Tafasitamab Medicine 10 June 2020 Extended indication Is indicated in combination with lenalidomide followed by monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from low grade lymphoma, who are not eligible for, or refuse, autologous stem cell transplant (ASCT). Therapeutic value Possible added value Total cost Registration phase Registration application pending Product Active substance Tafasitamab Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Aggressive non-Hodgkin’s lymphoma Extended indication Is indicated in combination with lenalidomide followed by monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from low grade lymphoma, who are not eligible for, or refuse, autologous stem cell transplant (ASCT). Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer MorphoSys Portfolio holder Mechanism of action Other, see general comments Route of administration Intravenous Therapeutical formulation Powder for solution for infusion Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Antibody-dependent cell cytotoxicity; CD19 antigen inhibitors. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity New medicine with Priority Medicines (PRIME) ATMP Unknown Submission date May 2020 Expected Registration June 2021 Orphan drug Yes Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options De behandeling voor DLBCL bestaat uit chemotherapie in combinatie met een antilichaam tegen CD20, in de derde lijn is CAR-T een optie. Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation In een fase 2 studie bij patiënten met relapsed/refractory DLBCL na 1-3 eerdere lijnen van behandeling werd een overall response rate gezien van 60%, 42,5% van de patiënten bereikte een complete remissie; deze responsen waren meestal bestendig (mediane responsduur not reached). Dit is een vergelijkbaar percentage als bijvoorbeeld bij CD19 CART cel behandelingen, wat momenteel als de hoogste standaard wordt gezien bij R/R DLBCL. Duration of treatment Median 9.3 month / months Frequency of administration 1 times every 2 weeks Dosage per administration 12mg/kg References NCT04150328 https://ashpublications.org/blood/article/134/Supplement_1/1582/427228/Subgroup-Analyses-from-L-Mind-a-Phase-II-Study-of?searchresult=1. Additional remarks The frequency is as follows: • Cycle 1: Administer the infusion on day 1, 4, 8, 15 and 22 of the cycle. • Cycles 2 and 3: Administer the infusion on day 1, 8, 15 and 22 of each cycle. • Cycle 4 until disease progression: Administer the infusion on day 1 and 15 of each cycle. Each cycle has 28 days. Expected patient volume per year Patient volume < 250 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Inschatting Horizonscan Geneesmiddelen axicabtagene ciloleucel. Additional remarks De incidentie van DLBCL (en varianten) in Nederland in 2015 was 1.214 patiënten. Ongeveer 40% van de patiënten reageert niet op de eerste lijnsbehandeling. Ongeveer 50% van de patiënten wordt in de tweede lijn behandeld met autologe stamceltransplantatie. Dit betekent dat naar schatting maximaal 250 van de patiënten in aanmerking zou komen voor behandeling met tafasitamab. Echter worden er beperkte patiëntaantallen verwacht gezien concurrerende geneesmiddelen (CAR-T). Expected cost per patient per year Cost References https://pharmaphorum.com/news/incyte-morphosys-take-on-car-ts-as-lymphoma-antibody-monjuvi-approved-in-us/ Additional remarks Amerikaanse prijs: "Before any rebates or discounts Monjuvi’s wholesale price will average $16,500 per month in the first year of therapy, followed by an average of $13,000 per month in subsequent years because of a decrease in the required number of doses per cycle. At around $198,000 for the first year". Dit zou neerkomen op zo'n €163.000 voor het eerste jaar. De prijs in Nederland voor dit product is nog onbekend. 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 Yes Indication extensions Er lopen op dit moment meerdere fase 2 studies. References Clinicaltrials.gov. Additional remarks Other information Additional remarks