Extended indication Extension of indication to include, in combination with platinum-based chemotherapy, first-line trea
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
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.
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

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).

Therapeutic value

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

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).

Expected cost per patient per year

Cost 30,000.00 - 50,000.00
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).

Potential total cost per year

Total cost

20,000,000.00

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.