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.