Atectura® and Enerzair® from May 1, 2021 with Health Insurance Coverage
The fixed combination of indacaterol acetate (LABA) and mometasone furoate (ICS) Atectura® and the fixed triple combination, which in addition to these two substances also includes glycopyrronium bromide (LAMA), Enerzair® for maintenance inhalation treatment of bronchial asthma, approved in the EU last year, have established health insurance coverage in the Czech Republic from May 1, 2021. We bring a summary of the conditions for reimbursement.
Atectura® Breezhaler®
The fixed combination Atectura® Breezhaler® (LABA/ICS) is reimbursed for patients with persistent asthma bronchiale over 12 years of age, who cannot achieve or maintain asthma compensation when administering low doses of ICS and short-acting beta2-adrenergic agonists (SABA). A prerequisite is also good patient cooperation.
Enerzair® Breezhaler®
The triple combination Enerzair® Breezhaler® (LABA/ICS/LAMA) is reimbursed for adult patients with asthma bronchiale, who are treated with maintenance therapy of high doses of ICS and LABA simultaneously, and who had at least one severe exacerbation in the previous year requiring or increasing systemic corticosteroid therapy, and who do not have asthma under control even with good cooperation.
Usage in Practice
Both products are available in the proven Breezhaler® inhalation system in dosage combinations of 125/62.5 µg, 125/127.5 µg, and 125/260 µg (Atectura®) and 114/46/136 µg (Enerzair®). They are administered once daily. Prescription restrictions include the specialties of pneumology and phthisiology, pediatric pneumology, allergology, and clinical immunology.
Based on the results of clinical studies, the administration of both products in approved indications can be expected to improve lung function and reduce the number of exacerbations in previously uncompensated asthma patients. According to established prices and reimbursements, treatment with these drugs will not increase the pharmacotherapy costs of the practice.
Note: ICS – inhaled corticosteroid; LABA – long-acting beta2-agonist; LAMA – long-acting muscarinic antagonist.
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Sources:
- SPC Enerzair® Breezhaler®.
- SPC Atectura® Breezhaler®.
- SUKLS254416/2020, sukl80001/2021.
- SUKLS230025/2020, sukl80024/2021.
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