Nintedanib Medicine 12 June 2018 Extended indication Systemic Sclerosis - Interstitial Lung Disease (SSc-ILD) Therapeutic value No judgement Total cost € 23,625,000.00 Registration phase Clinical trials Product Active substance Nintedanib Domain Lung diseases Reason of inclusion Main indication Lung other Extended indication Systemic Sclerosis - Interstitial Lung Disease (SSc-ILD) Current proprietary name Already available biosimilars / generics Proprietary name Ofev Manufacturer Boehringer Ingelheim Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Capsule Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Tyrosine kinase inhibitor. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Indication extension ATMP Unknown Submission date April 2019 Expected Registration February 2020 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Dit middel wordt onder voorwaarden voor reeds vergoed voor andere indicaties. Therapeutic value Current treatment options Corticosteroiden, cyclofosfamide, azathioprine, mycofenolaat. Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Nog geen uitkomsten van studies, maar de verwachting is dat de progressie met 50% wordt gereduceerd in de fibroserende vormen van SSc-ILD. Duration of treatment Frequency of administration 2 times a day Dosage per administration 150 mg References Giacomelli et al. Rheumatol Int 2017;37:853-63 Additional remarks Expected patient volume per year Patient volume 750 - 1,500 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References ILD Biobank; Solomon et al. Eur Respir Rev 2013;22(127):6-19 Additional remarks Ongeveer 20.000 personen ILD. Schatting is dat hiervan maximaal 3000 SSc-ILD betreft. Afhankelijk van patiëntkenmerken komt mogelijk 25 tot 50% in aanmerking voor behandeling. Expected cost per patient per year Cost € 17,000.00 - 25,000.00 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 Fabrikant; G-Standaard Additional remarks De prijs van het middel dat nu al op de markt is voor andere indicaties. Huidige prijs capsule 100mg is €1.683 per maand; een capsule van 150mg kost €2.474,52 per maand. Potential total cost per year Total cost € 23,625,000.00 Total cost for sluice Additional remarks 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