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Atezolizumab

Tecentriq

Extended indication Extensive-stage small-cell lung cancer, first-line treatment in combination with carboplatin and eto
Therapeutic value Possible added value
Total cost 18,000,000.00
Registration phase Registration application pending

Product

Active substance Atezolizumab
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Lung cancer
Extended indication Extensive-stage small-cell lung cancer, first-line treatment in combination with carboplatin and etoposide. Independent of PD-L1 expression.
Proprietary name Tecentriq
Manufacturer Roche
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 August 2018
Expected Registration September 2019
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Current treatment options Chemotherapie en in de toekomst ook immuuntherapie
Therapeutic value Possible added value
Substantiation Fabrikant: op basis van verbeterde PFS en OS
Duration of treatment Median 4.7 month / months
Frequency of administration 1 times every 3 weeks
Dosage per administration 1200 mg
References NCT02763579; Fabrikant; Horn et al. 2018. First-Line Atezolizumab plus Chemotherapy in Extensive-Stage Small-Cell Lung Cancer, NEJM
Additional remarks Atezolizumab intravenous infusion will be administered at a dose of 1.200 mg on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4) and maintenance phase (Cycle 5 onward).

Expected patient volume per year

Patient volume

500 - 700

Market share is generally not included unless otherwise stated.
References NKR2017, expertopinie.
Additional remarks In 2016 werden er 1.118 diagnoses stadium 4 SCLC geregistreerd. Inschatting patientvolume is sterk afhankelijk van precieze indicatie. De inschatting is dat er uiteindelijk 500-700 patiënten in aanmerking kunnen komen voor deze behandeling.

Expected cost per patient per year

Cost 20,000.00 - 40,000.00
References Fabrikant.
Additional remarks Mediane behandelduur met atezolizumab in klinische studie bedroeg 4,7 maanden. Dit betreft 7 toedieingen van 1.200mg atezolizumab, wat resulteert in een kleine €30.000,00 per patiënt, aangegeven range: €20.000,00 - €40.000,00 p.p.p.j.. 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

18,000,000.00

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

Off label use No
References Fabrikant

Indication extension

Indication extension Yes
Indication extensions Er zijn vele indicatie-uitbreidingen in ontwikkeling, momenteel heeft roche 19 fase III studies in hun pijplijn.
References Roche pipeline

Other information

There is currently no futher information available.