Pharmacoeconomic evaluation of mirabegron: results of the healthcare budget impact analysis

Overactive bladder (OAB) is a chronic disease that correlates with the age of the patient, and occurs in almost one in seven women and men. Pharmacotherapy is one of the main methods for correction of this nosology. Taking into account the absence of additional therapeutic option on the Vital and Essential Drugs List for patients with contraindications for the prescription of solifenacin and BTX-A, patients with intolerance to these drugs conduct, an analysis of the economic consequences of the use of mirabegron under the State Guarantees for Providing Free Medical Care for the OAB treatment. Approved recommendations on carrying out the budget impact analysis were used. Results of the study show, that the expansion of the mirabegron use in the treatment of patients with OAB in the target population leads to the reduction in the cost of medical therapy for this group of patients: with an increase in the share of mirabegron up to 5 %, costs will decrease by 7.8 %; with an increase in the mirabegron share up to 10 % costs will decrease by 12.5 %; when using in 15 % of the target population – by 22.3 %. Trend analysis of changes in the average weighted costs shows the following: an increase in the use of mirabegron leads to a significant reduction in total costs, the total benefit can reach 6 250 002 576 rubles per 3 years of the drug presence in the VED List, which allows attributing the OAB treatment with mirabegron to economically feasible and resource-saving medical technologies.

1. Irwin DE, Milsom I, Hunskaar S, et al. Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: Results of the EPIC study. Eur Urol. 2006;50:1306–15. Available at: http://dx.doi.org/10.1016/j.eururo.2006.09.019.

2. Stewart WF, Van Rooyen JB, Cundiff GW, et al. Prevalence and burden of overactive bladder in the United States. World J Urol. 2003;20:327–36.

3. Abrams P, Cardozo L, Fall M, et al. The standardisation of terminology of lower urinary tract function: Report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21:167–78. Available at: http://dx.doi.org/10.1002/nau.10052.

4. Brown JS, McGhan WF, Chokroverty S. Comorbidities associated with overactive bladder. Am J Manag Care. 2000;6:S574–9.

5. Wagner TH, Hu TW, Bentkover J, et al. Health-related consequences of overactive bladder. Am J Manag Care. 2002;8:S598–607.

6. Abrams P, Kelleher CJ, Kerr LA, et al. Overactive bladder significantly affects quality of life. Am J Manag Care. 2000;6:S580–90.

7. Wein AJ, Rackley RR. Overactive bladder: a better understanding of pathophysiology, diagnosis and management. J Urol. 2006;175(3 Pt 2):S5–10.

8. Semins MJ, Chancellor MB. Diagnosis and management of patients with overactive bladder syndrome and abnormal detrusor activity. Nat Clin Pract Urol. 2004;1(2):78–84; 109.

9. Blok B, et al. Persistence with antimuscarinics in a European study of patients with overactive bladder syndrome. IUGA 34th Annual Meeting, Italy, June 16–20, 2009.

10. Wein AJ, Rackley RR. Overactive bladder: a better understanding of pathophysiology, diagnosis and management. J Urol. 2006;175(3 Pt 2):S5–10.

11. Semins MJ, Chancellor MB. Diagnosis and management of patients with overactive bladder syndrome and abnormal detrusor activity. NatClinPractUrol. 2004;1(2):78–84; quiz 109.

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

13. Instrukciya po primeneniyu lekarstvennogo preparata dlya medicinskogo primeneniya Betmiga® [Instructions for the use of medicinal product for medical use BETMIGA®] (In Russ)

14. Informacionnyj portal OMS Sankt-Peterburga. [Information portal of the OMC of St. Petersburg. Available at: https://spboms.ru/] (In Russ)

15. Cui Y, et al. The efficacy and safety of mirabegron in treating OAB: a systematic review and meta-analysis of phase III trials. IntUrolNephrol. DOI: 10.1007/s11255-013-0509-9.

16. Sacco E, Bientinesi R. Mirabegron: a review of recent data and its prospects in the management of overactive bladder. TherAdvUrol 2012:1–10.

17. Bridgeman MB, et al. Mirabegron: β3-Adrenergic Receptor Agonist for the Treatment of Overactive Bladder. Ann Pharmacother 2013;47.

18. Gras J, et al. Mirabegron for the treatment of overactive bladder. Drugs of Today 2012;48(1): 25–32.

19. Bhide AA, et al. Use of mirabegron in treating overactive bladder. Int Urogynecol J. DOI: 10.1007/s00192-012-1724-0.

20. Caremel R, et al. What do we know and not know about mirabegron, a novel β3 agonist, in the treatment of overactive bladder? IntUrogynecol J. DOI 10.1007/s00192-013-2161-4.

21. Metodicheskie rekomendacii po ocenke vliyaniya na byudzhet v ramkah realizacii programmy gosudarstvennyh garantii besplatnogo okazaniya grazhdanam medicinskoj pomoshchi FGBU CEHKKMP Minzdrava Rossii Utverzhdeny prikazom FGBU "CEHKKMP" Minzdrava Rossii ot 23 dekabrya 2016 g. No 145-od Moskva 2016 [Methodical recommendations for assessing the impact on the budget as part of the program of state guarantees for free provision of medical care to citizens. FGBU "CEHKKMP" of the Ministry of Health of Russia. Approved by the order of FGBU "CEHKKMP" of the Ministry of Health of Russia from "23" December 2016 No 145-od. Moscow 2016] (In Russ)

22. Trapeznikova MF, Dutov VV, Bychkova NV, Golovchenko KV. EHpidemiologiya giperaktivnogo mochevogo puzyrya v Moskovskoj oblasti Materialy plenuma pravleniya Rossijskogo obshchestva urologov Tyumen, 2005. 410 c. [Epidemiology of the hyperactive bladder in the Moscow region. Materials of the plenary board of the Russian Society of Urology, Tyumen. – 2005. – 410 c.] (In Russ)

23. Pushkar DYu., Schaveleva OB. Rasprostranennost imperativnyh narushenij mocheispuksaniya sredi zhenshchin. Materialy plenuma pravleniya Rossijskogo obshchestva urologov. M, 2001. С. 150–151. [The prevalence of mandatory violations of urination among women. Materials of the plenary board of the Russian Society of Urology, M. – 2001. С. 150–151] (In Russ)

24. Kogan MI, Zachoval R, Ozyurt C, et al. Epidemiology and impact of urinary incontinence, overactive bladder, and other lower urinary tract symptoms: results of the EPIC survey in Russia, Czech Republic, and Turkey. Curr Med Res Opin. 2014;30 (10):2119 – 2130.

25. Federalnaya sluzhba statistiki. Demografiya. [Federal Service of Statistics. Demography. Available at: http://www.gks.ru/wps/wcm/connect/rosstat_main/ rosstat/ru/statistics/population/demography/#]

26. Tyagi S, Thomas CA, Hayashi Y, Chancellor MB. The overactive bladder: Epidemiology and morbidity. UrolClinNorthAm. 2006 Nov;33(4):433–8, vii.

27. Milsom I, Abrams P, Cardozo L, et al. How widespread are the symptoms of an overactive bladder and how are they managed? A populationbasedprevalencestudy. BJU Int. 2001;87(9):760–6.

28. Po dannym analiticheskoj kompanii IQVIA. [According to the analytical company IQVIA]. Available at: https://www.iqvia.com/ (In Russ)

29. Postanovlenie Pravitelstva RF ot 08.12.2017 No1492 "O Programme gosudarstvennyh garantij besplatnogo okazaniya grazhdanam medicinskoj pomoschi na 2018 god i na planovyj period 2019 i 2020 godov" [Decree of the Government of the Russian Federation of December 8, 2017 No 1492 "On the Program of State Guarantees of Free Medical Assistance to Citizens for 2018 and for the Planning Period of 2019 and 2020"] (In Russ)