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Glycopyrrolate / formoterol

Bevespi

Extended indication Chronic obstructive pulmonary disease (COPD); moderate to severe.
Therapeutic value No judgement
Total cost 15,000,000.00

Product

Active substance Glycopyrrolate / formoterol
Domain Lung diseases
Main indication COPD
Extended indication Chronic obstructive pulmonary disease (COPD); moderate to severe.
Proprietary name Bevespi
Manufacturer AstraZeneca
Route of administration Inhalation
Therapeutical formulation Aerosol
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date August 2017
Expected Registration June 2018
Orphan drug No

Therapeutic value

Current treatment options Huidige LABA/LAMA (Ultibro, Anoro, Spiolto, Duaklir).
Therapeutic value No judgement
Substantiation Langwerkend LABA/LAMA.

Expected patient volume per year

Patient volume

< 25,000

Market share is generally not included unless otherwise stated.
References Fabrikant; werkgroep; Hekking et al. J Allergy Clin Immunol. 2015 Apr;135(4):896-902
Additional remarks Het max. patiëntvolume is gebaseerd op GIP 2015 waaruit blijkt dat 21.065 patiënten LABA/LAMA gebruiken. Dat is afgerond naar boven omdat patiënten minder snel ICS zullen gebruiken in latere jaren, maar eerst optimale luchtweg verwijding krijgen. Expert opinion: de vraag is of patiënten minder snel ICS zullen gebruiken in latere jaren.

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

Total cost

15,000,000.00

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.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension No

Other information

There is currently no futher information available.