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.