Efbemalenograstim alfa Medicine 08 June 2021 Extended indication Ryzneuta is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes). Therapeutic value No estimate possible yet Total cost Registration phase Registered Product Active substance Efbemalenograstim alfa Domain Oncology Reason of inclusion New medicine (specialité) Main indication Oncology other Extended indication Ryzneuta is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes). Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Evive Biotech Portfolio holder Mechanism of action Other, see general comments Route of administration Intravenous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Granulocyte colony-stimulating factor replacement. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date September 2021 Expected Registration March 2024 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Geregistreerd maart 2024 Therapeutic value Current treatment options Pegfilgrastim en lipegfilgrastim Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Het is nog onduidelijk wat de toegevoegde waarde is van dit geneesmiddel in de dagelijkse praktijk. Het zal een extra optie vormen, maar waarschijnlijk niet zorgen voor veel substitutie van de huidige behandelopties. Duration of treatment Frequency of administration 2 times every 3 weeks Dosage per administration 20mg References NCT03252431; persbericht Evive Biotech Additional remarks 20mg fixed dose pre-filled syringe, administered on Day 2 of each of 4 chemotherapy cycles. Expected patient volume per year Patient volume < 7,721 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References GIPdatabank Additional remarks In 2019 waren er 2.650 gebruikers van pegfilgrastim en 5.071 gebruikers van lipegfilgrastim. Afhankelijk van de therapeutische waarde en plaats in de behandelrichtlijn van efbemalenograstim zal een deel van deze patiënten hiervoor in aanmerking kunnen komen. Expected cost per patient per year Cost References GIPdatabank Additional remarks Voor pegfilgrastim en lipegfilgrastim werd in 2019 respectievelijk €3.452 en €3.049 per patiënt vergoed. De prijs van efbemalenograstim zal sterk afhankelijk zijn van de concurrentie positie. 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