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Avelumab

Bavencio

Extended indication First line treatment of locally advanced or metastatic urothelial carcinoma (UC).
Therapeutic value No judgement
Total cost 11,025,000.00
Registration phase Clinical trials

Product

Active substance Avelumab
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Bladder cancer
Extended indication First line treatment of locally advanced or metastatic urothelial carcinoma (UC).
Proprietary name Bavencio
Manufacturer Merck/Pfizer
Mechanism of action PD-1 / PD-L1 inhibitor
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date 2020
Expected Registration 2021
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Current treatment options Chemotherapie en in de toekomst immuuntherapie.
Therapeutic value No judgement
Substantiation Studie heeft primair eindpunt (OS) behaald.
Dosage per administration 800 mg
References NCT02603432
Additional remarks Flat dosing

Expected patient volume per year

Patient volume

150 - 200

Market share is generally not included unless otherwise stated.
References Pembrolizumab urotheelcarcinoom record; NKR
Additional remarks Naar verwachting zal het patiëntvolume in lijn zijn met andere PD-1/PD-L1 remmers. Stadium 3 en 4 urotheelcarcinoom betrof in 2015, 1.018 patiënten. De verwachting is dat zo'n 20% hiervan de behandeling gaat krijgen.

Expected cost per patient per year

Cost 42,000.00 - 84,000.00
References G-standaard
Additional remarks In lijn met andere PD-1/PD-L1 remmers en indicaties voor avelumab. De behandelkosten per jaar zullen afhangen van de studieresultaten (gemiddelde dosering/behandelduur). AIP Bavencio 20mg/ml voor flacon 10 ml : €924,26 exclusief BTW (april 2019). Uitgaande van een behandeling van 6-12 maanden zullen de kosten respectievelijk €42.053,89 en €84.107,66 bedragen.

Potential total cost per year

Total cost

11,025,000.00

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 Verschillende lopende fase 3 studies
References adisinsight

Other information

There is currently no futher information available.