Brentuximab vedotin Medicine 09 January 2018 Extended indication Behandeling van volwassen patiënten met CD30-positief cutaan T-cel lymfoom (CTCL) na ten minste 1 eerdere systemische therapie. Therapeutic value No judgement Total cost € 1,500,000.00 Registration phase Registered and reimbursed Product Active substance Brentuximab vedotin Domain Oncology and Hematology Reason of inclusion Main indication Lymphoma Extended indication Behandeling van volwassen patiënten met CD30-positief cutaan T-cel lymfoom (CTCL) na ten minste 1 eerdere systemische therapie. Current proprietary name Already available biosimilars / generics Proprietary name Adcetris Manufacturer Takeda Portfolio holder Mechanism of action Unknown Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Indication extension ATMP Unknown Submission date August 2017 Expected Registration January 2018 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie november 2017. Geregistreerd in januari 2018. Therapeutic value Current treatment options Systemische chemotherapie Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 1,8 mg/kg References Fabrikant; Kim et al. Blood 2016 128:182; Prince et al. Lancet. 2017 Aug 5;390(10094):555-566. Additional remarks Toediningsfrequentie: 12 cycli; 1 maal per 3 weken. Expected patient volume per year Patient volume 11 - 18 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Fabrikant; Willemze. Ned Tijdschr Hematol 2008;5:3-11; Kantar Health 2015 Additional remarks Fabrikant: Max. patiëntvolume: Van 131 patiënten met CTCL (IKNL, 2016) heeft 45% mycosis fungoides en 10% cutaan anaplastich grootcellig lymfoom (totaal 55%, 72 patiënten). Hiervan ontvangt 35% direct een systemische therapie, en 23% na lokale therapie (42 patiënten). In verdere lijnen ontvangt 47% een tweede behandeling, en 48% hierna een derde systemische behandeling (20 + 9 patiënten). Van deze patiënten is 60% CD30 positief (ALCANZA studie). Van max. naar realistisch patiëntvolume: aangenomen aandeel van 60%. Expected cost per patient per year Cost € 80,000.00 - 120,000.00 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 Per cyclus zijn 2-3 vials nodig (1,8 mg/kg; 50 mg vial). Mediane behandelduur studie: 12 cycli. Prijs €3.300 per vial. 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 Unknown Indication extensions References Additional remarks Other information Additional remarks