Durvalumab

Extended indication	Extension of indication to include IMFINZI in combination with cisplatin-based chemotherapy as neoadjuvant treatment, followed by IMFINZI as monotherapy adjuvant treatment after radical cystectomy, for the treatment of adults with muscle invasive bladder cancer (MIBC)
Therapeutic value	No estimate possible yet
Total cost	14,666,400.00
Registration phase	Clinical trials

Product

Active substance	Durvalumab
Domain	Oncology
Reason of inclusion	Indication extension
Main indication	Bladder cancer
Extended indication	Extension of indication to include IMFINZI in combination with cisplatin-based chemotherapy as neoadjuvant treatment, followed by IMFINZI as monotherapy adjuvant treatment after radical cystectomy, for the treatment of adults with muscle invasive bladder cancer (MIBC)
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 remarks	PD-L1 remmer

Registration

Registration route	Centralised (EMA)
Type of trajectory	Normal trajectory
ATMP	No
Submission date	2025
Expected Registration	2026
Orphan drug	Yes
Registration phase	Clinical trials

Therapeutic value

Current treatment options	Chemotherapie en immuuntherapie
Therapeutic value	No estimate possible yet
Frequency of administration	1 times every 4 weeks
Dosage per administration	1500 mg
References	NCT03732677 (NIAGARA)
Additional remarks	Neo-adjuvant 4 cycli, adjuvant q4w 8 cycli.

Expected patient volume per year

Patient volume	150 - 200 Market share is generally not included unless otherwise stated.
References	IKNL 2021; Fabrikant; experts werkgroepen
Additional remarks	In 2021 waren er 459 diagnoses blaaskanker stadium 4. Fabrikant geeft aan dat het realistische patiëntvolume 412 patiënten bedraagt. De experts verwachten vergelijkbare patiëntvolumes zoals bij pembrolizumab met dezelfde indicatie, te weten 150 tot 200 patiënten.

Patient volume

150 - 200

Market share is generally not included unless otherwise stated.

References

IKNL 2021; Fabrikant; experts werkgroepen

Additional remarks

In 2021 waren er 459 diagnoses blaaskanker stadium 4. Fabrikant geeft aan dat het realistische patiëntvolume 412 patiënten bedraagt. De experts verwachten vergelijkbare patiëntvolumes zoals bij pembrolizumab met dezelfde indicatie, te weten 150 tot 200 patiënten.

Expected cost per patient per year

Cost	83,808.00
References	fabrikant; G-standaard https://www.annalsofoncology.org/action/showPdf?pii=S0923-7534%2824%2903907-3
Additional remarks	Dosering neo-adjuvant betreft 1.500mg IV Q3W (in combi met cis-gem) voor 4 cycles gevolgd door adjuvant 1.500mg IV Q4W voor 8 cycles dus 4+8=12 cycles (1 flacon durvalumab is 500ml dus per cycle 3 flacons = €6.984 12 cycles is dan €83.808 (op basis van apothekersinkoopprijs).

Cost

83,808.00

References

fabrikant; G-standaard
https://www.annalsofoncology.org/action/showPdf?pii=S0923-7534%2824%2903907-3

Additional remarks

Dosering neo-adjuvant betreft 1.500mg IV Q3W (in combi met cis-gem) voor 4 cycles gevolgd door adjuvant 1.500mg IV Q4W voor 8 cycles  dus 4+8=12 cycles (1 flacon durvalumab is 500ml dus per cycle 3 flacons = €6.984 
12 cycles is dan €83.808 (op basis van apothekersinkoopprijs).

Potential total cost per year

Total cost	14,666,400.00 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.

Total cost

14,666,400.00

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

Off label use	No

Indication extension

Indication extension	Yes
Indication extensions	Buiten de indicaties in de Horizonscan Geneesmiddelen voor meerdere indicaties in ontwikkeling: Biliary cancer; Cervical cancer; Fallopian tube cancer; Head and neck cancer; Liver cancer; Ovarian cancer; Peritoneal cancer; Renal cell carcinoma; Solid tumours.
References	adisinsight
Additional remarks	Fase 3

Other information

There is currently no futher information available.