Bempedoic acid / ezetimibe

Extended indication	Extension of indication to include treatment of adults with established or at high risk for atherosclerotic cardiovascular disease to reduce cardiovascular risk.
Therapeutic value	No estimate possible yet
Total cost	111,663,200.00
Registration phase	Registered and reimbursed

Product

Active substance	Bempedoic acid / ezetimibe
Domain	Cardiovascular diseases
Reason of inclusion	Indication extension
Main indication	Other medication for cardiovascular diseases
Extended indication	Extension of indication to include treatment of adults with established or at high risk for atherosclerotic cardiovascular disease to reduce cardiovascular risk.
Proprietary name	Nustendi
Manufacturer	Esperion
Portfolio holder	Daiichi Sankyo
Mechanism of action	Other
Route of administration	Oral
Therapeutical formulation	Film-coated tablet
Budgetting framework	Extramural (GVS)
Additional remarks	Esperion is een samenwerking gestart met Daiichi Sankyo voor het in de handel brengen van bempedoic acid. "First-in-class, small-molecule compound with a dual mechanism of action, inhibiting ATP citrate (pro-S)-lyase and stimulating AMP-activated protein kinase (AMPK). This inhibits fatty acid and cholesterol synthesis, and enhanced fatty acid oxidation."

Registration

Registration route	Centralised (EMA)
Type of trajectory	Normal trajectory
ATMP	No
Submission date	August 2023
Expected Registration	May 2024
Orphan drug	No
Registration phase	Registered and reimbursed
Additional remarks	Positieve CHMP-opinie maart 2024

Therapeutic value

Current treatment options	Losse tabletten bempedoinezuur en ezetimibe
Therapeutic value	No estimate possible yet
Substantiation	De meerwaarde van deze combinatietherapie hangt af van de uiteindelijke prijs. De prijs van een jaarlijkse behandeling met losse tabletten bempedoinezuur en ezetimibe kan rond de € 730 kosten (2). Als de prijs van dit middel gelijk of lager wordt kan er een meerwaarde zijn in toedieningsgemak en naleving van de behandeling.
Frequency of administration	1 times a day
References	NCT02993406 (1); Medicijnkosten.nl (2)

Expected patient volume per year

Patient volume	< 139,579 Market share is generally not included unless otherwise stated.
References	GIP databank; GVS advies bempedoïnezuur
Additional remarks	Er zullen ongeveer 139.000 patiënten in aanmerking komen.

Patient volume

< 139,579

Market share is generally not included unless otherwise stated.

References

GIP databank; GVS advies bempedoïnezuur

Additional remarks

Er zullen ongeveer 139.000 patiënten in aanmerking komen.

Expected cost per patient per year

Cost	600.00 - 1,000.00
References	Fabrikant
Additional remarks	De prijs van de PCSK9 antilichamen liggen rond de €6.000 per patiënt per jaar (niet rekening gehouden met het financieel arrangement). Het betreft hier een small molecule dat oraal beschikbaar is (tablet). De verwachting is dat de kosten veel lager zullen zijn dan de PCSK9 antilichamen. De fabrikant geeft aan een prijs van €600 tot €1.000 te verwachten. Dit is nog niet definitief.

Potential total cost per year

Total cost	111,663,200.00 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

111,663,200.00

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.