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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 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 van 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.