Atezolizumab

Active substance
Atezolizumab
Domain
Oncology and Hematology
Reason of inclusion in Horizonscan Geneesmiddelen
Indication extension
Main indication
Breast cancer
Extended indication
treatment of patients with previously untreated metastatic TNBC in combination with paclitaxel

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
IMpassion131

2. Registration

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

3. Therapeutic value

Current treatment options
Chemotherapie - trastuzumab - pertuzumab
Therapeutic value
No judgement
Duration of treatment
Not found
Frequency of administration
1 times every 2 weeks
Dosage per administration
840 mg
References
NCT03125902

4. Expected patient volume per year

References
NKR 2016
Additional comments
1.687 diagnoses mammacarcinoom HR-, HER-. Hiervan betreft het 563 patiënten in stadium 1, 747 patiënten in stadium 2, 239 patiënten in stadium 3 en 134 patiënten in stadium 4. Echter de inschatting is dat de combinatie met paclitaxel nauwelijks zal worden toegepast in Nederland.

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

There is currently nothing known about the possible total cost.

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, nierkanker en borstkanker
References
Horizonscan

9. Other information

There is currently no futher information available.