Extended indication preventie hart-en vaatziekten (exacte populaties niet bekend)
Therapeutic value Possible added value
Total cost 90,630,000.00
Registration phase Clinical trials

Product

Active substance Alirocumab
Domain Cardiovascular diseases
Main indication Lipid-lowering medications
Extended indication preventie hart-en vaatziekten (exacte populaties niet bekend)
Proprietary name Praluent
Manufacturer Sanofi
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Extramural (GVS)
Additional remarks PCSK9 remmer

Registration

Registration route Centralised (EMA)
Particularity Indication extension
Expected Registration 2019
Registration phase Clinical trials

Therapeutic value

Current treatment options statins en/of ezetimibe
Therapeutic value Possible added value
Substantiation ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab https://clinicaltrials.gov/ct2/show/NCT01663402 gepresenteerd op ACC 2018
Frequency of administration 1 times every 2 weeks
Dosage per administration 75 mg of 150 mg subcutaan

Expected patient volume per year

Patient volume

8,800 - 23,000

Market share is generally not included unless otherwise stated.

References Uitbreiding vergoeding voor patiƫnten met 1 cardiovasculair event en niet behalen streefwaarde ondanks maximaal verdraagbare dosering van huidige medicatie (statine en/of ezetimibe) de LDL-streefwaarde niet bereikt wordt. Is binnen huidige geregistreerde indicatie.

Expected cost per patient per year

Cost < 5,700.00
References Medicijnkosten.nl; fabrikant
Additional remarks Er is een financieel arrangement aangegaan met het ministerie van VWS.

Potential total cost per year

Total cost

90,630,000.00

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

Indication extension Yes

Other information

There is currently no futher information available.