Spheroids of human autologous matrix-associated chondrocytes Medicine 08 June 2021 Extended indication Repair of symptomatic articular cartilage defects of the femoral condyle and the patella of the knee (International Cartilage Regeneration & Joint Preservation Society [ICRS] grade III or IV) with defect sizes up to 10 cm2 in adults and adolescents with closed epiphyseal growth plate in the affected joint. Therapeutic value No estimate possible yet Total cost Registration phase Registered and reimbursed Product Active substance Spheroids of human autologous matrix-associated chondrocytes Domain Metabolism and Endocrinology Reason of inclusion Indication extension IND Main indication Other metabolism and Endocrinology Extended indication Repair of symptomatic articular cartilage defects of the femoral condyle and the patella of the knee (International Cartilage Regeneration & Joint Preservation Society [ICRS] grade III or IV) with defect sizes up to 10 cm2 in adults and adolescents with closed epiphyseal growth plate in the affected joint. Current proprietary name Already available biosimilars / generics Proprietary name Spherox Manufacturer Co.don AG Portfolio holder Mechanism of action Unknown Route of administration Unknown Therapeutical formulation Unknown Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Yes Submission date December 2020 Expected Registration June 2021 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in mei 2021. Therapeutic value Current treatment options 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 NCT01222559 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 Expected cost per patient per year Cost € 11,500.00 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 Autologous chondrocyte implantation with Spherox for treating articular cartilage defects in the knee. (NICE ID 851) Warwick Evidence ERG report October 19th 2017 Additional remarks In een rapport uit 2017 worden de kosten per patiënt geschat op £10.000. 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