Lutetium (177Lu) oxodotreotide

Extended indication	Lutathera is geïndiceerd voor de behandeling van niet-resecteerbare of gemetastaseerde, progressieve, goed gedifferentieerde (G1 en G2), somatostatinereceptor-positieve gastro-entero-pancreatische neuroendocriene tumoren (GEP-NET's) bij volwassenen.
Therapeutic value	Possible added value
Total cost	33,117,000.00
Registration phase	Registered and reimbursed

Product

Active substance	Lutetium (177Lu) oxodotreotide
Domain	Oncology and Hematology
Reason of inclusion	New medicine (specialité)
Main indication	Neuroendocrine cancer
Extended indication	Lutathera is geïndiceerd voor de behandeling van niet-resecteerbare of gemetastaseerde, progressieve, goed gedifferentieerde (G1 en G2), somatostatinereceptor-positieve gastro-entero-pancreatische neuroendocriene tumoren (GEP-NET's) bij volwassenen.
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.

Registration

Registration route	Centralised (EMA)
Type of trajectory	Accelerated assessment
Submission date	April 2016
Expected Registration	September 2017
Orphan drug	Yes
Registration phase	Registered and reimbursed
Additional remarks	Gergistreerd in september 2017. Opgenomen als add-ongeneesmiddel in juli 2018.

Therapeutic value

Current treatment options	Wordt nu magistraal door ziekenhuizen (2 in Nederland) zelf bereid. Substitutie met Sunitinib en Everolimus.
Therapeutic value	Possible added value
Duration of treatment	Average 24 week / weeks
Frequency of administration	1 times every 8 weeks
Dosage per administration	7.400 MBq
References	EPAR
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.

Expected patient volume per year

Patient volume	< 399 Market share is generally not included unless otherwise stated.
References	NKR
Additional remarks	NKR 2015: 399 neuroendocriene tumoren stadium 4

Patient volume

< 399

Market share is generally not included unless otherwise stated.

References

NKR

Additional remarks

NKR 2015: 399 neuroendocriene tumoren stadium 4

Expected cost per patient per year

Cost	83,000.00
References	G-standaard, SmPC
Additional remarks	Lutathera infusievloeistof 370 MBq/ml flacon 20,5-25ml kost €20.742,91. Eén flacon is voldoende voor een eenmalige toediening van 4.700 MBq. Bij 4 toedieningen zijn de totale kosten €82.971,64.

Potential total cost per year

Total cost	33,117,000.00 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

33,117,000.00

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

Other information

There is currently no futher information available.