Blinatumomab Medicine 03 December 2024 Extended indication Indicated as monotherapy as part of consolidation therapy for the treatment of adult patients with newly diagnosed Philadelphia chromosome negative CD-19 positive B-cell precursor ALL Therapeutic value Possible added value Total cost Registration phase Registration application pending Product Active substance Blinatumomab Domain Hematology Reason of inclusion Indication extension IND Main indication ALL Extended indication Indicated as monotherapy as part of consolidation therapy for the treatment of adult patients with newly diagnosed Philadelphia chromosome negative CD-19 positive B-cell precursor ALL Current proprietary name Already available biosimilars / generics Proprietary name BLINCYTO® Manufacturer Amgen Portfolio holder Amgen 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 Blinatumomab is een bispecifiek T-cel-engager-antilichaamconstruct dat specifiek bindt aan CD19 Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date March 2024 Expected Registration January 2025 Orphan drug Yes Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Intensieve combinatiechemotherapie zoals beschrven in het HOVON100 protocol (1) Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation De ECOG-ACRIN E1910-studie toonde aan dat de toevoeging van blinatumomab aan consolidatiechemotherapie resulteerde in een significant betere algehele overleving bij patiënten met nieuw gediagnosticeerde B-lineage ALL die MRD-negatief waren na intensiveringschemo (mediane OS: niet bereikt versus 71,4 maanden; Hazard ratio 0,42, 95% BI: 0,24 - 0,75; two-sided p=0,003). Mediane follow-up was 43 maanden). Er werden geen significante veiligheidszorgen opgemerkt (2,3). Duration of treatment Frequency of administration Dosage per administration References Richtlijn acute lymfatische leukemie Diagnostiek en behandeling. Organisatie HOVON leukemie werkgroep. 2020 (1); Litzow et al. N Engl J Med. 2024 (2). NCT02003222 (ECOG-ACRIN E1910) (3). Additional remarks Continuous blinatumomab IV for 28 days for maximum 4 cycles. 1 cycle consist of 28 days IV infusion with a fixed dosing of 28mg/day. Expected patient volume per year Patient volume < 33 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; Expertopinie Additional remarks Het geschatte aantal in aanmerking komende patiënten met Ph-precursor B-cel ALL die MRD- zijn na inductie en intensivering, wordt geschat op 33. Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Additional remarks Other information Additional remarks