Inclacumab Medicine 03 June 2025 Extended indication Prevention of recurrent VOCs in sickle cell disease patients ≥16 years old Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Inclacumab Domain Cardiovascular diseases Reason of inclusion New medicine (specialité) Main indication Other non-oncological hematological medications Extended indication Prevention of recurrent VOCs in sickle cell disease patients ≥16 years old Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Pfizer Portfolio holder Pfizer Mechanism of action Other, see general comments Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Monoclonal antibody that binds to P-selectin, blocking its interaction with ligands on neutrophils and monocytes. Under administration, this drug binds to P-selectin and inhibits platelet aggregation, maintains normal blood flow and minimize sickle cell-related pain crises (SCPC). Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date March 2026 Expected Registration June 2027 Orphan drug No Registration phase Clinical trials 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 Er zijn nog geen resultaten uit de fase 3 studie bekend. Duration of treatment Frequency of administration Dosage per administration References Clin trials.gov NCT05348915 Additional remarks Expected patient volume per year Patient volume < 2,000 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References https://www.erasmusmc.nl/nl-nl/patientenzorg/aandoeningen/sikkelcelziekte#26e2db54-b255-4e9e-997a-ef6e3e754212; RIVM, Sikkelcelziekte- Informatie in het kader van de neonatale hielprikscreening Additional remarks In Nederland zijn er ongeveer 2.000 patiënten met sikkelcelziekte. Elk jaar worden er zo’n 40 tot 60 baby’s geboren met sikkelcelziekte. Het geneesmiddel wordt nu getest in patiënten die 2 tot 10 crises per jaar hebben. Een deel van de patiënten in Nederland zal met de huidige therapie (hydrea en wisseltransfusies, mogelijk mitapivat in de toekomst) minder crises krijgen en daardoor niet in aanmerking komen voor inclacumab. Expected cost per patient per year Cost References Additional remarks De Nederlandse prijs is nog niet vastgesteld. De prijsstelling zal niet voor 2027 beschikbaar zijn. Potential total cost per year Total cost Total cost for sluice Additional remarks Er is op dit moment niets bekend over de verwachte prijs en kosten 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