Nerandomilast Medicine 03 June 2025 Extended indication Nerandomilast is a medicine used to treat adults with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). A disease of unknown cause in which connective tissue forms in the lungs; systemic sclerosis-associated interstitial lung disease, is a disease in which the immune system (the body's natural defences) is overactive. Which leads to the production of connective tissue and progressive scarring in the lungs; and other chronic fibrosing interstitial lung diseases that are progressive. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Nerandomilast Domain Lung diseases Reason of inclusion New medicine (specialité) Main indication Lung diseases other Extended indication Nerandomilast is a medicine used to treat adults with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). A disease of unknown cause in which connective tissue forms in the lungs; systemic sclerosis-associated interstitial lung disease, is a disease in which the immune system (the body's natural defences) is overactive. Which leads to the production of connective tissue and progressive scarring in the lungs; and other chronic fibrosing interstitial lung diseases that are progressive. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Boehringer Ingelheim Portfolio holder Boehringer Ingelheim Mechanism of action Other Route of administration Oral Therapeutical formulation Coated tablet Budgetting framework Extramural (GVS) Centre of expertise Erasmus MC Rotterdam, St Antonius Ziekenhuis Nieuwegein, OLVG Amsterdam, Amsterdam UMC Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date June 2025 Expected Registration July 2026 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Tijdslijn op basis van IHSI-inschatting. Therapeutic value Current treatment options Nintedanib (IPF en PPF) en Pirfenidon (IPF) Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Hoewel de voorlopige resultaten van nerandomilast veelbelovend zijn, is het op dit moment moeilijk om de effectiviteit direct te vergelijken met die van nintedanib en pirfenidon. Er zijn geen directe vergelijkende studies gedaan. Duration of treatment Frequency of administration 2 times a day Dosage per administration 9mg of 18mg References Fibroneer-IPF NCT05321069 Fibroneer-ILD NCT05321082 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Op dit moment is het niet mogelijk om hier een uitspraak over te doen. Dit is afhankelijk van de resultaten van de clinical trials. Expected cost per patient per year Cost References Additional remarks De kosten zullen vergelijkbaar zijn met Ofev op basis van clustering (indien GVS vergoed). Potential total cost per year Total cost Total cost for sluice Additional remarks Op dit moment is het niet mogelijk om hier een uitspraak over te doen. Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Additional remarks Other information Additional remarks