Daratumumab Medicine 08 December 2020 Extended indication Darzalex as monotherapy is indicated for the treatment of adult patients with smouldering multiple myeloma at high risk of developing multiple myeloma (see section 5.1). Therapeutic value No estimate possible yet Total cost € 13,379,800.00 Registration phase Registered Product Active substance Daratumumab Domain Hematology Reason of inclusion Indication extension IND Main indication Multiple Myeloma Extended indication Darzalex as monotherapy is indicated for the treatment of adult patients with smouldering multiple myeloma at high risk of developing multiple myeloma (see section 5.1). Current proprietary name Already available biosimilars / generics Proprietary name Darzalex Manufacturer Janssen Portfolio holder Mechanism of action Other, see general comments Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date December 2024 Expected Registration August 2025 Orphan drug Yes Registration phase Registered Reimbursement Medicine sluice Broadly excluded Additional remarks Positieve CHMP-opinie in juni 2025. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation In de studie is een voordeel op overall survival aangetoond. Echter er zijn methodologische 'issues' in de studie. De risicoclassificatie blijkt niet optimaal, voorkomt geen orgaanschade. Duration of treatment Frequency of administration Dosage per administration 1.800mg References NCT03301220 (AQUILA) Additional remarks Eerste jaar: 23 toedieningen; Tweede en derde jaar: 13 toedieningen. Maximale behandelduur van 36 maanden. Er zal meerwaarde zijn ten opzichte van niet behandelen. Expected patient volume per year Patient volume < 133 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2018(1); Pakketadvies daratumumab (2); Additional remarks Jaarlijks aantal nieuwe multipel myeloom patiënten bedraagt 1.333 (1). Hiervan is 10% asymptomatisch (2). Dit betekent dat er maximaal 133 patiënten in aanmerking zullen komen voor deze behandeling. Expected cost per patient per year Cost € < 100,600.00 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 Fabrikant, G-standaard Additional remarks Jaar 1: €100.571; Jaar 2 en 3: €56.845. Op basis van de lijstprijs. Potential total cost per year Total cost € 13,379,800.00 Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks