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 € 24,108,000.00 Registration phase Registered 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 Reimbursement Medicine sluice Additional remarks Daratumumab zit in de sluisprocedure. 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 Once weekly, for 6 weeks in Cycle 1 and then once every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity. Expected patient volume per year Patient volume < 287 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 patiënten bedraagt 1.117, waarvan 90% symptomatisch: 1.006. Patiënten die non-fit zijn voor ASCT zijn >70 jaar en >65 met comorbiditeiten (50%; 478 ptn). Hiervan zal naar verwachting 60% een behandeling met VMP krijgen, dit betekent dat 287 patiënten in aanmerking komen. Hoeveel patiënten hiervan daadwerkelijk ook met daratumumab zullen worden behandeld moet nog vastgesteld worden. 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 € 24,108,000.00 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