Formoterol / glycopyronium / budesonide Medicine 03 June 2025 Extended indication Maintenance treatment of asthma in patients 12 years of age and older who are not adequately controlled by a combination of a medium or high dose inhaled corticosteroid and a long-acting beta2-agonist. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Formoterol / glycopyronium / budesonide Domain Lung diseases Reason of inclusion Indication extension IND Main indication Asthma Extended indication Maintenance treatment of asthma in patients 12 years of age and older who are not adequately controlled by a combination of a medium or high dose inhaled corticosteroid and a long-acting beta2-agonist. Current proprietary name Already available biosimilars / generics Proprietary name Trixeo Manufacturer AstraZeneca Portfolio holder AstraZeneca Mechanism of action LABA / LAMA / ICS Route of administration Inhalation Therapeutical formulation Aerosol Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date August 2025 Expected Registration September 2026 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Veel patiënten hebben al LABA ICS + LAMA. Alleen voor therapietrouwheid zou dit een eventueel voordeel zijn. Duration of treatment Frequency of administration Dosage per administration References NCT04609878 (KALOS); NCT04609904 (LOGOS) Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Volksgezondheidenzorg.info; Weersink et al. Ned Tijdschr Geneeskd. 2013;157:A6232; expertopinie Additional remarks In 2015 waren er naar schatting 613.500 personen met astma. 5 tot 10% van de astmapopulatie is moeilijk instelbaar (30.000 tot 60.000). Uit analyses van declaratiecijfers blijkt dat er in 2020 ongeveer 5.000 astmapatiënten een vaste triple combinatie gebruikten. Momenteel gebruiken ruim 30.000 astmapatiënten losse triple-combinaties. Naar verwachting zal het aandeel vaste triples de komende jaren stijgen al zal zullen niet alle losse combinaties gesubstitueerd worden. LABA-ICS + LAMA is alleen geïndiceerd bij GINA stap 5, dat betreft 4 tot 17% van de totale astma populatie. Veel van deze patiënten krijgen al triple therapie, maar niet in 1 inhalator. De werkgroep verwacht geen patiënten die hiermee behandeld zullen worden. Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks