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.