Extended indication

Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer.

Therapeutic value

No estimate possible yet

Total cost

25,980,480.00

Registration phase

Clinical trials

Product

Active substance

Durvalumab

Domain

Oncology and Hematology

Reason of inclusion

Indication extension

Main indication

Oncology other

Extended indication

Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer.

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)

Registration

Registration route

Centralised (EMA)

Type of trajectory

Normal trajectory

ATMP

No

Submission date

2022

Expected Registration

2023

Orphan drug

No

Registration phase

Clinical trials

Additional comments
Fabrikant verwacht indiening in het tweede kwartaal van 2022 en registratie in het tweede kwartaal van 2023. Voor durvalumab geldt tot eind 2023 een financieel arrangement voor oncologische indicaties.

Therapeutic value

Current treatment options

Chemotherapie

Therapeutic value

No estimate possible yet

Substantiation

Er zijn nog geen resultaten van de TOPAZ-1 studie bekend.

Frequency of administration

1 times every 3 weeks

Dosage per administration

1500mg

References
NCT03875235 (TOPAZ-1).
Additional comments
Behandelduur tot progressie. Toedieningsfrequentie 8 cycli van 3 weken met chemotherapie, daarna om de 4 weken.

Expected patient volume per year

Patient volume

< 248

Market share is generally not included unless otherwise stated.

References
NKR
Additional comments
Er zijn ongeveer 700 patiënten in Nederland gediagnosticeerd met een cholangiocarcinoom. Hiervan zijn er 248 patiënten met een stadium 4 carcinoom.

Expected cost per patient per year

Cost

104,760.00

Additional comments
De fabrikant geeft aan dat de prijs nog niet bekend is. Inschatting: De dosis durvalumab is 1.500mg. Toedieningsfrequentie 8 cycli van 3 weken met chemotherapie, daarna 1x per 4 weken. Prijs per toediening is dan (3 x €2.328)=€6.984. Aantal toedieningen 8 + 7 * €6.984 = €104.760 per jaar.

Potential total cost per year

Total cost

25,980,480.00

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

No

References
Fabrikant

Other information

There is currently no futher information available.