Denosumab Medicine 09 January 2018 Extended indication Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) advanced malignancies involving bone. Therapeutic value No judgement Total cost € 1,792,000.00 Registration phase Registered and reimbursed Product Active substance Denosumab Domain Oncology and Hematology Reason of inclusion Main indication Multiple Myeloma Extended indication Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) advanced malignancies involving bone. Current proprietary name Already available biosimilars / generics Proprietary name XGEVA Manufacturer Amgen Portfolio holder Mechanism of action Unknown Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Indication extension ATMP Unknown Submission date April 2017 Expected Registration April 2018 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Positieve CHMP opinie februari 2018. Geregistreerd in april 2018. Therapeutic value Current treatment options Zoledroninezuur IV en APD IV Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times every 4 weeks Dosage per administration 120 mg References Fabrikant; Raje et al. Oral Presentation at the 16th Annual International Myeloma Workshop; March 1-4, 2017; New Delhi, India. Abstract OP-046. Additional remarks Fabrikant: Gemiddelde behandelduur nog niet bekend; 1x per 4 weken Expected patient volume per year Patient volume 448 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References IMS health market research data 2010; Terpos et al. J Clin Oncol. 2013;31:2347-57. Additional remarks Fabrikant: Max. patiëntvolume: In Nederland zijn er ongeveer 2.800 MM patienten die behandeld worden (stage I 22%, stage II 33% and stage III 45%). Multiple myeloma is a plasma cell malignancy typically characterized by bone disease, with approximately 80% of patients presenting with osteolytic lesions at diagnosis. Van max. naar realistisch patiëntvolume: Treatment rate stage I 45%, stage II 85%, and stage III 97%1. Ingeschat marktaandeel 20%. Berekening realistisch volume: 20% van 80% van 2.800 is 448 patiënten. Expected cost per patient per year Cost € 3,000.00 - 5,000.00 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 €336,07 denosumab injectievloeistof 70 mg/ml 1,7 ml. Inschatting pppj uitgaande van een jaar lang 1 maal per 4 weken 120 mg. Potential total cost per year Total cost € 1,792,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Bone metastases prevention in patients with breast cancer - adjuvant therapy (Ph III). References Additional remarks Other information Additional remarks