Budesonide Medicine 09 January 2018 Extended indication Eosinophilic esophagitis Therapeutic value No judgement Total cost € 10,625,000.00 Registration phase Unknown Product Active substance Budesonide Domain Chronic immune diseases Reason of inclusion Main indication Other chronic immune diseases Extended indication Eosinophilic esophagitis Current proprietary name Already available biosimilars / generics Proprietary name 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 Unknown ATMP Unknown Submission date July 2017 Expected Registration January 2018 Orphan drug Yes Registration phase Unknown Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie november 2017 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 < 8,500 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References EMA Additional remarks EMA Orphan designation: 'eosinophilic oesophagitis affected less than 5 in 10,000 people in the European Union (EU).' 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 € 10,625,000.00 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