Empagliflozine Medicine 07 December 2021 Extended indication Treatment of patients with chronic kidney disease. Therapeutic value Possible added value Total cost € 10,091,500.00 Registration phase Clinical trials Product Active substance Empagliflozine Domain Metabolism and Endocrinology Reason of inclusion Indication extension IND Main indication Other metabolism and Endocrinology Extended indication Treatment of patients with chronic kidney disease. Current proprietary name Already available biosimilars / generics Proprietary name Jardiance Manufacturer Boehringer Ingelheim Portfolio holder Mechanism of action SGLT inhibitor Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date January 2023 Expected Registration December 2023 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation SGLT2-remmers (empagliflozine en dapagliflozine): laten overtuigend gunstige effecten zien bij mensen met hartfalen en chronisch nierfalen die onafhankelijk zijn van het glucose verlagend effect, deze twee geneesmiddelen zullen vaak ingezet gaan worden bij die aandoeningen, zowel met als zonder diabetes, inmiddels staan ze ook al prominent in de richtlijnen. Duration of treatment Frequency of administration 1 times a day Dosage per administration 10mg References NCT03594110 Additional remarks Expected patient volume per year Patient volume < 20,183 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Nieratlas Additional remarks De patiënt met chronische nierschade heeft een ernstig verminderde nierfunctie die niet behandeld wordt met dialyse of een niertransplantatie. Deze patiënten hebben een diagnosebehandelcode (DBC) nummer 325 Expected cost per patient per year Cost € < 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 G-standaard Additional remarks €38,40 per 28 stuks Potential total cost per year Total cost € 10,091,500.00 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