Atezolizumab

Active substance
Atezolizumab
Domain
Oncology and Hematology
Reason of inclusion in Horizonscan Geneesmiddelen
Indication extension
Main indication
Liver cancer
Extended indication
Extension of indication to include, in combination with bevacizumab, the treatment of patients with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

1. Product

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 comments
An engineered anti-PD-L1 antibody

2. Registration

Registration route
Centralised (EMA)
Submission date
February 2020
Expected Registration
January 2021
Orphan drug
No
Registration phase
Registration application pending
Additional comments
Fabrikant verwacht registratie in januari 2021.

3. Therapeutic value

Current treatment options
Chemotherapie en best ondersteunde zorg
Therapeutic value
No judgement
Duration of treatment
Not found
Frequency of administration
1 times every 3 weeks
Dosage per administration
1.200 mg
References
fabrikant; NCT03434379

4. Expected patient volume per year

Patient volume

50 - 100

Market share is generally not included unless otherwise stated.

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

5. Expected cost per patient per year

Cost
30,000 - 50,000
Additional comments
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 2020).

6. Potential total cost per year

Total cost

3,000,000

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
Zie indicatie-uitbreidingen in de horizonscan op het gebied van: huidkanker, longkanker, leverkanker, blaaskanker en borstkanker
References
Fabrikant en Horizonscan

9. Other information

There is currently no futher information available.