Extended indication Tecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic
Therapeutic value No estimate possible yet
Registration phase Registered

Product

Active substance Atezolizumab
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Lung cancer
Extended indication Tecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have a PD-L1 expression ≥ 50% tumour cells (TC) or ≥ 10% tumour-infiltrating immune cells (IC) and who do not have EGFR mutant or ALK-positive NSCLC.
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 November 2019
Expected Registration April 2021
Orphan drug No
Registration phase Registered
Additional comments Positieve CHMP-opinie in maart 2021.

Therapeutic value

Therapeutic value No estimate possible yet
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 In 2018 waren er 5.062 patiënten 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 2023).

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 Geneesmiddelen op het gebied van: huidkanker, longkanker, leverkanker, blaaskanker en borstkanker.
References Fabrikant en Horizonscan Geneesmiddelen

Other information

There is currently no futher information available.