Lutetium (177Lu) edotreotide

Extended indication	Lutetium (177Lu) edotreotide monotherapy for first line treatment of inoperable, progressive grade 1 and 2, somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumour disease in adults and elderly.
Therapeutic value	No estimate possible yet
Total cost	45,186,120.00
Registration phase	Clinical trials

Product

Active substance	Lutetium (177Lu) edotreotide
Domain	Oncology
Reason of inclusion	New medicine (specialité)
Main indication	Neuroendocrine cancer
Extended indication	Lutetium (177Lu) edotreotide monotherapy for first line treatment of inoperable, progressive grade 1 and 2, somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumour disease in adults and elderly.
Manufacturer	ITM
Mechanism of action	Other, see general comments
Route of administration	Intravenous
Therapeutical formulation	Intravenous drip
Budgetting framework	Intermural (MSZ)
Additional remarks	Lutetium (177Lu) edotreotide is een radioconjugaat dat bestaat uit edotreotide gelabeld met lutetium-177. Lutetium (177Lu) edotreotide bindt aan somatostatinereceptoren (SSTRs), met hoge affiniteit voor type 2 SSTR, dat aanwezig is op de celmembranen van veel typen neuro-endocriene tumorcellen. Na binding en internalisatie levert dit radioconjugaat specifiek een cytotoxische dosis bètastraling aan SSTR-positieve cellen.

Registration

Registration route	Centralised (EMA)
Type of trajectory	Normal trajectory
ATMP	No
Submission date	March 2025
Expected Registration	April 2026
Orphan drug	Yes
Registration phase	Clinical trials
Additional remarks	Verwachte indiening op basis van primary completion datum in december 2024.

Therapeutic value

Therapeutic value	No estimate possible yet
Duration of treatment	Average 1 year / years
Frequency of administration	1 times every 3 months
Dosage per administration	7,5 ± 0,7 GBq
References	NCT03049189 (COMPETE)
Additional remarks	Maximaal 4 cycli van 7,5 ± 0,7 GBq (gigabequerel) 177Lu-edotreotide.

Expected patient volume per year

Patient volume	< 516 Market share is generally not included unless otherwise stated.
References	NKR 2022 (1); Das & Dasari. Curr Oncol Rep. 2021 (2); Fazio & Milione. The Oncologist. 2017 (3).
Additional remarks	Jaarlijks krijgen in Nederland ruim 900 mensen een neuro-endocriene tumor (NET) (1). 55-70% van NETs zijn gastro-enteropancreatische NETs (GEP-NETs) (2). 82% van GEP-NETs zijn graad 1 of 2 (3). Het is niet bekend hoeveel graad 1 of 2 GEP-NETs inoperabel zijn.

Patient volume

< 516

Market share is generally not included unless otherwise stated.

References

NKR 2022 (1); Das & Dasari. Curr Oncol Rep. 2021 (2); Fazio & Milione. The Oncologist. 2017 (3).

Additional remarks

Jaarlijks krijgen in Nederland ruim 900 mensen een neuro-endocriene tumor (NET) (1). 55-70% van NETs zijn gastro-enteropancreatische NETs (GEP-NETs) (2). 82% van GEP-NETs zijn graad 1 of 2 (3). Het is niet bekend hoeveel graad 1 of 2 GEP-NETs inoperabel zijn.

Expected cost per patient per year

Cost	87,570.00
Additional remarks	De kosten zullen mogelijk vergelijkbaar zijn met pluvicto €87.570 per patiënt per jaar.

Potential total cost per year

Total cost	45,186,120.00 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

45,186,120.00

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.