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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
Mechanism of action

PD-1 / PD-L1 inhibitor
Route of administration

Intravenous
Therapeutical formulation

Intravenous drip
Budgetting framework

Intermural (MSZ)
Additional comments 
An engineered anti-PD-L1 antibody

Registration

Registration route

Centralised (EMA)
Type of trajectory

Normal trajectory
Submission date

October 2018
Expected Registration

October 2019
Orphan drug

No
Registration phase

Registration application pending
Additional comments 
Deze potentiele indicatie-uitbreiding is gebaseerd op de klinische studie IMpower133.

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 comments 
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 comments 
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 comments 
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 per patiënt, aangegeven range: €20.000 - €40.000 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, zie ook huidige horizonscan.

Other information

There is currently no futher information available.