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Abatacept

Orencia

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
Main indication Rheumatism
Extended indication Polyarticular juvenile idiopathic arthritis (vanaf 2 jaar). Huidige indicatie is vanaf 6 jaar.
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 2018
Expected Registration May 2019
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Current treatment options Anti-TNF geneesmiddelen (etanercept en adalimumab)
Therapeutic value No judgement
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.
References Fabrikant

Expected cost per patient per year

Cost 13,000.00
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

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.

Off label use

Off label use No

Indication extension

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

Other information

There is currently no futher information available.