Nipocalimab Medicine 03 December 2024 Extended indication Add-on to standard therapy for the treatment of generalised Myasthenia Gravis (gMG) in adult and adolescent patients aged 12 years of age and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive. Therapeutic value Possible equal value Total cost Registration phase Registered Product Active substance Nipocalimab Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Muscular diseases other Extended indication Add-on to standard therapy for the treatment of generalised Myasthenia Gravis (gMG) in adult and adolescent patients aged 12 years of age and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive. Current proprietary name Already available biosimilars / generics Proprietary name Imaavy Manufacturer Janssen Portfolio holder Janssen Mechanism of action Receptor antagonist Route of administration Intravenous Therapeutical formulation Unknown Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Nipocalimab is a volledig humaan IgG1 mAb welke IgG binding aan de endogene neonatale Fc receptor (FcRn) voorkomt. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date September 2024 Expected Registration November 2025 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Rejected Additional remarks Positieve CHMP-opinie in september 2025, EC registratie november 2025. Therapeutic value Current treatment options Verwachting is dat nipocalimab ingezet zal worden bij refractaire MG. Voor patiënten met refractaire MG zijn meerdere geneesmiddelen beschikbaar, zoals de complementremmers eculizumab en ravulizumab, en remmers van de neonatale Fc-receptor (FcRn), zoals efgartigimod alfa. Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation De uitkomsten komen overeen met de uitkomsten van de FcRn-blokkers die bij refractaire gMG worden ingezet. Duration of treatment Frequency of administration 1 times every 2 weeks Dosage per administration Startdosering 30mg/kg op dag 1. Onderhoudsdosering 15mg/kg iedere 2 weken. References NCT04951622 (Vivacity-MG3); Antozzi et al. Lancet Neurol. 2025. Additional remarks Expected patient volume per year Patient volume 0 - 7 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Voor patiënten met refractaire MG zijn meerdere geneesmiddelen beschikbaar, zoals de complementremmers eculizumab, ravulizumab en zilucoplan, en remmers van de neonatale Fc-receptor (FcRn), zoals efgartigimod alfa en straks ook rozanolixizumab en nipocalimab. Het Zorginstituut schatte in mei 2024 in dat 19 refractaire gMG patiënten per jaar met efgartigimod zullen worden behandeld in jaar drie na opname in het pakket. Dit volume zal gedeeld worden met nipocalimab en rozanolixizumab . Additional remarks Expected cost per patient per year Cost References Additional remarks Gelijkwaardig aan de prijs van FcRn-blokkers die bij refractaire gMG worden ingezet. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions nipocalimab wordt onder andere onderzocht in warm autoimmune hemolytic anemia en Chronic Inflammatory Demyelinating Polyneuropathy. References clinicaltrials.gov Additional remarks Other information Additional remarks