Efgartigimod alfa / hyaluronidase-qvfc Medicine 03 December 2024 Extended indication Extension of indication to include the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP) with active disease despite treatment with corticosteroids or immunoglobulins Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Efgartigimod alfa / hyaluronidase-qvfc Domain Neurological disorders Reason of inclusion Indication extension IND Main indication Neurological disorders other Extended indication Extension of indication to include the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP) with active disease despite treatment with corticosteroids or immunoglobulins Current proprietary name Already available biosimilars / generics Proprietary name Vyvgart Hytrulo Manufacturer Argenx Portfolio holder Mechanism of action Receptor antagonist Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks FcRn-blokker Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date June 2024 Expected Registration August 2025 Orphan drug Yes Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options IVIg of SCIg Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Average 25 week / weeks Frequency of administration 1 times a week Dosage per administration 1.008 mg / 11.200 units (1.008 mg efgartigimod alfa and 11.200 units hyaluronidase) References NCT04281472 (ARGX-113-1802) (1); Vyvgart Hytrulo prescribing information (2). Additional remarks The recommended dosage of VYVGART HYTRULO is 1,008mg / 11,200 units (1,008mg efgartigimod alfa and 11,200 units hyaluronidase) administered subcutaneously over approximately 30 to 90 seconds as once weekly injections. The mean duration of treatment with VYVGART HYTRULO in stage B was 25 weeks. Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Orphanet (1); Fabrikant (2). Additional remarks De prevalentie van chronische inflammatoire demyeliniserende polyneuropathie voor volwassenen bedraagt 1 tot 7 op de 100.000 volwassenen, maar algemeen wordt aangenomen dat dit onderschattingen zijn (1). De fabrikant verwacht 80 tot 100 patiënten in Nederland (2). Expected cost per patient per year Cost € < 376,350.00 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 Drugs.com (1) Additional remarks In de Verenigde Staten liggen de kosten van Vyvgart Hytrulo (qvfc 180mg-2000 units/mL) rond de $16,618 voor een flacon van 5,6ml (1). Uitgaande van een behandeling van 25 weken met een wekelijkse injectie van een flacon kan een schatting gemaakt worden van € 376.350 per patiënt per jaar (€ 15.054*25). 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 Unknown Indication extensions References Additional remarks Other information Additional remarks