Rituximab

Extended indication	MabThera, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (Wegener’s) (GPA) and microscopic polyangiitis (MPA).
Therapeutic value	No judgement
Total cost	2,550,000.00
Registration phase	Registered and reimbursed

Product

Active substance	Rituximab
Domain	Chronic immune diseases
Reason of inclusion	Indication extension
Main indication	Cardiovascular diseases
Extended indication	MabThera, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (Wegener’s) (GPA) and microscopic polyangiitis (MPA).
Proprietary name	MabThera
Manufacturer	Roche
Mechanism of action	Immunosuppression
Route of administration	Intravenous
Therapeutical formulation	Intravenous drip
Budgetting framework	Intermural (MSZ)
Additional remarks	Monoklonaal antlichaam gericht tegen CD20

Registration

Registration route	Centralised (EMA)
Type of trajectory	Normal trajectory
Submission date	April 2018
Expected Registration	January 2019
Orphan drug	No
Registration phase	Registered and reimbursed
Additional remarks	Positieve CHMP-opinie november 2018. Geregistreerd in januari 2019.

Therapeutic value

Therapeutic value	No judgement
Substantiation	Ondanks IV behandeling wel een verrijking, gegeven de effectiviteit.
Duration of treatment	continuous
Frequency of administration	1 times every 4 months
Dosage per administration	1 g
References	NCT01697267

Expected patient volume per year

Patient volume	170 - 340 Market share is generally not included unless otherwise stated.
References	Cartin-Ceba et al. Curr Rheumatol Rep. 2012 Dec;14(6):481-93
Additional remarks	De incidentie van ANCA-associated vasculitis (granulomatose met polyangiitis (GPA), microscopische polyangiitis (MPA) en eosinophiele granulomatose met polyangiitis (EGPA)) wordt wereld wijd ingeschat op 10-20 gevallen per miljoen inwoners. Voor Nederland zou dit een aantal van 170-340 per jaar betekenen.

Patient volume

170 - 340

Market share is generally not included unless otherwise stated.

References

Cartin-Ceba et al. Curr Rheumatol Rep. 2012 Dec;14(6):481-93

Additional remarks

De incidentie van ANCA-associated vasculitis (granulomatose met polyangiitis (GPA), microscopische polyangiitis (MPA) en eosinophiele granulomatose met polyangiitis (EGPA)) wordt wereld wijd ingeschat op 10-20 gevallen per miljoen inwoners. Voor Nederland zou dit een aantal van 170-340 per jaar betekenen.

Expected cost per patient per year

Cost	10,000.00
References	Medicijnkosten.nl
Additional remarks	Per jaar wordt er per patiënt 4 g rituximab gebruikt. Dit komt neer op een bedrag van €10.042,86

Potential total cost per year

Total cost	2,550,000.00 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.

Total cost

2,550,000.00

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

There is currently nothing known about off label use.

Indication extension

Indication extension	Yes
Indication extensions	Pemphigus vulgaris
References	EMA

Other information

There is currently no futher information available.