The State Expert Center recommends considering the inclusion of the dual combination of umeclidinium bromide and vilanterol in the National List of Essential Medicines based on the results of the state health technology assessment.
The medicinal product is recommended as maintenance bronchodilator therapy for symptom relief in adult patients with chronic obstructive pulmonary disease (COPD) of GOLD group B.
Why it matters
COPD is one of the most common chronic respiratory diseases and one of the causes of high morbidity and mortality worldwide. The disease is accompanied by persistent airflow limitation, shortness of breath, and cough, reduces physical activity, and can significantly worsen patients' quality of life.
One of the key areas of COPD treatment is long-term bronchodilator therapy. Combining two bronchodilators with different mechanisms of action makes it possible to enhance bronchodilation and improve control of disease symptoms.
What the clinical data showed
The efficacy of the dual combination was assessed in three multicenter randomized phase III studies lasting 24 weeks, as well as in a pooled post hoc analysis of their results.
It was found that, compared with tiotropium bromide, the use of the combination of umeclidinium bromide and vilanterol improved lung function as measured by trough FEV1 and reduced the need for rescue therapy.
At the same time, no clinically significant advantage of the dual combination over tiotropium bromide was established in terms of quality of life and the frequency of moderate and severe COPD exacerbations.
What this means for patients
Including the combination of umeclidinium bromide and vilanterol in the National List may expand the options for COPD maintenance therapy available to doctors and patients. It will also make it possible to use dual bronchodilation in patients who need it.
The Center's recommendation to include the dual combination of umeclidinium bromide and vilanterol in the National List is based on a comprehensive assessment of clinical efficacy and safety, cost-effectiveness, and the budget impact on the health care system.
The full conclusion of the state health technology assessment is available at the link: https://surl.li/ygybvl
