Expand all sections

Lutetium (177Lu) oxodotreotide

Lutathera

Extended indication Lutetium (177lu) oxodotreotide in combination with long-acting octreotide for first line treatment o
Therapeutic value No estimate possible yet
Total cost 6,614,237.50
Registration phase Registration application pending

Product

Active substance Lutetium (177Lu) oxodotreotide
Domain Oncology
Reason of inclusion Indication extension
Main indication Neuroendocrine cancer
Extended indication Lutetium (177lu) oxodotreotide in combination with long-acting octreotide for first line treatment of metastasized or locally advanced, inoperable, well differentiated Grade 2 or Grade 3 somatostatin receptor-expressing gastroenteropancreatic neuroendocrine tumour disease in adolescents over 15 years of age, adults and elderly
Proprietary name Lutathera
Manufacturer Novartis
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks Lutathera is a radiolabeled somatostatin analog that selectively targets somatostatin receptors which are over-expressed in some tumour types. Aanvankelijk geproduceerd door Advanced Accelerator Applications (AAA), overgenomen door Novartis. Dit is de indicatieuitbreiding in combinatie met long-acting octreotide.

Registration

Registration route Centralised (EMA)
ATMP No
Submission date June 2024
Expected Registration July 2025
Orphan drug Yes
Registration phase Registration application pending
Additional remarks EMA-indiening in juni 2024. Fabrikant verwacht registratie in juli 2025.

Therapeutic value

Therapeutic value No estimate possible yet
Duration of treatment Average 24 week / weeks
Frequency of administration 1 times every 8 weeks
Dosage per administration 7.400 MBq
References Horizonscan record Lutetium (177Lu) oxodotreotide. 2018 (1); NCT03972488 (NETTER-2) (2).
Additional remarks Het aanbevolen behandelingsschema voor Lutathera bij volwassenen bestaat uit 4 infusies van elk 7.400 MBq. Het aanbevolen interval tussen elke toediening is 8 weken, hetgeen kan worden verlengd tot 16 weken in geval van toxiciteit waarvoor de dosis moet worden aangepast (1).

Expected patient volume per year

Patient volume

74 - 95

Market share is generally not included unless otherwise stated.
References NKR 2022 (1); Fazio & Milione. The Oncologist. 2017 (2); Das & Dasari. Curr Oncol Rep. 2021 (3).
Additional remarks Jaarlijks krijgen in Nederland ruim 900 mensen een neuro-endocrine tumor (NET) (1). Deze indicatieuitbreiding is voorlopig voor de toevoeging van graad 3 tumoren aan het label. 18% van NETs zijn graad 3 (2). 55-70% van NETs zijn gastro-entero-pancreatische NETs (3).

Expected cost per patient per year

Cost 78,275.00
References Fabrikant (1); SmPC (2)
Additional remarks De huidige AIP van Lutathera infusievloeistof 370MBq/ml flacon 20,5-25ml is €19.568,78 (1). Eén flacon is voldoende voor een eenmalige toediening van 7.400MBq (2). Bij vier toedieningen zijn de totale kosten €78.275.

Potential total cost per year

Total cost

6,614,237.50

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

Other information

There is currently no futher information available.