Version 1

Galcanezumab

Medicine

Extended indication Prophylactic treatment of migraine headache.
Therapeutic value Possible added value
Total cost € 120,000,000.00
Registration phase Unknown

Product

Active substance Galcanezumab
Domain Neurological disorders
Main indication Headache
Extended indication Prophylactic treatment of migraine headache.
Manufacturer Eli Lilly
Mechanism of action Unknown
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Extramural (GVS)
Additional remarks Werkingsmechanisme: 'Calcitonin gene-related peptide receptor (CGRPR)', monoklonaal antilichaam.

Registration

Registration route Centralised (EMA)
Type of trajectory Unknown
Particularity Unknown
ATMP Unknown
Submission date December 2017
Expected Registration October 2018
Orphan drug No
Registration phase Unknown
Additional remarks Registatieproces: 'Fast Track Designation' in Amerika (FDA).

Therapeutic value

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

This assessment does not indicate any potential inclusion in the package.
Substantiation Meerwaarde verwacht, bij die patiënten waarbij andere profylactische therapieën (zoals bijvoorbeeld betablokkers, anticonvulsiva, flunarizine) falen.
Frequency of administration 1 times a month
Dosage per administration 120 mg en 240 mg s.c.
References clinicaltrials.gov: NCT02959177, NCT02959190, NCT02797951, NCT02836613. https://investor.lilly.com/releasedetail.cfm?releaseid=1029791
Additional remarks Behandelduur: chronisch

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.
References Prescribing Outlook 2017
Additional remarks Verwachting is dat het meerkosten gaat opleveren. Prescribing Outlook 2017: 'High cost drug.' 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 Yes
Indication extensions Indicatie-uitbreiding: mogelijk bij episodische en chronische clusterhoofdpijn

Other information