Nintedanib Medicine 07 December 2022 Extended indication Treatment of chronic fibrosing interstitial lung diseases in paediatric patients from 6 to 17 years. Therapeutic value Possible added value Total cost € 200,208.00 Registration phase Registration application pending Product Active substance Nintedanib Domain Lung diseases Reason of inclusion Indication extension IND Main indication Lung diseases other Extended indication Treatment of chronic fibrosing interstitial lung diseases in paediatric patients from 6 to 17 years. Current proprietary name Already available biosimilars / generics Proprietary name Ofev Manufacturer Boehringer Ingelheim Portfolio holder Boehringer Ingelheim Mechanism of action Tyrosine kinase inhibitor Route of administration Oral Therapeutical formulation Capsule Budgetting framework Extramural (GVS) Centre of expertise ILD expertisecentrum St. Antoniusziekenhuis Nieuwegein, EMC Rotterdam, OLVG Amsterdam Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date September 2022 Expected Registration October 2023 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Geen Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation Het geneesmiddel is al geregistreerd bij IPF voor volwassenen. In de primaire resultaten van de fase 3 studie (INBUILD trial) is aangetoond dat de progressie van fibroserende vormen van SSc-ILD wordt gereduceerd met nintedanib). Geen aanwijzingen dat effectiviteit afhankelijk is van leeftijd. Als een kind leidt aan fibrose wordt hetzelfde effect verwacht. Duration of treatment Frequency of administration Dosage per administration References Additional remarks Expected patient volume per year Patient volume 5 - 10 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Expert opinie(1); Additional remarks Er wordt verwacht dat er in deze leeftijdsgroep 5 tot 10 patiënten in aanmerking komen in Nederland per jaar. Expected cost per patient per year Cost € < 25,026.00 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 De prijs voor kinderen is nog niet bekend. Huidige prijs voor volwassenen is als volgt: capsule van 150mg kost €2.258,04 per maand en de 100mg capsule kost €1.683,00 per maand. De gebruiksverhouding van de 100mg capsule en 150mg capsule is respectievelijk 30% en 70%, dus de gemiddelde kosten per patiënt per jaar zijn €25.026,00. Potential total cost per year Total cost € 200,208.00 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 No further indication extensions are expected Additional remarks Other information Additional remarks