Pharmacoeconomic efficiency of using the drug budesonide+glycopyrronium bromide+formoterol for the supportive therapy of patients with COPD

Chronic obstructive pulmonary disease (COPD) is one of the most widespread diseases with a significant socio-economic impact. Nevertheless, properly selected therapy makes it possible to effectively control the course of the disease. Fixed triple combinations are most effective in the severe forms. The list of drugs in this group is constantly expanding, which necessitates selecting the therapeutic approach with an optimal ratio of clinical effectiveness and economic effect of therapy.

The aim of the study was to conduct a clinical and economic analysis of the use of a fixed combination of budesonide + glycopyrronium bromide + formoterol (BGF) in patients with COPD receiving triple combinations of long-acting anticholinergic drugs/long-acting β2-agonists/inhaled corticosteroids (LAMA/LABA/ICS).

Methods. The triple fixed combination of vilanterol + umeclidinium bromide + fluticasone furoate (VUF) was selected as the active comparison. According to the adjusted indirect comparison data, the relative risk of death associated with BGF was 0.61 (95% CI 0.38 – 0.95) compared to VUF. A mathematical model of the COPD course against the use of the compared alternatives was proposed based on the adjusted indirect comparison data. The model was used to calculate the average number of life years and direct medical costs of the main drug therapy when using the considered alternatives over a modeling horizon of 3 years.

Results. The results of modeling the effectiveness of the considered alternatives conclude that therapy with BGF within the 3-year study horizon provides an additional 0.044 years of life compared with the use of VUF. Taking into account the termination of therapy due to death from all causes, the savings will amount to 47,091 rubles when using BGF in a 3-year horizon compared to the use of VUF (108,111 rubles vs 155,202 rubles). Thus, therapy with BGF is more effective and less expensive (dominant therapy).

Conclusion. From the perspective of the state payer’s budget, the BGF fixed combination is preferred over VUF for patients with COPD who are candidates for triple therapy and can be recommended for use in the Russian healthcare system.

1. Ministry of Health of the Russian Federation. [Clinical guidelines: Chronic obstructive pulmonary disease]. 2024. Available at: https://cr.minzdrav.gov.ru/preview-cr/603_3 [Accessed: January 17, 2025] (in Russian).

2. Bousquet J., Dahl R., Khaltaev N. Global alliance against chronic respiratory diseases. Allergy. 2007; 62 (3): 216–223. DOI: 10.1111/j.1398-9995.2007.01307.x.

3. Chuchalin A.G., Khaltaev N., Antonov N.S. et al. Chronic respiratory diseases and risk factors in 12 regions of the Russian Federation. Int J. Chron. Obstruct. Pulmon. Dis. 2014; 9: 963–974. DOI: 10.2147/COPD.S67283.

4. Russian Research Institute of Health. [Morbidity of the entire population of Russia in 2019: Statistical materials]. Moscow; 2020. Part II. Available at: https://mednet.ru/napravleniya/mediczinskaya-statistika/ (in Russian).

5. Malyavin A.G., Dzanaeva A.V., Avksentyeva M.V., Babak S.L. [Medical and economic analysis of the consequences of expanding the drug supply program for patients with chronic obstructive pulmonary disease in the Russian Federation]. Meditsinskie tekhnologii. 2019; (3): 53–61. DOI: 10.31556/2219-0678.2019.37.3.053-061 (in Russian).

6. Rabe K.F. Treating COPD – the TORCH trial, P values, and the Dodo. N. Engl. J. Med. 2007; 356 (8): 851–854. DOI: 10.1056/NEJMe068307.

7. Leshchenko I.V., Belevsky A.S. [The role of fixed triple combination in the treatment of chronic obstructive pulmonary disease]. Prakticheskaya pul'monologiya. 2021; (1): 20–27. Available at: https://www.atmosphere-ph.ru/modules/Magazines/articles//pulmo/pp_1_2021_20.pdf (in Russian).

8. Titova O.N., Kuzubova N.A., Sklyarova D.B. [Triple combination drug – budesonide/glycop rronium bromide/formoterol in patients with chronic obstructive pulmonary disease in real clinical practice (the first domestic experience)]. RMZh. Meditsinskoe obozrenie. 2024; 8 (8): 459–463. DOI: 10.32364/2587-6821-2024-8-8-3 (in Russian).

9. Avdeev S.N., Aisanov Z.R., Emel'yanov A.V. [First triple therapy in one inhaler for COPD patients: treatment approach (scientific data overview)]. Pul'monologiya. 2020; 30 (6): 813–821. DOI: 10.18093/0869-0189-2020-30-6-813-821 (in Russian).

10. Stolz D., Hermansson E., Ouwens M. et al. Mortality risk reduction with budesonide/glycopyrrolate/formoterol fumarate versus fluticasone furoate/umeclidinium/vilanterol in COPD: a matching-adjusted indirect comparison of ETHOS and IMPACT. Curr. Med .Res. Opinion. 2023; 39 (10): 1395–1405. DOI: 10.1080/03007995.2023.2247969.

11. Martinez F.J., Rabe K.F., Ferguson G.T. et al. Reduced all-cause mortality in the ETHOS trial of budesonide/glycopyrrolate/formoterol for chronic obstructive pulmonary disease: a randomized, double-blind, multicenter, parallel-group study. Am. J. Respir. Crit. Care Med. 2021; 203 (5): 553–564. DOI: 10.1164/rccm.202006-2618oc.

12. Lipson D.A., Barnhart F., Brealey N. et al. Once-daily single-inhaler triple versus dual therapy in patients with COPD. N. Engl. J. Med. 2018; 378 (18): 1671–1680. DOI: 10.1056/NEJMoa1713901.

13. [Resolution of the Government of the Russian Federation of August 28, 2014 No.871 (as amended on July 25, 2024) “On approval of the Rules for the formation of lists of medicinal products for medical use and the minimum range of medicinal products required to provide medical care”]. Available at: https://www.consultant.ru/document/cons_doc_LAW_167999/ [Accessed: December 10, 2024]. (in Russian).

14. Woods B., Sideris E., Palmer S. et al. NICE DSU technical support document 19: partitioned survival analysis for decision modelling in health care: a critical review. Report by the decision support unit. Sheffield: University of Sheffield; 2017. Available at: https://www.sheffield.ac.uk/sites/default/files/2022-02/TSD19-Partitioned-Survival-Analysis-final-report.pdf [Accessed: September 18, 2024].

15. Sievi N.A., Sepin J., Roeder M. et al. Are predictors for overall mortality in COPD patients robust over time? J. Clin. Med. 2023, 12 (4): 1587. DOI: 10.3390/jcm12041587.

16. Guyot P., Ades A., Ouwens M.J., Welton N.J. Enhanced secondary analysis of survival data: reconstructing the data from published Kaplan–Meier survival curves. BMC Med. Res. Methodol. 2012; 12: 9. DOI: 10.1186/1471-2288-12-9.

17. Liu N., Zhou Y., Lee J.J. IPDfromKM: reconstruct individual patient data from published Kaplan–Meier survival curves. BMC Med. Res. Methodol. 2021; 21 (1): 111. DOI: 10.1186/s12874-021-01308-8.

18. Grambsch P., Therneau T. Proportional hazards tests and diagnostics based on weighted residuals. Biometrika. 1994; 81 (3): 515–526. DOI: 10.1093/biomet/81.3.515.

19. Baio G. survHE: Survival analysis for health economic evaluation and cost-effectiveness modeling. J. Statistical Software. 2020; 95 (14): 1–47. DOI: 10.18637/jss.v095.i14.

20. Ministry of Health of the Russian Federation. [Minutes of the meeting of the commission of the Ministry of Health of the Russian Federation on the formation of lists of drugs for medical use and the minimum range of drugs necessary for the provision of medical care dated August 23, 2024]. Available at: https://minzdrav.gov.ru/ministry/61/10/stranitsa-858/stranitsa-7808 (in Russian).