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Atezolizumab

Tecentriq

Extended indication

In combination with cabozantinib patients with mCRPC previously treated with novel hormonal therapy

Therapeutic value

No estimate possible yet
Total cost

135,000,000.00
Registration phase

Clinical trials

Product

Active substance

Atezolizumab
Domain

Oncology
Reason of inclusion

Indication extension
Main indication

Prostate cancer
Extended indication

In combination with cabozantinib patients with mCRPC previously treated with novel hormonal therapy (NHT)
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
Submission date

July 2024
Expected Registration

March 2025
Orphan drug

No
Registration phase

Clinical trials

Therapeutic value

Therapeutic value

No estimate possible yet
Frequency of administration

1 times every 3 weeks
Dosage per administration

1200 mg
References 
NCT04446117

Expected patient volume per year

Patient volume

< 3,000

Market share is generally not included unless otherwise stated.
References 
record pembrolizumab;
NKR, CAPRI en Zinnige Zorg verbetersignalement: Zinnig gebruik van geneesmiddelen bij patiënten met castratie refractair prostaatcarcinoom
Additional remarks 
Totaal aantal nieuwe prostaatkankerpatiënten per jaar is meer dan 12.000. Patiënten geregistreerd in de NKR 2016 met "cM0cNX, cM0cN0, cMcN1, cM1, pM1" betreft 8.226 in totaal. Het gaat hierbij om zo’n 2.400 tot 3.000 CRPC patiënten (bron: CAPRI). Gezien bijna alle patiënten CRPC uitzaaiingen hebben is de verwachting dat het bijna de gehele groep mCRPC patiënten betreft.

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 d.d. 6 november 2023.  

Potential total cost per year

Total cost

135,000,000.00

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

Verschillende indicaties
References 
Product Development Portfolio

Other information

There is currently no futher information available.