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Denosumab

Medicine

Extended indication Geindiceerd voor de preventie van botcomplicaties (pathologische fractuur, bestraling van bot, ruggenmergcompressie of chirurgie van het bot) bij volw
Therapeutic value No judgement
Total cost € 6,496,000.00
Registration phase Unknown

Product

Active substance Denosumab
Domain Oncology and Hematology
Main indication Multiple Myeloma
Extended indication Geindiceerd voor de preventie van botcomplicaties (pathologische fractuur, bestraling van bot, ruggenmergcompressie of chirurgie van het bot) bij volwassenen met botmetastasen door multipel myeloom of solide tumoren. Bone metastases from multiple myeloma, reduction in skeletal related events.
Proprietary name XGEVA
Manufacturer Amgen
Mechanism of action Unknown
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity Unknown
ATMP Unknown
Submission date April 2017
Expected Registration February 2018
Orphan drug No
Registration phase Unknown
Additional remarks Dit is een indicatie-uitbreiding.

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.
Frequency of administration 1 times a month
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 - 2,800

Market share is generally not included unless otherwise stated.
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 2800 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 € 6,496,000.00

Off label use

Off label use Unknown

Indication extension

Indication extensions Yes
Indication extensions Bone metastases prevention in patients with breast cancer - adjuvant therapy (Ph III).

Other information