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Eculizumab

Soliris

Extended indication Refractory generalized myasthenia gravis (gMG) in patients who are anti-acetylcholine receptor (AChR
Therapeutic value No judgement
Total cost 612,000,000.00

Product

Active substance Eculizumab
Domain Neurological disorders
Main indication Muscular diseases
Extended indication Refractory generalized myasthenia gravis (gMG) in patients who are anti-acetylcholine receptor (AChR) antibody-positive.
Proprietary name Soliris
Manufacturer Alexion
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Expected Registration August 2017
Orphan drug Yes
Additional remarks Betreft een indicatie-uitbreiding. Geregistreerd in augustus 2017. Soliris is al geregistreerd voor indicatie PNH en aHUS.

Therapeutic value

Therapeutic value No judgement
Duration of treatment Not found

Expected patient volume per year

Patient volume

< 1,700

Market share is generally not included unless otherwise stated.
References https://www.spierziekten.nl/fileadmin/user_upload/VSN/documenten/Huisartsenbrochures/M010-MG-habrochmetbrieven.pdf
Additional remarks 1 patiënt per 10.000 inwoners

Expected cost per patient per year

Cost 360,000.00
References Zorginstituut Nederland, Prescribing Outlook 2017.
Additional remarks Zorginstituut: De kosten per patiënt per jaar bedragen voor eculizumab circa € 360.000. Rekening houdend met deze geneesmiddelkosten wordt het totale kostenbeslag, ondanks de kleine groep patiënten, geschat op € 25 miljoen in 2017. Prescribing Outlook 2017: 'Extremely expensive. At list price, cost is £352,800 per year; but alternative options are also expensive.'

Potential total cost per year

Total cost

612,000,000.00

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.