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Ublituximab

Briumvi

Extended indication Briumvi is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis
Therapeutic value Possible equal value
Total cost 4,000,000.00
Registration phase Registered

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
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)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date November 2021
Expected Registration June 2023
Orphan drug No
Registration phase Registered
Additional remarks Zorginstituut Nederland beoordeelt of ublituximab (Briumvi®) vergoed kan worden. Publicatie advies verwacht in november of december 2024.

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
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.
References NCT03277261; NCT03277248

Expected patient volume per year

Patient volume

< 200

Market share is generally not included unless otherwise stated.
References GIP databank, hersenstichting, Nationaal MS fonds. https://msvereniging.nl/over-ms/soorten-ms/#:~:text=RRMS%20is%20de%20meest%20voorkomende,met%20MS%20heeft%20deze%20vorm.
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. RRMS is de meest voorkomende vorm van MS; zo’n 85 procent 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
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

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.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension Yes
Indication extensions Diffuse large B cell lymphoma; Follicular lymphoma; Mantle-cell lymphoma; Marginal zone B-cell lymphoma
References AdisInsight

Other information

There is currently no futher information available.