Fluticasone furoate / umeclidinium / vilanterol Medicine 13 December 2018 Extended indication Asthma in adults inadequately controlled with dual steroid/beta agonist therapy Therapeutic value Possible equal value Total cost € 7,500,000.00 Registration phase Clinical trials Product Active substance Fluticasone furoate / umeclidinium / vilanterol Domain Lung diseases Reason of inclusion Indication extension IND Main indication Asthma Extended indication Asthma in adults inadequately controlled with dual steroid/beta agonist therapy Current proprietary name Already available biosimilars / generics Proprietary name Trelegy Ellipta Manufacturer GSK Portfolio holder Mechanism of action Unknown Route of administration Inhalation Therapeutical formulation Inhalation powder Budgetting framework Extramural (GVS) Centre of expertise Additional remarks glucocorticoid agonist + long-acting beta2 agonist + muscarinic acetylcholine antagonist Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date July 2019 Expected Registration May 2020 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Indiening verwacht in 2H 2019 Therapeutic value Current treatment options Aparte toediening van de bestanddelen Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. 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 Duration of treatment Frequency of administration 1 times a day Dosage per administration References NCT02924688 Additional remarks Expected patient volume per year Patient volume 5,000 - 15,000 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Volksgezondheidenzorg.info; Weersink et al. Ned Tijdschr Geneeskd. 2013;157:A6232; expertopinie Additional remarks 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 € 750.00 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 G-standaard Additional remarks 12 verpakkingen van 30 doseringen kosten €757,32. Potential total cost per year Total cost € 7,500,000.00 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 clincialtrials.gov Additional remarks Geen andere indicaties onderzocht in fase III van het klinisch onderzoek. Other information Additional remarks