Brentuximab vedotin Medicine 10 December 2019 Extended indication Adcetris in combination with cyclophosphamide, doxorubicin and prednisone (CHP) is indicated for adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL). Therapeutic value No judgement Total cost € 4,863,330.00 Registration phase Registered and reimbursed Product Active substance Brentuximab vedotin Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Aggressive non-Hodgkin’s lymphoma Extended indication Adcetris in combination with cyclophosphamide, doxorubicin and prednisone (CHP) is indicated for adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL). Current proprietary name Already available biosimilars / generics Proprietary name Adcetris Manufacturer Takeda Portfolio holder Mechanism of action Antibody-drug conjugate Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise HOVON A centra Additional remarks Antibody-drug conjugate (ADC) bestaande uit een anti-CD30-gericht monoklonaal antilichaam verbonden aan het antineoplastische middel monomethyl auristatin E (MMAE). Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date July 2019 Expected Registration May 2020 Orphan drug Yes Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Positieve-CHMP opinie in maart 2020. Therapeutic value Current treatment options Chemotherapie: CHOP (cyclophosphamide, doxorubicine, vincristine en prednison) of CHOEP (cyclophosphamide, doxorubicine, vincristine, etoposide en prednison), eventueel in combinatie met een stamcel transplantatie. Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation In de dubbelblinde, dubbel-dummy ECHELON-2 studie werden 452 patiënten gerandomiseerd tot Adcetris+CHP (cyclophosphamide, doxorubicine en prednison) of CHOP. Progressievrije overleving was significant verlengd in de A+CHP arm (mediaan 48.2 maanden versus 20.8 maanden; HR 0.71 p=0.0110) Ook totale overleving was significant beter in de A+CHP arm (HR 0.66 p=0.0244). Indien er sprake is van mogelijke meerwaarde ten opzichte van de huidige behandelopties dan zal dit middel de eerste keus worden. Duration of treatment Median 18 week / weeks Frequency of administration 1 times every 3 weeks Dosage per administration 1.8 mg / kg References ECHELON-2 studie: Lancet. 2019 Jan 19;393(10168):229-240. Additional remarks 6 toedieningen. Expected patient volume per year Patient volume 90 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Fabrikant op basis van: cijfersoverkanker.nl, Bossard Blood 2014, PALGA en expert-opinie. Additional remarks Circa 200 patiënten per jaar met T-cel lymfoom, geschat gemiddeld 45% CD30+: zo'n 90 patiënten per jaar. Expected cost per patient per year Cost € 54,037.00 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 Z-index, ECHELON-2 trial. Additional remarks Gemiddeld 3 vials van 50mg nodig per toediening x 6 cycli: € 3.002,07 x3x6 Cycli = € 54.037,26 (exclusief btw) (op basis van Nieuwe WGP limiet vanaf oktober 2020). Potential total cost per year Total cost € 4,863,330.00 Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References fabrikant Additional remarks Indication extension Indication extensions No Indication extensions References Fabrikant. Additional remarks Other information Additional remarks