Alirocumab

Extended indication	Indicated in adults with established atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors: • in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or, • alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.
Therapeutic value	No judgement yet
Total cost	90,630,000.00
Registration phase	Registered and reimbursed

Product

Active substance	Alirocumab
Domain	Cardiovascular diseases
Reason of inclusion	Indication extension
Main indication	Lipid-lowering medications
Extended indication	Indicated in adults with established atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors: • in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or, • alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.
Proprietary name	Praluent
Manufacturer	Sanofi
Mechanism of action	Enzyme inhibitor
Route of administration	Subcutaneous
Therapeutical formulation	Injection
Budgetting framework	Extramural (GVS)
Additional remarks	PCSK9 remmer

Registration

Registration route	Centralised (EMA)
Type of trajectory	Normal trajectory
Submission date	June 2018
Expected Registration	March 2019
Orphan drug	No
Registration phase	Registered and reimbursed
Additional remarks	Positieve CHMP-opinie in januari 2019. Een vergelijkbare indicatieuitbreiding van evolocumab wordt niet vergoed vanuit het basispakket. Het is dus nog onzeker of deze indicatieuitbreiding wel zal worden vergoed.

Therapeutic value

Current treatment options	Statines en/of ezetimibe
Therapeutic value	No judgement yet
Substantiation	ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab https://clinicaltrials.gov/ct2/show/NCT01663402 N Engl J Med 2018; 379:2097-2107
Frequency of administration	1 times every 2 weeks
Dosage per administration	75 mg of 150 mg subcutaan
References	N Engl J Med 2018; 379:2097-2107
Additional remarks	Primary endpoint MACE (composite of death from coronary heart disease, nonfatal myocardial infarction, fatal or nonfatal ischemic stroke, or unstable angina requiring hospitalization) 11.1% (placebo) vs 9.5% (alirocumab) P<0.001, median follow-up 2.8 jaar

Expected patient volume per year

Patient volume	8,800 - 23,000 Market share is generally not included unless otherwise stated.
Expected market share	100
References	Evolocumab record
Additional remarks	Uitgaande van 1% (op basis van PHARMO analyse) van totaal aantal patiënten dat cholesterolverlagende medicatie gebruikt. Niet alle patiënten die in aanmerking komen krijgen alirocumab, aangezien er ook een andere PCSK9-remmer is die toegepast kan worden voor patiënten die nu voor vergoeding in aanmerking komen (50% evolocumab).

Expected cost per patient per year

Cost	< 5,700.00
References	Medicijnkosten.nl; fabrikant

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.

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.