Brensocatib Medicine 04 June 2024 Extended indication Brinsupri is indicated for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in patients 12 years of age and older with two or more exacerbations in the prior 12 months Therapeutic value No estimate possible yet Total cost Registration phase Registered Product Active substance Brensocatib Domain Lung diseases Reason of inclusion New medicine (specialité) Main indication Lung diseases other Extended indication Brinsupri is indicated for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in patients 12 years of age and older with two or more exacerbations in the prior 12 months Current proprietary name Already available biosimilars / generics Proprietary name Brinsupri Manufacturer Insmed Portfolio holder Insmed Mechanism of action 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 Accelerated assessment Particularity New medicine with Priority Medicines (PRIME) ATMP No Submission date April 2025 Expected Registration December 2025 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in oktober 2025. 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 10mg tot 25mg References NCT03218917 (WILLOW); NCT04594369 (ASPEN) 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 € 75,000.00 - 76,000.00 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. References https://www.biopharmadive.com/news/insmed-fda-approval-brinsupri-brensocatib-bronchiectasis/757476/ Additional remarks De prijs in Nederland is nog niet bekend. De lijstprijs in de Verenigde Staten is $88.000. Omgerekend naar Nederland zou dat €75.000 tot €76.000 per patiënt per jaar betekenen. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use 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