Human normal immunoglobulin Medicine 06 June 2023 Extended indication Extension of indication to include treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy after stabilization with IVIg for adults, children and adolescents (0 to 18 years). Therapeutic value No estimate possible yet Total cost Registration phase Registered and reimbursed Product Active substance Human normal immunoglobulin Domain Neurological disorders Reason of inclusion Indication extension IND Main indication Neurological disorders other Extended indication Extension of indication to include treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy after stabilization with IVIg for adults, children and adolescents (0 to 18 years). Current proprietary name Already available biosimilars / generics Proprietary name HyQvia Manufacturer Takeda Portfolio holder Mechanism of action Unknown Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date February 2023 Expected Registration January 2024 Orphan drug Yes Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Geregistreerd januari 2024 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 HyQvia is de subcutane immunoglobuline waarbij je ook hyaluronidase geeft. Het idee is om een grotere pocket subcutaan te maken en dat het daarmee meer en minder frequent toe te dienen is dan met andere SCIg preparaten. Er wordt verwacht dat het redelijk budget neutraal uitkomt en dat een kleine patiëntengroep zal overstappen van IVIg of SCIg naar deze tussenvorm. Duration of treatment Frequency of administration Dosage per administration References Additional remarks Expected patient volume per year Patient volume 400 - 500 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References www.orpha.net (1); Additional remarks De prevalentie van Chronische inflammatoire demyeliniserende polyneuropathie voor volwassenen bedraagt 1-7/100.000 volwassenen, maar algemeen wordt aangenomen dat dit onderschattingen zijn (1). Aangenomen wordt dat er 400 tot 500 mensen IVIG of SCIg gebruiken. Expected cost per patient per year Cost References Additional remarks 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