Expand all sections

Eculizumab

Soliris

Extended indication Neuromyelitis optica (NMO) relapsing; second-line or add-on therapy.
Therapeutic value No judgement
Total cost 30,875,000.00
Registration phase Clinical trials

Product

Active substance Eculizumab
Domain Chronic immune diseases
Reason of inclusion Indication extension
Main indication Eye disorders
Extended indication Neuromyelitis optica (NMO) relapsing; second-line or add-on therapy.
Proprietary name Soliris
Manufacturer Alexion
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks First in class, humanised monoclonal antibody C5 complement inhibitor.

Registration

Registration route Centralised (EMA)
Submission date 2019
Expected Registration March 2020
Orphan drug Yes
Registration phase Clinical trials

Therapeutic value

Current treatment options geen
Therapeutic value No judgement

Expected patient volume per year

Patient volume

65

Market share is generally not included unless otherwise stated.
References Marrie and Gryba. Int J MS Care. 2013 Fall; 15(3): 113–118; Tackley et al. Mult Scler Relat Disord. 2016 May;7:21-5
Additional remarks Incidentie van NMO ligt rond de 0,4 per 100.000 inwoners, dit betekent voor Nederland ongeveer 70 patiënten. 93% van de patiënten ervaart een relapse wat neerkomt op 65.

Expected cost per patient per year

Cost 450,000.00 - 500,000.00
References Fabrikant; https://www.zorginstituutnederland.nl/publicaties/adviezen/2017/06/09/eculizumab-soliris-bij-pnh-herbeoordeling-pakketadvies
Additional remarks Voor alle indicaties van eculizumab geldt een financieel arrangement dat afloopt per eind 2020. Voor een andere indicatie van eculizumab werd een bedrag van €360.000 euro per patiënt per jaar gerekend (excl. afspraken financieel arrangement). De fabrikant geeft aan dat gebaseerd op de lijstprijs en het behandelschema voor 12 maanden de prijs €450.000-500.000 zal bedragen.

Potential total cost per year

Total cost

30,875,000.00

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 eculizumab biosimilar (ABP 959) · Paroxysmal nocturnal haemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS)
References SPS

Other information

There is currently no futher information available.