Glycopyrrolate / formoterol Medicine 09 January 2018 Extended indication Chronic obstructive pulmonary disease (COPD); moderate to severe. Therapeutic value No judgement Total cost € 21,600,000.00 Registration phase Registration application pending Product Active substance Glycopyrrolate / formoterol Domain Lung diseases Reason of inclusion Main indication COPD Extended indication Chronic obstructive pulmonary disease (COPD); moderate to severe. Current proprietary name Already available biosimilars / generics Proprietary name Bevespi Manufacturer AstraZeneca Portfolio holder Mechanism of action Unknown Route of administration Inhalation Therapeutical formulation Aerosol Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Beta2-sympaticomimeticum met parasympaticolyticum. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity New medicine ATMP Unknown Submission date August 2017 Expected Registration October 2018 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks 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 5 mg / 7,2 mg References Fabrikant Additional remarks 2 maal per dag 2 inhalaties. Expected patient volume per year Patient volume < 36,000 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 GIP 2016 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 € 550.00 - 650.00 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 Prescribing outlook 2017; medicijnkosten.nl Additional remarks Prijs zal waarschijnlijk competitief zijn aan bestaande inhalatoren. Vergelijkbaar met Trimbow. €66,13 per verpakking is de prijs €0,55 per dosis en €2,21 per dag (2dd 2 inhalaties). Duurder dan elk van de bestanddelen afzonderlijk maar goedkoper dan los. Potential total cost per year Total cost € 21,600,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Additional remarks Other information Additional remarks