Brentuximab vedotin Medicine 05 December 2023 Extended indication Extension of indication to include in combination with cyclophosphamide, doxorubicin, and prednisone (CHP) treatment of adult patients with previously untreated CD30+ peripheral T-cell lymphoma not otherwise specified (PTCL-NOS). Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Brentuximab vedotin Domain Hematology Reason of inclusion Indication extension IND Main indication Aggressive non-Hodgkin’s lymphoma Extended indication Extension of indication to include in combination with cyclophosphamide, doxorubicin, and prednisone (CHP) treatment of adult patients with previously untreated CD30+ peripheral T-cell lymphoma not otherwise specified (PTCL-NOS). 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 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 No Submission date June 2023 Expected Registration July 2024 Orphan drug Yes Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De huidige behandelopties zijn niet toereikend dus is er wel een unmet-need. De resultaten uit de ECHELON-2 zijn echter tot nu toe ook niet overtuigend. Er is nu 5 jaar folluw-up van van de ECHOLON 2 studie: PTCL NOS heeft een HR van 0,79 voor PFS en 0,75 voor OS. Duration of treatment Frequency of administration Dosage per administration 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles References ECHELON-2- NCT01777152 Additional remarks Expected patient volume per year Patient volume 27 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References IKNL 2021 (1); N Engl J Med 2018; 378:331-344 DOI: 10.1056/NEJMoa1708984 (2) Additional remarks Incidentie van Hodgkin lymfoom in Nederland was in 2021: 498 patiënten (1). Tot 30% van de patiënten met stadium III of IV Hodgkin lymphoom is refractair of krijgt een relapse na frontlinie behandeling met ABVD (2). Op basis van een expertopinie wordt er echter verwacht dat er ongeveer 27 patiënten per jaar in aanmerking zullen komen. Expected cost per patient per year Cost References https://www.farmacotherapeutischkompas.nl/bladeren/preparaatteksten/b/brentuximab_vedotine#koste Additional remarks Adcetris, 50mg poeder voor oplossing voor infusie 50mg: €3.520,51 (inclusief BTW) 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