Extended indication Adjuvant therapy after definitive local therapy in patients with high-risk locally advanced squamous
Therapeutic value No estimate possible yet
Total cost 16,875,000.00
Registration phase No registration expected

Product

Active substance Atezolizumab
Domain Oncology
Reason of inclusion Indication extension
Main indication Head and neck cancer
Extended indication Adjuvant therapy after definitive local therapy in patients with high-risk locally advanced squamous cell carcinoma of the head and neck.
Proprietary name Tecentriq
Manufacturer Roche
Portfolio holder Roche
Mechanism of action PD-1 / PD-L1 inhibitor
Route of administration Intravenous
Therapeutical formulation Concentrate for solution for infusion
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Orphan drug No
Registration phase No registration expected
Additional remarks IMvoke010 studie toont geen overall survival aan.

Therapeutic value

Therapeutic value No estimate possible yet
Substantiation De klinische studie loopt nog. Behandeling is na (operatie) en/of chemoradiotherapie.
Frequency of administration 1 times every 3 weeks
Dosage per administration 1200 mg
References NCT03452137

Expected patient volume per year

Patient volume

< 375

Market share is generally not included unless otherwise stated.

References NKR2020(1); expertopinie(2);
Additional remarks Er zijn in totaal 2.855 patiënten met SCC van het hoofd-halsgebied, 375 hiervan hebben stadium 3. Het is nog niet bekend of er ook een grens voor de PD-L1 expressie aangehouden zal worden.

Expected cost per patient per year

Cost 35,000.00 - 55,000.00
References https://zoek.officielebekendmakingen.nl/stcrt-2023-30299.html
Additional remarks Op basis van lijstprijs per vial (1.200mg atezolizumab) van €3.700. 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). Zie publicatie in Staatscourant van 6 november 2023.  

Potential total cost per year

Total cost

16,875,000.00

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 Meerdere indicaties in ontwikkeling
References Product Development Portfolio

Other information

There is currently no futher information available.