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

1. 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

2. Registration

Registration route
Centralised (EMA)
Type of trajectory
Normal trajectory
Submission date
July 2019
Expected Registration
May 2020
Orphan drug
No
Registration phase
Clinical trials
Additional comments
Indiening verwacht in 2H 2019

3. Therapeutic value

Current treatment options
Aparte toediening van de bestanddelen
Therapeutic value
Potential equal value
Substantiation
De mogelijke meerwaarde zit hem 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

4. 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.

5. Expected cost per patient per year

Cost
757
References
G-standaard
Additional comments
12 verpakkingen van 30 doseringen kosten €757,32.

6. Potential total cost per year

Total cost

7,570,000

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.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

Indication extension
No
References
clincialtrials.gov
Additional comments
Geen andere indicaties onderzocht in fase III van het klinisch onderzoek.

9. Other information

There is currently no futher information available.