Extended indication Extension of indication to include IMFINZI in combination with tremelimumab for the treatment of ad
Therapeutic value No estimate possible yet
Total cost 4,387,500.00
Registration phase Registration application pending

Product

Active substance Durvalumab
Domain Oncology
Reason of inclusion Indication extension
Main indication Liver cancer
Extended indication Extension of indication to include IMFINZI in combination with tremelimumab for the treatment of adults with unresectable hepatocellular carcinoma (uHCC).
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 April 2023
Orphan drug No
Registration phase Registration application pending
Additional comments 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

Cost 45,000.00 - 90,000.00
Additional comments De dosis durvalumab is 1.500mg elke 4 weken tot ziekteprogressie. Prijs per toediening is dan (3 x €2.328)=€6.984. Voor 6 maanden is dit 26/4 x €6.984 = €45.396; voor 52 weken is dit 52/4x €6.984 = €90.792. In de studie wordt durvalumab onderzocht als monotherapie en in combinatie met tremelimumab. Afhankelijk van de behandelduur zal de prijs per jaar tussen de €45.000-€90.000 bedragen uitgaande van 6 of 12 maanden behandeling. Deze kosten betreffen alleen durvalumab.

Potential total cost per year

Total cost

4,387,500.00

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.