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Economic aspects of biological therapy usage in chronic obstructive pulmonary disease with T2-inflammation

https://doi.org/10.37489/2588-0519-GCP-0001

EDN: ZEVCAB

Abstract

Actuality. Chronic obstructive pulmonary disease (COPD) is one of the leading causes of morbidity and mortality and is a medical and social problem accompanied by major economic damage. A direct relationship between COPD severity and treatment costs. The costs of hospitalization, outpatient visits, and oxygen supply increase dramatically with increasing COPD severity. Reducing the frequency of exacerbations and hospitalizations and slowing disease progression are ways to reduce the costs of COPD. Certain hopes are associated with the introduction of healthcare technology using targeted therapy with genetically engineered biological drugs, particularly with the addition of dupilumab to triple therapy (standard: inhaled glucocorticosteroid, long-acting anticholinergic drug and β2-agonist).

Objective. The clinical and economic effectiveness of this technology in COPD with T2-inflammation in adult patients in the Russian Federation (RF) should be assessed.

Materials and methods. An analytical Markov decision-making model in MS Excel with a 5-year horizon has been created. The calculation of the potential population of patients with COPD is based on the population of the RF, the prevalence of COPD, the percentage of patients with frequent exacerbations, having T2-inflammation, and receiving triple therapy. To quantify the dynamics of COPD exacerbations, data from digitized curves of the cumulative average number of exacerbations, survival analysis of patients with COPD, and the development of serious undesirable cardiovascular events (MACE) were used to calculate the number of life year gains and the number of prevented hospitalizations with dupilumab. The costs of medications, medical care (hospitalization due to COPD exacerbations, MACE, and deaths), DRG payments, and rehabilitation after a heart attack and stroke are considered. Indirect costs are calculated for patients up to the age of 72 years, adjusted for the level of employment by age, including payments for temporary disability, the reference ICER (triple therapy), and ICER for dupilumab.

Results. The annual incidence of moderate or severe exacerbations was significantly lower for dupilumab than for standard therapy: 0.79 (95% CI 0.69-0.92) and 1.16 (95% CI 1.01-1.33), respectively. Dupilumab therapy was associated with a significant decrease in overall mortality (Odds Ratio [OR], 0.53; 95% CI 0.43-0.65), a decrease in the need for emergency care (OR, 0.78; 95% CI 0.69-0.89), and actual exacerbations of COPD (OR, 0.59; 95% CI 0.53-0.65). The amount of additional funding that needs to be provided to expand the use of dupilumab when added to standard triple therapy amounts to 788,998 billion rubles over 5 years for all those in need of treatment. Simultaneously, budget savings (considering cost savings on hospitalization, mass, and deaths with a lower probability of disease progression) will amount to 590.301 billion RUB over 5 years on the analysis horizon. The ICER of dupilumab to prevent one exacerbation is 1.84 million rubles (below the threshold of willingness to pay 4.12 million RUB), one MACE is 4.61 million RUB, and fatal outcome is 12.6 million RUB. Sensitivity analysis confirmed the stability of the results obtained to changes in dupilumab prices while improving the clinical and economic indicators of drug use in patients with frequent severe exacerbations.

Conclusion. Dupilumab is a clinically and economically feasible healthcare technology for treating COPD with T2-inflammation in addition to standard triple therapy.

About the Authors

S. V. Nedogoda
Volgograd State Medical University
Russian Federation

Sergey V. Nedogoda — Dr. Sci. (Med.), Professor, honored doctor of the Russian Federation, Head of the Dept. of Internal Illness in Institute of continuing medical & pharmaceutical education

Volgograd


Competing Interests:

The authors state that there is no conflict of interest. 



S. N. Avdeev
Moscow State Medical University named after IM Sechenov ; Scientific Research Institute of Pulmonology of the Federal Medical-Biological Agency
Russian Federation

Sergey N. Avdeev — Dr. Sci. (Med.), Professor, Academician, Chief-physician in pulmonology of MoH RF; Head of the Pulmonology Dept. in Institute of clinical medicine named after NV Sklifosovsky; Leading Researcher 

Moscow 


Competing Interests:

The authors state that there is no conflict of interest. 



A. S. Salasyuk
Volgograd State Medical University
Russian Federation

Alla S. Salasyuk — Dr. Sci. (Med.), Professor in the Dept. of Internal Illness in Institute of continuing medical & pharmaceutical education

Volgograd


Competing Interests:

The authors state that there is no conflict of interest. 



S. L. Bolotova
Volgograd State Medical University
Russian Federation

Svetlana L. Bolotova — Cand. Sci. (Med), Associate Professor of the Dept. of Internal Illness in Institute of continuing medical & pharmaceutical education

Volgograd


Competing Interests:

The authors state that there is no conflict of interest. 



V. O. Lutova
Volgograd State Medical University
Russian Federation

Victoria O. Lutova — Cand. Sci. (Med), Associate Professor of the Dept. of Internal Illness in Institute of continuing medical & pharmaceutical education

Volgograd


Competing Interests:

The authors state that there is no conflict of interest. 



I. N. Barykina
Volgograd State Medical University
Russian Federation

Irina N. Barykina — Cand. Sci. (Med), Associate Professor of the Dept. of Internal Illness in Institute of continuing medical & pharmaceutical education

Volgograd


Competing Interests:

The authors state that there is no conflict of interest. 



E. A. Popova
Volgograd State Medical University
Russian Federation

Ekaterina A. Popova — Cand. Sci. (Med), Associate Professor of the Dept. of Internal Illness in Institute of continuing medical and pharmaceutical education

Volgograd


Competing Interests:

The authors state that there is no conflict of interest. 



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For citations:


Nedogoda S.V., Avdeev S.N., Salasyuk A.S., Bolotova S.L., Lutova V.O., Barykina I.N., Popova E.A. Economic aspects of biological therapy usage in chronic obstructive pulmonary disease with T2-inflammation. Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice. 2025;(4):4-18. (In Russ.) https://doi.org/10.37489/2588-0519-GCP-0001. EDN: ZEVCAB

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