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Formoterol/glycopyronium

Bevespi Aerosphere

Extended indication Bevespi Aerosphere is indicated as a maintenance bronchodilator treatment to relieve symptoms in adu
Therapeutic value No judgement
Registration phase Positive CHMP opinion

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)
Proprietary name Bevespi Aerosphere
Manufacturer AstraZeneca
Route of administration Inhalation
Therapeutical formulation Aerosol
Budgetting framework Extramural (GVS)
Additional remarks parasympaticolyticum + beta2-sympaticomimeticum

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date August 2017
Expected Registration December 2018
Orphan drug No
Registration phase Positive CHMP opinion
Additional remarks Positieve CHMP-opinie oktober 2018

Therapeutic value

Current treatment options Huidige LABA/LAMA (Ultibro, Anoro, Spiolto, Duaklir).
Therapeutic value No judgement
Substantiation Langwerkend LABA/LAMA.
Duration of treatment continuous
Frequency of administration 2 times a day
Dosage per administration 2x 7,2/5 µg
References Fabrikant (GOLD aanbevelingen http://goldcopd.org)
Additional remarks 2 maal per dag 2 inhalaties.

Expected patient volume per year

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 550.00 - 650.00
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

There is currently nothing known about the possible total cost.

Off label use

Off label use No

Indication extension

Indication extension No

Other information

There is currently no futher information available.