Alirocumab Medicine 12 June 2018 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 IND 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. Current proprietary name Already available biosimilars / generics Proprietary name Praluent Manufacturer Sanofi Portfolio holder Mechanism of action Enzyme inhibitor Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Extramural (GVS) Centre of expertise Additional remarks PCSK9 remmer Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date June 2018 Expected Registration March 2019 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice 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 This assessment does not indicate any potential inclusion in the package. 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 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. Maximum patient volume for sluice 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 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. References Medicijnkosten.nl; fabrikant Additional remarks Potential total cost per year Total cost € 90,630,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions References Additional remarks Other information Additional remarks