Sotagliflozine Medicine 10 June 2020 Extended indication Patients With Type 2 Diabetes Mellitus and Moderate Renal Impairment Who Have Inadequate Glycemic Control Therapeutic value No judgement Total cost Registration phase Clinical trials Product Active substance Sotagliflozine Domain Metabolism and Endocrinology Reason of inclusion Indication extension IND Main indication Diabetes Extended indication Patients With Type 2 Diabetes Mellitus and Moderate Renal Impairment Who Have Inadequate Glycemic Control Current proprietary name Already available biosimilars / generics Proprietary name Zynquista Manufacturer Lexicon Portfolio holder Mechanism of action SGLT inhibitor Route of administration Oral Therapeutical formulation Tablet + chewable tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Combinatie van Sodium-glucose transport protein 1 en 2 (SGLT-1/SGLT-2) remmers; dit zorgt voor verlaging van de glucoseopname en verhoogt uitscheiding via de urine. Dit heeft als gevolg dat de bloedsuikerspiegel verlaagt. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2021 Expected Registration 2022 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Datum indiening en verwachte registratie op basis van actual primary completion date fase 3 studie in april 2019. Therapeutic value Current treatment options Andere SGLT2-remmers, bijvoorbeeld dapagliflozine en empagliflozine. Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Er wordt verwacht dat sotagliflozine mogelijk potenter is dan andere SGLT2-remmers. Dit hoeft echter niet te betekenen dat er vaker voor dit geneesmiddel gekozen zal worden. Aangezien canagliflozine ook iets potenter is, maar nauwelijks gebruikt wordt. Duration of treatment Frequency of administration 1 times a day Dosage per administration 400 mg References NCT03242252 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Stichting farmaceutische ken getallen. Additional remarks De afgelopen jaren is er een sterke groei van SGLT-2 remmer gebruik. In 2018 maakten 19.000 diabetes patiënten gebruik van SGLT-2 remmers. Er wordt verwacht dat er substitutie plaats zal vinden onder de SGLT-2 remmers. Dit zullen echter geen grote aantallen zijn. Expected cost per patient per year Cost € 537.00 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 Vergelijkbare prijs met SGLT-2 remmers dapagliflozine. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Hartfalen References clinicaltrials.gov Additional remarks Other information Additional remarks