Denosumab

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
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.
Proprietary name	XGEVA
Manufacturer	Amgen
Route of administration	Subcutaneous
Therapeutical formulation	Injection
Budgetting framework	Extramural (GVS)

Registration

Registration route	Centralised (EMA)
Type of trajectory	Normal trajectory
Particularity	Indication extension
Submission date	April 2017
Expected Registration	April 2018
Orphan drug	No
Registration phase	Registered and reimbursed
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
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.
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.

Patient volume

448

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 2.800 is 448 patiënten.

Expected cost per patient per year

Cost	3,000.00 - 5,000.00
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 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.

Total cost

1,792,000.00

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.

Off label use

There is currently nothing known about off label use.

Indication extension

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

Other information

There is currently no futher information available.