Extended indication Extension of indication to include the first-line treatment of patients with metastatic non-small ce
Therapeutic value No judgement
Registration phase Registration application pending

Product

Active substance Atezolizumab
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Lung cancer
Extended indication Extension of indication to include the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumours express PD-L1.
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 IMpower110

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date December 2019
Expected Registration April 2021
Orphan drug No
Registration phase Registration application pending
Additional comments Fabrikant verwacht registratie in Q2 2021.

Therapeutic value

Therapeutic value No judgement
Substantiation complexe behandeling. Gaat de concurrentie aan met pembro+chemo in de eerste lijn.
Frequency of administration 1 times every 3 weeks
Dosage per administration 1200 mg
References NCT02409342

Expected patient volume per year

References NKR
Additional comments Jaarlijks presenteren er ongeveer 4.500 patiënten per jaar met NSCLC stadium IV. De inschatting is dat onder andere vanwege de complexe behandeling er slechts weinig patiënten voor deze behandeling in aanmerking zullen komen.

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 die is voortgekomen uit de onderhandelingen in de sluis (lopend tot en met 31 december 2020).

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

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

Other information

There is currently no futher information available.