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Рецепт. 2019; : 178-191

Фармакоэкономическая оценка применения лекарственного средства вилантерол/ флутиказона фуроат при лечении пациентов с бронхиальной астмой в условиях системы здравоохранения Республики Беларусь

Кожанова И. Н., Романова И. С., Сачек М. М.

Аннотация

Цель исследования - определение фармакоэкономической приемлемости использования лекарственного средства вилантерол/флутиказона фуроат в условиях системы здравоохранения Республики Беларусь. Материалы и методы. В ходе настоящего исследования на основании литературных данных (клинические исследования, мета-анализы и систематические обзоры) была установлена клиническая эффективность лекарственного средства вилантерол/флутиказона фуроат. На основании национальных данных (клинические протоколы, данные о рынке лекарственных средств) определены альтернативы для проведения фармакоэкономического анализа. В ходе исследования использованы методы минимизации затрат, влияния на бюджет, затраты/ эффективность. Расчеты проведены с учетом прямых медицинских, немедицинских затрат и непрямых затрат. Выполнен анализ чувствительности с учетом влияния диапазона цен от ми- нимальных до максимальных. Заключение. Полученные данные говорят о клинико-экономической целесообразности применения лекарственного средства вилантерол/флутиказона фуроат у пациентов трудоспособного возраста с бронхиальной астмой и частыми обострениями (более 2 в год), т. е. у пациентов с потенциально значительными прямыми затратами на ведение обострений и высокими трудовыми потерями.

Список литературы

1. Instruktsiya po meditsinskomu primeneniyu lekarstvennogo sredstva Relvar Elliptaot 13.06.2018 №599 [Instruction on medical use of Relvar Ellipta medicine].

2. Rudakova A.V. (2013). Farmakoekonomicheskie aspekti podderzhivayuschei terapii bronhial'noi astmi ingalyatsionnimi kortikosteroidami [Pharmacoeconomic aspects of maintaining therapy of bronchial asthma with inhalation corticosteroids]. Kachestvennaya klinicheskaya praktika [Quality clinical practice], no 1, pp. 47-49.

3. Ruzanov D.YU., Davidovskaya E.I., Baranovkaya T.V., Shebusheva T.T., Buinevich I.V. i soavt. (2015). Vozmozhnosti dostizheniya kontrolya nad bronhial'noi astmoi: rezul'tati respublikanskogo mnogotsentrovogo issledovaniya Rapira [The possibilities of reaching bronchial asthma control: the results of republican multicenter study of Rapira]. Zdravoohranenie [Healthcare], no 9, pp. 32-37.

4. Sachek M.M., Gavrilenko L.N., Kozhanova I.N., Nikolaeva S.N., Davidovskaya E.I., Baranovskaya T.V. (2014). Farmakoekonomicheskaya otsenka lecheniya patsientov s bronhial'noi astmoi s ispol'zovaniem informatsionnih tehnologii [Pharmacoeconomic evaluation of treatment of patients with bronchial asthma with the use of information technology]. Dostizheniya meditsinskoi nauki Belarusi [The achievement of medical science in Belarus].

5. Dwan K., Milan S.J., Bax L., Walters N., Powell C.V.E. Vilanterol and fluticasone furoate for asthma. Cochrane Database of Systematic Reviews 2016, Issue 9. Art. No.: CD010758. DOI: 10.1002/14651858.CD010758.pub2.

6. Friedman H.S., Urdaneta E., McLaughlin J.M., Navaratnam P. (2010) Mometasone furoate versus beclomethasone dipropionate: effectiveness in patients with mild asthma. Am. J. Manag. Care; vol. 16(7), pp. e151-6.

7. Loretta Jacques, Nawar Diar Bakerly, John P. New, Henrik Svedsater, James Lay-Flurrie & David A. Leather (2018) Effectiveness of fluticasone furoate/vilanterol versus fluticasone propionate/salmeterol on asthma control in the Salford Lung Study, Journal of Asthma, DOI: 10.1080/02770903.2018.1490751.

8. Man K.N., Tian Z., Lam D.C., Wan J.M.F., Tan-Un K.C. (2018) Satisfaction, preference and error occurrence of three dry powder inhalers as assessed by a cohort naïve to inhaler operation. Int J Chron Obstruct Pulmon Dis.; vol. 13, pp. 1949-1963. Published 2018 Jun 15. doi:10.2147/COPD.S152285.

9. Molimard M., Raherison C., Lignot S., Depont F., Abouelfath A., Moore N. (2003) Assessment of handling of inhaler devices in real life: an observational study in 3811 patients in primary care. J Aerosol Med. Fall; vol. 16(3), pp. 249-54.

10. NPJ Prim Care Respir Med. 2014 Jun 26; 24:14019. doi: 10.1038/npjpcrm.2014.19.Ease of use of the ELLIPTA dry powder inhaler: data from three randomised controlled trials in patients with asthma. Svedsater H1, Jacques L2, Goldfrad C3, Bleecker ER4.

11. Price D., Robertson A., Bullen K., et al. (2010) Improved adherence with once-daily versus twice-daily dosing of mometasone furoate administered via a dry powder inhaler: a randomized open-label study. BMC Pulm. Med.; vol. 10, no 1.

12. Sharma R., Sharma N. et al. (2014) Operability of the ELLIPTA™ Dry Powder Inhaler: A Comparative Evaluation of Handling Technique in Inhalation Therapy-Naïve Subjects. Am J RespirCrit Care Med., vol. 189.

13. Svedsater H., Dale P., Garrill K., Walker R., Woepse M.W. (2013) Qualitative assessment of attributes and ease of use of the ELLIPTA™ dry powder inhaler for delivery of maintenance therapy for asthma and COPD. BMC Pulm Med., vol. 13, 72 p.

14. Williams L.K., Peterson E.L., Wells K., et al. (2011) Quantifying the proportion of severe asthma exacerbations attributable to inhaled corticosteroid nonadherence. J. Allergy Clin. Immunol., vol. 128(6), pp. 1185-1191.

15. Williams L.K., Pladevall M., Xi H. et al. (2004) Relationship between adherence to inhaled corticosteroids and poor outcomes among adults with asthma. J. Allergy Clin. Immunol., vol. 114(6), pp. 1288-93.

16. (2018) Ob ustanovlenii Respublikanskogo formulyara lekarstvennih sredstvna 2018 god [Elektronnii resurs] [About establishing the Republican formular of medicines 2018]. Postanovlenie Ministerstva zdravoohraneniya Respubliki Belarus', 3 apr. 2018, № 33. Natsional'ni I pravovoi Internet-portal Respubliki Belarus'. Available at: http://pravo.by/ document/?guid=12551&p0=W21833004&p1=1 (accessed 6 November 2018)

17. O vnesenii I zmeneniya v postanovlenie Ministerstva zdravoohraneniya Respubliki Belarus' ot 16 iyulya 2007 g.

18. № 65 [Elektronniiresurs] [On amending in Ministry of Health of the Republic of Belarus act from 16 July 2007 № 65]. Postanovlenie Ministerstva zdravoohraneniya Respubliki Belarus', 13 avg. 2018 g., № 65 Natsional'nii pravovoi Internet-portal Respubliki Belarus'. Available at: http://pravo.by/document/?guid=12551&p0=W21833515&p1=1 (accessed 6 November 2018)

Recipe. 2019; : 178-191

Pharmacoeconomic Evaluation of the Vilanterol/Fluticasone Furoate Use in the Treatment of Patients with Asthmain the Health Care System of the Republic of Belarus

Kozhanova I. ., Romanova I. ., Sachek M. .

Abstract

The purpose of this study is to determine the pharmacoeconomic acceptability of Vilanterol/ Fluticasone Furoate use in the health care system of the Republic of Belarus.Materials and methods. The clinical efficacy of Vilanterol/fluticasone Furoate was established on the basis of literature data (clinical studies, meta-analyzes and systematic reviews). The alternatives have been identified for carrying out pharmacoeconomic analysis on the basis of national data (clinical protocols, data on the drug market). Cost-minimization analysis, budget impact analysis, cost/effectiveness analysis were performed. Direct medical and non-medical costs and indirect costs were used. A sensitivity analysis was performed taking into account the influence of the price range from the minimum to the maximum.Conclusion. The findings suggest a clinico-economic feasibility of Vilanterol/fluticasone Furoate using in patients with bronchial asthma of working age and frequent exacerbations (more than 2 per year), i.e. in patients with potentially significant direct costs of exacerbations and high labor losses.
References

1. Instruktsiya po meditsinskomu primeneniyu lekarstvennogo sredstva Relvar Elliptaot 13.06.2018 №599 [Instruction on medical use of Relvar Ellipta medicine].

2. Rudakova A.V. (2013). Farmakoekonomicheskie aspekti podderzhivayuschei terapii bronhial'noi astmi ingalyatsionnimi kortikosteroidami [Pharmacoeconomic aspects of maintaining therapy of bronchial asthma with inhalation corticosteroids]. Kachestvennaya klinicheskaya praktika [Quality clinical practice], no 1, pp. 47-49.

3. Ruzanov D.YU., Davidovskaya E.I., Baranovkaya T.V., Shebusheva T.T., Buinevich I.V. i soavt. (2015). Vozmozhnosti dostizheniya kontrolya nad bronhial'noi astmoi: rezul'tati respublikanskogo mnogotsentrovogo issledovaniya Rapira [The possibilities of reaching bronchial asthma control: the results of republican multicenter study of Rapira]. Zdravoohranenie [Healthcare], no 9, pp. 32-37.

4. Sachek M.M., Gavrilenko L.N., Kozhanova I.N., Nikolaeva S.N., Davidovskaya E.I., Baranovskaya T.V. (2014). Farmakoekonomicheskaya otsenka lecheniya patsientov s bronhial'noi astmoi s ispol'zovaniem informatsionnih tehnologii [Pharmacoeconomic evaluation of treatment of patients with bronchial asthma with the use of information technology]. Dostizheniya meditsinskoi nauki Belarusi [The achievement of medical science in Belarus].

5. Dwan K., Milan S.J., Bax L., Walters N., Powell C.V.E. Vilanterol and fluticasone furoate for asthma. Cochrane Database of Systematic Reviews 2016, Issue 9. Art. No.: CD010758. DOI: 10.1002/14651858.CD010758.pub2.

6. Friedman H.S., Urdaneta E., McLaughlin J.M., Navaratnam P. (2010) Mometasone furoate versus beclomethasone dipropionate: effectiveness in patients with mild asthma. Am. J. Manag. Care; vol. 16(7), pp. e151-6.

7. Loretta Jacques, Nawar Diar Bakerly, John P. New, Henrik Svedsater, James Lay-Flurrie & David A. Leather (2018) Effectiveness of fluticasone furoate/vilanterol versus fluticasone propionate/salmeterol on asthma control in the Salford Lung Study, Journal of Asthma, DOI: 10.1080/02770903.2018.1490751.

8. Man K.N., Tian Z., Lam D.C., Wan J.M.F., Tan-Un K.C. (2018) Satisfaction, preference and error occurrence of three dry powder inhalers as assessed by a cohort naïve to inhaler operation. Int J Chron Obstruct Pulmon Dis.; vol. 13, pp. 1949-1963. Published 2018 Jun 15. doi:10.2147/COPD.S152285.

9. Molimard M., Raherison C., Lignot S., Depont F., Abouelfath A., Moore N. (2003) Assessment of handling of inhaler devices in real life: an observational study in 3811 patients in primary care. J Aerosol Med. Fall; vol. 16(3), pp. 249-54.

10. NPJ Prim Care Respir Med. 2014 Jun 26; 24:14019. doi: 10.1038/npjpcrm.2014.19.Ease of use of the ELLIPTA dry powder inhaler: data from three randomised controlled trials in patients with asthma. Svedsater H1, Jacques L2, Goldfrad C3, Bleecker ER4.

11. Price D., Robertson A., Bullen K., et al. (2010) Improved adherence with once-daily versus twice-daily dosing of mometasone furoate administered via a dry powder inhaler: a randomized open-label study. BMC Pulm. Med.; vol. 10, no 1.

12. Sharma R., Sharma N. et al. (2014) Operability of the ELLIPTA™ Dry Powder Inhaler: A Comparative Evaluation of Handling Technique in Inhalation Therapy-Naïve Subjects. Am J RespirCrit Care Med., vol. 189.

13. Svedsater H., Dale P., Garrill K., Walker R., Woepse M.W. (2013) Qualitative assessment of attributes and ease of use of the ELLIPTA™ dry powder inhaler for delivery of maintenance therapy for asthma and COPD. BMC Pulm Med., vol. 13, 72 p.

14. Williams L.K., Peterson E.L., Wells K., et al. (2011) Quantifying the proportion of severe asthma exacerbations attributable to inhaled corticosteroid nonadherence. J. Allergy Clin. Immunol., vol. 128(6), pp. 1185-1191.

15. Williams L.K., Pladevall M., Xi H. et al. (2004) Relationship between adherence to inhaled corticosteroids and poor outcomes among adults with asthma. J. Allergy Clin. Immunol., vol. 114(6), pp. 1288-93.

16. (2018) Ob ustanovlenii Respublikanskogo formulyara lekarstvennih sredstvna 2018 god [Elektronnii resurs] [About establishing the Republican formular of medicines 2018]. Postanovlenie Ministerstva zdravoohraneniya Respubliki Belarus', 3 apr. 2018, № 33. Natsional'ni I pravovoi Internet-portal Respubliki Belarus'. Available at: http://pravo.by/ document/?guid=12551&p0=W21833004&p1=1 (accessed 6 November 2018)

17. O vnesenii I zmeneniya v postanovlenie Ministerstva zdravoohraneniya Respubliki Belarus' ot 16 iyulya 2007 g.

18. № 65 [Elektronniiresurs] [On amending in Ministry of Health of the Republic of Belarus act from 16 July 2007 № 65]. Postanovlenie Ministerstva zdravoohraneniya Respubliki Belarus', 13 avg. 2018 g., № 65 Natsional'nii pravovoi Internet-portal Respubliki Belarus'. Available at: http://pravo.by/document/?guid=12551&p0=W21833515&p1=1 (accessed 6 November 2018)