Extended indication Ponvory is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis
Therapeutic value Possible equal value
Total cost 4,900,000.00
Registration phase Registered

Product

Active substance Ponesimod
Domain Neurological disorders
Reason of inclusion New medicine (specialité)
Main indication Multiple sclerosis
Extended indication Ponvory 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 Ponvory
Manufacturer Janssen
Mechanism of action Receptor agonist
Route of administration Oral
Therapeutical formulation Coated tablet
Budgetting framework Extramural (GVS)
Additional comments Oral selective sphingosine-1 phosphate-1 receptor agonist

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date March 2020
Expected Registration May 2021
Orphan drug No
Registration phase Registered
Additional comments Positieve CHMP-opinie in maart 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 Tussen de sfingosine-1-fosfaat receptoragonisten is veel concurrentie en weinig verschil in aangetoonde effectiviteit. Het verschil tussen deze geneesmiddelen ligt met name in de bijwerkingsprofielen.
Frequency of administration 1 times a day
Dosage per administration 20 mg
References OPTIMUM (NCT02425644)

Expected patient volume per year

Patient volume

200 - 500

Market share is generally not included unless otherwise stated.

References GIP databank, hersenstichting, Nationaal MS fonds.
Additional comments 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 9,000.00 - 19,000.00
References GIP-databank
Additional comments Er is nog geen prijs bekend maar de verwachting is dat dit in lijn zal zijn met directe concurrenten. Bij substitutie geen toename in kosten.

Potential total cost per year

Total cost

4,900,000.00

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

References adis insight, clinicaltrials.gov
Additional comments Graft-versus-host disease (fase 2)

Other information

There is currently no futher information available.