Hydrocortison Medicine 04 December 2025 Extended indication Treatment of adrenal insufficiency (AI) in adolescents aged 12 years and over and adults Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Hydrocortison Domain Metabolism and Endocrinology Reason of inclusion Indication extension IND Main indication Metabolic diseases Extended indication Treatment of adrenal insufficiency (AI) in adolescents aged 12 years and over and adults Current proprietary name Already available biosimilars / generics Proprietary name Efmody Manufacturer Neurocrine Biosciences Portfolio holder Mechanism of action Route of administration Oral Therapeutical formulation Capsule Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date August 2025 Expected Registration March 2026 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References NCT05222152 (DIUR-016-AI) Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost References Additional remarks 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