Brensocatib Medicine 04 June 2024 Extended indication treatment of non–cystic fibrosis bronchiectasis Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Brensocatib Domain Lung diseases Reason of inclusion New medicine (specialité) Main indication Lung diseases other Extended indication treatment of non–cystic fibrosis bronchiectasis Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Insmed Portfolio holder Insmed Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks First in class reversible dipeptidyl peptidase 1 (DPP1) inhibitor. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date February 2025 Expected Registration November 2025 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation In de placebogroep had in de onderzochte periode 52% geen en 34% één exacerbatie. Voor de 10mg en 25mg brensocatib waren die percentages respectievelijk 68 en 67%, en 22 en 21%. Duration of treatment Frequency of administration 1 times a day Dosage per administration 10 mg - 25 mg References NCT04594369 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References FMS richtlijn Bronchiëctasieën 2017, longfonds Additional remarks De prevalentie van bronchiëctasieën is hoger dan men vroeger dacht; Europees en Amerikaans onderzoek gepubliceerd in 2015 toonde een prevalentie van 52 tot 67 per 100.000 (Ringshausen, 2015; Seitz, 2012; Quint, 2013). Ongeveer 60.000 mensen in Nederland hebben de diagnose BE. De longziekte bronchiëctasieën wordt het meest gediagnostiseerd op de leeftijd tussen 60 en 65 jaar. Vaak is de ziekte dan al jaren sluimerend aanwezig, maar waren de klachten nog niet merkbaar. Bronchiëctasieën ontstaan vaak door andere ziektebeelden, maar van ruim 30% is de oorzaak nog steeds niet te achterhalen. Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions cystic fibrosis, COVID 2019 infections, Chronic obstructive pulmonary disease References clinicaltrials.gov, Adis Insight Additional remarks Other information Additional remarks