Extended indication

Extension of indication to include IMFINZI in combination with tremelimumab for the treatment of ad

Therapeutic value

Possibly no place in the treatment regimen

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

Possibly no place in the treatment regimen

Substantiation

HIMALAYA studiedata ASCO GI 2022; De algehele overleving in de studie is waarschijnlijk niet voldoende om de PASKWIL criteria van cieBOM te halen. (hazard ratio [HR], 0,78; 96% confidence interval [CI], 0.65–0.92; p=0,0035; Table). Delta = 2,6 maanden.

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.