Extended indication

Relapsing multiple sclerosis

Therapeutic value

Possible equal value

Total cost

4,000,000.00

Registration phase

Registration application pending

Product

Active substance

Ublituximab

Domain

Neurological disorders

Reason of inclusion

New medicine (specialité)

Main indication

Multiple sclerosis

Extended indication

Relapsing multiple sclerosis

Proprietary name

Ublyxi

Manufacturer

TG Therapeutics

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

February 2023

Orphan drug

No

Registration phase

Registration application pending

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

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.
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

< 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.