Dimethyl fumarate Medicine 07 December 2021 Extended indication Tecfidera is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS). Therapeutic value No estimate possible yet Total cost € 316,525.00 Registration phase Registered and reimbursed Product Active substance Dimethyl fumarate Domain Neurological disorders Reason of inclusion Indication extension IND Main indication Multiple sclerosis Extended indication Tecfidera is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS). Current proprietary name Already available biosimilars / generics Proprietary name Tecfidera Manufacturer Biogen Portfolio holder Biogen Mechanism of action Unknown Route of administration Oral Therapeutical formulation Capsule Budgetting framework Extramural (GVS) Centre of expertise Additional remarks NF E2 related factor 2 stimulants; NF-kappa B inhibitor. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date June 2021 Expected Registration May 2022 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Positieve CHMp opinie ontvangen in januari 2022. Na een herbeoordeling op verzoek van de fabrikant, heeft de CHMP haar oordeel opnieuw gegeven in april 2022. Therapeutic value Current treatment options Interferon-β, fingolimod and glatirameeracetaat hebben een registratie voor deze patiëntengroep. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation In de klinische studie wordt dimethyl fumarate vergeleken met Interferon-β. Duration of treatment Frequency of administration Dosage per administration 120 mg, 240 mg References NCT02283853 (CONNECT) Additional remarks Expected patient volume per year Patient volume < 55 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References De Mol et al. J Neurol. 2018 Jun;265(6):1310-1319 Additional remarks Er zijn in Nederland circa 55 kinderen met multiple sclerose. Hiervan wordt op dit moment 90% behandeld, met name met interferon-β en 10%-15% staat momenteel op een 2e-lijns behandeling. Aangezien ook bij kinderen jonger dan 13 jaar MS wordt gediagnosticeerd is het verwachte patiëntvolume lager dan 55. Expected cost per patient per year Cost € < 5,755.00 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 GIPdatabank Additional remarks In 2021 werd er per volwassen gebruiker €5.755 vergoed. Dit valt mogelijk lager uit voor deze indicatie-uitbreiding Potential total cost per year Total cost € 316,525.00 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