Lerodalcibep

Extended indication	Heterozygous Familial Hypercholesterolemia
Therapeutic value	No estimate possible yet
Total cost	288,000,000.00
Registration phase	Clinical trials

Product

Active substance	Lerodalcibep
Domain	Cardiovascular diseases
Reason of inclusion	Indication extension
Main indication	Lipid-lowering medications
Extended indication	Heterozygous Familial Hypercholesterolemia
Manufacturer	LIB Therapeutics
Route of administration	Subcutaneous
Therapeutical formulation	Injection
Budgetting framework	Extramural (GVS)
Additional remarks	PCSK9-remmer.

Registration

Registration route	Centralised (EMA)
ATMP	No
Submission date	2025
Expected Registration	2026
Orphan drug	No
Registration phase	Clinical trials
Additional remarks	Primary completion datum fase 3 studie in juli 2023.

Therapeutic value

Therapeutic value	No estimate possible yet
Duration of treatment	continuous
Frequency of administration	1 times every 4 weeks
Dosage per administration	300 mg (1,2 mL)
References	NCT04797104 (LIB003-004, LIBerate-FH)

Expected patient volume per year

Patient volume	72,000 Market share is generally not included unless otherwise stated.
References	Fabrikant; Santos RD, Ruzza A, Hovingh GK, et al. Evolocumab in Pediatric Heterozygous Familial Hypercholesterolemia. N Engl J Med 2020; 383:1317-1327.
Additional remarks	De prevalentie van heterozygote FH is naar schatting één op de 250 personen in de algemene bevolking. Dit zou voor Nederland betekenen dat er mogelijk 72.000 patiënten in aanmerking zullen komen.

Patient volume

72,000

Market share is generally not included unless otherwise stated.

References

Fabrikant; Santos RD, Ruzza A, Hovingh GK, et al. Evolocumab in Pediatric Heterozygous Familial Hypercholesterolemia. N Engl J Med 2020; 383:1317-1327.

Additional remarks

De prevalentie van heterozygote FH is naar schatting één op de 250 personen in de algemene bevolking. Dit zou voor Nederland betekenen dat er mogelijk 72.000 patiënten in aanmerking zullen komen.

Expected cost per patient per year

Cost	4,000.00
Additional remarks	Indien de kosten vergelijkbaar zijn met concurrent evolocumab (ook een PCSK9 protein inhibitor) zullen de kosten mogelijk rond de €4.000 per patiënt per jaar bedragen.

Potential total cost per year

Total cost	288,000,000.00 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

288,000,000.00

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.