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New HTA Decisions in France
March 2021
Drug name
ATECTURA® BREEZHALER® (indacaterol acetate, mometasone furoate)
Company
Novartis Pharma
Decision date
16/12/2020
Therapeutic area
Respiratory conditions
Therapeutic sub area
Asthma
Official notice date
07/01/2021
Reimbursement %
65
Decision (SMR)
Important
Decision (ASMR)
No improvement (V)
Indication
ATECTURA® BREEZHALER® is indicated for the continuous treatment of asthma in adults and adolescents 12 years of age and older who are insufficiently controlled by taking an inhaled corticosteroid (ICS) and an inhaled short-acting beta-2-agonist (SABA).
Decision Type
New technology assessment
Summary
The opinion of the committee is favourable to the reimbursement of ATECTURA® BREEZHALER® for the continuous treatment of asthma in adults and adolescents 12 years of age and older who are insufficiently controlled by taking an inhaled corticosteroid (ICS) and an inhaled short-acting beta-2-agonist (SABA). The committee consider that ATECTURA® BREEZHALER® does not improve the actual benefit (ASMR V) compared to other combination inhalers which contain an inhaled corticosteroid (CSI) and a long-acting beta-2-agonist (LABA) considering: • demonstration of the superiority of the fixed combination indacaterol / mometasone furoate (IND / MF) for low (150/80 µg), medium (150/160 µg) and high (150/320 µg) inhaled corticosteroid doses compared to mometasone furoate monotherapy on lung function (assessed by residual FEV1 at 12 and 26 weeks depending on the study); • the absence of new risks identified compared to those known with its two active ingredients, but taking into account: • the lack of demonstration of a clinically relevant difference in asthma control (evaluated on ACQ-7 at 12 and 26 weeks depending on the study); • the absence of a robust demonstration of efficacy on exacerbations and quality of life, non-hierarchical secondary criteria; • the restrictive study framework (addition of a long-acting beta-2-agonist to treatment with ICS alone, evaluation on a functional endpoint at 26 weeks) Proposed reimbursement rate: 65%