Extended indication Extension of indication to include treatment of adults with established or at high risk for atherosc
Therapeutic value No estimate possible yet
Total cost 111,663,200.00
Registration phase Positive CHMP opinion

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 Positive CHMP opinion
Additional remarks Positieve CHMP-opinie maart 2024

Therapeutic value

Therapeutic value No estimate possible yet
References NCT02993406

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.

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.

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.