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Eptinezumab

Medicine

Extended indication Migraine profylaxe van 'frequent episodic migraine' (EM) en 'chronic migraine' (CM).
Therapeutic value Possible added value
Total cost € 120,000,000.00
Registration phase Unknown

Product

Active substance Eptinezumab
Domain Neurological disorders
Main indication Headache
Extended indication Migraine profylaxe van 'frequent episodic migraine' (EM) en 'chronic migraine' (CM).
Manufacturer Alder
Mechanism of action Unknown
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks Werkingsmechanisme: 'Calcitonin gene-related peptide receptor (CGRPR) monoklonaal antilichaam'. Toelichtin indicatie: EM is 5-14 dagen migraine per maand en CM is 15+ dagen hoofpijn per maand waarvan in ieder geval 8 keer migraine.

Registration

Registration route Centralised (EMA)
Type of trajectory Unknown
Particularity Unknown
ATMP Unknown
Orphan drug No
Registration phase Unknown

Therapeutic value

Current treatment options In ontwikkeling zijn andere GCRP antilichamen voor vergelijkbare indicatie: Erenumab, Galcanezumab, Fremanezumab. Huidige behandeling profylaxe: betablokkers, anticonvulsiva.
Therapeutic value Possible added value

This assessment does not indicate any potential inclusion in the package.
Substantiation Mogelijke meerwaarde, bij die patiënten waarbij andere profylactische therapieën (zoals bijvoorbeeld betablokkers, anticonvulsiva, flunarizine) falen.
Frequency of administration 4 times a year
Dosage per administration 300 mg
References clinicaltrials.gov: NCT02974153, NCT02985398. http://investor.alderbio.com/releasedetail.cfm?releaseid=1031418, http://investor.alderbio.com/releasedetail.cfm?ReleaseID=1039500.
Additional remarks Toedieningsfrequentie: elke 12 weken.

Expected patient volume per year

Patient volume 8,000 - 24,000

Market share is generally not included unless otherwise stated.
Additional remarks Patiëntenaantal gebasseerd op erenumab.

Expected cost per patient per year

Cost € 5,000.00 - 10,000.00

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.
Additional remarks Verwachting is dat het meerkosten gaat opleveren. Kosten waarschijnlijk hoog. Huidige standaardbehandeling (profylaxe) is goedkoop, echter ziekteverzuim a.g.v. migraine neemt mogelijk af en de daarmee gepaard gaande maatschappelijke kosten dus ook.

Potential total cost per year

Total cost € 120,000,000.00

Off label use

Off label use No

Indication extension

Indication extensions No

Other information