Balixafortide Medicine 08 June 2021 Extended indication In combination with eribulin in patients with HER2 Negative, Locally Recurrent or Metastatic Breast Cancer. Therapeutic value No estimate possible yet Total cost € 107,277,500.00 Registration phase Clinical trials Product Active substance Balixafortide Domain Oncology Reason of inclusion New medicine (specialité) Main indication Breast cancer Extended indication In combination with eribulin in patients with HER2 Negative, Locally Recurrent or Metastatic Breast Cancer. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Polyphor Portfolio holder Mechanism of action Receptor antagonist Route of administration Intravenous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks CXCR4 receptor antagonist. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2023 Expected Registration 2024 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 Op dit moment is er nog weinig bekend over de mogelijke meerwaarde van deze behandeling. Duration of treatment Frequency of administration Dosage per administration References NCT03786094 Additional remarks Expected patient volume per year Patient volume 2,400 - 2,769 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2020 (1) Pakketadvies palbociclib (Ibrance®) (2). Additional remarks Incidentie invasieve borstkanker 14.461 patiënten. Ongeveer 1.000 patiënten worden met een stadium IV tumor gediagnosticeerd (1). Van de patiënten met een stadium I-IIIB tumor, zal ongeveer 20% uiteindelijk metastases (2.692 patiënten) krijgen (2). In totaal zijn dit 3.692 patiënten, hiervan is 65% tot 75% HER2 negatief (2). Dit betekent dat er 2.400 tot 2.769 patiënten in aanmerking zullen komen. Expected cost per patient per year Cost € 41,500.00 This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year. References https://www.edisongroup.com/publication/balixafortide-phase-iii-data-coming-soon/27899/ Additional remarks Uit de grove inschatting van een investeringsfonds blijkt een toekomstige prijs van $50.000 op jaarbasis voor patiënten binnen Europa. De uiteindelijke prijs in Nederland is echter nog niet bekend. Potential total cost per year Total cost € 107,277,500.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Adis Insight Additional remarks Geen andere lopende Fase 3 studies (december 2020) Other information Additional remarks