Formoterol/glycopyronium Medicine 09 January 2018 Extended indication Bevespi Aerosphere is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD) Therapeutic value No judgement Total cost Registration phase Registered Product Active substance Formoterol/glycopyronium Domain Lung diseases Reason of inclusion New medicine (specialité) Main indication COPD Extended indication Bevespi Aerosphere is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD) Current proprietary name Already available biosimilars / generics Proprietary name Bevespi Manufacturer AstraZeneca Portfolio holder Mechanism of action LABA / LAMA Route of administration Inhalation Therapeutical formulation Aerosol Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Parasympaticolyticum + beta2-sympaticomimeticum Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity New therapeutical formulation ATMP Unknown Submission date August 2017 Expected Registration December 2018 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie oktober 2018. Geregistreerd in december 2018. Therapeutic value Current treatment options Huidige LABA/LAMA (Ultibro, Anoro, Spiolto, Duaklir). Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Langwerkend LABA/LAMA. Duration of treatment Frequency of administration 2 times a day Dosage per administration 2 inhalaties 7,2/5 µg References GOLD aanbevelingen http://goldcopd.org Additional remarks 2 maal per dag 2 inhalaties. Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References GIP-databank Additional remarks Het max. patiëntvolume is gebaseerd op gegevens waaruit blijkt dat 36.128 patiënten LABA/LAMA gebruiken. Binnen dit volume zal Bevespi gaan concurreren met de huidige behandelopties. Expected cost per patient per year Cost € 530.00 - 570.00 This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year. References Fabrikant Additional remarks Prijs zal waarschijnlijk competitief zijn aan bestaande inhalatoren. Vergelijkbaar met andere LAMA / LABAs. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Additional remarks Other information Additional remarks