Abatacept Medicine 13 December 2018 Extended indication Polyarticular juvenile idiopathic arthritis (vanaf 2 jaar). Huidige indicatie is vanaf 6 jaar. Therapeutic value No judgement Total cost € 130,000.00 Registration phase Registration application pending Product Active substance Abatacept Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Rheumatism Extended indication Polyarticular juvenile idiopathic arthritis (vanaf 2 jaar). Huidige indicatie is vanaf 6 jaar. Current proprietary name Already available biosimilars / generics Proprietary name Orencia Manufacturer BMS Portfolio holder Mechanism of action Unknown Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Abatacept is a fusion protein composed of the Fc region of the immunoglobulin IgG1 fused to the extracellular domain of CTLA-4. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date July 2018 Expected Registration May 2019 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Anti-TNF geneesmiddelen (etanercept en adalimumab) Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times a day Dosage per administration 50-125 mg References Fabrikant Additional remarks Gewicht 10 kg tot <25 kg: 50 mg orencia; Gewicht 25 kg tot 50 kg: 87,5 mg orencia; Gewicht ≥ 50 kg: 125 mg orencia Expected patient volume per year Patient volume < 10 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Fabrikant Additional remarks Expected cost per patient per year Cost € 13,000.00 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; medicijnkosten.nl Additional remarks Een behandeling met Orencia bij een patiënt van ≥ 50 kg bedraagt €255,- per toediening. Bij 52 toedieningen is dat max. € 13.260 Potential total cost per year Total cost € 130,000.00 Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions ANCA-Associated Vasculitis; Sjögrens Disease References Clinicaltrials.gov Additional remarks Other information Additional remarks