Extended indication

Bavencio is indicated as monotherapy for the first-line maintenance treatment of adult patients with

Therapeutic value

No judgement

Total cost

8,054,900.00

Registration phase

Registration application pending

Product

Active substance

Avelumab

Domain

Oncology and Hematology

Reason of inclusion

Indication extension

Main indication

Bladder cancer

Extended indication

Bavencio is indicated as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) whose disease has not progressed with platinum-based induction chemotherapy.

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

June 2020

Expected Registration

February 2021

Orphan drug

No

Registration phase

Registration application pending

Additional comments
Fabrikant verwacht registratie in Q1 2021.

Therapeutic value

Current treatment options

"- Platinum-gebaseerde chemotherapie - Pembrolizumab voor patiënten die eerder platinum bevattende chemotherapie hebben ondergaan, óf die niet in aanmerking komen voor cisplatine bevattende chemotherapie én bij wie de tumoren een PD-L1-expressie vertonen met een 'combined positive score' (CPS) ≥ 10."

Therapeutic value

No judgement

Substantiation

Studie heeft primair eindpunt (OS) behaald.

Duration of treatment

Median 24.9 week / weeks

Frequency of administration

1 times every 2 weeks

Dosage per administration

800 mg

References
NCT02603432
Additional comments
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 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.

Expected cost per patient per year

Cost

46,028.00

References
Fabrikant; Powels et al. 2020 NEJM Javelin Bladder 100 (DOI: 10.1056/NEJMoa2002788); z-index november 2020"
Additional comments
De kosten van een verpakking van 200 mg Bavencio bedragen €924.26 (z-index nov 2020). Het bij EMA ingediende label voor 1LM UC gaat uit van 800mg flat dosing iedere 2 weken toegediend. Uitgaande van een mediane behandelduur voor avelumab in 1LM UC van 24,9 weken (Powles et al. 2020) zullen de kosten €46.028,15 bedragen.

Potential total cost per year

Total cost

8,054,900.00

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

Longkanker, nierkanker

References
Fabrikant

Other information

There is currently no futher information available.