Ponesimod Medicine 10 December 2019 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. Therapeutic value Possible equal value Total cost € 4,305,000.00 Registration phase Registered and reimbursed 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. Current proprietary name Already available biosimilars / generics Proprietary name Ponvory Manufacturer Janssen Portfolio holder Mechanism of action Receptor agonist Route of administration Oral Therapeutical formulation Coated tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Oral selective sphingosine-1 phosphate-1 receptor agonist Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date March 2020 Expected Registration May 2021 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in maart 2021. Het Zorginstituut concludeert dat ponesimod (Ponvory®) onderling vervangbaar is met de andere geneesmiddelen in het GVS-cluster 0N07XXCO V. In dat cluster zijn verschillende middelen opgenomen voor de behandeling van RMS:ozanimod (Zeposia®); teriflunomide (Aubagio®); dimethylfumaraat (Tecfidera®). 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 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. Duration of treatment Frequency of administration 1 times a day Dosage per administration 20 mg References OPTIMUM (NCT02425644) Additional remarks Expected patient volume per year Patient volume 200 - 500 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 € < 12,300.00 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 Z-index Additional remarks De verwachte prijs per patiënt per jaar bedraagt circa €12.300. De prijzen voor de starterpack en maintenance pack staan in de z-index vermeld. Beide prijzen vallen binnen het maximale vergoedingslimiet. Er hoeft dus geen bijbetaling plaats te vinden. Potential total cost per year Total cost € 4,305,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References adis insight, clinicaltrials.gov Additional remarks Graft-versus-host disease (fase 2) Other information Additional remarks