TRELEGY ELLIPTA / ELEBRATO ELLIPTA (fluticasone / umeclidinium / vilanterol), inhaled corticosteroid (CSI) combination, long-acting beta-2 agonist (LABA) bronchodilator and long-acting muscarinic antagonist (LAMA) bronchodilator
Reason for request
Low clinical benefit in the management of severe chronic obstructive pulmonary disease (COPD) in adults unsatisfactorily treated with an inhaled corticosteroid and long-acting beta-2 agonistic bronchodilator and no demonstrated benefit in the therapeutic strategy.
Clinical benefit insufficient to justify its reimbursement in the management of moderate COPD.
TRELEGY ELLIPTA has been granted marketing authorisation for the continuous treatment of moderate to severe chronic obstructive pulmonary disease (COPD) in adult patients treated unsatisfactorily with a CSI-LABA combination.
It simplifies the treatment of patients with severe disease, requiring inhaled tritherapy combining long-acting bronchodilators (LABA + LAMA) with a CSI.
TRELEGY ELLIPTA was statistically superior to the budesonide/formoterol (CSI + LABA) and fluticasone/vilanterol (CSI + LABA) combinations on FEV1, quality of life and the occurrence of exacerbations, though the differences were modest.
Clinical Added Value
|no clinical added value||