Extended indication Tecentriq as monotherapy is indicated for the first-line treatment of adult patients with advanced N
Therapeutic value No estimate possible yet
Total cost 81,250,000.00
Registration phase Registered

Product

Active substance Atezolizumab
Domain Oncology
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 advanced NSCLC who are ineligible for platinum-based therapy.
Proprietary name Tecentriq
Manufacturer Roche
Portfolio holder 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)
ATMP No
Submission date September 2023
Expected Registration August 2024
Orphan drug No
Registration phase Registered
Additional remarks Positieve CHMP opinie juli 2024

Therapeutic value

Therapeutic value No estimate possible yet
References NCT03191786

Expected patient volume per year

Patient volume

750 - 2,500

Market share is generally not included unless otherwise stated.

References NKR2021; expertopinie
Additional remarks In 2021 waren er 10.096 diagnoses NSCLC in Nederland. Dit betrof 1.727 patiënten in stadium I, 822 patiënten in stadium II, 2.231 patiënten in stadium III, 5.247 patiënten in stadium IV. Ongeveer 50% van de patiënten in Nederland heeft een ECOG PS 2-3 of heeft co-morbiditeit. Indien atezolizumab alleen ingezet gaat worden bij PDL1 hoger dan 50% zou het om ongeveer 30% van deze patiënten gaan (750 per jaar). Indien het ook gegeven zal worden bij een lagere PDL1, worden er 2.500 patiënten verwacht.

Expected cost per patient per year

Cost 40,000.00 - 60,000.00
Additional remarks Op basis van lijstprijs per vial (1.200 mg atezolizumab) van €4.145, Kosten per patiënt per jaar zijn een inschatting in verband met onbekende behandelduur. Voor alle indicaties van atezolizumab geldt een financieel arrangement die is voortgekomen uit de onderhandelingen in de sluis (lopend tot en met 31 december 2026).

Potential total cost per year

Total cost

81,250,000.00

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.