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New HTA Decisions in France
March 2021
Drug name
GIBITER® EASYHALER® (formoterol, budesonide)
Company
Ménarini France
Decision date
20/01/2021
Therapeutic area
Respiratory conditions
Therapeutic sub area
Asthma
Therapeutic area 2
Respiratory conditions
Therapeutic sub area 2
Chronic obstructive pulmonary disease
Official notice date
26/01/2021
Reimbursement %
65
Decision (SMR)
Important
Decision (ASMR)
No improvement (V)
Indication
GIBITER® EASYHALER® is indicated in adults and adolescents 12 years of age and older for the regular treatment of asthma when the use of a combination of an inhaled corticosteroid and a long-acting beta-2 agonist bronchodilator is warranted: • in patients insufficiently controlled by inhaled corticosteroid therapy and taking a short-acting inhaled beta-2 agonist bronchodilator on demand. or • in patients controlled by the administration of inhaled corticosteroid therapy combined with continuous treatment with a long-acting inhaled beta-2 agonist.
Decision (SMR)
Moderate
Decision (ASMR)
No improvement (V)
Indication
GIBITER® EASYHALER® is indicated in adults (aged 18 and over) for symptomatic treatment in patients with chronic obstructive pulmonary disease with a post-bronchodilator maximal expiratory volume per second (FEV1) <70% of the theoretical value and a history of repeated exacerbations despite regular treatment with a bronchodilator.
Decision Type
New technology assessment
Summary
The committee considered the actual benefit of GIBITER® EASYHALER® to be 'important' in the treatment of asthma and 'moderate' in the treatment of chronic obstructive pulmonary disease. It was concluded that GIBITER® EASYHALER® 160 µg / 4.5 µg / dose and 320 µg / 9 µg dose powder for inhalation does not provide any improvement in actual benefit (ASMR V) compared to the presentations already registered. The committee proposed 65% reimbursement.