Extended indication

In combination with tremelimumab in patients with HCC not eligible for locoregional therapy (1L).

Therapeutic value

No estimate possible yet

Registration phase

Clinical trials

Product

Active substance

Durvalumab

Domain

Oncology and Hematology

Reason of inclusion

Indication extension

Main indication

Liver cancer

Extended indication

In combination with tremelimumab in patients with HCC not eligible for locoregional therapy (1L).

Proprietary name

imfinzi

Manufacturer

AstraZeneca

Mechanism of action

PD-1 / PD-L1 inhibitor

Route of administration

Intravenous

Therapeutical formulation

Intravenous drip

Budgetting framework

Intermural (MSZ)

Additional comments
PD-L1 mAb + CTLA-4 mAB.

Registration

Registration route

Centralised (EMA)

Submission date

April 2022

Expected Registration

February 2023

Orphan drug

No

Registration phase

Clinical trials

Additional comments
Fabrikant geeft aan indiening in de eerste helft van 2022. Voor durvalumab geldt tot eind 2023 een financieel arrangement voor oncologische indicaties.

Therapeutic value

Current treatment options

Sorafenib, lenvatinib.

Therapeutic value

No estimate possible yet

Substantiation

De resultaten van de fase 2 studie waren positief. De fase 3 studie (HIMALAYA) loopt nog op dit moment. De verwachting is dat er substitutie plaats zal vinden voor sorafenib en lenvatinib.

Frequency of administration

1 times every 4 weeks

Dosage per administration

1500 mg durvalumab + 300 mg tremelimumab 1x

References
HIMALAYA (NCT03298451).
Additional comments
Barcelona Clinic Liver Cancer stage B not eligible for locoregional therapy or stage C, and Child-Pugh A classification liver disease.

Expected patient volume per year

Patient volume

< 65

Market share is generally not included unless otherwise stated.

References
NKR
Additional comments
In 2016 waren er 110 stadium II en 132 stadium III patiënten met een hepatocellulair carcinoom. In totaal zullen er maximaal 142 patiënten in aanmerking komen voor behandeling. De verwachting is dat patiënten die op dit moment sorafenib/lenvatinib ontvangen mogelijk zullen overstappen. In 2019 waren er 65 patiënten die met sorafenib/lenvatinib behandeld werden.

Expected cost per patient per year

References
Fabrikant
Additional comments
Tremelimumab  prijs is onbekend. Imfinzi kost €2.328 per 500mg. De prijs per mg is dus €4,66. De kosten van een 1.500mg dosis zijn dus €6.984.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.