Rexlemestrocel-L Medicine 07 December 2021 Extended indication Advanced chronic heart failure in patients who are no longer responsive to maximal standard of care heart failure drugs Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Rexlemestrocel-L Domain Cardiovascular diseases Reason of inclusion New medicine (specialité) Main indication Other medication for cardiovascular diseases Extended indication Advanced chronic heart failure in patients who are no longer responsive to maximal standard of care heart failure drugs Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Teva Portfolio holder Mechanism of action Unknown Route of administration Intracardiac Therapeutical formulation Unknown Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Yes Submission date 2024 Expected Registration 2025 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Primary completion datum in mei 2020. Therapeutic value Current treatment options Harttransplantatie Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation In de afgelopen jaren zijn er nog geen goede resultaten bij vergelijkbare medicamenten gevonden. Op dit moment lopen de onderzoeken nog. Patiënten die niet in aanmerking komen voor een harttransplantatie, maar deze wel nodig hebben zouden in aanmerking kunnen komen voor deze behandeling. Duration of treatment Frequency of administration Dosage per administration References NCT02032004 (DREAM HF-1) Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References RIVM Additional remarks Patiënten die niet in aanmerking komen voor een harttransplantatie, maar deze wel nodig hebben zouden in aanmerking kunnen komen voor deze behandeling. 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 Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Acute myeloid leukaemia; Hodgkin's disease; Intervertebral disc degeneration; Non-Hodgkin's lymphoma; Precursor cell lymphoblastic leukaemia-lymphoma References Adisinsight Additional remarks Meerdere lopende fase 3 studies. Other information Additional remarks