Abatacept Medicine 13 December 2018 Extended indication Primary Sjögren's Syndrome Therapeutic value No judgement Total cost Registration phase Clinical trials Product Active substance Abatacept Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Other chronic immune diseases Extended indication Primary Sjögren's Syndrome 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 2019 Expected Registration May 2020 Orphan drug Unknown Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Nog te vroeg om iets te kunnen zeggen over de effectiviteit, meer data nodig. Duration of treatment Frequency of administration 1 times a week Dosage per administration 125 mg References NCT02067910 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Nationale Vereniging Sjögrenpatiënten (NVSP) Additional remarks Volgens de NVSP komt het syndroom van Sjögren voor bij ongeveer 0,5% van de volwassen wereldbevolking (prevalentie). In Nederland zouden dat ongeveer 68.000 volwassenen zijn. Afhankelijk van de precieze indicatiestelling is dit potentieel dus een grote groep patiënten. 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 G-standaard Additional remarks De prijs van Orencia 125 mg bedraagt €255. 52 toedieningen van 125 mg abatacept kost €13.260. 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 Yes Indication extensions ANCA-Associated Vasculitis References Clinicaltrials.gov Additional remarks Other information Additional remarks