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.

1. 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

2. 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.

3. 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

4. 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.

5. 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.

6. 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.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

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

9. Other information

There is currently no futher information available.