Cladribine Medicine 09 January 2018 Extended indication Behandeling van volwassenen met recidiverende vormen van multipele sclerose. Therapeutic value No judgement Total cost € 15,600,000.00 Registration phase Unknown Product Active substance Cladribine Domain Neurological disorders Reason of inclusion Main indication Multiple sclerosis Extended indication Behandeling van volwassenen met recidiverende vormen van multipele sclerose. Current proprietary name Already available biosimilars / generics Proprietary name Mavenclad Manufacturer Merck Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date August 2016 Expected Registration August 2017 Orphan drug No Registration phase Unknown Reimbursement Medicine sluice Additional remarks Vergoedingsdossier ingediend bij Zorginstituut Nederland. Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Average 2 year / years Frequency of administration 10 times a year Dosage per administration 12,25 mg/kg References Additional remarks De cumulatieve dosis is 1,75 mg/kg/jaar. Voor een patient van 70 kg: 122,5 mg/jaar. Expected patient volume per year Patient volume 400 - 800 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Verwachting: minder patiënten dan Ocrevus. Expected cost per patient per year Cost € 17,000.00 - 35,000.00 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 Prescribing Outlook 2017, Fabrikant. Additional remarks Prescribing Outlook 2017: 'Cost unknown but it will have to compete with other MS treatments. Annual cost of other disease-modifying therapies ranges from about £6,000 to £21,000.' Fabrikant geeft aan: 25% kostenbesparing tov fingolimod over 4 jaar. Fingolimod behandeling: 0,5 mg per dag, 4 jaar behandelduur: € 93.757,46 Mavenclad behandeling: 1,75 mg/kg cumulatieve dosis per jaar, hoeft maar 2 jaar gebruikt te worden voor een effect van 4 jaar: 3,5 mg/kg, dit zou 25% kostenbesparting opleveren over 4 jaar: €70.318,10. Mavenclad per jaar 1 en 2 zou dan zijn: €70.318,10/2 = € 35.159,05 p.p.p.j. per jaar 3 en 4 € 0,00. Potential total cost per year Total cost € 15,600,000.00 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 Additional remarks Other information Additional remarks