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Abatacept

Orencia

Extended indication Primary Sjögren's Syndrome
Therapeutic value No judgement
Registration phase Clinical trials

Product

Active substance Abatacept
Domain Chronic immune diseases
Reason of inclusion Indication extension
Main indication Other chronic immune diseases
Extended indication Primary Sjögren's Syndrome
Proprietary name Orencia
Manufacturer BMS
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
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
Submission date July 2019
Expected Registration May 2020
Registration phase Clinical trials

Therapeutic value

Therapeutic value No judgement
Substantiation Nog te vroeg om iets te kunnen zeggen over de effectiviteit, meer data nodig.
Duration of treatment continuous
Frequency of administration 1 times a week
Dosage per administration 125 mg
References NCT02067910

Expected patient volume per year

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
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

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension Yes
Indication extensions ANCA-Associated Vasculitis
References Clinicaltrials.gov

Other information

There is currently no futher information available.