Ublituximab Medicine 07 December 2021 Extended indication Relapsing multiple sclerosis Therapeutic value Possible equal value Total cost Registration phase Clinical trials Product Active substance Ublituximab Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Multiple sclerosis Extended indication Relapsing multiple sclerosis Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer TG Therapeutics Portfolio holder Mechanism of action Immunostimulation Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date 2022 Expected Registration 2023 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Indiening bij de FDA verwacht in september 2021. Therapeutic value Current treatment options Alemtuzumab, cladribine, fingolimod, glatiramer,interferon bèta-1a, interferon bèta-1b, natalizumab, ocrelizumab, peginterferon bèta-1a, teriflunomide Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation In de fase 3 trial werd superioriteit gezien ten opzichte van teriflunomide op basis van de multiple sclerosis functional composite (MSFC) score. Er wordt concurrentie met ocrelizumab (en rituximab) en ofatumumab als concurrerende anti-B cel therapie verwacht. Duration of treatment Frequency of administration Dosage per administration References NCT03277261; NCT03277248 Additional remarks Expected patient volume per year Patient volume < 200 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References GIP databank, hersenstichting, Nationaal MS fonds. Additional remarks Hersenstichting: In Nederland komt Multiple Sclerosis voor bij ongeveer 1 op de 1.000 inwoners. Nederland telt dus ongeveer 17.000 mensen met Multiple Sclerosis. RMS komt bij ongeveer 40% van alle mensen met Multiple Sclerosis voor (6.800 personen). Door de concurrentie aan middelen zal het verwachte marktaandeel op maximaal een paar honderd patiënten komen te liggen. 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 Yes Indication extensions Diffuse large B cell lymphoma; Follicular lymphoma; Mantle-cell lymphoma; Marginal zone B-cell lymphoma References AdisInsight Additional remarks Other information Additional remarks