2):ii105-114.

32. Eliopoulos GM, Cosgrove SE, Carmeli Y. The impact of antibacterial resistance on health and economic outcomes. Clin Infect Dis. 2003;36:1433-1437.

33. Cosgrove SE, Carmeli Y. The impact of antimicrobial resistance on health and economic outcomes. Clin Infect Dis. 2003;36:1433-1437.

34. Maragakis LL, Perencevich EN, Cosgrove SE. Clinical and economic burden of antimicrobial resistance. Expert Rev Anti Infect Ther. 2008;6:751-763.

35. Williamson DA, Barrett LK, Rogers BA, et al. Infectious complications following transrectal ultrasound-guided prostate biopsy: new challenges in the era of multidrug-resistant Escherichia coli. Clin Infect Dis. 2013;57:267-274. DOI: 10.1093/cid/cit193.

36. Wagenlehner FME., van Oostrum E, Tenke P, et al. Infective complications after prostate biopsy: outcome of the Global Prevalence Study of Infections in Urology (GPIU) 2010 and 2011, a prospective multinational multicentre prostate biopsy study. Eur Urol. 2013;63:521-527.

37. Arep’ieva MA, Kolbin AS, Sidorenko SV. Matematicheskaya model prognozirovaniya razvitiya bacterialnoy rezistentnosti, posytoennaya na osnove zavisimosti mezhdu urovnem rezistentnosti I ob’emom potrebleniya antibiotikov. Klinicheskaya farmacologiya I antimicrobnaya himioterapiya. 2016;18(3):200-211. (In Russ).

38. Arepyeva MA, Kolbin AS, Sidorenko SV, et al. A mathematical model for predicting the development of bacterial resistance based on the relationship between the level of antimicrobial resistance and the volume of antibiotic consumption. J Glob Antimicrob Resist. 2017;8:148-156.

39. Philips Z, Ginnelly L, Sculpher M, et al. Review of guidelines for good practice in decision-analytic modelling in health technology assessment. Health Technol Assess. 2004;8(36):1-158.

40. Lindenauer PK, et al. The performance of US hospitals as reflected in risk-standardized 30-daymortality and readmission rates for medicare beneficiaries with pneumonia. J Hosp Med. 2010;5(6):E12-8. DOI: 10.1002/jhm.822.

41. Lindenauer PK, et al. Development, validation, and results of a measure of 30-day readmission following hospitalization for pneumonia. J Hosp Med. 2011;6(3):142-50.

42. Principi organizacii perioperacionnoi antibioticoprofilaktiki v uchrezhdeniyah zdravoohraneniya. Federal’niye klinicheskie rekomendacii. Moscow: 2014. (In Russ).

43. Metodicheskie rekomendacii po raschetu zatrat pri provedenii kliniko-economicheskih issledovanii lekarstvennih preparatov. Utverzhdeni prikazom FGBU CEEKKMP 29.12.2017 #185-od. Moscow: 2017. (In Russ).

44. Prikaz Minkomekonomrazvitiya Rossii #192 “Ob utverzhdenii metodologii rascheta ekonomicheskih poter ot smertnosti, zabolevaemosti, I invalidizacii naseleniya. Zaregistririvan 28.04.2012 # 23983. (In Russ).

45. Postanovlenie Pravitelstva RF ot 28.08.2014 #871 “Ob utverzhdenii pravil formirovaniya perechey lekarstvennih preparatov dlya medicinskogo primeneniya I minimalnogo assortimenta lekarstvennih preparatov, neobhodimih dlya okazaniya medicinskoy pomoschi. (In Russ).

46. Proekt klinicheskih rekomendacij «Vnegospital’naya pnevmoniya». MAKMAH. 2018. (In Russ). URL: http://www.antibiotic.ru/files/pdf/2018/vp2018-project.pdf

47. Girmenia C, Rossolini GM, Piciocchi A, et al. Infections by carbapenem-resistant Klebsiella pneumoniae in SCT recipients: a nationwide retrospective survey from Italy. Bone Marrow Transplant. 2015;50:282-288. DOI: 10.1038/bmt.2014.231

48. McCann S, Byrne JL, Rovira M, et al. Outbreaks of infectious diseases in stem cell transplant units: a silent cause of death for patients and transplant programmes. Bone Marrow Transplant. 2004;33:519-529.

49. Bodro M, Sabe N, Tubau F, et al. Risk factors and outcomes of bacteremia caused by drug-resistant ESKAPE pathogens in solid-organ transplant recipients. Transplantation. 2013;96:843-849. DOI: 10.1097/TP.0b013e3182a049fd

50. Sganga G, Spanu T, Bianco G, et al. Bacterial bloodstream infections in liver transplantation: etiologic agents and antimicrobial susceptibility profiles. Transplant Proc. 2012;44:1973-1976. DOI: 10.1016/j.transproceed.2012.06.055

51. Torbica A, Tarricone R, Drummond M. Does the approach to economic evaluation in health care depend on culture, values, and institutional context? Eur J Health Econ. 2017. DOI: 10.1007/s10198-017-0943-1. DOI: 10.1007/s10198-017-0943-1

52. Drummond M, Tarricone R, Torbica A. Assessing the Added Value of Health Technologies: Reconciling Different Perspectives. Value in Health. 2013;16:7-13. DOI: 10.1016/j.jval.2012.10.007


Review

For citations:


Gomon Y.M., Kolbin A.S., Mazurenko S.O., Ivanov I.G. Principles of clinical and economic analysis of antimicrobial drugs. Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice. 2019;(2):35-44. (In Russ.) https://doi.org/10.24411/2588-0519-2019-10071

Views: 1208


Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.


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

  

OSZAR »