Atezolizumab

Active substance
Atezolizumab
Domain
Oncology and Hematology
Reason of inclusion in Horizonscan Geneesmiddelen
Indication extension
Main indication
Bladder cancer
Extended indication
Extension of indication to include, in combination with platinum-based chemotherapy, first-line treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) for Tecentriq.

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)
Type of trajectory
Normal trajectory
Submission date
March 2020
Expected Registration
February 2021
Orphan drug
No
Registration phase
Registration application pending
Additional comments
Voor alle indicaties van atezolizumab geldt een financieel arrangement (tot en met eind 2020).

3. Therapeutic value

Current treatment options
Chemotherapie en in de toekomst ook immuuntherapie
Therapeutic value
No judgement yet
Duration of treatment
Not found
Frequency of administration
1 times every 3 weeks
Dosage per administration
1.200 mg
References
NCT02807636

4. Expected patient volume per year

Patient volume

400 - 600

Market share is generally not included unless otherwise stated.

Additional comments
In totaal zijn er 3.337 patiënten met UC in 2016: 1.110 stadium 1, 622 stadium 2, 339 stadium 3, 636 stadium 4. Vergelijkbare groep patiënten zal in aanmerking komen als voor durvalumab (ongeveer 400 - 600 patiënten).

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 (tot en met eind 2020).

6. Potential total cost per year

Total cost

20,000,000

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
vele indicaties / lopende fase III studies
References
fabrikant en horizonscan

9. Other information

There is currently no futher information available.