Hydrocortison Medicine 03 June 2025 Extended indication Hydrocortisone monotherapy for treatment of active rectum Ulcerative colitis in adults and elderly. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Hydrocortison Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Bowel diseases Extended indication Hydrocortisone monotherapy for treatment of active rectum Ulcerative colitis in adults and elderly. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Cristcot Portfolio holder Mechanism of action Route of administration Rectal Therapeutical formulation Suppository Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Hydrocortisone Acetate is a corticosteroid with anti-inflammatory and immunosuppressive properties. Hydrocortisone acetate initially binds to the cytoplasmic glucocorticoid receptor; then the receptor-ligand complex is translocated to the nucleus where it initiates the transcription of genes encoding for anti-inflammatory mediators, such as cytokines and lipocortins. Lipocortins inhibit phospholipase A2, thereby blocking the release of arachidonic acid from membrane phospholipids and preventing the synthesis of prostaglandins and leukotrienes. Registration Registration route Centralised (EMA) Type of trajectory Particularity ATMP No Submission date December 2025 Expected Registration January 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Tijdslijn op basis van IHSI-inschatting. Therapeutic value Current treatment options Anti-TNF, vedolizumab, ustekinumab, tofacitinib Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De verwachting is dat er geen plek zal zijn binnen de Nederlandse behandelrichtlijn. Duration of treatment Frequency of administration 1 times a day Dosage per administration 90mg References NCT04469686 Additional remarks 90mg een of twee maal daags. Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Crohn-colitis.nl (1); NVMDL Leidraad IBD (2); declaratiedat Additional remarks Colitis ulcerosa komt steeds vaker voor met name in de Westerse landen. Er zijn momenteel ruim 90.000 mensen in Nederland met een chronische darmontsteking (1). Dit is ongeveer 1 op de 200 mensen. Hiervan heeft iets meer dan de helft ulcerative colitis(1). Doorgaans wordt gestart met een TNF-alfaremmer. Daarna worden ook andere biologische geneesmiddelen overwogen(2). In 2022 kregen 3.259 patiënten een biologisch geneesmiddel voorgeschreven anders dan TNFalfaremmers. De verwachting is dat deze vorm van hydrocortison nauwelijks ingezet zal worden in Nederland indien het op de markt gebracht wordt. Expected cost per patient per year Cost € 6,500.00 - 13,200.00 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 Een Hydrocortison tablet van 5mg kost €1,02. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks