Alirocumab

Active substance Alirocumab
Domain Cardiovascular diseases
Reason of inclusion in Horizonscan Geneesmiddelen 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.

Product

Proprietary name Praluent
Manufacturer Sanofi
Mechanism of action Enzyme inhibitor
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Extramural (GVS)
Additional comments 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 comments 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
Duration of treatment Not found
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 comments 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 comments 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
References Medicijnkosten.nl; fabrikant

Potential total cost per year

Total cost

90,630,000

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.