L-lysine / L-arginine

Active substance L-lysine / L-arginine
Domain Oncology and Hematology
Reason of inclusion in Horizonscan Geneesmiddelen New medicine (specialité)
Main indication Neuroendocrine cancer
Extended indication Reduction of renal radiation exposure during peptide-receptor radionuclide therapy (PRRT) with lutetium (177Lu) oxodotreotide in adults.

Product

Proprietary name Lysakare
Manufacturer Advanced Accelerator Applications
Mechanism of action Amino acid
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional comments Advanced Accelerator Applications

Registration

Registration route Centralised (EMA)
Particularity New therapeutical formulation
Submission date July 2018
Expected Registration July 2019
Orphan drug No
Registration phase Registered
Additional comments Positieve CHMP-opinie mei 2019. Geregistreerd in juli 2019.

Therapeutic value

Current treatment options Geen, het is een extra behandeloptie bij Lu-177 dotatate om de nieren te beschermen
Therapeutic value No judgement
Substantiation Mogelijke meerwaarde in latere lijns behandeling
Duration of treatment Average 24 week / weeks
Frequency of administration 1 times every 8 weeks
References http://www.ascopost.com/issues/march-10-2018/lutetium-lu-177-dotatate-in-gastroenteropancreatic-neuroendocrine-tumors/
Additional comments 30 minuten voor de behandeling met Lu-177 dotatate dient L-lysine / L-arginine te worden gegeven

Expected patient volume per year

Patient volume

< 399

Market share is generally not included unless otherwise stated.

References NKR
Additional comments NKR 2015: 399 neuroendocriene tumoren stadium 4.

Expected cost per patient per year

Cost 600
References Fabrikant
Additional comments €150 euro per 1.000 ml. Een behandeling is bestaat uit 4 toedieningen, in totaal dus €600 per patiënt per jaar. De fabrikant overweegt bij bestelling van Lutathera Lysakare gratis bij te leveren.

Potential total cost per year

Total cost

239,400

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 Yes
Indication extensions Mogelijk uitbreiding naar prostaatkanker indien Lutathera ook naar deze indicatie wordt uitgebreid.

Other information

There is currently no futher information available.