Daratumumab Medicine 12 June 2018 Extended indication Darzalex is indicated in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. Therapeutic value No judgement Total cost € 5,880,000.00 Registration phase Registered and reimbursed Product Active substance Daratumumab Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Multiple Myeloma Extended indication Darzalex is indicated in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. Current proprietary name Already available biosimilars / generics Proprietary name Darzalex Manufacturer Janssen Portfolio holder Mechanism of action Immunostimulation Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Antilichaam tegen CD38. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date October 2017 Expected Registration September 2018 Orphan drug Yes Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie juli 2018. Geregistreerd in september 2018. Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times a day Dosage per administration 16 mg/kg References NCT02195479 Additional remarks Eenmaal per week gedurende 6 weken in cyclus 1, daarna eenmaal per 3 weken in cyclus 2 tot en met 9. Daarna eenmaal per 4 weken tot aan progressie of toxiciteit. Expected patient volume per year Patient volume 70 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; Pakketadvies daratumumab (Darzalex®) bij multipel myeloom, ZIN 2017 Additional remarks Jaarlijks aantal nieuwe multipel myeloma patienten bedraagt 1.117, waarvan 90% symptomatisch: 1.006. Patiënten die non-fit zijn voor ASCT zijn >70 jaar en >65 met comorbiditeiten (352 patiënten). De inschatting is dat DARA-Rd/DARA-VMP/VMP/Rd in de verhouding van 60%, 20%, 10% en 10% voorgeschreven zal worden. Echter, dit is wel mede afhankelijk van de data in cytogenetic high risk patiënten en de PFS van DRd ten opzichte van Dara-VMP. Expected cost per patient per year Cost € 84,000.00 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 Medicijnkosten.nl Additional remarks Flacon 100 mg kost €431,36. Totaal is gebaseerd op een patiënt van 70 kg en een behandeling van 6 maanden. Voor deze indicatie geldt een financieel arrangement die is voortgekomen uit de onderhandelingen in de sluis (duur: tot 1 januari 2022). Potential total cost per year Total cost € 5,880,000.00 Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions References Additional remarks Other information Additional remarks