Fluticasone furoate / umeclidinium / vilanterol

Active substance Fluticasone furoate / umeclidinium / vilanterol
Domain Lung diseases
Reason of inclusion in Horizonscan Geneesmiddelen Indication extension
Main indication Asthma
Extended indication Asthma in adults inadequately controlled with dual steroid/beta agonist therapy

Product

Proprietary name Trelegy Ellipta
Manufacturer GSK
Mechanism of action LABA / LAMA / ICS
Route of administration Inhalation
Therapeutical formulation Inhalation powder
Budgetting framework Extramural (GVS)
Additional comments glucocorticoid agonist + long-acting beta2 agonist + muscarinic acetylcholine antagonist

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date January 2020
Expected Registration April 2021
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Current treatment options Aparte toediening van de bestanddelen
Therapeutic value Potential equal value
Substantiation De mogelijke meerwaarde zit vooral in het gebruiksgemak niet zo zeer in de werking. Het is niet mogelijk concentraties van individuele bestanddelen aan te passen.
Frequency of administration 1 times a day
References NCT02924688

Expected patient volume per year

Patient volume

5,000 - 15,000

Market share is generally not included unless otherwise stated.

References Volksgezondheidenzorg.info; Weersink et al. Ned Tijdschr Geneeskd. 2013;157:A6232; expertopinie
Additional comments In 2015 waren er naar schatting 613.500 personen met astma 5-10% van de astmapopulatie is moeilijk instelbaar (30.000-60.000). Afhankelijk van de precieze indicatiestelling en de plaats in de behandelrichtlijn zal een deel van deze patiënten in aanmerking komen. De werkgroep schat in dat dit ongeveer 5.000-15.000 patiënten zal bedragen.

Expected cost per patient per year

Cost 700
References G-standaard
Additional comments 12 verpakkingen van 30 doseringen kosten €703,80.

Potential total cost per year

Total cost

7,000,000

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
References clincialtrials.gov
Additional comments Geen andere indicaties onderzocht in fase 3 van het klinisch onderzoek.

Other information

There is currently no futher information available.