Sotagliflozin Medicine 12 June 2018 Extended indication Zynquista is indicated as an adjunct to insulin therapy to improve glycaemic control in adults with type 1 diabetes mellitus with a Body Mass Index (BMI) ≥ 27 kg/m2, who have failed to achieve adequate glycaemic control despite optimal insulin therapy. Therapeutic value No judgement Total cost € 1,500,000.00 Registration phase Registered Product Active substance Sotagliflozin Domain Metabolism and Endocrinology Reason of inclusion New medicine (specialité) Main indication Diabetes Extended indication Zynquista is indicated as an adjunct to insulin therapy to improve glycaemic control in adults with type 1 diabetes mellitus with a Body Mass Index (BMI) ≥ 27 kg/m2, who have failed to achieve adequate glycaemic control despite optimal insulin therapy. Current proprietary name Already available biosimilars / generics Proprietary name Zynquista Manufacturer Sanofi 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 Normal trajectory Particularity Unknown ATMP Unknown Submission date March 2018 Expected Registration April 2019 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie februari 2019. Geregistreerd in april 2019. Therapeutic value Current treatment options Insuline Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Het profiel van sotagliflozin is iets gunstiger, iets potenter dan dat van dapagliflozin. De andere kant is dat sotagliflozin (nog) niet is geregistreerd voor type 2. Duration of treatment Frequency of administration 1 times a day Dosage per administration References Additional remarks Expected patient volume per year Patient volume 1,000 - 4,000 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References GIPdatabank; GLP-1-agonisten bij diabetes mellitus type 2, ZIN 2016; Monitor Voorschrijfgedrag Huisartsen 2017 Additional remarks Totaal aantal gebruikers van diabetesmiddelen in 2016 was 814.714. 10% hiervan heeft diabetes type 1 dus het aantal patiënten in Nederland bedraagt ongeveer 80.000. Als we schatten dat er 80.000 ptn met type 1 zijn, waarvan er 20.000 een BMI boven 27 hebben dan zou het toch om enkele duizenden patiënten kunnen gaan. Expected cost per patient per year Cost € 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 Medicijnkosten.nl Additional remarks Vergelijkbare prijs met SGLT-2 remmers dapagliflozine en empagliflozine Potential total cost per year Total cost € 1,500,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Diabetes type 2 References Additional remarks Other information Additional remarks