Atezolizumab

Active substance
Atezolizumab
Domain
Oncology and Hematology
Reason of inclusion in Horizonscan Geneesmiddelen
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.

1. Product

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

2. 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.

3. Therapeutic value

Current treatment options
Chemotherapie en in de toekomst ook immuuntherapie
Therapeutic value
Potential 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).

4. 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.

5. Expected cost per patient per year

Cost
20,000 - 40,000
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.

6. Potential total cost per year

Total cost

18,000,000

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.

7. Off label use

Off label use
No
References
Fabrikant

8. 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.

9. Other information

There is currently no futher information available.