Expand all sections

Degarelix

Firmagon

Extended indication Firmagon is a gonadotrophin releasing hormone (GnRH) antagonist indicated 1) for treatment of high
Therapeutic value Possible equal value
Registration phase Registered and reimbursed

Product

Active substance Degarelix
Domain Oncology
Reason of inclusion Indication extension
Main indication Prostate cancer
Extended indication Firmagon is a gonadotrophin releasing hormone (GnRH) antagonist indicated 1) for treatment of high-risk localized and locally advanced hormone-dependent prostate cancer in combination with radiotherapy. 2) as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone-dependent prostate cancer.
Proprietary name Firmagon
Manufacturer Ferring
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Extramural (GVS)
Additional remarks Fabrikant Ferring. Werkingsmechanisme.gonadotrophin releasing hormone (GnRH) antagonist.

Registration

Registration route Centralised (EMA)
ATMP No
Submission date 2021
Expected Registration October 2021
Orphan drug No
Registration phase Registered and reimbursed
Additional remarks Positieve CHMP-opinie 16 september 2021.

Therapeutic value

Current treatment options Gonadoreline-agonisten
Therapeutic value Possible equal value
Substantiation Dit is een antagonist van LHRH, terwijl de huidige medicijnen zoals zoladex agonisten zijn. De toepassing lijkt echter niet anders te zijn. Uit de klinische studies bleek ook dat er geen overlevingswinst is ten opzichte van de huidige geneesmiddelen op de markt.

Expected patient volume per year

References Expert opinie
Additional remarks Betreft waarschijnlijk een kleine groep patiënten gezien de werkgroep geen andere toepassing ziet voor dit geneesmiddel in verhouding tot de bestaande behandelopties.

Expected cost per patient per year

Cost 1,057.00
References GIPdatabank
Additional remarks In 2021 werd er per gebruiker €1.057 vergoed.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension Yes
Indication extensions Preventie van cardiovasculaire gebeurtenissen bij mannen met gevorderde prostaatkanker.
References SPS UK

Other information

There is currently no futher information available.