Canagliflozine Medicine 03 December 2024 Extended indication Invokana is indicated for the treatment of adults and children aged 10 years and older with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise. Therapeutic value Possibly no place in the treatment regimen Total cost € 0.00 Registration phase Registered Product Active substance Canagliflozine Domain Metabolism and Endocrinology Reason of inclusion Indication extension IND Main indication Diabetes Extended indication Invokana is indicated for the treatment of adults and children aged 10 years and older with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise. Current proprietary name Already available biosimilars / generics Proprietary name Invokana Manufacturer Mundipharma 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 ATMP No Submission date August 2024 Expected Registration September 2025 Orphan drug No Registration phase Registered Reimbursement Reimbursed from the basic package Medicine sluice Additional remarks Positieve CHMP-opinie in juli 2025. Therapeutic value Current treatment options Dieet en glucosecontrole Therapeutic value Possibly no place in the treatment regimen This assessment does not indicate any potential inclusion in the package. Substantiation Canagliflozine wordt in Nederland amper gebruikt. De inschatting is dat dit al helemaal niet bij kinderen wordt gebruikt. Bovendien raken SGLT-2-remmers uit patent. Duration of treatment Frequency of administration 1 times a day Dosage per administration 100 tot 300mg References NCT03170518 (JNJ-28431754DIA3018); NCT02000700 (JNJ-28431754DIA1055); Expertopinie Additional remarks 100mg eenmaal daags of opvoeren tot 300mg eenmaal daags Expected patient volume per year Patient volume < 0 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Expertopinie Additional remarks Zie inschatting therapeutische waarde. Expected cost per patient per year Cost € 500.00 - 600.00 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 GIPdatabank Additional remarks In 2023 werd er €535,40 per gebruiker voor canagliflozine vergoed. Potential total cost per year Total cost € 0.00 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