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Atezolizumab

Tecentriq

Extended indication Tecentriq in combination with nab-paclitaxel is indicated for the treatment of adult patients with u
Therapeutic value No judgement
Total cost 4,480,000.00
Registration phase Registered and reimbursed

Product

Active substance Atezolizumab
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Breast cancer
Extended indication Tecentriq in combination with nab-paclitaxel is indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease.
Proprietary name Tecentriq
Manufacturer 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)
Type of trajectory Normal trajectory
Submission date October 2018
Expected Registration August 2019
Orphan drug No
Registration phase Registered and reimbursed
Additional remarks Positieve CHMP-opinie in juni 2019. Geregistreerd in augustus 2019.

Therapeutic value

Current treatment options Chemotherapie en in de toekomst ook immuuntherapie
Therapeutic value No judgement
Duration of treatment Median 26.5 week / weeks
Frequency of administration 1 times every 2 weeks
Dosage per administration 840 mg
References Fabrikant;Schmid et al. 2018.
Additional remarks Atezolizumab and Nab-Paclitaxel in Advanced Triple-Negative Breast Cancer, NEJM.

Expected patient volume per year

Patient volume

90 - 134

Market share is generally not included unless otherwise stated.
References NKR
Additional remarks Incidentie stadium IV borstkanker is ongeveer 6% van het totaal. Waarvan ongeveer 10%-15% TNBC. NKR 2016: 134 diagnoses mammacarcinoom HR-, HER-, stadium 4.

Expected cost per patient per year

Cost 30,000.00 - 50,000.00
References Fabrikant
Additional remarks Mediane behandelduur met atezolizumab in klinische studie was 26,5 weken. Dit betreft 13 toedieningen van 840 mg atezolizumab wat resulteert in een kleine €40.000 per patiënt, aangegeven range €30.000 - €50.000 per patiënt per jaar. Voor alle indicaties van atezolizumab geldt een financieel arrangement die is voortgekomen uit de onderhandelingen in de sluis (lopend tot en met 31 december 2019). Voor de indicatie blaaskanker zit atezolizumab nog in de sluis.

Potential total cost per year

Total cost

4,480,000.00

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

Off label use No
References Fabrikant

Indication extension

Indication extension Yes
Indication extensions Er lopen meerdere fase 3 studies.
References clinicaltrials.gov en zie huidige Horizonscan.

Other information

There is currently no futher information available.