Degarelix Medicine 07 December 2021 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. Therapeutic value Possible equal value Total cost Registration phase Registered and reimbursed Product Active substance Degarelix Domain Oncology Reason of inclusion Indication extension IND 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. Current proprietary name Already available biosimilars / generics Proprietary name Firmagon Manufacturer Ferring Portfolio holder Mechanism of action Unknown Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Fabrikant Ferring. Werkingsmechanisme.gonadotrophin releasing hormone (GnRH) antagonist. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date 2021 Expected Registration October 2021 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie 16 september 2021. Therapeutic value Current treatment options Gonadoreline-agonisten Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. 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. Duration of treatment Frequency of administration Dosage per administration References Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice 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 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 GIPdatabank Additional remarks In 2021 werd er per gebruiker €1.057 vergoed. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Preventie van cardiovasculaire gebeurtenissen bij mannen met gevorderde prostaatkanker. References SPS UK Additional remarks Other information Additional remarks