Version 4

Atezolizumab

Medicine

Extended indication Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC), after prior p
Therapeutic value No judgement yet
Total cost € 20,000,000.00
Registration phase Registration application pending

Product

Active substance Atezolizumab
Domain Oncology and Hematology
Reason of inclusion Indication extension IND
Main indication Bladder cancer
Extended indication Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC), after prior platinum containing chemotherapy, or who are considered cisplatin ineligible, and whose tumours have a PD-L1 expression ≥ 5%.
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)
Type of trajectory Normal trajectory
Particularity Unknown
ATMP Unknown
Submission date March 2020
Expected Registration March 2021
Orphan drug No
Registration phase Registration application pending
Additional remarks Voor alle indicaties van atezolizumab geldt een financieel arrangement (tot en met eind 2020).

Therapeutic value

Current treatment options Chemotherapie en in de toekomst ook immuuntherapie
Therapeutic value No judgement yet

This assessment does not indicate any potential inclusion in the package.
Substantiation In de fase III studie genaamd IMvigor130 werd een statistisch significant verschil gevonden voor de progressievrije overleving (PFS) ten opzichte van enkel chemotherapie. Voor de overall overleving (OS) werd geen statistisch significant verschil gevonden, (HR)=0.82. Mogelijk zullen hierdoor de PASKWIL-criteria niet gehaald worden.
Frequency of administration 1 times every 3 weeks
Dosage per administration 1.200 mg
References NCT02807636

Expected patient volume per year

Patient volume 400 - 600

Market share is generally not included unless otherwise stated.
References NKR
Additional remarks 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).

Expected cost per patient per year

Cost € 30,000.00 - 50,000.00

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.
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 (tot en met eind 2020).

Potential total cost per year

Total cost € 20,000,000.00

Off label use

Off label use Unknown

Indication extension

Indication extensions Yes
Indication extensions vele indicaties / lopende fase III studies
References fabrikant en horizonscan

Other information