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 estimate possible yet Total cost Registration phase No registration expected 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 Not applicable Therapeutical formulation Unknown Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks NOVOCART 3D is a autologous chondrocyte implantation product, meaning that the patient's own cartilage is harvested and cultivated to produce the implant. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Yes Submission date August 2020 Expected Registration Orphan drug No Registration phase No registration expected Reimbursement Medicine sluice Additional remarks De fabrikant heeft de indiening in december 2020 teruggetrokken vanwege aanvullende data die op het moment niet aangeleverd kon worden. Therapeutic value Current treatment options Andere autologe kraakbeencelimplantaties of microfractuurbehandeling (MF) Therapeutic value No estimate possible yet 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