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Atezolizumab

Tecentriq

Extended indication Extension of indication to include, in combination with bevacizumab, the treatment of patients with
Therapeutic value Possible added value
Total cost 3,000,000.00
Registration phase Registered

Product

Active substance Atezolizumab
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Liver cancer
Extended indication Extension of indication to include, in combination with bevacizumab, the treatment of patients with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy.
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 January 2020
Expected Registration November 2020
Orphan drug No
Registration phase Registered
Additional remarks Positieve CHMP-opinie september 2020.

Therapeutic value

Current treatment options Chemotherapie en best ondersteunde zorg.
Therapeutic value Possible added value
Substantiation In de fase III studie IMbrave150 werden statistisch significante waarden voor progressievrije survival (PFS) en overall overleving (OS) gevonden. Er wordt verwacht dat op basis van de resultaten deze behandeling mogelijk standaardzorg zal worden.
Frequency of administration 1 times every 3 weeks
Dosage per administration 1.200 mg
References Fabrikant; NCT03434379.

Expected patient volume per year

Patient volume

50 - 100

Market share is generally not included unless otherwise stated.
References NKR
Additional remarks NKR 2016: 158 patiënten met HCC stadium 4. De werkgroep verwacht dat hier van 50-100 patiënten voor deze behandeling in aanmerking komen.

Expected cost per patient per year

Cost 30,000.00 - 50,000.00
Additional remarks Afhankelijk van behandelduur. Deze is op dit moment onbekend. Om die reden op basis van andere indicaties van atezolizumab de inschatting gemaakt dat deze mogelijk €30.000-€50.000 per patiënt per jaar kan gaan kosten. Voor alle indicaties van atezolizumab geldt een financieel arrangement die is voortgekomen uit de onderhandelingen in de sluis (lopend tot en met 31 december 2020).

Potential total cost per year

Total cost

3,000,000.00

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

There is currently nothing known about off label use.

Indication extension

Indication extension Yes
Indication extensions Zie indicatie uitbreidingen in de Horizonscan op het gebied van: huidkanker, longkanker, leverkanker, blaaskanker en borstkanker.
References Fabrikant en Horizonscan

Other information

There is currently no futher information available.