Autologous human chondrocytes in vitro expanded Medicine 08 December 2020 Extended indication Treatment of localised, full-thickness cartilage defects of the knee joint caused by acute or repetitive trauma or as a result of osteochondritis dissecans. Therapeutic value No judgement Total cost Registration phase Registration application pending Product Active substance Autologous human chondrocytes in vitro expanded Domain Metabolism and Endocrinology Reason of inclusion New medicine (specialité) Main indication Other metabolism and Endocrinology Extended indication Treatment of localised, full-thickness cartilage defects of the knee joint caused by acute or repetitive trauma or as a result of osteochondritis dissecans. Current proprietary name Already available biosimilars / generics Proprietary name NOVOCART 3D Manufacturer TETEC Portfolio holder Mechanism of action Unknown Route of administration Unknown Therapeutical formulation Unknown Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks ATMP Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Yes Submission date August 2020 Expected Registration September 2021 Orphan drug Unknown Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Andere autologe kraakbeencelimplantaties of microfractuurbehandeling (MF) Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References NCT01957722; NCT01656902 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Autologe kraakbeencelimplantatie bij een kraakbeendefect in het kniegewricht: innovatieve DBC Additional remarks De prevalentie van hyalinekraakbeendefecten aan de knie is niet bekend, mede vanwege vele verschillende oorzaken. De incidentie ligt rondom de 2,6 patiënten per 1.000 volwassenen. Dit betekent dat er jaarlijks 44.200 patiënten in Nederland deze klachten hebben. Een deel hiervan zal mogelijk in aanmerking komen voor deze behandeling. 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 Unknown Indication extensions References Additional remarks Other information Additional remarks