Dapagliflozin / saxagliptin / metformin Medicine 13 December 2018 Extended indication Qtrilmet is indicated in adults aged 18 years and older with type 2 diabetes mellitus: to improve glycaemic control when metformin with or without sulphonylurea (SU) and either saxagliptin or dapagliflozin does not provide adequate glycaemic control or when already being treated with metformin and saxagliptin and dapagliflozin Therapeutic value Possible equal value Total cost € 147,300.00 Registration phase Registered Product Active substance Dapagliflozin / saxagliptin / metformin Domain Metabolism and Endocrinology Reason of inclusion New medicine (specialité) Main indication Diabetes Extended indication Qtrilmet is indicated in adults aged 18 years and older with type 2 diabetes mellitus: to improve glycaemic control when metformin with or without sulphonylurea (SU) and either saxagliptin or dapagliflozin does not provide adequate glycaemic control or when already being treated with metformin and saxagliptin and dapagliflozin Current proprietary name Already available biosimilars / generics Proprietary name Qtrilmet Manufacturer AstraZeneca Portfolio holder Mechanism of action Combination therapy Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks DPP-4 inhibitor/SGLT-2 inhibitor Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date July 2018 Expected Registration November 2019 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in september 2019. Geregistreerd in november 2019. Therapeutic value Current treatment options Overige DPP-4 en SGLT-2 remmers Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation Voor de combinatiepreparaten ertugliflozin/metformin en ertugliflozin/sitagliptin (een dpp-iv remmer) is geen meerwaarde te verwachten ten opzichte van de momenteel al op de markt zijnde combinatiepreparaten van een SGLT-2 inhibitor met metformin of een dpp-iv inhibitor. Gebruik van combinatiepreparaten is in Nederland niet heel gebruikelijk. Duration of treatment Frequency of administration 1 times a day Dosage per administration 10 / 5 / 1500-2000 mg References NCT01606007 Additional remarks Expected patient volume per year Patient volume < 491 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References GIPdatabank Additional remarks In 2017 werden er bij 491 patiënten combinatiepreparaten met SGLT-2 remmers voorgeschreven (Xigduo, Vokanamet en Synjardy) en 46 patiënten op een combinatietherapie met een DPP-4-remmer (Komboglyze). De verwachting is dat triple-therapie niet veel gebruikt zal worden in Nederland dus zal van deze groep patiënten slechts een deel hiermee behandeld worden. 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 Deze behandeling zal moeten concurreren met de huidige behandelopties en dus naar verwachting vergelijkbaar geprijsd worden. De prijs zal mogelijk een som van de losse componenten zijn. saxagliptine 5 mg € 1,16; dapagliflozine 5 mg €1,01; metformine tablet 500 mg, €0,02. Inschatting zo'n €100-€500 per patiënt per jaar. Potential total cost per year Total cost € 147,300.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Additional remarks Other information Additional remarks