Avelumab

Active substance
Avelumab
Domain
Oncology and Hematology
Reason of inclusion in Horizonscan Geneesmiddelen
Indication extension
Main indication
Bladder cancer
Extended indication
First line treatment of locally advanced or metastatic urothelial carcinoma (UC).

1. Product

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)

2. Registration

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

3. Therapeutic value

Current treatment options
Chemotherapie en in de toekomst immuuntherapie.
Therapeutic value
No judgement
Substantiation
Studie heeft primair eindpunt (OS) behaald.
Duration of treatment
Not found
Dosage per administration
800 mg
References
NCT02603432
Additional comments
Flat dosing

4. Expected patient volume per year

Patient volume

150 - 200

Market share is generally not included unless otherwise stated.

References
Pembrolizumab urotheelcarcinoom record; NKR
Additional comments
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.

5. Expected cost per patient per year

Cost
42,000 - 84,000
References
G-standaard
Additional comments
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.

6. Potential total cost per year

Total cost

11,025,000

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.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

Indication extension
Yes
Indication extensions
Verschillende lopende fase 3 studies
References
adisinsight

9. Other information

There is currently no futher information available.