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Eculizumab

Soliris

Extended indication Neuromyelitis optica (NMO) relapsing; second-line or add-on therapy.
Therapeutic value No judgement
Total cost 23,400,000.00
Registration phase Clinical trials

Product

Active substance Eculizumab
Domain Chronic immune diseases
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)
Particularity Indication extension
Submission date 2018
Expected Registration 2019
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 360,000.00
References https://www.zorginstituutnederland.nl/publicaties/adviezen/2017/06/09/eculizumab-soliris-bij-pnh-herbeoordeling-pakketadvies
Additional remarks Voor een andere indicatie van Soliris (eculizumab) werd een bedrag van 360000 euro per patiënt per jaar gerekend (excl. afspraken financieel arrangement).

Potential total cost per year

Total cost

23,400,000.00

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.