Budesonide Medicine 09 January 2018 Extended indication Geïndiceerd voor de behandeling van eosinofiele oesofagitis (EoE) bij volwassenen (ouder dan 18 jaar). Therapeutic value No judgement Total cost € 437,500.00 Registration phase Registered Product Active substance Budesonide Domain Chronic immune diseases Reason of inclusion Main indication Other chronic immune diseases Extended indication Geïndiceerd voor de behandeling van eosinofiele oesofagitis (EoE) bij volwassenen (ouder dan 18 jaar). Current proprietary name Already available biosimilars / generics Proprietary name Jorveza Manufacturer Dr. Falk 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 Accelerated assessment Particularity New medicine ATMP Unknown Submission date July 2017 Expected Registration January 2018 Orphan drug Yes Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie november 2017. Geregistreerd in januari 2018. Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 2 times a day Dosage per administration 2 mg References Additional remarks Expected patient volume per year Patient volume < 350 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Van Osselen. Ned Tijdschr Geneeskd. 2017;161:C3606 Additional remarks De incidentie van eosinofiele oesofagitis in 2016 was 2,07 per 100.000 inwoners. Dit komt neer op een patiëntenaantal van 352 per 17 miljoen inwoners. Het is nog niet duidelijk hoeveel patiënten daadwerkelijk voor behandeling met budesonide in aanmerking komen. Expected cost per patient per year Cost € 1,000.00 - 1,500.00 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 Medicijnkosten.nl Additional remarks €3,25 voor een dagelijkse dosis Potential total cost per year Total cost € 437,500.00 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