Hydrocortison slow-release Medicine 04 December 2025 Extended indication Efmody is indicated in adolescents aged 12 years and over and adults for the treatment of adrenal insufficiency (AI). Therapeutic value Possible added value Total cost € 2,720,000.00 Registration phase Registered Product Active substance Hydrocortison slow-release Domain Metabolism and Endocrinology Reason of inclusion Indication extension IND Main indication Metabolic diseases Extended indication Efmody is indicated in adolescents aged 12 years and over and adults for the treatment of adrenal insufficiency (AI). Current proprietary name Already available biosimilars / generics Proprietary name Chronocort 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 Yes Registration phase Registered Reimbursement Reimbursed from the basic package Medicine sluice Additional remarks Positieve CHMP-opinie in januari 2026. Therapeutic value Current treatment options Plenadren Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation Op dit moment wordt plenadren gegeven voor primaire bijnierinsufficiëntie. Met Chronocort zijn er betere waarden aangetoond bij kwaliteit van leven en het cortisolniveau in de ochtend dan bij Plenadren. Duration of treatment Frequency of administration 1 times a day Dosage per administration 5 of 10 mg References NCT05222152 (CHAMPAIN, DIUR-016-AI); Prete et al. eClinicalMedicine. 2026. Additional remarks Expected patient volume per year Patient volume 600 - 1,100 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Orphanet; Declaratiedata; Expertopinie Additional remarks De prevalentie van de ziekte van Addison bedraagt 1 op de 9.000 tot 1 op de 6.900. Binnen de doelgroep van twaalf jaar en ouder (ongeveer 15,8 miljoen mensen) zou dit tussen de 1.800 en 2.300 patiënten zijn. Mogelijk zullen de gebruikers van Plenadren overstappen naar Chronocort. Er zijn tussen de 600 en 1.100 gebruikers van Plenadren. Expected cost per patient per year Cost € < 3,200.00 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 Declaratiedata Additional remarks Mogelijk zijn de kosten gelijk aan Plenadren. In 2024 werd er ongeveer 3.200 euro per gebruiker Plenadren 20 mg vergoed. Potential total cost per year Total cost € 2,720,000.00 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