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Pharmacoeconomic analysis of flexible-dose administration regimen of Xeomine® in patients with focal dystonia

https://doi.org/10.24411/2588-0519-2018-10038

Abstract

Relevance. ‹The most effective treatment for focal dystonia (blepharospasm (BsP) and cervical dystonia (CD)) is use of botulinum toxin, including onabotulinumtoxinА (BoNTA-Ona), incobotulinumtoxin А (BoNTA-Inco), abobotulinumtoxinА (BoNTA-Abo). In 2016, it became possible to use ­exible-dose regimens of incobotulinumtoxin А, thus necessitating analysis of pharmacoeconomic properties of such regimens. Aim. To determine pharmacoeconomic properties of BsP and CD therapy with incobotulinumtoxin А relative to regimens based on onabotulinumtoxinА (BoNTA-Ona and abobotulinumtoxinА (BoNTA-Abo) accounting for properties of ­exible administration regimen of incobotulinumtoxin А. Methodology. Pharmacoeconomic analysis was performed from the perspective of Russian healthcare system within context of mandatory healthcare insurance, as well as from the perspective of overall social interests of Russian Federation, including impact upon GDP. Modelling horizon was 5 years. A complex Markov model was developed to estimate costs and outcomes. ‹The parameter used for clinical efficacy assessment was number of days patient spend in remission state. Cost effectiveness analysis (CEA), cost utility analysis (CUA) and budget impact analysis (BIA) were performed based on modelling results, and sensitivity analysis (SA) was performed to ascertain model robustness. Result. Incobotulinumtoxin А in fl­exible dose regimen demonstrated pharmacoeconomic superiority during CEA for cervical dystonia and blepharospasm indications. When indirect costs are accounted for, superiority of incobotulinumtoxin А increases. Similar results were obtained during CUA. BIA indicates that use of ­flexible-dose regimen of incobotulinumtoxin А allows to achieve reduction of budgetary burden. SA has conŒrmed the robustness of these results. Conclusion. Use of incobotulinumtoxin А in a ­flexible-dose regimen is pharmacoeconomically justiŒed.

 

About the Authors

A. E. Cheberda
http://www.healtheconomics.ru/
LLC "Center for pharmacoeconomics research", Moscow
Russian Federation

Ph.D., MBA, Executive Director

SPIN code: 6912-3783



D. Yu. Belousov
LLC "Center for Pharmacoeconomics Research", Moscow
Russian Federation

General Director 

SPIN code: 6067-9067



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

MD, professor, Head of Department of General and Clinical Pharmacology

SPIN code: 2725-9981



References

1. Analiticheskaya informaciya, DSM Rossiya, 2017 g. [Analytical information, DSM Russia, 2017. (In Russ)] Available at: http://www.dsm.ru/marketing/freeinformation/analytic-reports/

2. Artemenko AR, Kurenkov AL. Botulinicheskij toksin: vchera, segodnya, zavtra. Nervno-myshechnye bolezni [Botulinum toxin: yesterday, today, tomorrow. (In Russ)] Neuromuscular diseases. 2013;26–18.

3. Gosudarstvennyj reestr predelnyh otpusknyh cen. [State register of maximum selling prices. (In Russ.)] Available at: http://grls.rosminzdrav.ru/pricelims.aspx

4. Zyryanov SK, Belousov DYu, Cheberda AE. Farmakoehkonomicheskij analiz primeneniya preparata Kseomin dlya lecheniya pacientov s fokalnoj distoniej. [Pharmacoeconomic analysis of the use of Xeomin® for the treatment of patients with focal dystonia. (In Russ)]. Kachestvennaya klinicheskaya praktika. 2016;2:16-23.

5. Informacionnyj servis [Information service (In Russ)] "aptekamos.ru". Available at: http://aptekamos.ru/apteka/

6. Loginova NV, Karakulova YuV. Komorbidnost bolevogo sindroma i ehmocionalnyh rasstrojstv u pacientov so spasticheskoj krivosheej. Sovremennye problemy nauki i obrazovaniya [Comorbidity of pain syndrome and emotional disorders in patients with spastic torticollis] (In Russ) Modern problems of science and education. 2015;6. DOI: 10.17513/spno.130-23088.

7. Metodicheskie rekomendacii po ocenke sravnitel'noj klinikoehkonomicheskoj ehffektivnosti i bezopasnosti lekarstvennogo sredstva. M., FGBU "Centr ehkspertizy i kongtrolya kachestva medicinskoj pomoshchi". 2016; 27S. [Methodical recommendations on the evaluation of the comparative clinical and economic effectiveness and safety of the medicinal product. M., FGBU "Center for Expertise and Control of Quality of Medical Care". 2016. – P. 27] (In Russ)

8. Orlova OR. Fokalnye distonii diagnostika i sovremennaya terapiya s primeneniem botulinicheskogo toksina tipa A (po materialam Evropejskogo konsensusa i Rossijskih klinicheskih rekomendacij) gl. v kn. Gusev EI, Gekht AB. Bolezni mozga — medicinskie i socialnye aspekty. M. OOO "Buki-Vedi" 2016. — 768 s. (S. 553-568) [Orlova OR. Focal dystonia: diagnosis and modern therapy using botulinum toxin type A (based on the European consensus and Russian clinical recommendations) Ch. in the book. Gusev EI, Gekht A.B. Diseases of the brain — medical and social aspects. — M.: OOO Buki-Vedi, 2016. — 768 p. (Pp. 553-568)] (In Russ)

9. Otraslevoj standart. "Kliniko-ehkonomicheskie issledovaniya. Obshchie polozheniya". Prikaz Minzdrava RF ot 27.05.2002 g. No163 vmeste s OST 91500.14.0001-2002 [Industry standard "Clinical and economic research. General provisions. "Order of the Ministry of Health of the Russian Federation of May 27, 2002 No 163 together with OST 91500.14.0001-2002] (In Russ)

10. Prikaz Ministerstva truda i socialnoj zashchity RF ot 17.12.2015 No 1024n “O klassifikaciyah i kriteriyah ispolzuemyh pri osushchestvlenii mediko-socialnoj ehkspertizy grazhdan federalnymi gosudarstvennymi uchrezhdeniyami medikosocialnoj ehkspertizy [Order of the Ministry of Labor and Social Protection of the Russian Federation of December 17, 2015 № 1024н "On classifications and criteria used in the implementation of medical and social expertise of citizens by federal state institutions of medical and social expertise"] (In Russ)

11. Sajt Gosudarstvennogo reestra lekarstvennyh sredstv [The site of the State Register of Medicines (In Russ.)]. Available at: http://grls.rosminzdrav.ru

12. Standart specializirovannoj medicinskoj pomoshchi pri distoniyah Utverzhdyon prikazom MZ RF No1540n ot 24.12.2012 g. [The standard of specialized medical care for dystonia. Approved by the order of the Ministry of Health of the Russian Federation No. 1540n dated December 24, 2012] (In Russ)

13. Tarifnoe soglashenie na oplatu medicinskoj pomoshchi okazyvaemoj po territorialnoj programme obyazatelnogo medicinskogo strahovaniya goroda Moskvy na 2017 god ot 29 dekabrya 2016 goda s prilozheniyami g. Moskva [Tariff agreement for payment of medical assistance provided under the territorial program of compulsory medical insurance in Moscow for 2017 from "29" December 2016, with annexes, Moscow (In Russ.)]. Available at: http://www.mgfoms.ru

14. Federalnaya sluzhba gosudarstvennoj statistiki "Srednyaya zarabotnaya plata po 10-procentnym gruppam rabotnikov" dannye za 2017 g. [Federal State Statistics Service, "Average salary for 10 percent groups of employees" data for 2017] (In Russ) Available at: http://www.gks.ru/free_doc/new_site/population/trud/ sr-zpl3.xls

15. Federalnaya sluzhba gosudarstvennoj statistiki, dannye za 2017 g. Chislennost i sostav naseleniya v 2017 g. [Federal State Statistics Service, data for 2017. Number and composition of population in 2017] (In Russ) Available at: http://www.gks.ru/ wps/wcm/connect/rosstat_main/rosstat/ru/statistics/population/demography/#

16. Federalnyj zakon ot 29.12.2006 No 255-FZ dejstvuyushchaya redakciya ot 01.05.2017 "Ob obyazatelnom socialnom strahovanii na sluchaj vremennoj netrudosposobnosti i v svyazi s materinstvom" [Federal Law No. 255-FZ of 29 December 2006 (current version, dated 01.05.2017) "On compulsory social insurance in case of temporary incapacity for work and in connection with maternity"] (In Russ)

17. Yagudina RI, Kulikov AYu, Krysanov IS, Litvinenko MM, Morozov AL. Osobennosti metodologii farmakoehkonomicheskih issledovanij v usloviyah zdravoohraneniya Rossijskoj Federacii obzor publikacij za period s 1995 po 2007 gg. [Peculiarities of the methodology of pharmacoeconomic research in the health care of the Russian Federation (review of publications for the period from 1995 to 2007)] (In Russ) Pharmacoeconomics. 2009;1:3-6.

18. Yagudina RI, Kulikov AYu, Metelkin IA. Metodologiya analiza zatratyehffektivnost pri provedenii farmakoehkonomicheskih issledovanij Farmakoehkonomika Sovremennaya farmakoehkonomika i farmakoehpidemiologiya [Methodology of cost-effectiveness analysis in conducting pharmacoeconomic studies. (In Russ)] Pharmacoeconomics. Modern pharmacoeconomics and pharmacoepidemiology. 2012;4:3–8.

19. Yagudina RI, Sorokovikov IV. Metodologiya provedeniya analiza zatratypoleznost pri provedenii farmakoehkonomicheskih issledovanij. Farmakoehkonomika. Sovremennaya farmakoehkonomika i farmakoehpidemiologiya [Methodology of carrying out the cost-utility analysis in carrying out pharmacoeconomic studies] (In Russ) Pharmacoeconomics. Modern pharmacoeconomics and pharmacoepidemiology. 2012;5:9–-12.

20. Albanesel A, Abbruzzese G, Dressler D, et al. Practical guidance for CD management involving treatment of botulinum toxin: a consensus statement. J Neurol 2015;262:2201–2213.

21. Comella CL, Jankovic J, Truong DD, et al. Efficacy and safety of incobotulinumtoxinA (NT 201, XEOMIN, botulinum neurotoxin type A, without accessory proteins) in patients with cervical dystonia. J Neurol Sci 2011;308:103–109.

22. Dashtipour K, Chen JJ, Espay AJ, et al. Onabotulinumtoxin A and Abobotulinumtoxin A dose conversion: a systematic literature review. Movement Disorders Clinical Practice 2015. Published online 12 October 2015 in Wiley InterScience. DOI:10.1002/mdc3.12235.

23. Dressler D, Mander G, Fink K. Measuring the potency labelling of onabotulinumtoxin A (Botox®) and incobotulinumtoxin A (Xeomin®) in an LD50 assay. J Neural Transm 2012; 119:13–15.

24. Evidente VG, Fernandez HH., LeDoux MS, et al. A randomized, double-blind study of repeated incobotulinumtoxinA (Xeomin®) in cervical dystonia. J Neural Transm 2013;120(12):1699–1707.

25. Evidente VG, Truong D, Jankovic J, Comella CL, Grafe S, Hanschmann A. IncobotulinumtoxinA (Xeomin®) injected for blepharospasm or cervical dystonia according to patient needs is well tolerated. J Neurol Sci. 2014;346:116–120.

26. Grosset DG, Tyrrell EG, Grosset KA. Switch from abobotulinumtoxinA (Dysport) to incobotulinumtoxinA (Xeomin) botulinum toxin formulation: a review of 257 cases. J Rehabil Med 2015;47: 183–186.

27. Hilker R, Schischniaschvili M, Ghaemi M, Jacobs A, Rudolf J. Health related quality of life is improved by botulinum neurotoxin type A in long term treated patients with focal dystonia. J Neurol Neurosurg Psychiatry 2001;71(2):193–199.

28. Jankovic J. Clinical efficacy and tolerability of xeomin in the treatment of blepharospasm. Eur J Neurol 2009;16(Suppl. 2):14–18.

29. Jankovic J, Comella C, Hanschmann A, Grafe S. Efficacy and safety of incobotulinumtoxinA (NT 201, Xeomin) in the treatment of blepharospasm – a randomized trial. Mov Disord 2011;26:1521–1528.

30. Jost W. Pictorial Atlas of botulinum toxin injection. Dosage. Localization. Application. First English Edition. Quintessence Book, 2008. 264 p.

31. Marchetti A, Magar R, Findley L, et al. Retrospective evaluation of the dose of Dysport and BOTOX in the management of cervical dystonia and blepharospasm: The REAL DOSE study. Mov Disord 2005;20:937–944.

32. Poliziani M, Koch M, Liu X. Striving for more good days: patient perspectives on botulinum toxin for the treatment of cervical dystonia. Patient preference and adherence. 2016;10:1601–1608.

33. Ranoux D, Gury C, Fondarai J, et al. Respective potencies of Botox and Dysport: a double blind, randomised, crossover study in cervical dystonia. JNNP 2002;72(4):459–62.

34. Scaglione F. Conversion ratio between Botox®, Dysport®, and Xeomin® in clinical practice. Toxins 2016;8(3):65.

35. Schwartz R. Biological modeling and simulation: a survey of practical models, algorithms and numerical methods. The MIT Press, 2008.

36. Sethi KD, Rodriguez R, Olayinka B. Satisfaction with botulinum toxin treatment: a cross-sectional survey of patients with cervical dystonia. Jornal of Medical Economics 2012;15(3):419–423.

37. Simpson DM, Hallett M, Ashman EJ, et al. Practice guideline update summary: Botulinum neurotoxin for the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache. Neurology 2016;86:1818–1826.

38. Stacy M. Handbook of Dystonia. Second Edition. Informa healthcare. 2012. 540 p.

39. Tilden D, Guarnieri C. Cost-effectiveness of incobotulinumtoxin-A with flexible treatment intervals compare to onabotulinumtoxin-A in the management of blepharospasm and cervical dystonia. Value in Health 2016;19:145-152.

40. Truong D, Dressler D, Hallett M. Manual of Botulinum Toxin Therapy. Cambridge University Press, 2009. 218 p.

41. Truong DD, Gollomp SM, Jankovic J, et al. Xeomin US Blepharospasm Study Group Sustained efficacy and safety of repeated incobotulinumtoxinA (Xeomin®) injections in blepharospasm. J Neural Transm 2013;120(9):1345–1353.


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For citations:


Cheberda A.E., Belousov D.Yu., Zyryanov S.K. Pharmacoeconomic analysis of flexible-dose administration regimen of Xeomine® in patients with focal dystonia. Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice. 2018;(1):53-65. (In Russ.) https://doi.org/10.24411/2588-0519-2018-10038

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