Ublituximab Medicine 07 December 2021 Extended indication Briumvi is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features Therapeutic value Possible equal value Total cost € 4,000,000.00 Registration phase Registered and reimbursed Product Active substance Ublituximab Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Multiple sclerosis Extended indication Briumvi is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features Current proprietary name Already available biosimilars / generics Proprietary name Briumvi Manufacturer TG Therapeutics Portfolio holder Neuraxpharm 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 November 2021 Expected Registration June 2023 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Ublituximab, voor zover verstrekt in het kader van geneeskundige behandelingen met uitzondering van de toepassing als behandeling van volwassen patiënten met relapsing vormen van multiple sclerose (RMS) met actieve ziekte (Staatscourant 2025, 15098 | Overheid.nl > Officiële bekendmakingen). Zorginstituut Nederland heeft de minister van Volksgezondheid, Welzijn en Sport (VWS) in februari 2025 geadviseerd om ublituximab (Briumvi®) na prijsonderhandelingen te vergoeden uit het basispakket van de zorgverzekering. 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. https://msvereniging.nl/over-ms/soorten-ms/ Additional remarks Hersenstichting: In Nederland komt Multiple Sclerosis voor bij ongeveer 1 op de 1.000 inwoners. Nederland telt dus ongeveer 18.000 mensen met Multiple Sclerosis. RRMS is de meest voorkomende vorm van MS; zo’n 85% van mensen met MS heeft deze vorm. 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 € < 20,000.00 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 https://biopharma.media/ublituximab-highly-effective-future-drug-for-multiple-sclerosis-1982/ Additional remarks De kosten liggen mogelijk in lijn met ofatumumab en ocrelizumab. Potential total cost per year Total cost € 4,000,000.00 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