Extended indication For the 1L treatment of patients with metastatic HCC in combination with bevacizumab.
Therapeutic value No judgement
Total cost 3,000,000.00
Registration phase Clinical trials

Product

Active substance Atezolizumab
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Liver cancer
Extended indication For the 1L treatment of patients with metastatic HCC in combination with bevacizumab.
Proprietary name Tecentriq
Manufacturer Roche
Mechanism of action PD-1 / PD-L1 inhibitor
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks An engineered anti-PD-L1 antibody

Registration

Registration route Centralised (EMA)
Submission date February 2020
Expected Registration December 2020
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Current treatment options Chemotherapie en best ondersteunde zorg
Therapeutic value No judgement
Frequency of administration 1 times every 3 weeks
Dosage per administration 1.200 mg
References fabrikant (De resultaten van de klinische studie zijn nog niet bekend)

Expected patient volume per year

Patient volume

50 - 100

Market share is generally not included unless otherwise stated.

References NKR
Additional remarks NKR 2016: 158 patiënten met HCC stadium 4. De werkgroep verwacht dat hier van 50-100 patiënten voor deze behandeling in aanmerking komen.

Expected cost per patient per year

Cost 30,000.00 - 50,000.00
Additional remarks Afhankelijk van behandelduur. Deze is op dit moment onbekend. Om die reden op basis van andere indicaties van atezolizumab de inschatting gemaakt dat deze mogelijk €30.000 - €50.000 per patiënt per jaar kan gaan kosten. Voor alle indicaties van atezolizumab geldt een financieel arrangement die is voortgekomen uit de onderhandelingen in de sluis (lopend tot en met 31 december 2019). Voor de indicatie blaaskanker zit atezolizumab nog in de sluis.

Potential total cost per year

Total cost

3,000,000.00

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 vele indicaties / lopende fase III studies
References Fabrikant en Horizonscan

Other information

There is currently no futher information available.