Based on the results of the HTA conducted, the State Expert Center recommends including the combination medicinal product formoterol/beclometasone in the National List of Essential Medicines.
The preparation is used for the regular treatment of patients with bronchial asthma whose symptoms are insufficiently controlled with inhaled glucocorticosteroids (ICS) and rapid-acting beta2-agonists, which are used when the use of a combination product is appropriate.
The corresponding conclusion of the state HTA is published on the Center’s website: http://surl.li/uqkyx
Disease priority: for which patients is it important?
Bronchial asthma is among the diseases that affect population mortality rates and significantly reduce the patient's quality of life.
According to epidemiological observations, the burden of bronchial asthma has increased over the past 30 years. As of 2019, according to the Global Burden of Disease Study, the prevalence of bronchial asthma worldwide was 262,41 million people, mortality – 461,07 million people, and disability-adjusted life years – 21,55.
The prevalence of bronchial asthma in Ukraine as of 2019 was 1 268 398,99 people.
Reducing the prevalence, morbidity, and mortality from bronchial asthma is one of the priority areas of healthcare development (MoH order of 07.10.2022 No. 1832 “On approval of the priority areas of healthcare development for the years 2023-2025”). The National Health Service of Ukraine reimburses medicinal products within the medical guarantees program for the treatment of chronic lower respiratory tract diseases (in accordance with the resolution of the Cabinet of Ministers of Ukraine of 22.12.2023 No. 1394).
About the medicinal product under assessment
The medicinal product contains beclometasone dipropionate and formoterol, which have different mechanisms of action and exert an additive effect on reducing the frequency of asthma exacerbations, similar to other combination medicinal products containing inhaled corticosteroids (ICS) and beta2-agonists.
According to the analysis of a multicenter, double-blind, randomized, controlled phase III study, over 12 weeks in patients with persistent moderate to severe bronchial asthma, formoterol/beclometasone (6 mcg/100 mcg) was no less effective than formoterol/budesonide (6 mcg/200 mcg).
Asthma exacerbations occurred in 15,9% of the formoterol/beclomethasone group and 11,0% of the formoterol/budesonide group, with no statistical difference in the result. The median time to the first exacerbation was 29 days in the formoterol/beclomethasone group and 24 days in the formoterol/budesonide group.
Adverse reactions were reported in both groups (13,8% of patients in the formoterol/beclometasone group and 16,5% in the formoterol/budesonide comparator group), none of which was classified as serious.
Formoterol/beclometasone is included in the WHO Basic List of Essential Medicines-23 (2023).
UO recommendations
Based on the results of the conducted state HTA, it is recommended to consider the possibility of including the medicinal product formoterol/beclomethasone (metered-dose inhalation aerosol, 6/100 mcg/dose, 120 doses per container) in the National List of Essential Medicines.
The medicinal product is recommended for the regular treatment of bronchial asthma where the use of a combination product (inhaled corticosteroid and long-acting beta2-agonist) is appropriate, in patients whose disease symptoms are not adequately controlled with inhaled corticosteroids and rapid-acting beta2-agonists used as needed.
