Ertugliflozin Medicine 09 January 2018 Extended indication Diabetes mellitus type 2 Therapeutic value Possible equal value Total cost Registration phase Unknown Product Active substance Ertugliflozin Domain Metabolism and Endocrinology Reason of inclusion Main indication Diabetes Extended indication Diabetes mellitus type 2 Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer MSD Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Samenwerking tussen MSD en Pfizer, MSD is de registratiehouder. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date March 2017 Expected Registration April 2018 Orphan drug No Registration phase Unknown Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Huidige SGLT2 remmers. Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation Dit middel zal na empagliflozin, dapagliflozin en canagliflozin de vierde SGLT2 remmer op de markt worden. Het is een ‘me too’ preparaat. Empagliflozin heeft in een cardiovasulaire outcome trial mortaliteitsreductie laten zien, voor ertugliflozin is nog geen cardiovasculaire outcome trial beschikbaar. Voor de combinatiepreparaten ertugliflozin/metformin en ertugliflozin/sitagliptin (een dpp-iv remmer) is ook geen meerwaarde te verwachten tov de momenteel al op de markt zijnde combinatiepreparaten van een SGLT2 remmer met metformin of een dpp-iv remmer. Duration of treatment Frequency of administration Dosage per administration References Zinman et al. N Engl J Med. 2015 Nov 26;373(22):2117-28. doi: 10.1056/NEJMoa1504720 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks SLGT2 remmers zullen in de toekomst wel meer gebruikt gaan worden, dit lijkt een 'me too' product met een laag te verwachten patiëntvolume. Expected cost per patient per year Cost € 100.00 - 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 Medicijnkosten.nl Additional remarks €1,07 Dapagliflozine tablet 5 mg (Forxiga); €1,68 Empagliflozine tablet 25 mg (Jardiance); €1,47 Canagliflozine tablet 100 mg (Invokana) 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 Unknown Indication extensions References Additional remarks Other information Additional remarks